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Engelberg Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

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Page 1: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 2: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

PATIENT MEDICATION INFORMATION

Bryon M. Pearsall, JD, RPh Division Director, Division of Medical Policy Programs Office of Medical Policy Initiatives Center for Drug Evaluation and Research

Exploring the Promise of Patient Medication Information The Brookings Institution July 1, 2014

Page 3: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

3

For Today

• Brief History

• Proposed Framework

• Next Steps

Page 4: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

4

History • September 2009: Public workshop on providing effective

information to consumers about drug risks and benefits.

• September 2010: Part 15 Public Hearing on new framework for development and distribution of PMI.

• FDA convened a series of expert meetings and public workshops through a cooperative agreement with the Engelberg Center for Health Care Reform at Brookings:

– Jul 21, 2010: Expert workshop on content and format PMI

– Oct 12, 2010: Public forum to discuss patient access to effective PMI

– Feb 23, 2011: Expert workshop that summarized previous activities and considered pilot studies for PMI distribution

Page 5: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

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Patient Medication Information

• Patient focused document

• Clear, accessible, and actionable information

• Single page

• Consistent and easily understood format

• Provided with outpatient prescription medication

• Intended for use at home

• Not intended to replace patient counseling or instructions for use

Page 6: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

6

PMI Framework

• Development

• Central Repository

• Distribution

• Quality Surveillance

Page 7: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

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Development

• Created by product manufacturer based on content, format, and testing standards

• Format examples – Single page, black ink only, minimum font size (10)

• Content examples – Information based on approved prescribing

information, predefined headings

Page 8: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

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Central Repository

• Single accurate PMI data source

• Open access to patients, health care providers, and pharmacies

• Data standards to control format and content

• Key stakeholder of interest in development: National Library of Medicine

Page 9: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

9

Distribution

Variety of distribution pathways available

• In pharmacy in paper and electronic formats

• Online via email or other electronic method (QR code)

• Sent to patient in electronic health record

Page 10: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

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Quality Surveillance

Potential methods may include:

• Review and approval by FDA

• Content based on approved Prescribing Information

• Consumer focused comprehension testing

Page 11: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

11

PMI Framework

PMI Central

Repository

Manufacturer

(PMI Creator) INPUT

Healthcare Provider

Pharmacy (Primary Distribution)

Direct Patient Access

Patient

(End User)

Development Repository Distribution

Page 12: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

12

Next Steps

• Regulation development

• Central repository development

• Stakeholder outreach and input

Page 13: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 14: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Julie L. Aker, MT(ASCP)

President & CEO

Concentrics Research

Presented to The Brookings Institute

Washington, DC 1 July 2014

14

An Evaluation of Two Novel CMI Formats “Consumers Better Understand and Prefer

Simplified Written Drug Information”

Page 15: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Acknowledgements

• GSK

– Julie Papay, Pharm.D.

– Tom Cantu, Pharm.D.

– Dan Keravich, RPh., MSc., MBA

• Concentrics

– Melissa Beck

– Sara Travis

– Project Management Team

– Staff interviewers and Site team

©2014 Concentrics Research LLC. All rights reserved.

2

Page 16: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

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Objectives and Methodology

Objectives

• Obtain consumer input to

guide creation and

adaptation of a more

patient-friendly PMI

• Evaluate

– Patient preferences on

formatting

– Patient motivation to

read

– Ability to navigate

– Ability to understand

Methodology & Sample

• One-on-one in-depth

interviews

• English-speaking adults,

aged 18 years or older

• Consumers assigned to 1 of

3 drugs and rotated into one

of six groups

• Interviews started

immediately after

participants were provided

with a copy of the prototype

©2014 Concentrics Research LLC. All rights reserved.

Page 17: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

17

“New” Format • Summary information at the top of

the page

– What it is

– What it does

– How to take it

– Possible side effects

• Four major headings of

information with

a corresponding simple icon:

– Important Warnings

– Get Medical Help

– Ask a Doctor

– Follow Directions

©2014 Concentrics Research LLC. All rights reserved.

Page 18: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

18

“Bubble” Format • Included six categories of

information that were outlined by a soft edged box:

• Presented information in chunked bubbles

• Presented by FDA as a possible prototype for further research

Uses Important Warnings

Tell your Doctor

Call your Doctor right away if

Common side effects

Directions for use

©2014 Concentrics Research LLC. All rights reserved.

Page 19: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

19

Current CMI

The “Current” CMI for each medication was

obtained from a large pharmacy chain store

and was provided to participants without

further modification.

©2014 Concentrics Research LLC. All rights reserved.

Page 20: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

20

PMI Distribution

20

105 subjects enrolled

Coumadin (n=37) Low literate (n=7)

New (n=15)

vs. Bubble (n=11) vs. Current (n=4)

Bubble (n=14)

vs. New (n=10) vs. Current (n=4)

Current (n=8)

vs. New (n=4) vs. Bubble (n=4)

Ortho Tri-Cyclen (n=33) Low literate (n=3)

New (n=12)

vs. Bubble (n=8) vs. Current (n=4)

Bubble (n=12)

vs. New (n=8) vs. Current (n=4)

Current (n=9)

vs. New (n=5) vs. Bubble (n=4)

Parnate (n=35) Low literate (n=5)

New (n=14)

vs. Bubble (n=10) vs. Current (n=4)

Bubble (n=14)

vs. New (n=10) vs. Current (n=4)

Current (n=7)

vs. New (n=4) vs. Bubble (n=3)

©2014 Concentrics Research LLC. All rights reserved.

Page 21: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

21

Coumadin

0%

20%

40%

60%

80%

Layout Formatting Content Ordering Ease ofNavigation

Preference Likelihood toread

64% 68%

46%

68% 68%

57%

75%

56% 52%

22%

48%

52% 52%

62%

13% 13%

73%

20%

13%

33%

14%

New

Bubble

Current

©2014 Concentrics Research LLC. All rights reserved.

Page 22: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

22

Ortho Tri-Cyclen

0%

20%

40%

60%

80%

100%

Layout Formatting Content Ordering Ease ofNavigation

Preference

80%

88%

44%

84% 88%

84%

46% 46% 38% 42%

46% 46%

12%

0%

59%

12%

0% 0%

New

Bubble

Current

©2014 Concentrics Research LLC. All rights reserved.

Page 23: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

23

Parnate

0%

20%

40%

60%

80%

100%

Layout Formatting Content Ordering Ease ofNavigation

Preference Likelihood toread

79% 79%

55%

86% 86%

79% 83%

38%

41% 41%

35% 31%

38%

52%

19%

60%

44%

13% 13% 13%

56%

New

Bubble

Current

©2014 Concentrics Research LLC. All rights reserved.

Page 24: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

24

Do simple pictures/icons help? How would you

rate the use of

pictures (or

icons)?

Ortho Tri-

Cyclen Parnate Coumadin

Total Responding: 25 28 30

n % n % n %

The pictures made

it easier to find

information

19 76.0% 22 78.6% 27 90.0%

The pictures made

no difference in

finding information

5 20.0% 5 17.9% 3 10.0%

The pictures made

it more difficult to

find information

1 4.0% 1 3.6% -- --

©2014 Concentrics Research LLC. All rights reserved.

Page 25: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

25

Ability to Understand

Participants

correctly

answered

more

questions

with New and

Bubble PMI

than current

CMI

Asked up to 10 questions relating to specific sections on the PMI.

0

10

20

30

40

50

60

70

80

90

100

Ortho Tri-Cyclen

Parnate Coumadin

New

Bubble

Current

©2014 Concentrics Research LLC. All rights reserved.

Page 26: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

26

Key Findings • Participants prefer PMI

presented in a table

format with icons.

• Format strongly influences

consumers’ propensity to

read PMI.

– A visually inviting

format may motivate

consumers to read and

understand PMI.

