Targeting Chronic Pain in Primary Care Settings Using Behavioral Health Consultants, A Randomized Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 716
- 试验地点
- 10
- 主要终点
- Defense and Veterans Pain Rating Scale (DVPRS)
研究概览
简要总结
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. 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Pragmatic trial using a behavioral intervention. Treatment condition cannot be masked to the provider, patient or booster contact personnel. Assessments are self-report.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Some research activities (i.e., Focus Groups) will include Clinic Providers and Staff:
- •Inclusion Criteria for Clinic Provider/Staff Participants
- •BHC trained to deliver care according to the Chronic Pain Clinical Pathway
- •Clinic providers/staff caring for patient participants enrolled in this study
- •Exclusion Criteria for Clinic Provider/Staff Participants: none
研究组 & 干预措施
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).
干预措施: Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) (Behavioral)
Standard BCBT-CP with Telephone Booster
Participants will receive standard BCBT-CP as described in the Standard BCBT-CP arm. They will also receive telephone or video teleconference booster contacts as follows:
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 contact, review of most recent BCBT-CP module(s) and reminder about the next BCBT-CP appointment (if one is scheduled).
干预措施: Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) (Behavioral)
Standard BCBT-CP with Telephone Booster
Participants will receive standard BCBT-CP as described in the Standard BCBT-CP arm. They will also receive telephone or video teleconference booster contacts as follows:
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 contact, review of most recent BCBT-CP module(s) and reminder about the next BCBT-CP appointment (if one is scheduled).
干预措施: BCBT-CP Booster (Other)
结局指标
主要结局
Defense and Veterans Pain Rating Scale (DVPRS)
时间窗: Baseline to 18 months
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.
Behavioral Health Measure-20 (BHM-20)
时间窗: Baseline to 18 months
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.
次要结局
- Pain Intensity, Enjoyment and General Activity (PEG-3)(Baseline to 18 months)
- Modified Oswestry Disability Index (ODI)(Baseline to 18 months)
- Pain Catastrophizing Scale (PCS)(Baseline to 18 months)
- Insomnia Severity Index (ISI)(Baseline to 18 months)
- Chronic Pain Acceptance Questionnaire (CPAQ)(Baseline to 18 months)
- Two-Item Patient Health Questionnaire (PHQ-2)(Baseline to 18 months)