Trial Outcomes & Findings for Pragmatic RCT of SBIRT-PM (NCT NCT04062214)

Last Updated: 2025-05-07

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

1101 participants

Primary outcome timeframe

36 weeks

Results posted on

2025-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Week 12 STARTED	558	543
Week 12 COMPLETED	457	432
Week 12 NOT COMPLETED	101	111
Week 36 STARTED	488	461
Week 36 COMPLETED	434	409
Week 36 NOT COMPLETED	54	52

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Week 12 Death	1	1
Week 12 Withdrawal by Subject	14	13
Week 12 Lost to Follow-up	55	68
Week 12 Intermittent missing	31	29
Week 36 Withdrawal by Subject	4	5
Week 36 Lost to Follow-up	50	46
Week 36 Death	0	1

Baseline Characteristics

Pragmatic RCT of SBIRT-PM

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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.	Total n=1101 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 11.1 • n=93 Participants	38.9 years STANDARD_DEVIATION 10.9 • n=4 Participants	39.1 years STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	69 Participants n=93 Participants	82 Participants n=4 Participants	151 Participants n=27 Participants
Sex: Female, Male Male	489 Participants n=93 Participants	461 Participants n=4 Participants	950 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	72 Participants n=93 Participants	83 Participants n=4 Participants	155 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	486 Participants n=93 Participants	460 Participants n=4 Participants	946 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Black	64 Participants n=93 Participants	72 Participants n=4 Participants	136 Participants n=27 Participants
Race/Ethnicity, Customized White	443 Participants n=93 Participants	424 Participants n=4 Participants	867 Participants n=27 Participants
Race/Ethnicity, Customized Unknown/Other	51 Participants n=93 Participants	47 Participants n=4 Participants	98 Participants n=27 Participants
Education	15 years STANDARD_DEVIATION 2.4 • n=93 Participants	14.7 years STANDARD_DEVIATION 2.2 • n=4 Participants	14.9 years STANDARD_DEVIATION 2.3 • n=27 Participants
Married	303 Participants n=93 Participants	276 Participants n=4 Participants	579 Participants n=27 Participants
Working for pay	446 Participants n=93 Participants	427 Participants n=4 Participants	873 Participants n=27 Participants
Legal Involvement	65 Participants n=93 Participants	65 Participants n=4 Participants	130 Participants n=27 Participants
BPI-Intensity	5.4 units on a scale STANDARD_DEVIATION 1.2 • n=93 Participants	5.4 units on a scale STANDARD_DEVIATION 1.3 • n=4 Participants	5.4 units on a scale STANDARD_DEVIATION 1.3 • n=27 Participants
BPI-Interference	5.1 units on a scale STANDARD_DEVIATION 2.1 • n=93 Participants	5.2 units on a scale STANDARD_DEVIATION 2.3 • n=4 Participants	5.2 units on a scale STANDARD_DEVIATION 2.2 • n=27 Participants
PEG	5.7 units on a scale STANDARD_DEVIATION 1.9 • n=93 Participants	5.7 units on a scale STANDARD_DEVIATION 2.0 • n=4 Participants	5.7 units on a scale STANDARD_DEVIATION 2.0 • n=27 Participants
Has high-impact chronic pain	388 Participants n=93 Participants	372 Participants n=4 Participants	760 Participants n=27 Participants
Impact of COVID on health care access Reduced ability to get health care A LOT	74 Participants n=93 Participants	86 Participants n=4 Participants	160 Participants n=27 Participants
Impact of COVID on health care access Reduced ability to get health care A LITTLE	127 Participants n=93 Participants	127 Participants n=4 Participants	254 Participants n=27 Participants
Impact of COVID on health care access NOT AFFECTED ability to get health care	314 Participants n=93 Participants	284 Participants n=4 Participants	598 Participants n=27 Participants
Impact of COVID on health care access IMPROVED ability to get health care	26 Participants n=93 Participants	33 Participants n=4 Participants	59 Participants n=27 Participants
Impact of COVID on health care access no response	17 Participants n=93 Participants	13 Participants n=4 Participants	30 Participants n=27 Participants
Problematic Substance Use (any)	277 Participants n=93 Participants	295 Participants n=4 Participants	572 Participants n=27 Participants
Problematic Tobacco Use	189 Participants n=93 Participants	193 Participants n=4 Participants	382 Participants n=27 Participants
Problematic Alcohol Use	69 Participants n=93 Participants	98 Participants n=4 Participants	167 Participants n=27 Participants
Problematic Cannabis Use	117 Participants n=93 Participants	112 Participants n=4 Participants	229 Participants n=27 Participants
Problematic Use of substance other than tobacco, alcohol, cannabis))	22 Participants n=93 Participants	20 Participants n=4 Participants	42 Participants n=27 Participants

PRIMARY outcome

Timeframe: 36 weeks

Outcome measures

Outcome measures
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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 Intensity Subscale of Brief Pain Inventory week 0	5.39 score on a scale Interval 5.28 to 5.49	5.39 score on a scale Interval 5.28 to 5.5
Change in Pain Intensity Subscale of Brief Pain Inventory week 12	5.02 score on a scale Interval 4.88 to 5.15	4.97 score on a scale Interval 4.81 to 5.14
Change in Pain Intensity Subscale of Brief Pain Inventory week 36	4.60 score on a scale Interval 4.45 to 4.76	4.86 score on a scale Interval 4.69 to 5.02

PRIMARY outcome

Timeframe: 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". 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

Outcome measures

Outcome measures
Measure	SBIRT-PM n=277 Participants 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.	Usual Care n=295 Participants 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 Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) week 0	1.47 # substances that need treatment Interval 1.38 to 1.56	1.47 # substances that need treatment Interval 1.38 to 1.57
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) week 12	1.32 # substances that need treatment Interval 1.2 to 1.44	1.19 # substances that need treatment Interval 1.07 to 1.32
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) week 36	1.26 # substances that need treatment Interval 1.12 to 1.39	1.19 # substances that need treatment Interval 1.06 to 1.31

PRIMARY outcome

Timeframe: 36 weeks

Total costs divided by quality-adjusted life years

Outcome measures

Outcome measures
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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.
Cost-Effectiveness Ratios (ICERs) Societal perspective	129527 $/Quality-adjusted life years	129527 $/Quality-adjusted life years
Cost-Effectiveness Ratios (ICERs) VA perspective	-86925 $/Quality-adjusted life years	-86925 $/Quality-adjusted life years

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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.
Cost-Effectiveness Acceptability Curves (CEACs) Threshold of $10k/QALY	.83 cost-effectiveness probability	.83 cost-effectiveness probability
Cost-Effectiveness Acceptability Curves (CEACs) Threshold of $50k/QALY	.73 cost-effectiveness probability	.73 cost-effectiveness probability
Cost-Effectiveness Acceptability Curves (CEACs) Threshold of $250k/QALY	.29 cost-effectiveness probability	.29 cost-effectiveness probability

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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.
Non-pharmacological Pain Service Utilization week 0	2.72 # pain treatment modalities used Interval 2.56 to 2.87	2.49 # pain treatment modalities used Interval 2.34 to 2.64
Non-pharmacological Pain Service Utilization week 12	3.48 # pain treatment modalities used Interval 3.28 to 3.68	3.31 # pain treatment modalities used Interval 3.11 to 3.51
Non-pharmacological Pain Service Utilization week 36	3.33 # pain treatment modalities used Interval 3.15 to 3.51	3.00 # pain treatment modalities used Interval 2.8 to 3.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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.
Pain Interference Subscale of Brief Pain Inventory week 0	5.15 score on a scale Interval 4.97 to 5.32	5.16 score on a scale Interval 4.96 to 5.35
Pain Interference Subscale of Brief Pain Inventory week 12	4.93 score on a scale Interval 4.73 to 5.14	4.78 score on a scale Interval 4.55 to 5.02
Pain Interference Subscale of Brief Pain Inventory week 36	4.35 score on a scale Interval 4.13 to 4.58	4.61 score on a scale Interval 4.38 to 4.84

SECONDARY outcome

Timeframe: 36 weeks

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).

