Clinical trial NCT06407115: Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain
Official title: Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Pain
Keywords: chronic pain
behavioral health
rural health
telehealth
exercise
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility phase to prepare for randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Pain Interference
timeFrame: Baseline, Post-intervention (6 months after baseline)
Secondary outcomes:
measure: Physical functioning
timeFrame: Baseline, Post-intervention (6 months after baseline)
measure: Pain catastrophizing
timeFrame: Baseline, Post-intervention (6 months after baseline)
measure: Sleep Disturbance
timeFrame: Baseline, Post-intervention (6 months after baseline)
measure: Depression
timeFrame: Baseline, Post-intervention (6 months after baseline)
measure: Anxiety
timeFrame: Baseline, Post-intervention (6 months after baseline)
measure: Unhealthy Substance Use
timeFrame: Baseline, Post-intervention (6 months after baseline)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health/Wake Forest Baptist
state: North Carolina
Study officials:
affiliation: University of Washington
name: Sebastian Tong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: