Methods for the Collection of Patient Reported Outcomes in a Safety Net-Oriented Practice Based Research Network: A SAFTINet Demonstration Project

SAFTINet: Scalable Architecture for Federated Translational Inquiries Network

1Bethany M. Kwan, PhD, MSPH,

2Deborah Graham, MSPH,

1,3Marion Sills, MD, MPH,

4Alicyn Kaiser, PA-C, MMSc,

2Elias Brandt, BS, BA,

2Emily Bullard, MPH, CHES,

1Lisa M. Schilling, MD, MSPH

1University of Colorado School of Medicine,

2American Academy of Family Physicians National Research Network,

3Children’s Hospital Colorado,

4Metro Community Provider Network

The Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) is a safety net-oriented practice-based research network with an associated federated database of existing electronic health data to support comparative effectiveness research (CER)

We selected and implemented PROs in primary care practices to enhance the data set available for re-search and to inform clinical care

SAFTINet CER protocols concern the effects of the Patient-Centered Medical Home on health outcomes for 2 cohorts of patients at risk for cardiovascular disease (CVD): those with hypertension and/or hyperlipidemia

Patient-Reported Outcomes • Data collected directly from patients (often

in a questionnaire), pertaining to:

– Symptoms (impairments) and other

aspects of well-being

– Functioning (disability)

– Health status

– General health perceptions

– Quality of life (QoL)

– Health related quality of life (HRQoL)

– Reports and ratings of health care

(e.g., satisfaction)

– Behavior (adherence, physical activity,

smoking, etc)

• General, or disease-specific

To describe stakeholder engagement methods for selecting and implementing

Patient-Reported Outcomes (PROs) for cohorts of patients with hypertension

and/or hyperlipidemia

RESEARCH OBJECTIVE

We engaged three key stakeholder groups (investigators, providers, and patients) to systematically select, implement, and track collection of a CVD-relevant PRO in 42 safety-net primary care practices

from 4 organizations in 2 states

METHODS

Collectively, clinical partners and CER investigators decided to:

Assess medication adherence

Provide checklist of common barriers

Offer provider guidance and assess utility of the tool

When implementing a PROM in a real-world setting, high fidelity to a specific protocol across a wide variety of practices is difficult to achieve.

While there are benefits of conducting research with real clinical practices (e.g., external validity), practices’ primary objective is to provide

patient care, while research and data collection are secondary. Investigators can work with practices to enhance standardization of data

collection, but should remain flexible and considerate of the need to compromise. Using stakeholder engagement methods to select and

implement PROs is a time-consuming and effortful process - we are nearly 18 months into the process, and only about half of practices have

implemented the survey. It is not yet clear whether this method enhances data quality or sustainability.

CONCLUSIONS

• Screening for

undiagnosed conditions

• Monitoring symptoms,

disease progress, and

responsiveness to

treatment

• Feedback to patients

• Clinical decision aid

• Facilitating team

communications

• Enhance patient-provider

communication and

shared decision making

• Evaluation of quality/

outcomes

Clinical and Research Utility of PROs

• What are the goals for collecting PROs in clinical practice and what

resources are available? Which key barriers require attention?

• Which groups of patients will you assess?

• How do you select which questionnaire to use?

• How often should patients complete questionnaires? Should it be tied

to visits or a way to follow patients between visits?

• How will the PROs be administered and scored?

• What tools are available to aid in interpretation and how will scores

requiring follow-up be determined?

• When, where, how, and to whom will results be presented?

• What will be done to respond to issues identified through the PROs?

• How will the value of using PROs be evaluated?

ISOQOL Research User Guide for use of PRO assessment in clinical practice

Stakeholder Engagement Methods 1. Align multiple stakeholder perspectives and evidence-based PRO options via regular group discussion

(Annual partner convocation, twice monthly Partner Engagement Community and CER team meetings, PRO work group)

2. Provide structured materials to aid in planning and set “minimum criteria” for research use, informed by the ISOQOL user guide

3. Conduct field testing, gather patient and provider feedback, and iterate 4. Tracking templates and one-on-one and group discussion of progress and barriers We applied these methods throughout five steps required for implementation of PROs:

PRO Implementation Steps 1. Select a content area; 2. Select a measurement tool; 3. Implement the tool in participating practices; 4. Capture data in structured fields; and 5. Monitor progress, identify barriers, and adjust methods accordingly.

Step 5. Tracking Progress and Identifying Barriers

Between 1/1/13 and 5/31/13:

1,652 survey results were documented in structured fields

25 of 42 practices collected > 1 survey

Mean = 39

Median = 5

Range = 0 — 363

One organization represents 80% of completed surveys

Barriers include conflicting organizational priorities (e.g.,

EMR upgrades) and time required to implement and stand-

ardize new workflows (e.g., care coordinator outreach)

Our process of selection and implementation for PROs relevant to hypertension/hyperlipidemia was guided by:

The 7p stakeholder engagement framework to bridge research and clinical needs (Concannon et al.); and

The International Society of Quality of Life (ISOQOL) User Guide (Snyder et al.) 0

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Number of MAS Results Collected as of 5/31/13

