Pragmatic RCT of SBIRT-PM

Pain Clinical Trial

Official title:

Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04062214
• Other study ID #: 2000022664
• Secondary ID: 4UH3AT009758-031
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. 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 reduce risky substance use, in part by helping Veterans get comprehensive pain treatment. The study will involve clinicians at a single site contacting Veterans throughout New England by phone to deliver SBIRT-PM counseling in a pragmatic, randomized, clinical trial.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim,

• Reports a score of =4 (threshold for moderately severe pain) on the BPI's Pain Severity subscale (average of four pain intensity items);

• Availability of a landline or cellular telephone for SBIRT-PM.

Exclusion Criteria:

• Reports inability to participate during the study enrollment call

• Received three or more non-pharmacological pain treatment modalities within the last 12 weeks from VA.

• Participating in another PMC3 study as evidenced by a research protocol alert for that study at the time the study invitation letter is mailed.

Related Conditions & MeSH terms

• Pain
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• SBIRT-PM
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.

Locations

Country	Name	City	State
United States	VA Maine Healthcare System	Augusta	Maine
United States	Edith Nourse Rogers Memorial VA Hospital (VA Bedford)	Bedford	Massachusetts
United States	VA Boston Healthcare System	Boston	Massachusetts
United States	VA Central Western Massachusetts Healthcare System	Leeds	Massachusetts
United States	Manchester VA Medical Center	Manchester	New Hampshire
United States	Yale University	New Haven	Connecticut
United States	Providence VA Medical Center	Providence	Rhode Island
United States	VA Connecticut Healthcare System (VACHS)	West Haven	Connecticut
United States	White River Junction VA Hospital	White River Junction	Vermont

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH), National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Pain Severity subscale of Brief Pain Inventory	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).	36 weeks
Primary	Change in number of Problem Substances measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)	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	36 weeks
Primary	Cost-Effectiveness Ratios (ICERs)	Total costs divided by quality-adjusted life years	36 weeks
Primary	Cost-Effectiveness Acceptability curves (CEACs)	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	36 weeks
Secondary	non-pharmacological pain service utilization	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.	36 weeks
Secondary	Pain Interference subscale of Brief Pain Inventory	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.	36 weeks
Secondary	Overall Health measured by EQ-5D-5L	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.	36 weeks
Secondary	Individual substances of misuse generated by the ASSIST, and nail clipping toxicology	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.	36 weeks