Chronic Pain Management In Primary Care Using Behavioral Health Consultants

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04680000
• Other study ID #: HSC20200520H
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Donald McGeary, PhD
• Phone: 210-567-5454
• Email: mcgeary[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 716
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)
BCBT-CP is the standard of care for behavioral management of acute and chronic pain in the Defense Health Agency Stepped Care Pain Pathway. BCBT-CP is a 7-module, CBT-based intervention for the treatment of acute and chronic pain in the primary care setting. The BCBT-CP manual was developed in a collaboration between the Defense Health Agency and the Department of Veterans Affairs as an intervention tailored for use by Behavioral Health Consultants embedded in Military Health System primary care clinics and Patient Centered Medical Homes. Details on BCBT-CP content can be found in the treatment arm description section of this listing.

Other:
• BCBT-CP Booster
The BCBT-CP Booster is a telephone or videoteleconference-based booster contact designed to extend the benefits of the standard of care BCBT-CP intervention. BCBT-CP Booster contacts are not clinical interventions (i.e., no new clinical content is provided), but are intended to help motivate patients to use BCBT-CP module content, problem-solve BCBT-CP skills practice and offer reminders for future appointments. BCBT-CP Booster content was developed using feedback from focus groups with patients who completed standard BCBT-CP treatment in a military primary care clinic. Details on BCBT-CP Booster contacts can be found in the treatment arm description section of this listing.

Locations

Country	Name	City	State
United States	Uniformed Services University for the Health Sciences	Bethesda	Maryland
United States	Carl R. Darnall Army Medical Center	Fort Hood	Texas
United States	Brooke Army Medical Center	San Antonio	Texas
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas
United States	Wilford Hall Ambulatory Surgical Center	San Antonio	Texas

Sponsors (7)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	59th Medical Wing, Brooke Army Medical Center, C.R.Darnall Army Medical Center, Defense Health Agency, Massachusetts General Hospital, Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Alcohol Use Disorders Identification Test (AUDIT-C)	Change in score on a Brief, self-report screening tool for Alcohol Use Disorder using 3 items scored from 0 (never) to 4 (4 or more times a week) with a total possible score of 0 to 12, with a lower score indicating a lower alcohol usage.	Baseline to 18 months
Other	Pain Collaboratory Questionnaires	Change in score on a Standard PMC-3 questionnaires assessing use of Complementary and Integrative Health options for pain management using 2 items scored from 0 (never) to 3 (every day). Total score ranges from 0-8 with a lower score indicting less days of pain.	Baseline to 18 months
Other	UCLA 3-Item Loneliness Scale	Change in score on a Three-item self-report assessment of loneliness with each item scored from 1 (hardly ever) to 3 (often). Total scores range from 3-9, with a lower score indicating less lonliness.	Baseline to 18 months
Other	Effect of Coronavirus Pandemic Questionnaire	Self-report questionnaire about the effect of COVID-19 pandemic on health, coping and healthcare utilization	Baseline to 18 months
Other	Health Questionnaire Addendum	semi-structured interview with some self-report items assessing healthcare utilization for pain management (including pharmacotherapy), acknowledged as Yes/No for current use and Yes/No if prescribed for pain	Baseline to 18 months
Other	Electronic Health Record Review	Review of electronic health record to track pain treatment in the military health system, and number of times the subject has been treated for pain.	Baseline, Final (18-month) follow-up assessment
Other	Treatment Satisfaction Questionnaire	Brief, self-report assessment of treatment satisfaction, rated by the participant by making a vertical mark along a line rated from "Extremely unhelpful" to "Extremely helpful", with 10 graduations.	At 3- and 12-month follow-up assessments
Primary	Defense and Veterans Pain Rating Scale (DVPRS)	Change in score on a Five-item self-report assessment of pain and pain interference. Scoring on each item is from 0, no pain to 10, as bad as the pain could be, nothing else matters. Total possible minimum score is 0 and maximum 50, with 50 being the worst pain.	Baseline to 18 months
Primary	Behavioral Health Measure-20 (BHM-20)	Change in score on a Twenty-item self-report mental health assessment. Scoring is from 0-4 on each item. Possible total scores range from 0 to 80, with lower scores indicating poorer behavioral health.	Baseline to 18 months
Secondary	Pain Intensity, Enjoyment and General Activity (PEG-3)	Change in score on a Three-item pain assessment for primary care scored from 0 (no pain) to 10 (pain as bad as can be imagined). Total scores can range from 0 to 30 with a lower score indicating less pain intensity.	Baseline to 18 months
Secondary	Modified Oswestry Disability Index (ODI)	Change in score on a Ten-item self-report assessment of pain-related disability with each item scored from 0 (least impact) to 5 (most impact). Total score can range from 0 to 50, with a higher score indicating more pain related disability.	Baseline to 18 months
Secondary	Pain Catastrophizing Scale (PCS)	Change in score on a Thirteen-item self-report measure of pain coping each scored out of 4 from 0 (not at all) to 4 (all the time). Totals scores range from 0 to 52, with a lower score indicating better pain coping.	Baseline to 18 months
Secondary	Chronic Pain Acceptance Questionnaire (CPAQ)	Change in score on a Self-report measure of chronic pain acceptance (activity and willingness) with 20 items, each item scored from 0 (never true) to 6 (always true). Total scores range from 0 to 120, with a lower score indicating more pain acceptance.	Baseline to 18 months
Secondary	Insomnia Severity Index (ISI)	Change in score on a Five-item self-report measure of sleep disturbance and insomnia scored from 1 to 4. Total scores range from 0 to 20, with a lower score indicating less insomnia.	Baseline to 18 months
Secondary	Two-Item Patient Health Questionnaire (PHQ-2)	Change in score on a Two-item self-report screening tool for depression with each item scored from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 6, with a lower score indicating better health outlook.	Baseline to 18 months