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

Investigating the Use of A Patient Navigator to Address the Social Drivers of Health in the Management of Pain: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer); Behavioral: Social Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PainTrainer Followed by Social Intervention; 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); 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: Social Intervention; At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.
Experimental: Social Intervention Followed by PainTrainer; 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); 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: Social Intervention; At least six phone call visits, plus or minus 4, with patient navigator to coordinate care.
Experimental: PainTrainer Only; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain, Enjoyment, General Activity (PEG) Survey	Pain, Enjoyment, General Activity (PEG) Survey asks three questions about pain severity. Total score range is 0-30. Higher scores represent worse pain.	Baseline, Week 12, Week 24
PROMIS Sleep Disturbance 6a+ Sleep Duration	PROMIS Sleep Disturbance 6a+ Sleep Duration is a 13 question survey about sleep "over the past 7 days." Total score range from 13-65. Higher score indicates worse sleep and sleep related impairment.	Baseline, Week 12, Week 24
Pain Catastrophizing Scale	Pain Catastrophizing Scale is a 6 question survey about how often a patient thinks catastrophically about their pain. Total scores range from 0-24. Higher score indicates increased thoughts and time spent on thinking about their pain.	Baseline, Week 12, Week 24
PHQ-8	PHQ-8 is an 8 question survey assessing depression severity. Total score range from 0-24. Higher score indicates more severe depression.	Baseline, Week 12, Week 24
GAD-7	GAD-7 is a 7 question survey assessing general anxiety "over the last 2 weeks." Total score range from 0-21. Higher score indicates more severe anxiety.	Baseline, Week 12, Week 24
World Health Organization Quality of Life Survey	World Health Organization Quality of Life is a 2 question survey assessing patient perception of quality of life. Total score range from 2-10 for each question. Higher score indicates high quality of life perception.	Baseline, Week 12, Week 24
UCLA Loneliness Scale	UCLA Loneliness Scale is a 3 question survey assessing social isolation. Total score range from 3-9. Higher score indicates higher level of social isolation.	Baseline, Week 12, Week 24
PROMIS Physical Functioning Short Form 6b	PROMIS Physical Functioning Short Form 6b is a 6 question survey about ability to perform basic physical daily activities. Total score range is 6-30. Higher score indicates better functioning.	Baseline, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Dennis Ang, MD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Actual): October 7, 2025
• Study Completion (Actual): October 7, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: pain management; musculoskeletal pain; daily pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Musculoskeletal Pain; Agnosia; Health Services; Health Care Facilities Workforce and Services; Social Work
• Other Study ID Numbers: IRB00118893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No