TASK: COLLECT PRO DATA FOR CVD RISK COHORTS

SAFTINet PRO Planning Worksheet 1. Selecting ambulatory patients with hypertension/hyperlipidemia

2. Manner of questionnaire administration

3. Administering questionnaire to patients/families

4. Scoring the questionnaire

5. Making the results available to providers

6. Presentation of results to patients

7. Capturing the results in an electronic database

8. Interpreting and responding to scores

9. Training of providers and staff

10. Resources required to make the implementation a success in a practice

11. Anticipated barriers

Step 1. Select a content area Research criteria:

Outcome theoretically related to PCMH characteristics

Evidence supports relationship with CVD risk/outcomes

Clinical criteria:

Missing or inconsistent information about patients with hy-pertension or hyperlipidemia that would inform better care

Lifestyle behaviors, social determinants, patient activa-tion, health literacy

Aligns with organizational initiatives (meaningful use, PCMH)

Minimize need for additional data collection

Step 2. Select a measurement tool Research criteria:

Consistent with conceptual and measurement model

Acceptable reliability, validity, and responsiveness to change

Clinical criteria:

Brief, interpretable and actionable

Spanish language translation available

SAFTINet provided a Planning Worksheet to facilitate partner implementation and communicate minimum research criteria

Research criteria:

Standardized variables across practices and patients

Data for all patients in the hypertension and hyperlipidemia cohorts

Associated patient ID and date for linkage

Clinical criteria:

Feasible and effective within the particular practice context, workflow and re-

sources

Field testing and feedback

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

Partner Implementation Plans

Org 1: Administered by phone by care coordinators; patients with barriers scheduled for appointment with provider; responses entered into EHR

template

•Org 2: Administered on scannable form upon check-in for visit, available to provider at the point of care; responses scanned into database

•Org 3: Administered as part of electronic pre-appointment checklist upon check-in for visit, responses available to provider at the point of care

through EHR

•Site 4: Care managers call ACO patients, administer health risk appraisal, schedule appointments with provider as necessary to address poor

adherence/barriers; data entered into EHR template

Lessons learned include the importance of balancing

the need for fidelity to research protocols with the

priorities of real-world healthcare settings. Research

requires standardized data collection, while clinical

care needs actionable information for patients and

providers and feasible data collection strategies

tailored to unique practice environments.

Supported by AHRQ 1R01 HS019908 Scalable Architecture for Federated Translational Inquiries Network (PI: Lisa Schilling, MD, MSPH)

Valid and reliable measures of

medication adherence

Consultation with expert in medi-

cation adherence measures: rec-

ommends Morisky-8

Garfield et al. systematic review

—>narrow down to 1-question

instruments —>CER team review

—> selected Gehi measure

No acceptable measure of medi-

cation adherence barriers; opted

for simple checklist

RAND Corporation systematic

review of barriers found to pre-

dict measured medication ad-

herence

Regimen complexity

Cost-sharing (e.g., prescription

copayments, formulary tiers, co-

insurance, pharmacy benefit

caps or monthly prescription lim-

its, formulary restrictions, and ref-

erence pricing)

Depression

Beliefs about medications

(perceived risks of having a side

effect and perceived impact and

need for the medication)

Literature Review and Expert Consultation

Step 3. Implement PRO in practices / Step 4. Capture data in structured fields

1. Greenhalgh J, Meadows K. The effectiveness of the use of patient-based measures of health in routine practice in improving the process and outcomes of patient care: a literature review. Journal of evaluation in clinical practice. Nov 1999;5(4):401-416.

2. Marshall S, Haywood K, Fitzpatrick R. Impact of patient-reported outcome measures on routine practice: a structured review. Journal of evaluation in clinical practice. Oct 2006;12(5):559-568.

3. Valderas JM, Kotzeva A, Espallargues M, et al. The impact of measuring patient-reported outcomes in clinical practice: A systematic review of the literature. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 2008;17(2):179-193.

4. Snyder CF, Aaronson NK, Choucair AK, et al. Implementing patient-reported outcomes assessment in clinical practice: a review of the options and considerations. Quality of life research : an international

journal of quality of life aspects of treatment, care and rehabilitation. Oct 2012;21(8):1305-1314.

5. Concannon TW, Meissner P, Grunbaum JA, et al. A new taxonomy for stakeholder engagement in patient-centered outcomes research. J Gen Intern Med. Aug 2012;27(8):985-991.

6. Garfield S, Clifford S, Eliasson L, Barber N, Willson A. Suitability of measures of self-reported medication adherence for routine clinical use: a systematic review. BMC Med Res Methodol. 2011;11:149.

7. Gellad WF, Grenard JL, Marcum ZA. A systematic review of barriers to medication adherence in the elderly: looking beyond cost and regimen complexity. Am J Geriatr Pharmacother. Feb 2011;9(1):11-23.

8. Gehi A, Ali S, Whooley M. Self-reported medication adherence and cardiovascular events in patients with stable coronary heart disease: The heart and soul study. Circulation. May 29 2007;115(21):E584-E584.

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Poster Presented at the AcademyHealth Annual Research Meeting, June 24, 2013, Baltimore, MD

RESULTS