Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain
- Conditions
- Pain
- Registration Number
- NCT06665906
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The purpose of this study is to see if patients with chronic pain can improve how they manage their pain and daily function by working with a care manager and by learning pain coping skills from an online teaching tool.
- Detailed Description
This study will determine the effects of patient navigator-delivered care coordination to address the major social drivers of health on pain-related outcomes. All participants will have access to web-based cognitive behavior therapy (PainTrainer) - a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. Some participants will also receive phone call visits with patient navigator to coordinate care.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Patients with daily pain for 3 months or longer
- Chronic daily musculoskeletal pain with Pain, Enjoyment, General Activity (PEG) Survey score >=4
- Primary care provider must be an Atrium provider
- Has at least one social driver of health: Financial insecurity, work and income, housing, food insecurity, safety, health literacy and at least one of the above, lack of social support and at least one of the above
- Patients who have active cancer
- Cognitive impairment severe enough to preclude participation in a behavioral/lifestyle change program
- Live in a nursing home or inpatient treatment facility
- Unable to read and converse in English
- Those who are already connected to a patient navigator or nurse coordinator or social worker
- Planned elective surgery in the next 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of Participant Recruitment Through study completion, on average 16 months Mean number of participants recruited each month. Formula for calculation is planned number of enrolled and randomized participants (30) divided by total number of months needed to recruit 30 participants. The higher the number, the faster the recruitment is (i.e., 30 participants divided by 15 months = 2 per month).
Rate of Participant Retention Week 24 Percentage of participants that completed study. Formula for calculation is number of participants that completed last study visit divided by the number of participants that were enrolled and randomized. Range 0 to 100%. The closer the percentage to 100%, the better is the follow-up rate (i.e., 26 completed week 24 study visit divided by 30 randomized participants = 86.6%).
Rate of Participant Engagement with Patient Navigator Week 24 Percentage of completed patient navigator phone calls. Formula for calculation is mean number of completed phone calls with the patient navigator divided by 6 scheduled phone calls. Range 0 to 100%. The higher the percentage, the better the rate of participant engagement with the patient navigator (i.e., 4 (average) number of completed phone calls divided by 6 scheduled calls = 66.6%).
Rate of Participant Engagement with PainTrainer Week 24 Percentage of completed PainTrainer modules. Formula for calculation is average number of completed PainTrainer modules divided by total number of modules (8). Range 0 to 100%. The closer the percentage to 100%, the better the rate of participant engagement with PainTrainer.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States