Quality Improvement &Research

•Donna Saxton, MHA, MPH, FACHE

VP, Quality and Safety

•Stephanie Gaudreau, CIP

IRB Administrator

Session Objectives

• Review difference between Quality Assurance and Quality Improvement

• Review definition of research and role of IRB

• Demonstrate the use of exempt research in Quality Improvement

• Provide an overview of the expedited review process

• Share real life experience

Improvement = Managing Variation

• To reduce variation, one must find a new process with a new level of random variation – that is superior to that of the original process

• This is Quality Improvement

Therefore…

•Plan a change (Design a new process)

•Do it in a trial (On a small test group)

•Study the results (Does the new process have a level of performance and/or random variation that is superior to that displayed by the old process?)

•Act (Either implement the test alternative, modify it and test again, or discard it)

The Shewhart PDSA cycle is a simple application of the scientific method

Measurement is Central an Improvement Team’s Ability to Improve

•Measurement in Quality Improvement is to see if change resulted in an improvement

•Teams seek usefulness, not perfection with data sources, indicator of directionality

•Not concerned with statistical “power”, often use loose sampling techniques as well as qualitative data sources

What is Research?

• … a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to “generalizable” knowledge.

Role of the IRB

• The purpose of the IRB is to protect the rights and safety of human subjects.

• The IRB must carefully examine research proposals to arrive at an independent determination that the research will meet certain criteria:

Risks to subjects are minimized.  Risks to subjects are reasonable in relation to anticipated benefits.  Selection of subjects is equitable.  Informed consent is sought from each prospective subject or the subject's

legally authorized representative.  Informed consent is appropriately documented. 

 

Role of the IRB

When appropriate, the research plan makes adequate provision for monitoring the data collected, to ensure the safety of subjects. 

When appropriate, there are adequate provisions to protect the privacy of

subjects, and to maintain the confidentiality of data. 

Additional safeguards are included to insure that members of vulnerable

populations (e.g., children, prisoners, pregnant women, mentally disabled

persons, or economically or educationally disadvantaged persons) are not

the subject of coercion or undue influence. 

When is it a QI Activity?

• QI activities that are designed solely for internal program evaluation purposes, with no external application or generalization, usually do not constitute human subject research and usually do not require IRB review.

• QI activities constitute human subject research and require IRB review, when they are designed or intended, at least in part, to develop or contribute to generalizable knowledge.

When is an QI Activity Exempt?

• Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt

– Exemptions b(1-6) [45 CFR 46.101(b)]– Exemption categories 1-5 are not applicable to research

governed by FDA regulations (21 CFR 50.20.)

Categories of Exempt Research

1.Research conducted in established educational settings, involving normal educational practices

2.Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior

3.Same as # 2, but covers elected officials

4.Research involving use of existing data

5.Research and demonstration projects by approval of agency heads

6.Taste and food quality (patient satisfaction)

IRB Determinations for Exemptions

• Determination made by IRB Chair or IRB member designated by the Chair

• Exemption documented on IRB letter (including category)

What about expedited review?

• No more than Minimal Risk.

• Must fit one or more of the categories on the Expedited Review Categories List [Authority: 45 CFR 46.110 and 21 CFR 56.110]

• Minor changes in previously approved research during the period for which the approval is authorized

Minimal Risk

…means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests. (45 CFR 46.102(i))

Expedited Categories

• Clinical studies of drugs and medical devices only under specific conditions

• Collection of blood samples

• Biological specimens obtained by non-invasive means

• Collection of data through non-invasive procedures

• Materials collected solely for non-research purposes

• Collection of data from voice, video, etc.

• Research employing surveys, etc.

• Continuing review under specific conditions

IRB Expedited Determinations

• IRB Chair or one or more experienced reviewers designated by the Chair from among members of the IRB

• Notification of IRB members & PI

• Minutes and/or protocol file must reflect eligibility category

• Subject to continuing review based on IRB approval date

What are some characteristics of “human subjects research”?

• One of the main goals of the project is to advance general knowledge in the academic, scientific, or professional community

• The project will have a specific hypothesis or research question (s).

• The project will be conducted using a research design that will lead to scientifically valid findings (control groups; random selection of subjects, statistical analysis, sample design, etc)

What are some characteristics of Quality Improvement projects?

• The main goal of the project is to improve patient outcomes, a clinical program or service

• The project identifies specific services, clinical practices or processes or outcomes within a department, clinical program or facility for improvement

• Project does not impose risks or burden to patients, does not randomize or stratify

What does the IRB look for?