• Participants preferred

simple, clear statements

in lay terminology.

©2014 Concentrics Research LLC. All rights reserved.

Page 27: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

27

Key Findings – Need for Flexibility • Elements of patient-friendly PMI should consider the

target population for the drug (e.g., age, gender, medical

conditions, etc.), key warnings with directions on actions

to take, ordering of information, and prominence of

information.

• While certain format and design attributes scored better in

either the “New” or “Bubble” prototypes, it is clear that

some degree of flexibility may be required, based on the

unique warnings with each drug.

• Thus, the ability for some customization of PMI should be

permitted so that key information can be appropriately

highlighted.

©2014 Concentrics Research LLC. All rights reserved.

Page 28: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

28

SUMMARY

©2014 Concentrics Research LLC. All rights reserved.

Page 29: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

29

Creating Engaging PMI: The Next Chapter

• These studies demonstrate the importance and

value of obtaining consumer feedback to adopt

more patient friendly PMI.

• When PMI is presented in a simplified format with

clear directives, patients can efficiently find

information and understand the actions to take.

• These data have been shared with FDA;

evidence continues to be generated & dialogue

continues with FDA as they evaluate all data.

©2014 Concentrics Research LLC. All rights reserved.

Page 30: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

30

Contact Information:

Julie L. Aker

President & CEO

Concentrics Research

[email protected]

1.973.737.7107

THANK YOU!

©2014 Concentrics Research LLC. All rights reserved.

Page 31: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 32: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

32

Improvements in

Patient Labeling

July 1, 2014

Michael S. Wolf, PhD MPH

Professor, Medicine and Learning Sciences

Associate Division Chief - Research

Division of General Internal Medicine

Feinberg School of Medicine

Northwestern University

Page 33: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Overview

• Objective: Share process and results from a new approach to

developing and testing patient labeling

• Partnership between Merck and health literacy experts

– External Health Literacy Leaders (Northwestern & Emory Universities)

• Michael Wolf, PhD, MPH

• Ruth Parker, MD

• Kara Jacobson, MPH

– Cross Divisional Working Team at Merck (established in 2011)

33

• Labeling

• Marketing

• Market Research

• Health Literacy Strategy

• Office of CMO (Chief Medical Officer)

• Legal

• Regulatory

Page 34: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Patient Labeling Pilot

• Purpose

– Demonstrate increased patient understanding and use by optimizing

development and testing of PPI for a type of skin cancer

• Partnership

– Merck identified an opportunity to engage leaders in the field of health

literacy to leverage their expertise to improve patient labeling and

create internal best practices

– Academia recognized an opportunity to put best practices into use in

patient labels used by many patients

34

Page 35: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Patient Labeling Pilot

• Merck’s past approach to patient labeling testing

– Merck included a range of education levels in PPI testing; however,

few respondents presented with limited health literacy

• These individuals are harder to locate and less likely to participate

in research.

• Ensuring the comprehension of the research task and quality of

their responses required application of best practices from the field

of health literacy

– Directionally, limited health literacy respondents had lower

comprehension scores than those with adequate health literacy

35

Page 36: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Process Overview: Patient Labeling

Development and Testing

36

PPI sent to Nationally

Recognized Health Literacy

Experts

• Nationally recognized experts applied health literacy principles to patient labeling

• Patient Label draft approved by sponsor with minimal changes

Externally Conducted Focus

Groups

• Two focus conducted in Chicago and Atlanta

• Patient Label revised and sent to sponsor

Merck Internal Research

• Qualitative research with limited and adequate health literacy respondents (Phase 1 (n=100) & Phase 2 (n=30))

• Labeling revised after each phase with patient input

Page 37: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Draft Patient Label

37 * NOT YET SUBMITTED TO FDA

Page 38: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Draft Patient Label

38

38 * NOT YET SUBMITTED TO FDA

Page 39: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

39

Average Comprehension Test Score: 93%

Well organized and easy to read

Overall Clarity

Rating: 9.2 out of 10

• Easy to understand: What it treats, potential side

effects, and how to store it

• Easy to read: Clear sections, font size, and “just

right” amount of information

• Better than others: Less wordy and less confusing

Results

Final Results: Comprehension Strong,

Patient Labeling Well Received

Limited Health

Literacy

Adequate Health

Literacy

91% 95%

•Strong comprehension by respondents with both

adequate and limited health literacy

Page 40: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Key Learnings

40

• Patient Labeling Research:

– Must include a broad range of respondents across all

health literacy levels

– Must be an iterative process that incorporates patient

feedback at each step

• Partnership between academia and industry is key to

developing patient centric communications

• It is possible to achieve patient labeling that is well

understood by individuals of all health literacy levels

Page 41: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 42: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Exploring the Promise of Patient Medication Information The Brookings Institution July 1, 2014

Experimental Study of Patient Information Prototypes

Murewa Oguntimein, M.H.S., CHES. Social Science Analyst, Division of Medical Policy Programs

Office of Medical Policy Initiatives

Center for Drug Evaluation and Research

Page 43: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Overview

• Purpose of Study

• Prototype Description

• Review of Study Phases and Results

• Conclusion

43

Page 44: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Purpose of Study

• Evaluation of PMI prototypes

– Assess comprehension and readability in individuals with and without chronic health conditions

– Examine the impact on outcomes including perceived risk, comprehension, and behavioral intentions

44

Page 45: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Prototype Development Process

• Reviewed:

– Scientific literature

– Current labeling practices and guidance

– Stakeholder feedback

• Recommendations:

– Use less complex terminology

– Present text in shorter sentences

– Offer more organized or “chunked” text

– Include section headings, bullets, and other design elements

45

Page 46: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Rheutopia

• Fictitious drug

• Description of Rheutopia

– Multiple indications

– Several serious risks (includes boxed warning)

– Administered by injection

46

Page 47: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Bubbles

47

Page 48: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Over The Counter (OTC)

48

Page 49: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Medication Guide

49

Page 50: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Phases

50

Page 51: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Phase 1: Formative Research

Purpose:

• To explore preferences across different versions of the PMI prototypes:

– Format: OTC or Bubbles

– Font: Arial or Times New Roman

– Order of Information: Directions first or Warning first

– Context: With context or No context

51

Page 52: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Phase 1: Formative Research Design

• One-On-One interviews

• English-speaking adults (n=90)

• Three population segments:

– Target medical condition diagnosis

– Chronic condition requiring a non-pill medication (e.g., injectable, inhaler)

– General population

• Recruitment

– Recruited through local rheumatology clinics and focus group facilities

– Over sampled lower literacy individuals

52

Page 53: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Phase 1: Results

• The prototypes were preferred by most participants over the current patient information they receive.

• Participants preferred the Bubbles format over the OTC format

• Participants preferred Arial font over the Times New Roman font

• Findings for Order and Context preference were mixed

53

Page 54: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Phase 2: Main Experiment

Purpose:

• To obtain a large scale quantitative comparison of the PMI prototypes (Bubbles and OTC) to the Medication Guide prototype.

• To determine if any one PMI prototype resulted in:

– Better comprehension of the information

– Increased application of the information

54

Page 55: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Phase 2: Experimental Design

55

Paper Online

Bubbles OTC Control

(Med Guide)

Context No Context Context No Context

Page 56: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Phase 2: Results

56

Variable Comprehension Application

Format ***Bubbles > Med Guide ***OTC > Med Guide

NS

Mode **Print > Online NS

Health literacy *Higher > Lower **Higher > Lower

Illness knowledge *Higher > Lower NS

Age *60-69 yrs. > Under 50 yrs. Other age differences NS

**60-69 yrs. > Under 50 yrs.

Other age differences NS

Race/Ethnicity *Non-Hispanic White> Non-Hispanic Black

Other race/ethnicity differences NS

**Non-Hispanic White> Non-Hispanic Black Other race/ethnicity

differences NS

Gender NS NS

Education NS NS

* Indicates a finding significant at p<.05; ** Indicates findings significant at p<.01; *** Indicates findings significant at p<.001.

