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Pragmatic RCT of SBIRT-PM

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04062214
Enrollment
1101
Registered
2019-08-20
Start date
2019-10-23
Completion date
2024-04-11
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Substance Use Disorders

Brief 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.

Detailed 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. 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.

Interventions

BEHAVIORALSBIRT-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.

Sponsors

Yale University
Lead SponsorOTHER
National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
US Department of Veterans Affairs
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.

Intervention model description

Participants receive either usual care or study intervention

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Pain Intensity Subscale of Brief Pain Inventory36 weeksPain Intensity subscale of the 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/intensity items: "worst" pain in the last 24 hours, "least" pain in the last 24 hours, "average" pain, and pain right "now". The pain intensity subscale is scored as a composite of the four pain items (mean intensity score).
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)36 weeksAlcohol, 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". The number of problem substances are defined as the number of substances above the "no intervention" threshold \*only participants who had a problem substance reported at baseline were analyzed for this outcome

Secondary

MeasureTime frameDescription
Cost-Effectiveness Ratios (ICERs)36 weeksThe Incremental Cost-Effectiveness Ratio (ICER) was determined as the ratio of the difference in cost (mean cost in the treatment group less mean cost in the usual care group) divided by the difference in outcomes (QALYs in the treatment group less QALYs in the usual care group) Health care system perspective costs includes the intervention and services sponsored by VA. We limited these to care for musculoskeletal disorders. The societal perspective adds the cost of health services received outside of VA and costs incurred by participants, including the value of time spent seeking health services and obtaining self-directed care, and the value of the effect of disability on employment and normal activities.
Cost-Effectiveness Acceptability Curves (CEACs)36 weeksProbability 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 Utilization36 weeksNumber 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 Inventory36 weeksPain 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-5L36 weeksThe Eq-5D-5L is a standardized measure of health status designed for clinical and economic appraisals. It includes a health scale which asks respondents to rate their health today on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Individual Substances of Misuse Generated by the ASSIST36 weeksAlcohol, Smoking and Substance Involvement Screening Test (ASSIST) (Version 3.1) measures substance use risk over the last 3 months. It consists of 7 questions about use of and consequences of use for 11 classes of substances (including nicotine, THC and medical THC). Scores for each substance are summed and mapped to a three-point ordinal score of severity. Risk scores for alcohol range from 0-39, where a score of 0-10 indicates "no need for treatment", a score of 11-26 indicates "need for a brief intervention" and a score of 27+ indicates "need for an intensive intervention". Risk scores for tobacco range from 0-31, risk scores for all other substances range from 0-39, where a score of 0-3 indicates "no need for treatment", a score of 4-26 indicates "need for a brief intervention" and a score of 27+ indicates "need for an intensive intervention". Individual substances rated above the "no intervention" threshold will be analyzed here.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarc Rosen, MD

Yale University/ VA Connecticut Healthcare System

PRINCIPAL_INVESTIGATORSteve Martino, PhD

Yale University/ VA Connecticut Healthcare System

Participant flow

Participants by arm

ArmCount
SBIRT-PM
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: 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.
558
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.
543
Total1,101

