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| Name | Class |
|---|---|
| Wright State University | OTHER |
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This study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone (SAR) in opioid-dependent patients. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be completed at 3 and 6 months, by staff who are blinded to treatment condition.
As addiction treatment becomes increasingly integrated into the medical care system, two models have rightly received a great deal of attention. The first is the use of Screening, Brief Intervention, and Referral to Treatment (SBIRT) models to identify cases, provide therapeutic contact, and refer the more severe cases to longer-term care. The second is the treatment of addictions using medical models of treatment, including those that can be implemented in primary care settings. Much less attention has been paid to optimizing strategies for bridging the gap between SBIRT and more intensive/longer-term treatment for those on the severe end of the spectrum. This factor is of critical importance for opioid dependent patients, whose needs are not met by brief interventions or brief treatment. Emergency room interventions for substance use disorders have been largely limited to brief interventions/SBIRT models, and these have focused primarily on alcohol. Although there is a substantial literature documenting the value of case management in linking drug users to treatment, this approach has not been applied to drug users in the emergency department (ED) setting.
In a sample of opioid dependent patients seen in a medical ED who are not currently engaged in treatment, this study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) Screening, Assessment and Referral or 2) up to 6 sessions of SBCM based on the model previously implemented by Rapp and colleagues in prior studies. Staff who are blinded to treatment condition will complete follow-up assessments at 3 and 6 months. Aims of the study are to identify the main effects of SBCM on substance abuse treatment initiation and engagement, use of opioids and other drugs, and broader measures of health and life functioning; to examine the interactions between treatment assignment and selected participant attributes in predicting treatment initiation, engagement, and substance use outcomes; and to examine effects of treatment involvement on substance use outcomes in the two treatment groups.
The proposed study will be the first trial using a case management approach to link drug dependent patients presenting in EDs to longer-term addiction treatment. It will be one of the first trials focusing specifically on opioid dependent patients in medical EDs. A further innovative feature is that the case management approach will emphasize linkage to pharmacotherapy, facilitating linkage to office-based buprenorphine, methadone, or naltrexone for patients who desire this treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengths-based Case Management (SBCM) | Experimental | The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance. |
|
| Screening, Assessment and Referral (SAR) | Active Comparator | Following randomization, participants in the SAR condition will be provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strengths-based Case Management (SBCM) | Behavioral | The six case management sessions for the proposed trial are based on those described in manuals developed by Dr. Rapp for two clinical trials, one supported by National Institute on Drug Abuse (NIDA) and another by the Centers for Disease Control (CDC). Each session is guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence in a specialty or primary care setting. Objectives from the earlier trials will be adapted to fit the specific context of this trial, linking with and staying in treatment following an emergency department visit. Initiation of the relationship between client and case manager begins immediately following random assignment and termination takes place when either (1) six sessions have occurred; (2) ninety days have elapsed; or (3) clients discontinue involvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of Treatment for Opioid Dependence | "Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D. | 3 months |
| Engagement in Treatment for Opioid Dependence | Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Outcome for Opioid Use | "Successful outcome" will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Bogenschutz, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellevue Hospital Center | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32883337 | Derived | Regis A, Meyers-Ohki SE, Mennenga SE, Greco PP, Glisker R, Kolaric R, McCormack RP, Rapp RC, Bogenschutz MP. Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial. Trials. 2020 Sep 3;21(1):761. doi: 10.1186/s13063-020-04684-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Strengths-based Case Management (SBCM) | The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance. The six case management sessions for this trial were based on those described in manuals developed by Dr. Rapp for two previous clinical trials. Each session was guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence. Initiation of the relationship between client and case manager began immediately following random assignment and termination took place when either (1) six sessions had occurred; (2) ninety days had elapsed; or (3) clients discontinued involvement. |
| FG001 | Screening, Assessment and Referral (SAR) | Participants in the SAR condition were provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment. The research assistant provided SAR participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet included names, addresses, and phone numbers of local addiction treatment agencies. Participants also received an informational pamphlet about drug use and its consequences, addiction, and treatment. Because the emergency department does not currently screen or refer systematically, the SAR condition represented a level of care significantly higher than "treatment as usual." |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
2 SBCM participants excluded from analysis (1 determined ineligible; 1 pilot SBCM participant); 1 SAR participant excluded from analysis (withdrawn)
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| ID | Title | Description |
|---|---|---|
| BG000 | Strengths-based Case Management (SBCM) | Participants received up to six sessions of Strengths-based Case Management (SBCM) within 90 days of randomization. |
| BG001 | Screening, Assessment and Referral (SAR) |
| 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 | Initiation of Treatment for Opioid Dependence | "Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D. | Intention to treat | Posted | Count of Participants | Participants | 3 months |
|
Consent through final 6-month follow-up
Events not meeting the study definition of AE:
Events not meeting the study definition of SAE:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strengths-based Case Management (SBCM) | Strengths-based Case Management (SBCM) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Bogenschutz | NYU School of Medicine | 646-501-4026 | michael.bogenschutz@nyulangone.org |
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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 | Jun 26, 2017 | Mar 4, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D012149 | Restraint, Physical |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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|
| Screening, Assessment, and Referral (SAR) | Behavioral | The research assistant will provide these participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet includes names, addresses, and phone numbers of local addiction treatment agencies. Because the emergency department does not currently screen or refer systematically, the SAR condition represents a level of care significantly higher than "treatment as usual." Participants will also receive an informational pamphlet about drug use and its consequences, addiction, and treatment. |
|
| Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire | The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20. | 3 months |
| Initiation in Participants With Higher Levels of Environmental Instability at Baseline | "Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D. | 3 months |
| Engagement in Participants With Higher Levels of Environmental Instability at Baseline | Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records. | 3 months |
Participants received a detailed referral sheet, an informational pamphlet, and scripted feedback recommending they seek treatment.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Primary | Engagement in Treatment for Opioid Dependence | Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records. | Intention to treat | Posted | Mean | Standard Deviation | % days | 3 months |
|
|
|
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| Secondary | Number of Participants With Successful Outcome for Opioid Use | "Successful outcome" will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation. | Intention to treat | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire | The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20. | Intention to treat | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
|
|
| Secondary | Initiation in Participants With Higher Levels of Environmental Instability at Baseline | "Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D. | Intention to treat | Posted | Mean | Standard Error | % of participants | 3 months |
|
|
|
|
| Secondary | Engagement in Participants With Higher Levels of Environmental Instability at Baseline | Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records. | Posted | Mean | Standard Error | % days | 3 months |
|
|
|
|
| 4 |
| 150 |
| 17 |
| 150 |
| 3 |
| 150 |
| EG001 | Screening, Assessment and Referral (SAR) | Screening, Assessment and Referral (SAR) | 1 | 150 | 8 | 150 | 2 | 150 |
| Death (cause unknown) | General disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Hepatobiliary disorder | Hepatobiliary disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
|
| Musculoskeletal disorders | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Withdrawal of life support | Surgical and medical procedures | MedDRA (19.0) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
|
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Vascular disorder | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
|
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| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |