Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain

NCT06665906 | Completed

• 1 other identifier: IRB00118893
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

daily pain; musculoskeletal pain; pain management

Outcome Measures

Primary Outcomes (4)

• Rate of Participant Recruitment

  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).

  Through study completion, on average 16 months

• Rate of Participant Retention

  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%).

  Week 24

• Rate of Participant Engagement with Patient Navigator

  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%).

  Week 24

• Rate of Participant Engagement with PainTrainer

  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.

  Week 24

Other Outcomes (8)

• Pain, Enjoyment, General Activity (PEG) Survey

  Baseline, Week 12, Week 24

• PROMIS Physical Functioning Short Form 6b

  Baseline, Week 12, Week 24

• PROMIS Sleep Disturbance 6a+ Sleep Duration

  Baseline, Week 12, Week 24

Study Arms (3)

PainTrainer Followed by Social Intervention

EXPERIMENTAL

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is 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. At Week 12, social intervention will begin. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer); Behavioral: Social Intervention

Social Intervention Followed by PainTrainer

EXPERIMENTAL

Participants will have social intervention at study entry. Social intervention includes at least six phone call visits, plus or minus 4, with patient navigator to coordinate care. At week 12, web-based cognitive behavior therapy (PainTrainer) will begin. PainTrainer is 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.

Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer); Behavioral: Social Intervention

PainTrainer Only

EXPERIMENTAL

At study entry participants will receive web-based cognitive behavior therapy (PainTrainer) which is 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.

Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer)

Interventions

Web-Based Cognitive Behavioral Therapy (PainTrainer) BEHAVIORAL

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.

PainTrainer Followed by Social Intervention; PainTrainer Only; Social Intervention Followed by PainTrainer

Social Intervention BEHAVIORAL

At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.

PainTrainer Followed by Social Intervention; Social Intervention Followed by PainTrainer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pain; Musculoskeletal Pain; Agnosia

Interventions

Social Work

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dennis Ang, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 30, 2024
• Study Start: November 19, 2024
• Primary Completion: October 7, 2025
• Study Completion: October 7, 2025
• Last Updated: January 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)