Pragmatic RCT of SBIRT-PM
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04062214|
Recruitment Status : Not yet recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorders Pain||Behavioral: SBIRT-PM||Not Applicable|
In 2015 alone, 97,223 new Veterans under age 35 began receiving compensation for injuries related to their military service. In total, there are 559,999 post-9/11 Veterans being compensated for back or neck conditions, and a partially overlapping 596,250 for limitation of flexion in joints. Veterans seeking compensation for musculoskeletal conditions often develop chronic pain and are at high risk for substance misuse. Early intervention is needed to arrest worsening pain and risky substance use, particularly among post-9/11 Veterans for whom engagement in non-pharmacological pain treatment has the potential to improve their overall quality of life and spare them the complications of opioid treatments. The service-connection application is an ideal point-of contact for initiating early intervention treatments for these at-risk Veterans. The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM), designed to reduce pain and risky substance use. In brief, the counselor explains that treating both physical and psychological aspects of pain leads to the best outcomes, outlines what VA (and non-VA if preferred) services are available to Veterans, explains that substances are sometimes used for pain relief, and segues into traditional SBIRT. SBIRT-PM's efficacy is supported by a completed clinical trial of 101 Veterans applying for service-connection for MSD, and by studies showing the efficacy of SBIRT for people with risky substance use and of Motivational Interviewing for engagement in non-pharmacological pain care.
During a two-years pilot study, the study team prepared SBIRT-PM for implementation by establishing communication (Relational Coordination is the theoretical framework) between the "hub" where the SBIRT-PM clinician is sited and the "spoke" sites, establishing study related procedures, and piloting the intervention at each of the eight VA medical centers in New England.
In this full clinical trial, investigators will randomize 1100 Veterans applying for compensation related to MSD to either SBIRT-PM or Usual Care (UC) across eight VA medical centers in New England. Outcome assessment by phone will occur at 12 and 36-week follow-ups, and will be corroborated with other sources of information ---the electronic health record and toxicology testing of nail clippings. Investigators hypothesize that, compared to Usual Care, SBIRT-PM will be more effective and cost-effective in improving Veterans' pain and substance use. Investigators further hypothesize that a mediator of these improvements will be use of non-pharmacological services, as extracted from VA records from structured data fields and from narrative text in the medical record using an innovative natural language processing algorithm. Screening and referral to treatment at service-connection examinations can transform a widely-used point of entry to VA into a health promoting encounter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants receive either usual care or study intervention|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Research Assistants collect data from participant interviews at 12 and 36 weeks follow-up. They will be blind to randomization condition.|
|Official Title:||Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed to promote engagement in multi-modal non-pharmacological pain management among compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with the Veteran after the compensation examination to address the presenting MSD complaint. The clinician addresses Veterans' motivation for multi-modal pain care, and explains how pain can be managed using a variety of non-pharmacological pain management services. The clinician spells out how those services can be accessed at VA. Using permissive language about how pain is commonly self-medicated with substances, the clinician transitions to inquiries about use of prescription and non-prescription substances. The clinician then attempts to motivate Veterans to change their behavior if they are misusing substances. Thus, SBIRT-PM addresses the Veteran's presenting pain complaint first and nascent substance use subsequently.
SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.
No Intervention: Usual Care
A Veteran who completes a Compensation examination ordinarily has no further treatment, referral or debriefing as part of the Compensation examination. Veterans will be advised that they should continue to pursue whatever counseling they need outside the study.
- change in Pain Severity subscale of Brief Pain Inventory [ Time Frame: 36 weeks ]Pain Severity subscale of Brief Pain Inventory uses a 0-10 numeric rating scale (0=no pain to 10=pain as bad as you can imagine) to measure four pain severity items: "worst" pain in the last 24 hours, "least" pain in the last 24 hours, "average" pain, and pain right "now". The pain severity subscale is scored as a composite of the four pain items (mean severity score).
- Change in number of Problem Substances measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [ Time Frame: 36 weeks ]Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed to detect and manage substance use and related problems. Substance use will be measured over the last 3 months using Version 3.1.After a screening question focusing on substances ever used, the ASSIST consists of 7 questions about use of and consequences of use of each of 11 classes of substances over the preceding three months (including nicotine, THC and medical THC). Scores are generated for each substance that are mapped to a three-point ordinal score of severity: "no need for treatment", "need for a brief intervention" and "need for an intensive intervention". When a positive toxicology result disagrees with a self-report of no use, the middle value on the ordinal scale (brief intervention) will be derived and used as the primary substance use outcome. The number of problem substances are defined as the number of substances above the "no intervention" threshold
- Cost-Effectiveness Ratios (ICERs) [ Time Frame: 36 weeks ]Total costs divided by quality-adjusted life years
- Cost-Effectiveness Acceptability curves (CEACs) [ Time Frame: 36 weeks ]Probability that SBIRT is cost-effective compared to usual care over a range of monetary values that a decision-maker might consider the maximum acceptable to avoid to improve pain
- non-pharmacological pain service utilization [ Time Frame: 36 weeks ]Number of modalities of non-opioid pain services used will be assessed using a modified version of the Pain Management Collaboratory's "non-pharmacological and self-care approaches" questionnaire. This questionnaire asks about use of a list of 3 pharmacological and 23 non-pharmacological pain treatment modalities. For each modality, respondents indicate if the treatment was used in the past three months, if the treatment was delivered in an individual or group setting or if done on own (self-care), and the number of sessions/visits attended in the past 3 months. Number of non-pharmacological modalities will be summed.
- Pain Interference subscale of Brief Pain Inventory [ Time Frame: 36 weeks ]Pain interference subscale of Brief Pain Inventory uses a 0-10 numeric rating scale (0=no interference to 10=interferes completely) to measure seven daily activities: general activity, walking, work, mood, enjoyment of life, relations with others, sleep. The pain interference subscale is scored as the mean of the seven interference items. This mean can be used if more than 50% (4/7 items) have been completed on a given administration.
- Overall Health measured by EQ-5D-5L [ Time Frame: 36 weeks ]The Eq-5D-5L is a standardized measure of health status designed to provide a single index value of health utility for clinical and economic appraisals. It consists of 5 dimensions in the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. A 6th question asks respondent to rate his health today on a scale from 0-100. The 5 dimensions are combined in a 5-digit number describing the respondent's health state. A total of 3125 possible health states are defined and can be used to calculate quality-adjusted life years (QALYs) used to inform the economic evaluation.
- Individual substances of misuse generated by the ASSIST, and nail clipping toxicology [ Time Frame: 36 weeks ]
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed to detect and manage substance use and related problems. Substance use will be measured over the last 3 months using Version 3.1. After a screening question focusing on substances ever used, the ASSIST consists of 7 questions about use of and consequences of use of each of 11 classes of substances over the preceding three months (including nicotine, THC and medical THC). Scores are generated for each substance that are mapped to a three-point ordinal score of severity: "no need for treatment", "need for a brief intervention" and "need for an intensive intervention". When a positive toxicology result disagrees with a self-report of no use, the middle value on the ordinal scale (brief intervention) will be derived and used as the primary substance use outcome.
Individual substances rated above the "no intervention" threshold will be analyzed here.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062214
|Contact: Christina Lazar, MPH||203-932-5711 ext firstname.lastname@example.org|
|United States, Connecticut|
|Yale University||Not yet recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Christina Lazar, MPH 203-932-5711 email@example.com|
|Contact: Marc I Rosen, MD|
|VA Connecticut Healthcare System (VACHS)||Not yet recruiting|
|West Haven, Connecticut, United States, 06516|
|Contact: Christina Lazar, MPH 203-932-5711 ext 4833 firstname.lastname@example.org|
|Contact: Marc I Rosen, MD|
|Principal Investigator:||Marc Rosen, MD||Yale University/ VA Connecticut Healthcare System|
|Principal Investigator:||Steve Martino, PhD||Yale University/ VA Connecticut Healthcare System|