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

NCT06407115 | Enrolling By Invitation DMC

• 3 other identifiers: STUDY000195951UG3NR0209304UH3NR020930-02
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

chronic pain; behavioral health; rural health; telehealth; exercise

Outcome Measures

Primary Outcomes (1)

• Pain Interference

  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.

  Baseline, Post-intervention (6 months after baseline), 12-month follow-up

Secondary Outcomes (9)

• Physical functioning

  Baseline, Post-intervention (6 months after baseline), 12-month follow-up

• Pain catastrophizing

  Baseline, Post-intervention (6 months after baseline), 12-month follow-up

• Sleep Disturbance

  Baseline, Post-intervention (6 months after baseline), 12-month follow-up

• Depression

  Baseline, Post-intervention (6 months after baseline), 12-month follow-up

• Anxiety

  Baseline, Post-intervention (6 months after baseline), 12-month follow-up

Study Arms (2)

Nurse Care Manager Arm

EXPERIMENTAL

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 counsel participants on physical exercise and refer patients to tele-EnhanceFitness, an online community program that allows users to access instructor-led group exercise classes from home.

Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Exercise Counseling and tele-EnhanceFitness; Other: Care Coordination; Other: Standard Clinical Practice Regimen

Treatment as Usual

ACTIVE COMPARATOR

In the Treatment as Usual arm, participants will continue receiving routine care from their primary care team. This may include referrals to specialists or allied health professionals, Given the heterogeneity among patients and between sites, it will be characterized in research assessments to allow for transparent reporting.

Other: Standard Clinical Practice Regimen

Interventions

Standard Clinical Practice Regimen OTHER

Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals.

Nurse Care Manager Arm; Treatment as Usual

Care Coordination OTHER

Care manager will meet with patient in virtual sessions once a month to create a care plan and monitor progress. Care manager will assess social determinants of health and link participants to resources in the community as appropriate. In addition, participants will take monthly assessments about pain and mood to help guide clinical decision making.

Nurse Care Manager Arm

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

CBT in this study will consist of a series of 6-10, 30-45-minute sessions with the care manager. These 1-on-1 sessions will occur every week or every other week virtually. Content will be focus on addressing unhelpful thinking and small behavioral changes that may help participants better manage their pain.

Nurse Care Manager Arm

Exercise Counseling and tele-EnhanceFitness BEHAVIORAL

Participants will be counseling on physical exercise and encouraged enroll in instructor-led exercises classes for up to an hour, 3 days per week. These classes can be accessed from home. Data plans and tablets are available to aid participants that need them to gain access to the classes.

Nurse Care Manager Arm

Eligibility Criteria

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

You may qualify if:

• Current primary care patient with one care visit in the last year
• Have a chronic pain diagnosis (more than 3 months)
• Live in a rural area
• Proficient in English or Spanish
• A total score ≥ 12 on the 3-item Pain, Enjoyment, and General Activities scale

You may not qualify if:

• Ongoing treatment with chemotherapy and/or radiation therapy
• Scheduled surgical procedures 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 Alzheimer's or dementia diagnosis in EHR or score 12 or lower on the telephone Montreal Cognitive Assessment)
• Living in a nursing home or inpatient treatment facility
• Receipt of palliative care

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): collaborator
• University of Washington: lead

Study Sites (1)

Atrium Health/Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sebastian Tong, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine

Model Details: Phase 1: Feasibility phase with a single intervention arm. Phase 2: RCT with two arms: the NCM model and treatment as usual.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The protocol and analysis plan will be published in a peer-reviewed journal. It is pending review.
• Access Criteria: Open Access

Locations

US (1)