• The intent of the project should be clear in the description – Generalizability – if the primary intent of the project is to

generate generalizable knowledge– Additional risk or burden – if the project will impose risks or

burdens beyond the standard of practice to make the results generalizable

– Design – if a project involves randomization or an element that may be considered other than standard of care

IRB Review

• What information does the IRB need to make a determination if a project requires IRB oversight?

– Call/email Stephanie or Dr. Breault– Create ERSA application– All related documentation should be uploaded in ERSA (project

summary, survey, data collection sheet, detailed description of plan)

– If you are not sure whether the project meets the definition of research

CONTACT THE IRB!!!!

An Improvement Story…

An Intervention to Decrease Catheter-Related Bloodstream Infections if the ICU

•There was this simple idea…

Intervention

1. Wash their hands with soap.

2. Clean the patient’s skin with chlorhexidine.

3. Put sterile drapes over the entire patient.

4. Wear a sterile mask, hat, gown and gloves.

5. Put a sterile dressing over the catheter site.

Grant Title: Statewide Efforts to Improve Care in Intensive Care Unit

• We hypothesize that we can improve patient safety; improve safety culture; and reduce ICU mortality, blood stream infections, aspiration pneumonia and ICU length of stay.

• To accomplish this, we will partner with the Michigan Hospital Association, whose has over 130 Michigan hospitals, to implement a safety program and other interventions in a cohort of hospitals

Statewide Efforts to Improve Care in Intensive Care Unit

Specific aims are to implement and evaluate:

• impact of the Comprehensive Unit-based Safety Program that includes the ICU Safety Reporting System;

• effect of an intervention to improve communication and staffing in ICUs;

• effect of an intervention to reduce/eliminate catheter related blood stream infections;

• effect of an intervention to improve the care of ventilated patients; and

• effect of an intervention to reduce mortality.

The results were published in NEJM

And the results were very good…

Lead Researcher Becomes A Celebrity

What went wrong?

Questions were raised by OHRP

OHRP Findings

OHRP Findings

OHRP Corrective Action

OHRP Findings

Timeline

OHRP Sends Final Determination LetterJuly 2008

OHRP Clarified Study

OHRP Final Determination Letter

OHRP Final Determination Letter

Quality Division Vision:

To Be Famous For Quality

Mind The Gap

Decision Points: When should a QI/QA project be Presented to the IRB?

Source of Data

Patient Selection

Publication/Presentation

De-identified/summary level data

Patient specific data

Specific population, i.e. gender/age/condition specific

Not specific, i.e. “everyone”

Specific population, i.e. gender/age/condition specific

“Best Practice Sharing”

Defining a Project as QI/QA or Research

Research QI/QA

Purpose To test a hypothesis OR to establish clinical practice standards where none are already accepted

To assess or improve a process, program, or system OR to improve performance

Starting Point To answer a question or test a hypothesis

Identify a clinical problem or issue and use specific indicates to measure performance

Benefits May or may not benefit current subjects, but may benefit future patients

Directly benefits a process/program/system and may or may not directly benefit patients

Risks May put participants at risk Does not increase risks to patients

Defining a Project as QI/QA or Research

Research QI/QA

Data Collection Systematic Data Collection Systematic Data Collection

End Point Answer a research question Improve a program/process/system

Testing/Analysis Statistically prove or disprove a hypothesis

Compare a program/process/system to an established set of standards

IRB Oversight Required Not required**

No

YES

YES

YES

Does the research involve intervention or interaction with the individuals? Intervention means physical procedures (i.e. venipuncture) to gather data and manipulations of subject or their environment performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)(1), (2)]

Is the Information the investigator receives individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information?) [45 CFR 46.102(f)(2)]

Activity is research involving human subjects. Unless exempt, 45 CFR 46 requirements apply. Check Exemption Decision Trees.

Is the information private? (About behavior that occurs in a context in which an individual can reasonably expect no observation or recording is taking place, or provided for specific purpose and individual can reasonably expect will not be made public.) [45 CFR 46.102(f)(2)]

Activity is not research. No

Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge? [45 CFR 46.102(d)]

Activity is Research.Does the research involve obtaining information about living individuals? [45 CFR 46.102(f)]

YES

No

YES

Activity is not human research. No

No

Questions?

Thank you

Donna Saxton, MHA, MPH, FACHE

VP, Quality and Safety

Ochsner Health System

1514 Jefferson Hwy

Brent House 610

New Orleans, LA 70121

504.842.7079 (o)

504.842.4597 (f)

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Stephanie Gaudreau, CIP

IRB Administrator

Ochsner Institutional Review Boards

1514 Jefferson Highway

New Orleans, LA 70121

Phone: 504-842-3563

Fax: 504-842-3899

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