Page 57: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Conclusion

• Preference for Bubbles and OTC prototype over currently available patient information.

• Bubbles and OTC prototypes resulted in better comprehension than Medication Guide.

57

Page 58: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Acknowledgements

FDA would like to acknowledge the entire RTI staff for their work and support throughout this project.

58

Page 59: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Contact Information

• Please email any questions concerning PMI to the Office of Medical Policy Initiatives at [email protected]

59

Page 60: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 61: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Designs for PMI: Improving Attention, Comprehension, and Memory

Brookings Institution / July 1, 2014

Ruth S. Day / Duke University

Page 62: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Comprehension, memory, and use

of drug information.

RuthDay

Rx Drug X

Xxxxxxxx

xxxxxxxx

xxxxxxxx

xxxxxxxx

xxxxxxxx

Page 63: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Cognitive Enhanced Cognitive

Analyses Displays Experiments

Basic Approach

Ruth Day

Page 64: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Cognitive Enhanced Cognitive

Analyses Displays Experiments

Basic Approach

--Obtain quantitative measures

--Calculate “cognitive accessibility”

Ruth Day

Page 65: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Cognitive Enhanced Cognitive

Analyses Displays Experiments

Basic Approach

--Obtain quantitative measures

--Calculate “cognitive accessibility”

--Same info

--Based on cognitive principles

Ruth Day

Page 66: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Cognitive Enhanced Cognitive

Analyses Displays Experiments

Basic Approach

Test effects on:

--Attention

--Comprehension

--Memory

--Problem Solving

--Decision Making

--Behavior

--Obtain quantitative measures

--Calculate “cognitive accessibility”

--Same info

--Based on cognitive principles

Ruth Day

Page 67: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Cognitive Enhanced Cognitive

Analyses Displays Experiments

Basic Approach

Test effects on:

--Attention

--Comprehension

--Memory

--Problem Solving

--Decision Making

--Behavior

Health Outcomes

--Obtain quantitative measures

--Calculate “cognitive accessibility”

--Same info

--Based on cognitive principles

Ruth Day

Page 68: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Cognitive Accessibility

Ruth Day

Page 69: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

The ease with which

Cognitive Accessibility

Ruth Day

Page 70: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

The ease with which

people can information

find

understand

remember

use

Cognitive Accessibility

Ruth Day

Page 71: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

The ease with which

people can information

find

understand

remember

use

in a safe and effective manner.

Cognitive Accessibility

Ruth Day

Page 72: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

The ease with which

people can information

find

understand

remember

use

in a safe and effective manner.

Cognitive IN-Accessibility

Ruth Day

Page 73: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

PMI

Page 74: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

PMI Versions 1 Page

Ruth Day

Page 75: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

FDA

Prototype

(“Bubble”)

PMI Versions

Ruth Day

1 Page

Page 76: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

FDA

Prototype

(“Bubble”)

PMI Versions

Enhanced-1 Enhanced-2

Ruth Day

1 Page

Page 77: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

FDA

Prototype

(“Bubble”)

PMI Versions

Enhanced

--Same info

--Plus cognitive enhancements

Enhanced-1 Enhanced-2

1 Page

Page 78: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Number: >1,400

Patients

Ruth Day

Page 79: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Number: >1,400

Wide Demographics Age: 19-97

Gender: 48%-52% (male-female)

Education: 1st grade – postgrad degree

Occupations:

--unskilled, skilled, clerical, sales, managerial,

professional, retired, unemployed

Geographic Area: 38 states

Patients

Ruth Day

Page 80: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Number: >1,400

Wide Demographics Age: 19-97

Gender: 48%-52% (male-female)

Education: 1st grade – postgrad degree

Occupations:

