Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain

Not Applicable

• Conditions: Chronic Pain
• Interventions: Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Enhance Fitness; Other: Care Coordination

• Registration Number: NCT06407115
• Lead Sponsor: University of Washington

Brief Summary

Chronic pain affects over 20% U.S. adults and has debilitating effects on quality of life and physical and mental health. Individuals living in rural communities experience higher rates of chronic pain as well as poorer health outcomes due to pain. The 46 million Americans who live in rural areas frequently lack access to evidence-based, non-pharmacologic treatments for chronic pain. As such, a critical need exists to implement effective, comprehensive programs for pain management that include treatment options other than medications. Nurse care management (NCM) has been successfully used to enhance care for individuals with other long-term health issues. The study teams proposes to adapt, pilot, and implement a NCM model that includes care coordination, cognitive behavioral therapy (CBT), and referrals to a remotely delivered exercise program for rural patients with chronic pain.

Detailed Description

Care managers will provide care coordination to help patients address their health holistically and help link them key resources in the community. In addition, the care managers will be trained to deliver cognitive behavioral therapy (CBT) to address unhelpful thought patterns and behaviors around chronic pain and also facilitate patients' participation in EnhanceFitness (tele-EF), an evidence-based exercise program that can be accessed from home. The rationale is that both tele-EF and CBT have been independently shown to improve pain, functioning, and quality of life and that care managers could support patients in accessing and engaging in these services.

This phase allows the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain. Investigators plan to test the intervention in rural serving health care systems using two practice-based research networks with substantial rural presence, the WWAMI (Washington, Wyoming, Alaska, Montana, and Idaho) region Practice and Research Network and Mecklenburg Area Partnership for Primary Care Research in North Carolina. In combination, recruitment in these two networks will allow the study team to reach ethnically diverse participants across broad rural geographies.

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Study Start: 2024-05-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Current primary care patient with one care visit in the last year
• Experience pain for at least 3 months
• Live in a rural area
• Proficient in English
• A mean score ≥ 4 on the Pain, Enjoyment, and General Activities scale

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Exclusion Criteria

• Pain is cancer-related
• Has plans for major surgery in the next 6 months
• Has received skills training or education for pain management in the past 6 months
• Moderate or severe cognitive impairment (documented diagnosis or score 12 or lower on the telephone Montreal Cognitive Assessment)
• Living in a nursing home or inpatient treatment facility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Care Manager Arm	Cognitive Behavioral Therapy (CBT)	In this feasibility pilot, all participants will be assigned to work with a care manager for 6 months and receive all components of the intervention. The care manager will meet with participants in virtual appointments every month to create a care plan and monitor progress. The program will also include: 6-10 sessions of Cognitive Behavioral Therapy (CBT) for chronic pain, which focuses on skills and strategies to empower participants to better manage their pain. Finally, the Care Manager will help refer patients to Enhance Fitness, an online community program that allows users to access instructor-led group exercise classes from home.
Care Manager Arm	Enhance Fitness	In this feasibility pilot, all participants will be assigned to work with a care manager for 6 months and receive all components of the intervention. The care manager will meet with participants in virtual appointments every month to create a care plan and monitor progress. The program will also include: 6-10 sessions of Cognitive Behavioral Therapy (CBT) for chronic pain, which focuses on skills and strategies to empower participants to better manage their pain. Finally, the Care Manager will help refer patients to Enhance Fitness, an online community program that allows users to access instructor-led group exercise classes from home.
Care Manager Arm	Care Coordination	In this feasibility pilot, all participants will be assigned to work with a care manager for 6 months and receive all components of the intervention. The care manager will meet with participants in virtual appointments every month to create a care plan and monitor progress. The program will also include: 6-10 sessions of Cognitive Behavioral Therapy (CBT) for chronic pain, which focuses on skills and strategies to empower participants to better manage their pain. Finally, the Care Manager will help refer patients to Enhance Fitness, an online community program that allows users to access instructor-led group exercise classes from home.

Primary Outcome Measures

Name	Time	Method
Pain Interference	Baseline, Post-intervention (6 months after baseline)	The Pain, Enjoyment and General Activities scale is a validated 3-item, 0-10 rating scale that measures pain intensity and pain interference with enjoyment of life and general activity. The 3 items are averaged to get the mean score (out of 10). A higher score indicates more severe pain and pain-related interference with life and activities.

Secondary Outcome Measures

Name	Time	Method
Physical functioning	Baseline, Post-intervention (6 months after baseline)	The Patient Reported Outcomes Measurement Information (PROMIS) pain interference short form (version 6b) measures changes in functionality. Scores range from 6-30 that are converted to T-scores with a range of 0-100. Higher scores indicate better physical functioning.
Anxiety	Baseline, Post-intervention (6 months after baseline)	The General Anxiety Disorder (7-item) measures anxiety symptoms. Scores range from 0 to 21 with higher scores indicating more severe anxiety.
Unhealthy Substance Use	Baseline, Post-intervention (6 months after baseline)	The Tobacco, Alcohol, Prescription Medication, and Other Substance Use tool is a 4-item screener that identifies unhealthy substance use. Sum scores are not calculated for the 4-item screener. Unhealthy use is any use for the questions about prescription medication and other drugs and monthly use or more for the questions about tobacco and alcohol.
Pain catastrophizing	Baseline, Post-intervention (6 months after baseline)	The Patient Reported Outcomes Measurement Information (PROMIS) 6-item pain catastrophizing scale indicates the degree to which respondents have thoughts and feelings when they are experiencing pain. Scores are computed on a scale of 0-24 with higher scores indicating more catastrophic thoughts.
Sleep Disturbance	Baseline, Post-intervention (6 months after baseline)	The Patient Reported Outcomes Measurement Information (PROMIS) 6-item sleep disturbance short form (version 6a) represents how much difficulty respondents have with sleep. It is scored from 6 to 30 and then converted to T-scores 0-100 with higher scales indicating more sleep problems.
Depression	Baseline, Post-intervention (6 months after baseline)	The Personal Health Questionnaire (8-item) measures depressions symptoms. Scores range from 0 to 24 with higher scores indicating more severe depression.

Trial Locations

Locations (1)

Atrium Health/Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States