Baseline characteristics

CharacteristicSBIRT-PMUsual CareTotal
Age, Continuous39.4 years
STANDARD_DEVIATION 11.1
38.9 years
STANDARD_DEVIATION 10.9
39.1 years
STANDARD_DEVIATION 11
BPI-Intensity5.4 units on a scale
STANDARD_DEVIATION 1.2
5.4 units on a scale
STANDARD_DEVIATION 1.3
5.4 units on a scale
STANDARD_DEVIATION 1.3
BPI-Interference5.1 units on a scale
STANDARD_DEVIATION 2.1
5.2 units on a scale
STANDARD_DEVIATION 2.3
5.2 units on a scale
STANDARD_DEVIATION 2.2
Education15 years
STANDARD_DEVIATION 2.4
14.7 years
STANDARD_DEVIATION 2.2
14.9 years
STANDARD_DEVIATION 2.3
Ethnicity (NIH/OMB)
Hispanic or Latino
72 Participants83 Participants155 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
486 Participants460 Participants946 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Has high-impact chronic pain388 Participants372 Participants760 Participants
Impact of COVID on health care access
IMPROVED ability to get health care
26 Participants33 Participants59 Participants
Impact of COVID on health care access
no response
17 Participants13 Participants30 Participants
Impact of COVID on health care access
NOT AFFECTED ability to get health care
314 Participants284 Participants598 Participants
Impact of COVID on health care access
Reduced ability to get health care A LITTLE
127 Participants127 Participants254 Participants
Impact of COVID on health care access
Reduced ability to get health care A LOT
74 Participants86 Participants160 Participants
Legal Involvement65 Participants65 Participants130 Participants
Married303 Participants276 Participants579 Participants
PEG5.7 units on a scale
STANDARD_DEVIATION 1.9
5.7 units on a scale
STANDARD_DEVIATION 2
5.7 units on a scale
STANDARD_DEVIATION 2
Problematic Alcohol Use69 Participants98 Participants167 Participants
Problematic Cannabis Use117 Participants112 Participants229 Participants
Problematic Substance Use (any)277 Participants295 Participants572 Participants
Problematic Tobacco Use189 Participants193 Participants382 Participants
Problematic Use of substance other than tobacco, alcohol, cannabis))22 Participants20 Participants42 Participants
Race/Ethnicity, Customized
Black
64 Participants72 Participants136 Participants
Race/Ethnicity, Customized
Unknown/Other
51 Participants47 Participants98 Participants
Race/Ethnicity, Customized
White
443 Participants424 Participants867 Participants
Sex: Female, Male
Female
69 Participants82 Participants151 Participants
Sex: Female, Male
Male
489 Participants461 Participants950 Participants
Working for pay446 Participants427 Participants873 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 5582 / 543
other
Total, other adverse events
109 / 55889 / 543
serious
Total, serious adverse events
100 / 55892 / 543

Outcome results

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. The number of problem substances are defined as the number of substances above the no intervention threshold \*only participants who had a problem substance reported at baseline were analyzed for this outcome

Time frame: 36 weeks

ArmMeasureGroupValue (MEAN)
SBIRT-PMChange in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)week 01.47 # substances that need treatment
SBIRT-PMChange in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)week 121.32 # substances that need treatment
SBIRT-PMChange in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)week 361.26 # substances that need treatment
Usual CareChange in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)week 01.47 # substances that need treatment
Usual CareChange in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)week 121.19 # substances that need treatment
Usual CareChange in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)week 361.19 # substances that need treatment
Primary

Change in Pain Intensity Subscale of Brief Pain Inventory

Pain Intensity subscale of the 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/intensity items: worst pain in the last 24 hours, least pain in the last 24 hours, average pain, and pain right now. The pain intensity subscale is scored as a composite of the four pain items (mean intensity score).

Time frame: 36 weeks

ArmMeasureGroupValue (MEAN)
SBIRT-PMChange in Pain Intensity Subscale of Brief Pain Inventoryweek 05.39 score on a scale
SBIRT-PMChange in Pain Intensity Subscale of Brief Pain Inventoryweek 125.02 score on a scale
SBIRT-PMChange in Pain Intensity Subscale of Brief Pain Inventoryweek 364.60 score on a scale
Usual CareChange in Pain Intensity Subscale of Brief Pain Inventoryweek 05.39 score on a scale
Usual CareChange in Pain Intensity Subscale of Brief Pain Inventoryweek 124.97 score on a scale
Usual CareChange in Pain Intensity Subscale of Brief Pain Inventoryweek 364.86 score on a scale
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

Time frame: 36 weeks

ArmMeasureGroupValue (NUMBER)
SBIRT-PMCost-Effectiveness Acceptability Curves (CEACs)Threshold of $10k/QALY.83 cost-effectiveness probability
SBIRT-PMCost-Effectiveness Acceptability Curves (CEACs)Threshold of $50k/QALY.73 cost-effectiveness probability
SBIRT-PMCost-Effectiveness Acceptability Curves (CEACs)Threshold of $250k/QALY.29 cost-effectiveness probability
Usual CareCost-Effectiveness Acceptability Curves (CEACs)Threshold of $10k/QALY.83 cost-effectiveness probability
Usual CareCost-Effectiveness Acceptability Curves (CEACs)Threshold of $50k/QALY.73 cost-effectiveness probability
Usual CareCost-Effectiveness Acceptability Curves (CEACs)Threshold of $250k/QALY.29 cost-effectiveness probability
Primary

Cost-Effectiveness Ratios (ICERs)

