Chronic Pain Management In Primary Care Using Behavioral Health Consultants (NCT04680000) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Chronic Pain Management In Primary Care Using Behavioral Health Consultants
United States716 participantsStarted 2021-08-17
Plain-language summary
The purpose of this randomized pragmatic trial is to assess the effect of monthly booster contacts on long-term Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) pain outcomes compared to BCBT-CP without a booster in 716 Military Health Systems (MHS) beneficiaries referred to a Behavioral Health Consultant (BHC) for pain management using BCBT-CP. Patients will be randomly assigned to receive either standard BCBT-CP (working with a BHC in the medical home clinic) or standard BCBT-CP with adjunctive monthly booster contacts. Additionally, patient participants and clinic providers and staff will be offered the opportunity to participate in separate post-treatment Focus Groups using a semi-structured interview format designed to assess the usability, ease of use, perceived effectiveness, helpfulness, and barriers to the pain management intervention. Patient participants will be assessed 3-, 6-, 12- and 18-Months following their first appointment for BCBT-CP. Prospective data will be supplemented by a national data pull in collaboration with the Defense Health Agency and the Uniformed Services University Center for Rehabilitation Sciences Research. Pulled data will include a national deidentified dataset of electronic health record data for all individuals treated in the military health system who had access to a Behavioral Health Consultant for the treatment under study in this trial.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. DoD/MHS beneficiary (including active duty service members, veterans, and family members) age 18 and older.
✓. Presenting with a chronic pain complaint (pain occurring more days than not over the past three months that is ongoing at the time of baseline evaluation).
✓. Referred for BCBT-CP with a BHC by a Primary Care provider.
✓. Speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.
Exclusion criteria
✕. Scheduled for a planned pain-related surgery or pain intervention within 6 weeks of enrollment (because the intervention may obscure BCBT-CP outcomes).
✕. Inability or unwillingness of individual to give written informed consent.
✕. Experiencing another health problem of higher priority for care or that prohibits ability to attend BCBT-CP or research appointments.
✕. BHC trained to deliver care according to the Chronic Pain Clinical Pathway
What they're measuring
1
Defense and Veterans Pain Rating Scale (DVPRS)
Timeframe: Baseline to 18 months
2
Behavioral Health Measure-20 (BHM-20)
Timeframe: Baseline to 18 months
Trial details
NCT IDNCT04680000
SponsorThe University of Texas Health Science Center at San Antonio