Clinical trial NCT06665906: Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain
Official title: Investigating the Use of A Patient Navigator to Address the Social Drivers of Health in the Management of Pain: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: daily pain
musculoskeletal pain
pain management
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of Participant Recruitment
timeFrame: Through study completion, on average 16 months
measure: Rate of Participant Retention
timeFrame: Week 24
measure: Rate of Participant Engagement with Patient Navigator
timeFrame: Week 24
measure: Rate of Participant Engagement with PainTrainer
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
measure: Pain, Enjoyment, General Activity (PEG) Survey
timeFrame: Baseline, Week 12, Week 24
measure: PROMIS Physical Functioning Short Form 6b
timeFrame: Baseline, Week 12, Week 24
measure: PROMIS Sleep Disturbance 6a+ Sleep Duration
timeFrame: Baseline, Week 12, Week 24
measure: Pain Catastrophizing Scale
timeFrame: Baseline, Week 12, Week 24
measure: PHQ-8
timeFrame: Baseline, Week 12, Week 24
measure: GAD-7
timeFrame: Baseline, Week 12, Week 24
measure: World Health Organization Quality of Life Survey
timeFrame: Baseline, Week 12, Week 24
measure: UCLA Loneliness Scale
timeFrame: Baseline, Week 12, Week 24
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist
name: Dennis Ang, MD
role: PRINCIPAL_INVESTIGATOR
References: