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| Name | Class |
|---|---|
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This study will evaluate the feasibility of delivering symptom-triggered alcohol withdrawal management by telemedicine and determine whether this intervention is satisfactory to patients.
This single-arm pilot feasibility study will recruit actively drinking participants with a history of alcohol withdrawal in order to provide remotely monitored symptom-triggered alcohol withdrawal treatment using telemedicine. Participants will initially complete a screening and eligibility visit. If eligible, participants will then be scheduled for 3-day remote withdrawal management (which can be extended by 1-2 days if medically indicated). During remote withdrawal management, participants will receive symptom-triggered diazepam treatment using a modified version of the Clinical Institute Withdrawal Assessment for Alcohol Scale, revised (CIWA-Ar). Within one week following termination of withdrawal treatment, participants will be scheduled for a remote follow up visit in which they will complete patient satisfaction questionnaires and will be offered weekly counselling sessions and anticraving medication to prevent relapse to alcohol use. Approximately 30 days following treatment initiation, relapse to alcohol use will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptom-triggered diazepam treatment | Experimental | Participants will be treated for a period of 3 days using a symptom-triggered withdrawal management protocol delivered over telemedicine. Participants who score 10 or above on the modified CIWA-Ar will be advised to take a specific dose of diazepam (either 10 or 20mg, at the clinician's discretion). Participants will be reassessed regularly over the 3-day period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam | Drug | Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Treatment | Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol. | 3-5 day treatment period |
| Transfer to a Higher Level of Care | Transfer to a higher level of care, as measured by the percentage of participants sent to the emergency room due to complications, need for intensive monitoring, or acute intoxication. If ≤ 20%, of participants require transfer to a higher level of care, we will consider this as additional evidence of feasibility. | 3-5 day treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction With the Treatment Protocol | Satisfaction with the overall treatment protocol, measured with the Client Satisfaction Questionnaire-8 (minimum score = 8; maximum score = 32; higher score indicates greater client satisfaction). | Measured within 1 week of completing the remote withdrawal procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Sloan, MD, MSc | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J 1H4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symptom-triggered Diazepam Treatment | Participants will be treated for a period of 3 days using a symptom-triggered withdrawal management protocol delivered over telemedicine. Participants who score 10 or above on the modified CIWA-Ar will be advised to take a specific dose of diazepam (either 10 or 20mg, at the clinician's discretion). Participants will be reassessed regularly over the 3-day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symptom-triggered Diazepam Treatment | Participants will be treated for a period of 3 days using a symptom-triggered withdrawal management protocol delivered over telemedicine. Participants who score 10 or above on the modified CIWA-Ar will be advised to take a specific dose of diazepam (either 10 or 20mg, at the clinician's discretion). Participants will be reassessed regularly over the 3-day period. Diazepam: Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion |
| 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 | Retention in Treatment | Retention in treatment, as measured by the percentage of participants who complete the entire 3-day remote withdrawal management protocol. | Posted | Count of Participants | Participants | 3-5 day treatment period |
|
The adverse events reported were collected throughout the withdrawal treatment phase of the study (Detox day 1-3)
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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 | Symptom-triggered Diazepam Treatment | Participants will be treated for a period of 3 days using a symptom-triggered withdrawal management protocol delivered over telemedicine. Participants who score 10 or above on the modified CIWA-Ar will be advised to take a specific dose of diazepam (either 10 or 20mg, at the clinician's discretion). Participants will be reassessed regularly over the 3-day period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew E. Sloan | Centre for Addiction and Mental Health (CAMH) | 416-535-8501 | 33840 | matthew.sloan@camh.ca |
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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 17, 2022 | Dec 24, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Patient Satisfaction With the Telemedicine Platform |
Satisfaction with the telemedicine platform, measured with a modified version of the Telehealth Satisfaction Scale (minimum score = 12; maximum score = 48; higher score indicates greater satisfaction with the telemedicine platform). |
| Measured within 1 week of completing the remote withdrawal procedure |
