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

Chronic Pain Clinical Trial

— AIM-CP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06407115
• Other study ID #: STUDY00019595
• Secondary ID: 1UG3NR020930
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: May 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.
• Enhance Fitness
Participants will be encouraged to 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.

Locations

Country	Name	City	State
United States	Atrium Health/Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Depression	The Personal Health Questionnaire (8-item) measures depressions symptoms. Scores range from 0 to 24 with higher scores indicating more severe depression.	Baseline, Post-intervention (6 months after baseline)
Secondary	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)
Secondary	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)