Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain (AIM-CP)

Expanding Rural Access to Chronic Pain Care Through Nurse Care Management

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT); Other: Care Coordination; Behavioral: Exercise Counseling and tele-EnhanceFitness; Other: Standard Clinical Practice Regimen

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 physical exercise. One exercise option offered is 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.

Phase 1 allowed the study team to prepare for a randomized controlled trial to test the adapted NCM model with rural patients who have chronic pain. Investigators assessed feasibility of implementing this 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.

Phase 2 is the randomized controlled trial across multiple sites of the integrated NCM model to test whether it is effective in reducing pain interference.

• Study Type: Interventional
• Enrollment (Estimated): 450
• 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:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nurse Care Manager Arm; 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); 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.; Other: Care Coordination; 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.; Behavioral: Exercise Counseling and tele-EnhanceFitness; 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.; Other: Standard Clinical Practice Regimen; Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals.
Active Comparator: Treatment as Usual; 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; Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical functioning	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.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Pain catastrophizing	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.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Sleep Disturbance	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.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Anxiety	The General Anxiety Disorder (7-item) measures anxiety symptoms. Scores range from 0 to 21 with higher scores indicating more severe anxiety.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Unhealthy Substance Use	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.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Depression	The Personal Health Questionnaire (9-item) measures depressions symptoms. Scores range from 0 to 24 with higher scores indicating more severe depression.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Opioid Use	Morphine Milligram Equivalents calculated by extracting prescription data from the electronic health record.	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Healthcare Utilization	Patient reported accounting of health services such as physical therapy, behavioral, primary care, urgent care, emergency room visits and referrals and appointments with specialists and/or allied health professionals (e.g., physical therapy, etc.).	Baseline, Post-intervention (6 months after baseline), 12-month follow-up
Loneliness	The UCLA Loneliness Scale (3-item) will be used to assess loneliness. It is scored on a scale from 3-9, with a threshold of 6 or greater indicating loneliness.	Baseline, Post-Intervention (6 months after baseline) and 12-month follow-up

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Sebastian Tong, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; exercise; telehealth; behavioral health; rural health
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Chronic Pain; Motor Activity; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: STUDY00019595; 1UG3NR020930 (U.S. NIH Grant/Contract); 4UH3NR020930-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All trial outcomes data will be shared according to HEAL Initiative standards in the NIMH Data Archive.
• IPD Sharing Time Frame: The protocol and analysis plan will be published in a peer-reviewed journal. It is pending review.
• IPD Sharing Access Criteria: Open Access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No