Total costs divided by quality-adjusted life years

Time frame: 36 weeks

ArmMeasureGroupValue (NUMBER)
SBIRT-PMCost-Effectiveness Ratios (ICERs)VA perspective-86925 $/Quality-adjusted life years
SBIRT-PMCost-Effectiveness Ratios (ICERs)Societal perspective129527 $/Quality-adjusted life years
Usual CareCost-Effectiveness Ratios (ICERs)VA perspective-86925 $/Quality-adjusted life years
Usual CareCost-Effectiveness Ratios (ICERs)Societal perspective129527 $/Quality-adjusted life years
Secondary

Individual Substances of Misuse Generated by the ASSIST

Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (Version 3.1) measures substance use risk over the last 3 months. It consists of 7 questions about use of and consequences of use for 11 classes of substances (including nicotine, THC and medical THC). Scores for each substance are summed and mapped to a three-point ordinal score of severity. Risk scores for alcohol range from 0-39, where a score of 0-10 indicates no need for treatment, a score of 11-26 indicates need for a brief intervention and a score of 27+ indicates need for an intensive intervention. Risk scores for tobacco range from 0-31, risk scores for all other substances range from 0-39, where a score of 0-3 indicates no need for treatment, a score of 4-26 indicates need for a brief intervention and a score of 27+ indicates need for an intensive intervention. Individual substances rated above the no intervention threshold will be analyzed here.

Time frame: 36 weeks

ArmMeasureGroupValue (MEAN)
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTTobacco, week 1211.48 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTAlcohol, week 3612.93 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTAlcohol, week 019.32 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTMarijuana, week 09.14 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTTobacco, week 3611.09 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTMarijuana, week 127.83 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTAlcohol, week 1215.81 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTMarijuana, week 367.33 score on a scale
SBIRT-PMIndividual Substances of Misuse Generated by the ASSISTTobacco, week 014.05 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTMarijuana, week 366.51 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTTobacco, week 013.35 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTTobacco, week 1211.97 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTTobacco, week 3610.80 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTAlcohol, week 017.72 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTAlcohol, week 1213.04 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTAlcohol, week 3611.82 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTMarijuana, week 08.80 score on a scale
Usual CareIndividual Substances of Misuse Generated by the ASSISTMarijuana, week 126.69 score on a scale
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.

Time frame: 36 weeks

ArmMeasureGroupValue (MEAN)
SBIRT-PMNon-pharmacological Pain Service Utilizationweek 02.72 # pain treatment modalities used
SBIRT-PMNon-pharmacological Pain Service Utilizationweek 123.48 # pain treatment modalities used
SBIRT-PMNon-pharmacological Pain Service Utilizationweek 363.33 # pain treatment modalities used
Usual CareNon-pharmacological Pain Service Utilizationweek 02.49 # pain treatment modalities used
Usual CareNon-pharmacological Pain Service Utilizationweek 123.31 # pain treatment modalities used
Usual CareNon-pharmacological Pain Service Utilizationweek 363.00 # pain treatment modalities used
Secondary

Overall Health Measured by EQ-5D-5L

The Eq-5D-5L is a standardized measure of health status designed for clinical and economic appraisals. It includes a health scale which asks respondents to rate their health today on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Time frame: 36 weeks

ArmMeasureGroupValue (MEAN)
SBIRT-PMOverall Health Measured by EQ-5D-5Lweek 065.13 score on a scale
SBIRT-PMOverall Health Measured by EQ-5D-5Lweek 1266.72 score on a scale
SBIRT-PMOverall Health Measured by EQ-5D-5Lweek 3668.61 score on a scale
Usual CareOverall Health Measured by EQ-5D-5Lweek 1268.82 score on a scale
Usual CareOverall Health Measured by EQ-5D-5Lweek 065.74 score on a scale
Usual CareOverall Health Measured by EQ-5D-5Lweek 3669.20 score on a scale
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.

Time frame: 36 weeks

ArmMeasureGroupValue (MEAN)
SBIRT-PMPain Interference Subscale of Brief Pain Inventoryweek 05.15 score on a scale
SBIRT-PMPain Interference Subscale of Brief Pain Inventoryweek 124.93 score on a scale
SBIRT-PMPain Interference Subscale of Brief Pain Inventoryweek 364.35 score on a scale
Usual CarePain Interference Subscale of Brief Pain Inventoryweek 05.16 score on a scale
Usual CarePain Interference Subscale of Brief Pain Inventoryweek 124.78 score on a scale
Usual CarePain Interference Subscale of Brief Pain Inventoryweek 364.61 score on a scale

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026