NCT Number: NCT06091202
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 3
VA Minneapolis Health Care System, Minneapolis, Minnesota, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Nurse-led collaborative care
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.
Other names: One-time Education Session
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Scores are on a range of 0 - 10, with higher scores indicating more severe pain.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
Data on suicidal behaviors will be extracted from the electronic health record.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Time frame: Baseline, 3-, 6-, 9-, and 12 Months
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.
Oregon Health and Science University
Other
Tele-Collaborative Outreach to Rural Patients With Chronic Pain: The CORPs Trial
Acronym: CORPs
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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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