Enhancing Geriatric Pain Care

Study Overview
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Brief Summary
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This project is focused on Veteran patients 65 and older with chronic pain. In this project, the investigators will understand the impact of a contextual patient generated data (PGD). Contextual PGD are data about what is important to patients, information about the Veterans social and home contexts (for example, how the Veterans medications are stored and how much help they receive from others). In this study the investigators will talk with Veterans with chronic pain and the Veterans informal caregivers (family members or friends who help them) and find out about how they are coping with chronic pain and what information might be helpful to provide to the Veterans healthcare team. Then, the investigators will talk to clinicians about information that might be helpful to them. The investigators will collect contextual PGD and use it to develop a computer application for collecting contextual PGD and displaying it to patients and doctors in a visit. The investigators will also test the impact of having contextual PGD in a visit on patient satisfaction with the Veterans care plan and how well they are able to follow the care plan.

Detailed Description
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The investigators proposal addresses the use of patient generated data (PGD) - an innovative approach to deliver patient centered care to older Veterans that is characterized by attention to patient priorities, values, and goals. The investigators clinical focus is on chronic pain in older Veterans, which is widespread. PGD broadly encompasses many sources and types of data. The investigators will categorize contextual PGD into 3 core components 1) relational PGD (patient-clinician relationship and patient individual differences such as pain catastrophizing) 2) whole person PGD (what matters to the patient including patient preferences), and 3) behavioral PGD (pain self-efficacy and patient actions related to health , pain management, functional status). The investigators study is mixed methods. In aim 1 the investigators will: Prioritize content for contextual PGD profile displays to support patient centered care for geriatric Veterans with chronic pain. The investigators will conduct focus groups with geriatric Veterans with chronic pain and the Veterans caregivers to explore Veterans' perspectives on the content of the PGD profile displays and the Veterans attitudes toward them. The investigators will conduct focus groups with clinicians about desired content of the PGD profile displays specific to pain management. The investigators will iteratively prioritize PGD elements in accordance with pain care management needs of geriatric patients, incorporating results of a card sort exercise performed by clinicians. In aim 2 the investigators will :Develop a prototype contextual PGD profile display and evaluate its usability. The investigators will develop a prototype clinician-facing PGD profile display containing PGD elements and guides to interpretation/use for clinicians. The investigators will refine the PGD profile display prototype with clinicians in user-centered design sessions. The investigators will broadly assess usability in a simulation study with primary care clinicians. In aim 3 the investigators will: Examine the impact of contextual PGD profile displays on patient adherence, pain function, satisfaction, and shared decision making in a randomized trial. The investigators will evaluate operationalization of the pain care plan and the shared decision making process in the visit by coding study visit recordings. The investigators will assess the impact of contextual PGD by comparing patient adherence to pain care regimens, pain function, patient satisfaction, and shared decision making process for a sample of 150 geriatric patients with chronic pain in VA primary care clinics. The investigators will compare between-subjects visits that include access to contextual PGD profile displays to visits without access. The investigators primary hypothesis is that access to contextual PGD profile displays during a clinical visit will result in better adherence to the pain care plan at 30 days, compared with no PGD profile display. Throughout the project the investigators will work with stakeholders in clinic settings and implementation of the electronic health record to ensure future implementation can be optimized.

Official Title
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Enhancing Geriatric Pain Care With Contextual Patient Generated Data Profiles

Conditions
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Pain

Intervention / Treatment
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* Other: Availability of contextual PGD at the visit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinicians are eligible if they are a primary care clinician or PACT member including physicians, nurse practitioners, nurses, social workers, pharmacists, and psychologists for Veteran patients over age 65 diagnosed with chronic pain in primary care, geriatrics clinic, or a local or rural CBOC within the Salt Lake City catchment. Eligible VHA patients will be age 65 and older with a diagnosis of chronic pain defined by ICD 10 codes. Veteran caregivers (including spouses, other relatives, or close friends involved in the daily life of the Veteran) will also be eligible for participation in this study. Vulnerable populations, women, and minorities are eligible to the extent that they are represented in the above described population or are a caregiver. Exclusion Criteria: - Veterans who need a legally authorized representative to consent.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: During aim 3, participants will be randomized to experimental or control group. Both groups will contribute PGD, but the availability of PGD at the visit will be the basis on which groups are compared. Earlier aims are not randomized but total anticipated enrollment is listed below.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>This group will contribute PGD and it will be available in the study visit. | Other: Availability of contextual PGD at the visit<br>* Contextual PGD will be availability in a display at the visit.<br>|
| No Intervention: Control<br>This group will contribute PGD but it will not be available during a study visit, it will be available to the provider in a subsequent visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the Pain Care Plan | MOS General Adherence Scale-Participants rate adherence on a 1-5 scale with higher scores indicating better adherence | Between 2 years and 4.5 years after study start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with the Visit | SHEP communication scale, 4 items used to assess satisfaction with visit communication | 1.5 years to 4 years after study start | 
| Shared Decision Making in the Visit | Participatory Decision making style questionnaire, used in Medical Outcomes Study and relates to satisfaction with care. Participants rate participation on a 1-5 scale with higher scores indicating higher participation | 1.5 years to 4 years after study start | 
| Shared Decision Making in the visit | OPTION coding, a standardized coding scheme to capture shared decision making in the visit. | 1.5 years to 4 years after study start | 
| Pain Function | West Haven Yale Multidimensional Pain Inventory (WHYMPI). WHYMPI Statements are rated on a 0-6 Likert scale with higher scores indicating higher intensity | Between 2 years and 4.5 years after study start | 
| Patient perspective of Shared Decision Making | OPACIC adapted for older adults from the Patient Assessment of Chronic Illness Scale. This measure includes 5 subscales, patient activation, deliver system design/decision support, goal setting and tailoring, and follow-up/coordination. OPACIC statements are rated on a 1-5 Likert scale with higher scores indicating higher intensity | Between 2 years and 4.5 years after study start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient generated health data, geriatrics, pain, contextual data, patient centered care, adherence