Asthma Control Test (ACT) and Medication Adherence Survey (MAS): Patient-Reported Outcome (PRO) Selection, Implementation and Data Collection

Background and Methods PRO content area selection

PRO measurement tool selection

Plan for PRO implementation Plan for documentation of PRO results

Background from existing literature

Regarding potential for success: PROs more likely to improve process then outcome Greatest improvement in diagnostics and patient-provider communication

Content areas include Quality of life Symptoms Behaviors Psychosocial

Clinical utility: enhanced by selection of measures that are easily understood by the patient and interpreted by the provider

Research perspective: selection should start from a theory about the mechanism for what the PRO is intended to accomplish

PRO implementation must include these processes: feedback of information to the provider discussion between patient and provider treatment plan informed by the PRO

A challenge to assessing PROs from a clinical utility perspective is quantifying the impact that they have on outcomes

Clinical and research perspectives and priorities

Clinical and research perspectives on priorities for content area: disease prevalence disease morbidity/mortality potential for successful intervention

Clinical perspectives on content: seamlessly integrated into organizational and patient care needs align with existing initiatives requiring data collection

Research perspective: selected PRO content area needs to: be related to the independent/explanatory variable, with supporting evidence for

such an association have valid and reliable measurement tool require data typically not available or of research quality EHR improve research quality

Clinical perspective on priorities for tool: improve clinical care brief and actionable improve knowledge

Research priorities: reliability and validity of measurement

Clinical perspective: need plan for responding to issues raised by PROs need for workflow, efficiency, and consistency with process of care. data collection must not interfere with practices’ foremost priority: providing

high-quality care Research perspective to reduce bias, data collection needs to be implemented broadly

and standardized across practices.

Clinical perspective: challenges include determining how to modify EHR templates to support the most efficient clinical workflow (or set up

separate data collection system) integrate a template into existing clinical workflow.

Research perspective: to reduce bias data needs to be documented in a structured, discrete field (ideally, but not necessarily, in an EHR) with an associated patient ID and date

ACT PRO content selected by research priorities as pre-specified in grant application Of SAFTINet priority conditions, asthma has the fewest measures of disease control in

pre-existing clinical and claims data and is the most symptomatic condition of the three

PEC priorities for asthma PRO Simplicity Does not interfere with workflow Appropriate for literacy level and language of patients Alignment with other organizational efforts and initiatives 1 partner already used the ACT extensively, 1 other used it sporadically

CER team priorities for asthma PRO Validity, reliability Administer at least once annually to patients who

are not currently having asthma exacerbation have ICD-9 code for asthma

Based on the discussions, the ACT was chosen from among several asthma instruments considered

The PEC designed a planning worksheet to facilitate the integration and implementation of the ACT that each clinical organization completed and discussed with the SAFTINet Project

Manager and one of the PEC Co-Chairs. The CER team reviewed the worksheet template to ensure it included research

priorities for ACT implementation

Different integration of data into clinical workflow 1 organization administering by phone rather than at point-of-care; thus PRO data

not tied to a clinical encounter 1 organization obtaining ACT by research assistant; ACT result not available to

clinical provider 1 organization using separate spreadsheet for entering data, separate from EHR

MAS CER team met with a panel of cardiovascular outcomes researchers to discuss PROs that

are important for the cardiovascular cohorts’ research hypotheses have been shown to be measureable by PRO and relevant to improving outcomes Based on this, the CER team recommended medication adherence as PRO content

area The PEC discussion started from these specific priorities:

PRO content should align with existing initiatives including Meaningful Use Patient Centered Medical Home (PCMH) Accountable Care Organization (ACO)

Content should help clinicians provide better care: e.g., lifestyle behaviors, environmental factors, social determinants (e.g., social isolation), patient activation, and health literacy

Based these discussions, the teams agreed to pursue a medication adherence PRO.

Within medication adherence, the specific content areas were adherence and barriers thereto.

