Enhancing Geriatric Pain Care

NCT04560920 | Completed

• 1 other identifier: IIR 19-265
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

patient generated health data; geriatrics; pain; contextual data; patient centered care; adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Satisfaction with the Visit

  1.5 years to 4 years after study start

• Shared Decision Making in the Visit

  1.5 years to 4 years after study start

• Shared Decision Making in the visit

  1.5 years to 4 years after study start

• Pain Function

  Between 2 years and 4.5 years after study start

• Patient perspective of Shared Decision Making

  Between 2 years and 4.5 years after study start

Study Arms (2)

Experimental

EXPERIMENTAL

This group will contribute PGHD and it will be available in the study visit.

Other: Availability of contextual PGHD at the visit

Control

NO INTERVENTION

This group may contribute PGHD but if so, it will not be available during a study visit, it will be available to the provider in a subsequent visit.

Interventions

Availability of contextual PGHD at the visit OTHER

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

Experimental

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Veterans who need a legally authorized representative to consent.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Utah: collaborator

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorie Butler, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be informed that they are participating in a study of patient information and that this information will be discussed when available at the visit.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: During aim 3, participants will be randomized to experimental or control group. Both groups will contribute PGHD, but the availability of PGHD at the visit will be the basis on which groups are compared. Earlier aims are not randomized but total anticipated enrollment is listed below.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 23, 2020
• Study Start: February 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)