--unskilled, skilled, clerical, sales, managerial,

professional, retired, unemployed

Geographic Area: 38 states

Patients

42% 58%

Phone Web

Ruth Day

Page 81: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Number: >1,400

Wide Demographics Age: 19-97

Gender: 48%-52% (male-female)

Education: 1st grade – postgrad degree

Occupations:

--unskilled, skilled, clerical, sales, managerial,

professional, retired, unemployed

Geographic Area: 38 states

Patients

42% 58%

Phone Web

lisinopril

Ruth Day

Page 82: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Basic Methods

Ruth Day

Page 83: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Basic Methods

Study Test

time

Ruth Day

Page 84: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Basic Methods

Study Test

time

Ruth Day

A

C

OR

B

Page 85: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Basic Methods

Study Test

time

Ruth Day

A

C

OR

B

Random assignment

of formats to patients

Page 86: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Basic Methods

Study Test

time

All Multiple Content Tasks

Ruth Day

--benefits --risks --directions --etc

--attention

--comprehension

--memory

Page 87: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Basic Methods

Study Test

time

All Multiple Content Tasks

Ruth Day

--attention

--comprehension

--memory

--benefits --risks --directions --etc

Page 88: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

lisinopril

Page 89: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

“Bubble”

Ruth Day

Page 90: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced

Ruth Day

Page 91: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information
Page 92: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Primary + coded data

= > 2,000,000 cells

Therefore….

Page 93: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information
Page 94: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Time

Ruth Day

Page 95: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Time

Fixed Own

Time Time

Ruth Day

Page 96: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Time

Fixed Own

Time Time

How long did they take

to read the PMI?

Ruth Day

Page 97: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Time Own Time Condition

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Prototype Enhanced-1 Enhanced-2

Stu

dy T

ime (

min

)

Ruth Day

Page 98: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Time Own Time Condition

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Prototype Enhanced-1 Enhanced-2

Stu

dy T

ime (

min

)

Ruth Day

Page 99: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Study Time Own Time Condition

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Prototype Enhanced-1 Enhanced-2

Stu

dy T

ime (

min

)

Ruth Day

Page 100: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Medication Name

Ruth Day

Page 101: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Medication Name

“What is the name of this medicine?”

Ruth Day

Page 102: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Medication Name

“What is the name of this medicine?”

Enhanced > Prototype

Ruth Day

Page 103: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Medication Name

“What is the name of this medicine?”

atenolol linsinporil

linsiporil

lipasporin lipersel

lipisoril

Lipitrol lipopril

Liprocil

Listensapril

Lysoprin

lystisol

Enhanced > Prototype

Sample Errors

Ruth Day

Page 104: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

Ruth Day

Page 105: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Multiple cognitive tasks

--attention

--recall

--recognition

--action

--likelihood

Side Effects

Ruth Day

Page 106: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Multiple cognitive tasks

--attention

--recall

--recognition

--action

--likelihood

Levels of knowledge

--surface

--moderate

--deep

Side Effects

Ruth Day

Page 107: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

Ruth Day

Page 108: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

Ruth Day

Page 109: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

Ruth Day

Page 110: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

~100 % >100 %

Ruth Day

Page 111: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

Closed-Book

~100 % >100 %

Ruth Day

Page 112: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

Left = Closed-Book

Right = Open Book

Ruth Day

Page 113: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

Left = Closed-Book

Right = Open Book

Ruth Day

Page 114: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Side Effects

“About how many side effects?”

0

5

10

15

20

Prototype Enhanced-1 Enhanced-2

Nu

mb

er

Esti

mate

d

Left = Closed-Book

Right = Open Book

300 % > 300 %

Ruth Day

Page 115: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

“What are the side effects?”

Ruth Day

Page 116: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Prototype Enhanced-1 Enhanced-2

% C

orr

ect

“What are the side effects?”

Ruth Day

Page 117: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Prototype Enhanced-1 Enhanced-2

% C

orr

ect

Left = Closed Book

Right = Open Book

“What are the side effects?”