| Duration of Active Withdrawal Treatment | Duration of active withdrawal treatment, as measured by the number of days that patients received diazepam among patients who received benzodiazepines. | 3-5 day treatment period |
| Requirement of Benzodiazepines | Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment. | 3-5 day treatment period |
| Diazepam Dose | Diazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam. | 3-5 day treatment period |
| Withdrawal Severity | Withdrawal severity, as measured by the average peak Clinical Institute Withdrawal Assessment for Alcohol Scale, revised score measured over the treatment period (minimum score = 0; maximum score = 67; higher score indicates greater withdrawal severity). | 3-5 day treatment period |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Prior Detoxification Experience | Count of Participants | Participants |
|
| Alcohol Use Disorders Identification Test (AUDIT) | The AUDIT is a brief screening questionnaire for determining if there are drinking problems. The total score ranges from 0 to 40. A higher score indicates a higher risk of alcohol use disorder, with a score of 8 and above indicating problematic alcohol use. | Mean | Standard Deviation | units on a scale |
|
| Penn Alcohol Cravings Scale (PACS) | The PACS is a brief questionnaire used for assessing alcohol cravings. The score ranges from a total score of 0 to 30, with the higher the score, the higher the craving. | Mean | Standard Deviation | units on a scale |
|
| Total Standard Drinks | Assessed using 30-day Timeline Follow Back for Alcohol Use | Mean | Standard Deviation | Standard Drinks |
|
| Total Drinking Days | Assessed using 30-day Timeline Follow Back for Alcohol Use | Mean | Standard Deviation | Days |
|
| Average Standard Drinks per Drinking Day | Assessed using 30-day Timeline Follow Back for Alcohol Use | Mean | Standard Deviation | Standard Drinks Per Drinking Day |
|
| Binge Drinking Days | Assessed using 30-day Timeline Follow Back for Alcohol Use *binge drinking days were defined as ≥5 SD per day for males, ≥4 SD per day for females | Mean | Standard Deviation | Days |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Transfer to a Higher Level of Care | Transfer to a higher level of care, as measured by the percentage of participants sent to the emergency room due to complications, need for intensive monitoring, or acute intoxication. If ≤ 20%, of participants require transfer to a higher level of care, we will consider this as additional evidence of feasibility. | Posted | Count of Participants | Participants | 3-5 day treatment period |
|
|
|
|
| Secondary | Patient Satisfaction With the Treatment Protocol | Satisfaction with the overall treatment protocol, measured with the Client Satisfaction Questionnaire-8 (minimum score = 8; maximum score = 32; higher score indicates greater client satisfaction). | Posted | Mean | Standard Deviation | Score on a scale | Measured within 1 week of completing the remote withdrawal procedure |
|
|
|
| Secondary | Patient Satisfaction With the Telemedicine Platform | Satisfaction with the telemedicine platform, measured with a modified version of the Telehealth Satisfaction Scale (minimum score = 12; maximum score = 48; higher score indicates greater satisfaction with the telemedicine platform). | Posted | Mean | Standard Deviation | Score on a scale | Measured within 1 week of completing the remote withdrawal procedure |
|
|
|
| Secondary | Duration of Active Withdrawal Treatment | Duration of active withdrawal treatment, as measured by the number of days that patients received diazepam among patients who received benzodiazepines. | Posted | Mean | Standard Deviation | days | 3-5 day treatment period |
|
|
|
| Secondary | Requirement of Benzodiazepines | Benzodiazepines requirement, as measured by the percentage of participants requiring benzodiazepine treatment. | Posted | Count of Participants | Participants | 3-5 day treatment period |
|
|
|
| Secondary | Diazepam Dose | Diazepam dose, as measured by the average dose of diazepam required to control symptoms among patients who received diazepam. | Posted | Median | Inter-Quartile Range | mg | 3-5 day treatment period |
|
|
|
| Secondary | Withdrawal Severity | Withdrawal severity, as measured by the average peak Clinical Institute Withdrawal Assessment for Alcohol Scale, revised score measured over the treatment period (minimum score = 0; maximum score = 67; higher score indicates greater withdrawal severity). | Posted | Mean | Standard Deviation | score on a scale | 3-5 day treatment period |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 22 |
| 30 |
| Clumsiness | Nervous system disorders | Systematic Assessment |
|
| Memory Loss | Nervous system disorders | Systematic Assessment |
|
| Confusion | Nervous system disorders | Systematic Assessment |
|
| Falls | Nervous system disorders | Systematic Assessment |
|
| Seizures | Nervous system disorders | Systematic Assessment |
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| Hallucination | Nervous system disorders | Systematic Assessment |
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| Delirium | Nervous system disorders | Systematic Assessment |
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| Light-headedness | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Leg Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
|
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|