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Clinical Trial 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 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04560920
Study type Interventional
Source VA Office of Research and Development
Contact Jorie Butler, PhD
Phone (801) 582-1565
Email Jorie.Butler@va.gov
Status Recruiting
Phase N/A
Start date February 1, 2023
Completion date September 30, 2024

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