300 % 300 %

Ruth Day

Page 118: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Eye Tracking Related

Study

Ruth Day

Page 119: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Eye Tracking

As people read,

--where do they look?

--how long do they spend in specific regions?

--how many times do they re-visit?

--what paths do they take?

Ruth Day

Page 120: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Eye Tracking

As people read,

--where do they look?

--how long do they spend in specific regions?

--how many times do they re-visit?

--what paths do they take?

Do eye movements predict

comprehension & memory? Ruth Day

Page 121: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Heat

Map

First

10-sec

Ruth Day

Page 122: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Next

10-sec

Ruth Day

Page 123: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 124: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 125: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 126: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 127: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 128: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day Ruth Day

Page 129: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 130: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 131: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Ruth Day

Page 132: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Prototype

--Linear (vertical)

--Go all the way through

--Stop or repeat Ruth Day

Page 133: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Design

--Linear (vertical)

--Go all the way through

--Stop or repeat Ruth Day

Page 134: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Design

First

1-sec

Ruth Day

Page 135: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Design

First

1-sec

--Distinctive features

direct eye gaze

immediately

Ruth Day

Page 136: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Design

--Flexible gaze

--Systematic gaze

--Get an overview

--Then focus

--More time on important information

Then

Ruth Day

Page 137: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Design

--Flexible gaze

--Systematic gaze

--Get an overview

--Then focus

--More time on important information

--Compare regions

--Optimize re-visits

--Search

--Form a mental image?! --Can improve cognition

Then

Ruth Day

Page 138: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information
Page 139: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

“If your doctor prescribed a medication for you in the future,

how would you like to get information about it?

Ruth Day

Page 140: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Options

“If your doctor prescribed a medication for you in the future,

how would you like to get information about it?

Get a leaflet printed on paper,

given with the medicine at the pharmacy

Get an internet link to the leaflet,

given at the pharmacy

Do an internet search

on your own

Have the leaflet sent to you by email,

from the pharmacy

Have the leaflet sent to your cell phone,

from the pharmacy. Ruth Day

Page 141: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

“If your doctor prescribed a medication for you in the future,

how would you like to get information about it?

Printed Get a leaflet printed on paper,

given with the medicine at the pharmacy

WebLink Get an internet link to the leaflet,

given at the pharmacy

WebSearch Do an internet search

on your own

Email Have the leaflet sent to you by email,

from the pharmacy

Cell Phone Have the leaflet sent to your cell phone,

from the pharmacy.

Options

Ruth Day

Page 142: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

Ruth Day

Page 143: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

Ruth Day

Page 144: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

Ruth Day

Page 145: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

Age Effect?

Generation Effect?

Mean Age

= 57

Ruth Day

Page 146: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

Ruth Day

Page 147: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

College students

Tech-savvy

Ruth Day

Page 148: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

0

20

40

60

80

100

Patients Young Adults

% Y

es

+ M

ayb

e

Printed

WebLink

WebSearch

Email

Cell Phone

Ruth Day

Page 149: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information
Page 150: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Developed with great care.

Have many positive features.

Ruth Day

Page 151: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Developed with great care.

Have many positive features.

But some drawbacks, too.

--i.e., cognitive accessibility

Ruth Day

Page 152: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Now is a good time to consider: --Key cognitive principles

--Overall spatial design

--how it can direct attention

and facilitate cognition

--Distinctive designs for specific content

--The role of mental images

--in supporting cognition

Ruth Day

Page 153: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Now is a good time to consider: --Key cognitive principles

--Overall spatial design

--how it can direct attention

and facilitate cognition

--Distinctive designs for specific content

--The role of mental images

--in supporting cognition

The evidence presented here

--invites this consideration. Ruth Day

Page 154: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

INFORMATION

Physically

present

Ruth Day

Page 155: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

INFORMATION

Physically Functionally

present absent

Ruth Day

Page 156: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Enhanced Designs for PMI: Improving Attention, Comprehension, and Memory

