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Enrolling by Invitation

NCT Number: NCT06407115

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

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.

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Key information

Conditions

Chronic Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health/Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Standard Clinical Practice Regimen

Other

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

Primary outcomes

  1. Pain Interference

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

    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 outcomes

  1. Physical functioning

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

    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.

  2. Pain catastrophizing

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

    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.

  3. Sleep Disturbance

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

    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.

  4. Depression

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

    The Personal Health Questionnaire (9-item) measures depressions symptoms. Scores range from 0 to 24 with higher scores indicating more severe depression.

  5. Anxiety

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

    The General Anxiety Disorder (7-item) measures anxiety symptoms. Scores range from 0 to 21 with higher scores indicating more severe anxiety.

  6. Unhealthy Substance Use

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

    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.

  7. Opioid Use

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

    Morphine Milligram Equivalents calculated by extracting prescription data from the electronic health record.

  8. Healthcare Utilization

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

    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.).

  9. Loneliness

    Time frame: Baseline, Post-Intervention (6 months after baseline) and 12-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Expanding Rural Access to Chronic Pain Care Through Nurse Care Management

Acronym: AIM-CP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 9, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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