Contextual PGD for Pain Management in Older Adults

Overseen By Joshua D Judd, MBA BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Need legal representative

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

230 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on understanding your pain management and care context rather than changing your medication.

What data supports the effectiveness of the treatment Contextual Patient Generated Data for pain management in older adults?

The development of systems like the pediatric pain data repository, which collects patient-reported outcomes and integrates them with medical records, suggests that using patient-generated data can improve pain management by providing comprehensive information to support medical decisions. ^{1 2 3 4 5}

How does Contextual PGD for Pain Management in Older Adults differ from other pain treatments?

Contextual PGD for Pain Management in Older Adults is unique because it likely involves a personalized approach, potentially using data-driven methods to tailor pain management strategies to individual patients, unlike traditional treatments that may not account for personal differences in pain response. ^{1 6 7 8 9}

Research Team

Jorie Butler, PhD

Principal Investigator

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

Eligibility Criteria

This trial is for Veterans aged 65 or older with chronic pain, their informal caregivers, and clinicians involved in their care. Participants must be within the Salt Lake City area. It's not suitable for Veterans who require a legal representative to consent.

Inclusion Criteria

I am 65 or older with chronic pain diagnosed by a doctor.

I am a healthcare provider for patients over 65 with chronic pain in the Salt Lake City area.

Veteran caregivers (including spouses, other relatives, or close friends involved in the daily life of the Veteran)

Exclusion Criteria

Veterans who need a legally authorized representative to consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Usability Testing

Development of a prototype contextual PGHD profile display and evaluation of its usability through user-centered design sessions and simulation studies with clinicians.

6 months

Randomized Trial

Examine the impact of contextual PGHD profile displays on patient adherence, pain function, satisfaction, and shared decision making in a randomized trial.

2 years

Follow-up

Participants are monitored for adherence to the pain care plan and shared decision making outcomes.

2.5 years

Treatment Details

Interventions

• Contextual Patient Generated Data

Trial Overview The study tests how sharing contextual patient-generated data (like daily routines and support levels) affects satisfaction with care plans and adherence among elderly patients with chronic pain when this information is available during medical visits.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Personalized medicine and opioid analgesic prescribing for chronic pain: opportunities and challenges. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Using electronic health records data to identify patients with chronic pain in a primary care setting. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Developing a pediatric pain data repository. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Testing the Decision Support Tool for Responsible Pain Management for Headache and Facial Pain Diagnosis with Opioid-Risk-Stratified Treatment. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Optimizing and Accelerating the Development of Precision Pain Treatments for Chronic Pain: IMMPACT Review and Recommendations. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Can subjective pain be inferred from objective physiological data? Evidence from patients with sickle cell disease. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Digital Pain Mapping and Tracking in Patients With Chronic Pain: Longitudinal Study. [2021]