Brookings Institution / July 1, 2014

Ruth S. Day / Duke University

Page 157: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 158: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Patient Medication

Information

Operational Pilot

Paul Wilson

SVP Health Consumer Insights and Analytics

Page 159: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

PMI Operational Pilot Survey Background

• Adheris Health in conjunction with a large retail chain ran a test of the

PMI for 3 chronic brands

• PMI content developed by Pfizer (Celebrex), GSK (Ventolin HFA) and

Janssen (Prezista)

• Test ran in California and Michigan between 8/6/12 and 9/30/12

• Follow up survey asked 3,200 health consumers

– if they received new PMI

– what they did with the PMI

– if they found the information useful, and

– how they would like to receive newly-formatted PMI in the future

15

9

Page 160: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

16

0

0%

20%

40%

60%

80%

Very useful Somewhat useful Not very useful Not useful at all

63.5%

28.1%

4.5% 3.9%

68.8%

24.7%

4.4% 2.1%

63.8%

29.9%

5.3% 1.0%

% o

f R

espondents

18-40

41-64

65+

Most patients found the information was very useful

After reading the written medication information provided to you with your

[medication] prescription, how useful did you find the information?

Page 161: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

16

1

0%

20%

40%

60%

80%

I would like to have theinformation printed on apiece of paper from my

pharmacy

I would like to haveinformation explained tome by my pharmacist or

doctor

I would like to haveinformation sent to methrough email from mypharmacy or available

online

Other

31.9%

61.7% 60.0%

22.7%

36.2%

65.5%

54.3%

23.3%

39.3%

63.2%

39.2%

19.4%

% o

f R

espo

nd

en

ts 18-40

41-64

65+

Younger patients prefer electronic delivery of the information more than older patients

In the future, how would you prefer to receive the information about

medicines that you obtain from your pharmacy?

(You may choose more than one)

I would like to have

the information

printed on a piece

of paper from my

pharmacy

I would like to have

information

explained to me by

my pharmacist or

doctor

I would like to have

information sent to

me through email

from my pharmacy

or available online

Other

Page 162: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Key Findings

• The pilot executed successfully

• Over 90% of patients recalled receiving the PMI; less than 5% reported they

did not receive it

• Two-thirds of all patients read the information

• New patients are more likely to keep the information than

experienced patients

• Over 90% of patients felt the information was very or somewhat useful

• Over a third of patients preferred written, verbal or digital communication

• Patients aged 65+ preferred written or verbal information but almost 40%

preferred electronic delivery either by email or link to a web-site

16

2

Page 163: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information

Page 164: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Building a PMI Central Repository

Gregory Daniel The Brookings Institution

Page 165: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

The challenge:

Ensuring that patients, consumers, caregivers, providers, and other health care professionals have consistent live

access to Patient Medication Information

Page 166: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

The solution: A central online repository

Patients

Providers

Pharmacies

EHR systems

Third-party vendors

Caregivers

Central Repository

Page 167: Exploring the Promise of Patient Medication … Center for Health Care Reform The Brookings Institution Washington, DC July 1, 2014 Exploring the Promise of Patient Medication Information

Testing the repository:

• Brookings is currently working with pharmacies and electronic health record vendors to explore access to and use of the NLM repository

• Stakeholder groups are asked for their feedback on potential applications of the PMI document within their systems and processes

• A link to prototype PMI for Rheutopia is provided for testing purposes

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Stakeholder feedback:

• In general, stakeholders are supportive of the PMI effort and look forward to exploring how best to use the documents

• The repository should support multiple modes of access – Live, single-document retrieval – Full PMI library download – Active “pushing” through links

• The repository needs to be consistently up-to-date – Mechanisms for communicating updates to stakeholder groups

• “Last updated on” language on website • Email alerts for new or updated documents

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Engelberg Center for Health Care Reform The Brookings Institution

Washington, DC

July 1, 2014

Exploring the Promise of Patient Medication Information