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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3AT009758-03 | U.S. NIH Grant/Contract | View source | |
| 1UG3AT009758-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
| US Department of Veterans Affairs | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBIRT-PM | Experimental | 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. |
|
| Usual Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBIRT-PM | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 36 weeks |
| 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 | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-Effectiveness Ratios (ICERs) | The 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Rosen, MD | Yale University/ VA Connecticut Healthcare System | Principal Investigator |
| Steve Martino, PhD | Yale University/ VA Connecticut Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| VA Connecticut Healthcare System (VACHS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41741869 | Derived | Rosen MI, Gilstad-Hayden K, Lazar CM, Sellinger J, Mattocks K, Barnett PG, Brummett BR, Higgins DM, Holtzheimer P, Livingston NA, Ngo T, Reznik TE, Schimelman B, Semiatin AM, Solzhenitsyn C, Martino S. Motivational Interviewing Targeting Pain and Substance Use in Veterans Seeking Service-Connection Payments: A Multisite Randomized Clinical Trial. J Gen Intern Med. 2026 Feb 25. doi: 10.1007/s11606-025-10127-2. Online ahead of print. |
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Data are available upon reasonable request. Datasets containing individually identifiable data will only be shared with a written assurance from the recipient that (1) the information will only be used for research purposes and will not be used to identify any individual participant; (2) the information will be secured using appropriate computer technology; and (3) the data will be destroyed or returned after analyses are completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 12 |
|
| |||||||||||||||||||||
| Week 36 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 36 weeks |
|
36 weeks
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency room visit | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Emergency room visit for pain condition |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Report of suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Rosen, MD | Yale University | 2039325711 | 12112 | marc.rosen@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 12, 2024 | Mar 4, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2020 | Feb 15, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Participants receive either usual care or study intervention
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Research Assistants collect data from participant interviews at 12 and 36 weeks follow-up. They will be blind to randomization condition.
|
| 36 weeks |
| 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 |
| 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 |
| 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 |
| 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). | 36 weeks |
| 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. | 36 weeks |
| West Haven |
| Connecticut |
| 06516 |
| United States |
| VA Maine Healthcare System | Augusta | Maine | 04330 | United States |
| Edith Nourse Rogers Memorial VA Hospital (VA Bedford) | Bedford | Massachusetts | 01730 | United States |
| VA Boston Healthcare System | Boston | Massachusetts | 02301 | United States |
| VA Central Western Massachusetts Healthcare System | Leeds | Massachusetts | 02053 | United States |
| Manchester VA Medical Center | Manchester | New Hampshire | 03104 | United States |
| Providence VA Medical Center | Providence | Rhode Island | 02908 | United States |
| White River Junction VA Hospital | White River Junction | Vermont | 05001 | United States |
| Lost to Follow-up |
|
| Intermittent missing |
|
| NOT COMPLETED |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Married | Count of Participants | Participants |
|
| Working for pay | Employment pattern over past 12 months has been full- or -part-time work | Count of Participants | Participants |
|
| Legal Involvement | Participant endorsed either having (1) served time in jail or (2) has pending charges trial or sentence | Count of Participants | Participants |
|
| BPI-Intensity | Brief Pain Inventory (intensity) is a measure for assessing clinical pain. There are four pain severity items rated on a 0-10 scale assessing pain in the past 24 hours. A composite score is the mean of the four severity items on a 0-10 scale with higher scores indicating worse pain. | Mean | Standard Deviation | units on a scale |
|
| BPI-Interference | Brief Pain Inventory (intensity) is a measure for assessing clinical pain. There are seven pain intensity items rated on a 0-10 scale assessing how pain interfered with seven daily activities (including general activity, walking, work, mood, enjoyment of life, relations with others, sleep) in the past 24 hours. A composite score is the mean of the seven interference items on a 0-10 scale with higher scores indicating worse pain interference. | Mean | Standard Deviation | units on a scale |
|
| PEG | The "Pain, Enjoyment, General Activity" scale assesses pain intensity and interference in the past week with three questions rated on a 0-10 scale. Questions ask about average pain, pain interference with enjoyment of life, and pain interference with general activity. Mean summary score is calculated using the average of the three items (range 0-10) with a high score indicating more pain intensity/interference. | Mean | Standard Deviation | units on a scale |