Outcome measures

Outcome measures
Measure	SBIRT-PM n=558 Participants 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.	Usual Care n=543 Participants 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.
Overall Health Measured by EQ-5D-5L week 12	66.72 score on a scale Interval 65.2 to 68.24	68.82 score on a scale Interval 67.22 to 70.41
Overall Health Measured by EQ-5D-5L week 0	65.13 score on a scale Interval 63.79 to 66.46	65.74 score on a scale Interval 64.25 to 67.23
Overall Health Measured by EQ-5D-5L week 36	68.61 score on a scale Interval 67.11 to 70.11	69.20 score on a scale Interval 67.58 to 70.83

SECONDARY outcome

Timeframe: 36 weeks

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.

Outcome measures

Outcome measures
Measure	SBIRT-PM n=277 Participants 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.	Usual Care n=295 Participants 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.
Individual Substances of Misuse Generated by the ASSIST Tobacco, week 0	14.05 score on a scale Interval 13.08 to 15.01	13.35 score on a scale Interval 12.34 to 14.35
Individual Substances of Misuse Generated by the ASSIST Tobacco, week 12	11.48 score on a scale Interval 10.23 to 12.73	11.97 score on a scale Interval 10.55 to 13.38
Individual Substances of Misuse Generated by the ASSIST Tobacco, week 36	11.09 score on a scale Interval 9.75 to 12.42	10.80 score on a scale Interval 9.46 to 12.14
Individual Substances of Misuse Generated by the ASSIST Alcohol, week 0	19.32 score on a scale Interval 17.44 to 21.2	17.72 score on a scale Interval 16.38 to 19.06
Individual Substances of Misuse Generated by the ASSIST Alcohol, week 12	15.81 score on a scale Interval 13.44 to 18.17	13.04 score on a scale Interval 11.04 to 15.04
Individual Substances of Misuse Generated by the ASSIST Alcohol, week 36	12.93 score on a scale Interval 10.61 to 15.24	11.82 score on a scale Interval 9.99 to 13.66
Individual Substances of Misuse Generated by the ASSIST Marijuana, week 0	9.14 score on a scale Interval 8.04 to 10.25	8.80 score on a scale Interval 7.98 to 9.62
Individual Substances of Misuse Generated by the ASSIST Marijuana, week 12	7.83 score on a scale Interval 6.63 to 9.03	6.69 score on a scale Interval 5.7 to 7.67
Individual Substances of Misuse Generated by the ASSIST Marijuana, week 36	7.33 score on a scale Interval 6.21 to 8.45	6.51 score on a scale Interval 5.51 to 7.5

Adverse Events

SBIRT-PM

Serious events: 100 serious events

Other events: 109 other events

Deaths: 1 deaths

Usual Care

Serious events: 92 serious events

Other events: 89 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	SBIRT-PM n=558 participants at risk 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.	Usual Care n=543 participants at risk 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.
Musculoskeletal and connective tissue disorders Emergency room visit	11.1% 62/558 • Number of events 99 • 36 weeks	14.2% 77/543 • Number of events 117 • 36 weeks
Musculoskeletal and connective tissue disorders Surgery	7.3% 41/558 • Number of events 44 • 36 weeks	4.4% 24/543 • Number of events 27 • 36 weeks
Psychiatric disorders Emergency room visit or Hospital Care	0.90% 5/558 • Number of events 5 • 36 weeks	0.18% 1/543 • Number of events 1 • 36 weeks
Psychiatric disorders Residential treatment	0.18% 1/558 • Number of events 1 • 36 weeks	0.18% 1/543 • Number of events 1 • 36 weeks

Other adverse events

Other adverse events
Measure	SBIRT-PM n=558 participants at risk 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.	Usual Care n=543 participants at risk 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.
Psychiatric disorders Report of suicidal ideation	19.5% 109/558 • Number of events 176 • 36 weeks	16.4% 89/543 • Number of events 131 • 36 weeks

Additional Information

Marc Rosen, MD

Yale University

Phone: 2039325711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place