Tele-Collaborative Outreach to Rural Patients With Chronic Pain

Chronic Pain Clinical Trial

— CORPs  

Official title:

Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06091202
• Other study ID #: 25384
• Secondary ID: 1UG3AT012257-014
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: September 2027

Study information

• Verified date: June 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial comparing the effectiveness of a remotely delivered collaborative care intervention for chronic pain versus a minimally enhanced control group. The specific aims of the study are: (1) compare the effectiveness of tele-collaborative pain care vs. minimally enhanced usual care to improve pain interference over 12 months of follow-up, and (2) oversample women and rural veterans of minoritized race/ethnicity to test heterogeneity of treatment effects across birth sex and race/ethnicity.

Description:

The CORPs trial is a multisite pragmatic effectiveness trial taking place at four geographically diverse VA sites. The CORPs trial will assess the effectiveness of a nurse-led tele-collaborative pain care intervention (CORPs) compared to a one-time education session with a nurse (minimally enhanced usual care, or MEUC) at improving pain and health outcomes for Veterans living in rural areas. This study focuses on management of pain with non-medication services and therapies.

Veterans who enroll will participate for 12-months and will be randomized to one of 2 groups:

1) CORPs (with access to a nurse by phone/video for the duration of the study), or 2) One-time education session with the nurse by phone/video to review resources for pain. All participants complete research assessments at the start of the study, and at 3-, 6-, 9-, and 12-months by phone.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 608
• Est. completion date: September 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• U.S. Veteran

• Rural Residence based on Rural Urban Commuting Area codes

• High Impact Chronic pain, determined through a phone screening

• Access to landline or cell phone

• English Speaking

Exclusion Criteria:

• Cognitive impairment that would impact participation in the study

• Plans to move in the next 3 months

• Surgery in the past 3 months

• In long-term inpatient or hospice care

• Terminal illness (defined as life expectancy of less than 12 months)

• Active participation in another pain intervention study

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• CORPs Intervention
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.
• Minimally Enhanced Usual Care (MEUC)
Participants will be randomly assigned to the intervention or to the comparator arm. The follow-up period is 12 months. The primary outcome is a change in pain interference. After the baseline assessment, participants will complete a masked telephone assessments with research staff at 3-, 6-, 9-, and 12-months. A subset of individuals may be invited to participate in a qualitative interview at 12-month follow-up.

Locations

Country	Name	City	State
United States	VA North Texas Health Care System	Dallas	Texas
United States	VA Minneapolis Health Care System	Minneapolis	Minnesota
United States	VA Tennessee Valley Health Care System	Nashville	Tennessee
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Oregon Health and Science University	Minneapolis Veterans Affairs Medical Center, National Center for Complementary and Integrative Health (NCCIH), North Texas Veterans Healthcare System, Portland VA Medical Center, VA Tennessee Valley Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Interference - Brief Pain Inventory (BPI)	Pain Interference subscale from the Brief Pain Inventory. Scores are reported on a range of 0 - 10, with higher scores indicating more impairment due to pain.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Pain Intensity - Brief Pain Inventory (BPI)	Scores are on a range of 0 - 10, with higher scores indicating more severe pain.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Physical Functioning - PROMIS Physical Functioning Scale	Physical Functioning will be assessed with the 4-item PROMIS Physical Functioning scale. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with one representing a better outcome.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Quality of Life - Veterans RAND-12 (VR-12)	Quality of Life will be assessed with the Veterans RAND 12-item Health Survey (VR-12). VR-12 scores are summarized into two scores, a Physical Health component score and a Mental Health component score. Each component score is on a range of 0 - 100, with higher scores indicating more impairment in physical or mental health, respectively.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Depressive Symptoms - Patient Health Questionnaire-9 (PHQ-9)	Depressive symptoms will be assessed with the Patient Health Questionnaire-9 (PHQ-9). Scores on the PHQ-9 range from 0 - 24, with higher scores indicating more severe symptoms of depression.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Anxiety Symptoms - Generalized Anxiety Disorder-7 (GAD-7)	Anxiety symptoms will be assessed with the Generalized Anxiety Disorder-7 (GAD-7) questionnaire. Scores on the PHQ-9 range from 0 - 24, with higher scores indicating more severe symptoms of depression. Scores on the GAD-7 range from 0 - 21, with higher scores indicating more severe symptoms of anxiety.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Suicidal Behavior - Electronic Health Record (EHR)	Data on suicidal behaviors will be extracted from the electronic health record.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Quality of Sleep - PROMIS Sleep Disturbance Scale	Quality of sleep will be assessed with the PROMIS Sleep Disturbance 4-item short-form. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with one representing a better outcome.	Baseline, 3-, 6-, 9-, and 12 Months
Secondary	Engagement in Non-Pharmacological Services/Treatments - Nonpharmacological Self-Care Approaches survey (NSCAP)	Engagement in nonpharmacological pain treatment will be assess with the Use of Nonpharmacological Self-Care Approaches survey (NSCAP). This survey assesses the number of times each of 9 treatments were used in the past 3 months.	Baseline, 3-, 6-, 9-, and 12 Months