|
| Has high-impact chronic pain | High impact chronic pain is a three question assessment that asks about pain in the past three months. Questions ask about how often respondent had pain (never, some days, most days, every day), how often pain limited work activities (never, some days, most days, every day), and if respondent was not working or unable to work due to pain (yes, not). | Count of Participants | Participants |
|
| Impact of COVID on health care access | Respondents were asked how much the COVID pandemic impacted their ability to access healthcare. | Count of Participants | Participants |
|
| Problematic Substance Use (any) | The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) v3.0 was used to assess problematic substance use. It consists of 8 questions asking about experience with tobacco products, alcoholic beverages, cannabis, cocaine, amphetamine stimulants, inhalants, sedatives, hallucinogens, opioids, and other substances. For each substance endorsed in Q1, scores from Q2-7 are added together to give a specific substance involvement score. A specific substance involvement score above 10 (alcohol) or above 3 (all others) indicates problematic use. | Count of Participants | Participants |
|
| Problematic Tobacco Use | The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) v3.0 was used to assess problematic substance use. It consists of 8 questions asking about experience with tobacco products, alcoholic beverages, cannabis, cocaine, amphetamine stimulants, inhalants, sedatives, hallucinogens, opioids, and other substances. For each substance endorsed in Q1, scores from Q2-7 are added together to give a specific substance involvement score. A specific substance involvement score above 10 (alcohol) or above 3 (all others) indicates problematic use. | Count of Participants | Participants |
|
| Problematic Alcohol Use | The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) v3.0 was used to assess problematic substance use. It consists of 8 questions asking about experience with tobacco products, alcoholic beverages, cannabis, cocaine, amphetamine stimulants, inhalants, sedatives, hallucinogens, opioids, and other substances. For each substance endorsed in Q1, scores from Q2-7 are added together to give a specific substance involvement score. A specific substance involvement score above 10 (alcohol) or above 3 (all others) indicates problematic use. | Count of Participants | Participants |
|
| Problematic Cannabis Use | The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) v3.0 was used to assess problematic substance use. It consists of 8 questions asking about experience with tobacco products, alcoholic beverages, cannabis, cocaine, amphetamine stimulants, inhalants, sedatives, hallucinogens, opioids, and other substances. For each substance endorsed in Q1, scores from Q2-7 are added together to give a specific substance involvement score. A specific substance involvement score above 10 (alcohol) or above 3 (all others) indicates problematic use. | Count of Participants | Participants |
|
| Problematic Use of substance other than tobacco, alcohol, cannabis)) | The ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) v3.0 was used to assess problematic substance use. It consists of 8 questions asking about experience with tobacco products, alcoholic beverages, cannabis, cocaine, amphetamine stimulants, inhalants, sedatives, hallucinogens, opioids, and other substances. For each substance endorsed in Q1, scores from Q2-7 are added together to give a specific substance involvement score. A specific substance involvement score above 10 (alcohol) or above 3 (all others) indicates problematic use. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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 | Posted | Mean | 95% Confidence Interval | # substances that need treatment | 36 weeks |
|
|
|
| Secondary | Cost-Effectiveness Ratios (ICERs) | The 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. | Posted | Number | $/Quality-adjusted life years | 36 weeks |
|
|
|
| Secondary | 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 | Posted | Number | cost-effectiveness probability | 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. | Posted | Mean | 95% Confidence Interval | # pain treatment modalities used | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 36 weeks |
|
|
|
| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | 36 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 36 weeks |
|
|
|
| 1 |
| 558 |
| 100 |
| 558 |
| 109 |
| 558 |
| EG001 | 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. | 2 | 543 | 92 | 543 | 89 | 543 |
|
| Surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Surgery for musculoskeletal disorder |
|
| Emergency room visit or Hospital Care | Psychiatric disorders | Non-systematic Assessment | ER visit or Hospital care for substance use condition |
|
| Residential treatment | Psychiatric disorders | Non-systematic Assessment | Residential treatment for substance use condition |
|
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| week 36 |
|
| Threshold of $250k/QALY |
|
| week 36 |
|
| week 36 |
|
| week 36 |
|
| Tobacco, week 36 |
|
| Alcohol, week 0 |
|
| Alcohol, week 12 |
|
| Alcohol, week 36 |
|
| Marijuana, week 0 |
|
| Marijuana, week 12 |
|
| Marijuana, week 36 |
|