RECRUITING

Chronic Pain Management In Primary Care Using Behavioral Health Consultants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeting Chronic Pain in Primary Care Settings Using Behavioral Health Consultants, A Randomized Pragmatic Trial

Quick Facts

Study Start:2021-08-17
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04680000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. DoD/MHS beneficiary (including active duty service members, veterans, and family members) age 18 and older.
  2. 2. 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).
  3. 3. Referred for BCBT-CP with a BHC by a Primary Care provider.
  4. 4. Speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.
  1. 1. Scheduled for a planned pain-related surgery or pain intervention within 6 weeks of enrollment (because the intervention may obscure BCBT-CP outcomes).
  2. 2. Inability or unwillingness of individual to give written informed consent.
  3. 3. Experiencing another health problem of higher priority for care or that prohibits ability to attend BCBT-CP or research appointments.
  4. 1. BHC trained to deliver care according to the Chronic Pain Clinical Pathway
  5. 2. Clinic providers/staff caring for patient participants enrolled in this study

Contacts and Locations

Study Contact

Donald McGeary, PhD
CONTACT
210-567-5454
mcgeary@uthscsa.edu

Principal Investigator

Donald J McGeary, PhD
PRINCIPAL_INVESTIGATOR
UT Health San Antonio

Study Locations (Sites)

Uniformed Services University for the Health Sciences
Bethesda, Maryland, 20814
United States
Carl R. Darnall Army Medical Center
Fort Hood, Texas, 76544
United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
United States
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, 78236-9908
United States
Brooke Army Medical Center
San Antonio, Texas, 78257
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

  • Donald J McGeary, PhD, PRINCIPAL_INVESTIGATOR, UT Health San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-17
Study Completion Date2027-01

Study Record Updates

Study Start Date2021-08-17
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Chronic Pain
  • CBT
  • Behavioral Health Consultant
  • Primary Care

Additional Relevant MeSH Terms

  • Chronic Pain