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Completed

NCT Number: NCT04560920

Enhancing Geriatric Pain Care

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 health data (PGHD). Contextual PGHD 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 PGHD and use it to develop a computer application for collecting contextual PGHD and displaying it to patients and doctors in a visit. The investigators will also test the impact of having contextual PGHD in a visit on patient satisfaction with the Veterans care plan and how well they are able to follow the care plan.

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Key information

Age range

65 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

About this study

The investigators proposal addresses the use of patient generated health data (PGHD) - 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. PGHD broadly encompasses many sources and types of data. The investigators will categorize contextual PGHD into 3 core components 1) relational PGHD (patient-clinician relationship and patient individual differences such as pain catastrophizing) 2) whole person PGHD (what matters to the patient including patient preferences), and 3) behavioral PGHD (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 PGHD profile displays to support patient centered care for geriatric Veterans with chronic pain. The investigators will conduct focus groups or interviews with geriatric Veterans with chronic pain and the Veterans caregivers to explore Veterans' perspectives on the content of the PGHD profile displays and the Veterans attitudes toward them. The investigators will conduct focus groups with clinicians about desired content of the PGHD profile displays specific to pain management. The investigators will iteratively prioritize PGHD 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 PGHD profile display and evaluate its usability. The investigators will develop a prototype clinician-facing PGHD profile display containing PGHD elements and guides to interpretation/use for clinicians. The investigators will refine the PGHD 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 PGHD 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 PGHD 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 PGHD profile displays to visits without access.

The investigators primary hypothesis is that access to contextual PGHD profile displays during a clinical visit will result in better adherence to the pain care plan at 30 days, compared with no PGHD 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Availability of contextual PGHD at the visit

Other

Contextual PGD will be available in a display at the visit.

Primary outcomes

  1. Adherence to the Pain Care Plan

    Time frame: Between 2 years and 4.5 years after study start

    MOS General Adherence Scale-Participants rate adherence on a 1-5 scale with higher scores indicating better adherence

Secondary outcomes

  1. Patient Satisfaction with the Visit

    Time frame: 1.5 years to 4 years after study start

    SHEP communication scale, 4 items used to assess satisfaction with visit communication

  2. Shared Decision Making in the Visit

    Time frame: 1.5 years to 4 years after study start

    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

  3. Shared Decision Making in the visit

    Time frame: 1.5 years to 4 years after study start

    OPTION coding, a standardized coding scheme to capture shared decision making in the visit.

  4. Pain Function

    Time frame: Between 2 years and 4.5 years after study start

    West Haven Yale Multidimensional Pain Inventory (WHYMPI). WHYMPI Statements are rated on a 0-6 Likert scale with higher scores indicating higher intensity

  5. Patient perspective of Shared Decision Making

    Time frame: Between 2 years and 4.5 years after study start

    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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Utah

Registry information

Official study title

Enhancing Geriatric Pain Care With Contextual Patient Generated Data Profiles

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2020
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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