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

Wake Forest University (WFU)

Status: Completed

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06665906

IRB00118893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

PainTrainer Followed by Social Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer)

Behavioral: Social Intervention

Social Intervention Followed by PainTrainer

Experimental group

Description:

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.

Treatment:

Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer)

Behavioral: Social Intervention

PainTrainer Only

Experimental group

Description:

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.

Treatment:

Behavioral: Web-Based Cognitive Behavioral Therapy (PainTrainer)