MedDataX Logo

Enhancing Geriatric Pain Care

NCT ID: NCT04560920

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

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

Group Type EXPERIMENTAL

Availability of contextual PGHD at the visit

Intervention Type OTHER

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Availability of contextual PGHD at the visit

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Utah

OTHER

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jorie Butler, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIR 19-265

Identifier Type: -

Identifier Source: org_study_id