CER team discussion: Focus on medication adherence question for research use

PEC discussion: No pre-existing barriers checklists reflected the barriers their patients faced, so the

PEC adapted a barriers checklist including barriers that the PEC felt would contribute valuable data to clinicians to improve communications with and care provided to patients

Medication adherence should be brief, ideally 1 question. On reviewing brief instruments, the PEC selected a validated 1-question instrument.

Before moving on to implementation of the PRO, three partners piloted the PRO. The goals of the pilot included:

Test the process flow feasibility and clinical utility of the MAS Seek input on the questions and format: Do patients understand? Is wording clear?

Is the information obtained useful? Clarify the wording of the barriers checklist

The PEC used the same planning worksheet process used for the ACT implementation. Each clinical organization designed the implementation process of the MAS PRO that

would best fit within their clinical care processes, while still maintaining fidelity to the project protocol. Table A describes the data collection mechanisms designed by the clinical organizations.

Issues around standardization of PRO data: Different data structure, different field names, and non-standardized responses.

E.g., the barriers question can either be captured in a yes/no column for each response, or all positive responses concatenated into a single field.

Ability to link responses to the proper patient ID and date. In the common data model, survey responses are entered as multiple rows within a table, such that each survey results in many records.

Ability to link responses to each survey to other clinical data related to the visit. Survey responses are not necessarily tied to a specific visit.

Partners adopted different approaches for capturing data from the MAS. The approaches involve entering data into an electronic data capture system using either an EHR template or using an ancillary system such as optical character recognition. In the extraction and transformation process, the PRO data is pulled from its original location and transformed to fit into a common data model.. By the time the PRO data is available to the researchers it has been standardized.

ACT Worksheet Sample Data

Partner 1 Partner 2 Partner 3 Partner 4

How to identify asthma patients? How does this translate to distributing ACT?

Run reports to yield patient registries based upon ICD9 codes, by clinical analyst & providers

ICD-9 code on problem list NextGen diagnosis code data, via IT query of asthma pts weekly, pre-visit planning from support staff, by nursing staff at triage

Patient query by clinic and diagnosis, by clinic managers

Which visits? How often? (e.g., at least every 6 months)

All asthma-related visits, or at least 1x per year (not acute asthma exacerbations)

All visits Well Child Exams & Annual Well Visits

Annually at preventative visits and any visit due to asthma related symptoms/issues

Which staff and when/where to distribute?

MA MA (in exam room) Front office staff at check-in At registration

By what means? Pencil & paper survey Dry erase, laminated print survey

Pencil & paper survey Portable device, web-based

Who will score? Rooming nurse, before provider enters room

MA, upon completion Rooming nurse Rooming nurse/MA

MAS Worksheet Sample Data

Partner 1 Partner 2 Partner 3 Partner 4

Population All pts with hypertension or hyperlipidemia

All pts with hypertension or hyperlipidemia

All adults All pts with hypertension

How often Yearly At all visits All visits Hypertension visits (2x/year)

How is tool administered Administered by phone by care coordinators.

Administered on scannable form upon ckeck-in for visit.

Administered as part of electronic pre-appointment checklist upon check-in for visit

Making data available to provider

Patients with barriers scheduled for appt with provider

Available to provider at point of care

Available to provider at point of care through EHR

Available to provider at point of care

Documenting results Responses entered into EHR template

Responses scanned into ancillary database

Responses entered into EHR template

Table A: Topics in PRO Planning WorksheetSelecting ambulatory patients with asthmaManner of questionnaire administrationAdministering questionnaire to patients/familiesScoring the questionnaireMaking the results available to providersPresentation of results to patientsDocumenting the results in the electronic health recordInterpreting and responding to scoresTraining of providers and staffResources required to make the implementation a success in your practiceAnticipated barriers

Objective• To describe stakeholder engagement methods and the challenges, solutions

and compromises in several critical steps needed to collect PRO data for clinical and research purposes in SAFTINet: those steps are • PRO content area selection• PRO measurement tool selection• PRO implementation plan• Plan for documentation of PRO results