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

Official title

Expanding Rural Access to Chronic Pain Care Through Nurse Care Management

Overview

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 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.

Interventions

• 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.
• 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 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.
• Other Standard Clinical Practice Regimen
  Routine clinical care provided by the primary care team. This may include, consultations, medications, and referrals.

Primary outcome measures

• Pain Interference [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]

Secondary outcome measures (9)

• Physical functioning [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Pain catastrophizing [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Sleep Disturbance [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Depression [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Anxiety [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Unhealthy Substance Use [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Opioid Use [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Healthcare Utilization [Time frame: Baseline, Post-intervention (6 months after baseline), 12-month follow-up]
• Loneliness [Time frame: Baseline, Post-Intervention (6 months after baseline) and 12-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Atrium Health/Wake Forest Baptist — Winston-Salem

Publications

• Keiser B, Cortez K, Hoffman E, Wang J, Reeves K, Humbert A, Bailey RW, Shaw Welch S, Jawort S, Baldwin LM, Holtzer C, Tapp H, Ludden T, Belza B, Patel KV, Tong ST. Expanding rural access to chronic pain care through nurse care management: A hybrid type I effectiveness-implementation trial protocol. PLoS One. 2026 May 27;21(5):e0349526. doi: 10.1371/journal.pone.0349526. eCollection 2026. PMID 42201860

Identifiers

NCT: NCT06407115 · STUDY00019595 · 1UG3NR020930 · 4UH3NR020930-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