Clinical trial NCT04680000: Chronic Pain Management In Primary Care Using Behavioral Health Consultants
Official title: Targeting Chronic Pain in Primary Care Settings Using Behavioral Health Consultants, A Randomized Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
CBT
Behavioral Health Consultant
Primary Care
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Uniformed Services University of the Health Sciences
name: Massachusetts General Hospital
name: Defense Health Agency
name: 59th Medical Wing
name: Brooke Army Medical Center
name: C.R.Darnall Army Medical Center
First posted: 2020-12-22
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic trial randomizing to two conditions (standard BCBT-CP and BCBT-CP + Booster) in a 1:1 ratio at the level of the individual
Primary purpose: TREATMENT

Brief 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.

Detailed description: The proposed study is the first effort to test a manualized cognitive-behavioral therapy intervention for chronic pain delivered by behavioral health providers working in primary care clinics. If successful, findings from this study will inform Defense Health Agency (DHA) policy nationwide. The study teams' DHA collaborators write these policies and the PIs are active participants in the DHA MHS Stepped Care Pain Pathway workgroup. Data from this study will inform military, VA and civilian primary care services about the contribution of integrated behavioral health pain management to pain outcomes, healthcare utilization, and satisfaction with care.

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.

Active Comparator: Standard BCBT-CP

Brief Cognitive Behavior Therapy for Chronic Pain (BCBT-CP) is a seven-module intervention for chronic pain based on the efficacious specialty-care, ten-session version of this treatment called Cognitive Behavioral Therapy for Chronic Pain (CBT-CP). CBT-CP has been disseminated throughout the VA healthcare system as a manualized, non-pharmacological intervention for chronic pain (Stewart et al., 2015). Preliminary studies of CBT-CP found that most patients completed all ten CBT-CP modules (Stewart et al., 2015) and better outcomes were associated with home-based skills practice (Edmond et al., 2017). One study of CBT-CP in the VA found that over 50% of patients who were offered the treatment declined and individuals with a history of opioid use were under-engaged for this efficacious treatment (Higgins et al., 2018). Thus, the DHA abbreviated CBT-CP to only seven modules for implementation in primary care, where most patients with pain are seen (including those with active and past opioid use). The seven modules are:

(A) Assessment, engagement and goal setting, (B) Education on chronic pain and relaxation training, (C) Discussion of the importance of activity engagement and pacing, (D) Progressive muscle relaxation and guided imagery, (E) Identifying thoughts that negatively impact pain, (F) Modifying thoughts that negatively impact pain, and (G) Developing an action plan.

Patients are encouraged to complete a minimum of four modules with their provider (i. e., A, B, G, and at least one additional module). BCBT-CP was developed in collaboration with the developers of CBT-CP to establish a brief version of protocol suitable for delivery by BHCs working in MHS Primary Care clinics.

Each module appointment lasts approximately 30 minutes and includes the following treatment components:

Introduction to the module and confirmation of session agenda Check on mood and completion of patient measures (DVPRS, PEG-3, BHM-20, PHQ-9, PCL-5) Review of material from previous modules, including home practice Introduction of the new material and answer questions Module wrap-up BHCs are trained by the DHA on how to effectively introduce and "sell" BCBT-CP to patients and have access to supplemental and appended materials to address comorbidities.

BCBT-CP Booster Contacts are intended to refresh BCBT-CP content without introducing new skills. To accomplish this, Booster Contacts are manualized (see appended Booster Protocol form) to cover: assessment of pain since last BCBT-CP appointment, refresh BCBT-CP module content, and remind about next BCBT-CP appointment.

Booster contacts will be scheduled 1-week following each BCBT-CP module. Booster contacts will occur at least one week after a BCBT-CP module but no more than 2 weeks after a BCBT-CP module. Following completion of care on the BCBT-CP pathway, booster contacts will continue monthly through month 12 of study participation. Depending on how often the BHC can meet with the patient-participant to receive module care, participants could have a varying number of booster calls, but based on the investigators' pilot study when patients could only meet with their BHC on average once a month, the investigators believe that most patients will receive 12 booster contacts. The booster contacts may occur via telephone or video conferencing and will be audio-recording using and independent device (separate from the conferencing platform, e.g. Zoom).

All Booster providers (research staff) will receive a two-hour training on conducting Booster Contacts from the study PIs including description of how to complete the BCBT-CP Booster Protocol Form.

National data pull for will include healthcare utilization data for all individuals with identified musculoskeletal pain treated in the Military Health System in a clinic with an identified BHC trained to provide BCBT-CP between Jan 2018 and Dec 2024. The data pull will be coordinated in collaboration with the Defense Health Agency and the Uniformed Services University Center for Rehabilitation Sciences Research. The group will complete a DRT request to identify data items to collect, establish a data management and transfer plan (including a plan for deidentifying data) and an analysis plan (analysis to complete with collaborators at Harvard Medical School).

Eligibility criteria: Inclusion Criteria:

1. DoD/MHS beneficiary (including active duty service members, veterans, and family members) age 18 and older.
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. Referred for BCBT-CP with a BHC by a Primary Care provider.
4. Speaks and reads/understands English well enough to fully participate in the intervention and to reliably complete assessment measures.

Exclusion Criteria:

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. Inability or unwillingness of individual to give written informed consent.
3. Experiencing another health problem of higher priority for care or that prohibits ability to attend BCBT-CP or research appointments.

Some research activities (i.e., Focus Groups) will include Clinic Providers and Staff:

Inclusion Criteria for Clinic Provider/Staff Participants

1. BHC trained to deliver care according to the Chronic Pain Clinical Pathway
2. Clinic providers/staff caring for patient participants enrolled in this study

Exclusion Criteria for Clinic Provider/Staff Participants: none

Primary outcomes:
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Baseline to 18 months
measure: Behavioral Health Measure-20 (BHM-20)
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: Pain Intensity, Enjoyment and General Activity (PEG-3)
timeFrame: Baseline to 18 months
measure: Modified Oswestry Disability Index (ODI)
timeFrame: Baseline to 18 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 18 months
measure: Chronic Pain Acceptance Questionnaire (CPAQ)
timeFrame: Baseline to 18 months
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline to 18 months
measure: Two-Item Patient Health Questionnaire (PHQ-2)
timeFrame: Baseline to 18 months
Other outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT-C)
timeFrame: Baseline to 18 months
measure: Pain Collaboratory Questionnaires
timeFrame: Baseline to 18 months
measure: UCLA 3-Item Loneliness Scale
timeFrame: Baseline to 18 months
measure: Effect of Coronavirus Pandemic Questionnaire
timeFrame: Baseline to 18 months
measure: Health Questionnaire Addendum
timeFrame: Baseline to 18 months
measure: Electronic Health Record Review
timeFrame: Baseline, Final (18-month) follow-up assessment
measure: Treatment Satisfaction Questionnaire
timeFrame: At 3- and 12-month follow-up assessments
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University for the Health Sciences
state: Maryland
city: Fort Hood
country: United States
facility: Fort Cavazos
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Donald J McGeary, PhD
role: PRINCIPAL_INVESTIGATOR
References: