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This research program is intended to improve the treatment engagement and outcomes of Veterans who receive inpatient detoxification, and decrease their use of VA inpatient and emergency department services. It is intended to increase the use of substance use disorder care and 12-step mutual-help groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.
Annually, about 25,000 Veterans receive inpatient detoxification (detox) for substance use disorders (SUDs). Detox is not SUD treatment; it is the medical management of withdrawal to prevent complications, which may be fatal. Detox inpatients who enter SUD treatment and peer-based mutual-help groups (e.g., Alcoholics Anonymous) have much better outcomes (less substance use, HIV/HCV risk behaviors, homelessness, rehospitalizations, Emergency Department visits) than those who do not. However, because of their unique characteristics (severe and chronic addictions, co-morbidities, lack of resources, self- and provider-perceptions as unsuitable for treatment), most Veterans discharged from inpatient detox do not enter SUD treatment. For many Veterans, a pattern of repeated inpatient detox, with each episode incurring a higher risk of overdose, occurs. Therefore, in its Uniform Services Handbook, Mental Health Operations places major emphasis on increasing the rate of SUD treatment initiation and engagement following detox to benefit Veterans' outcomes and prevent more use of costly health care.
The primary objective of this project is to implement and evaluate Enhanced Telephone Monitoring (ETM) as a new and innovative telehealth intervention to facilitate the transition from inpatient detox to SUD specialty treatment (residential, outpatient, pharmacotherapy), thereby improving Veterans' outcomes and decreasing VA health care costs. In a randomized trial at two sites (VA Palo Alto and Boston), investigators hypothesize that patients receiving ETM, compared to patients in usual care (UC), will be more likely to enter and engage in SUD treatment and mutual-help, have better SUD and related outcomes, and have fewer and delayed acute care episodes. This project will also conduct a formative evaluation of how to implement ETM VA-wide, focusing on diverse subgroups of Veterans. Further, it will conduct a Budget Impact Analysis (BIA) to determine the impact of ETM on total costs of VA care. Investigators hypothesize that the higher costs associated with ETM (because patients will engage in SUD treatment) will be more than offset by its lower costs of acute care.
Patients in the ETM condition will receive an in-person session while in detox, followed by coaching over the telephone for 3 months after discharge. The intervention will incorporate Motivational Interviewing, and Contracting, Prompting, and Reinforcing, to provide support while waiting for treatment, and facilitate entry into treatment and mutual-help, and improved responses to crises. Patients will be assessed at baseline and 3 and 6 months post-discharge for outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and ETM groups on course of outcomes over time. The formative evaluation to inform the implementation of ETM will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Semi-structured interviews will be conducted with inpatient detox staff and patients to yield facilitators of ETM implementation and modifiable barriers with associated action plans. For the BIA, costs of ETM will be measured through microcosting methods. For patients in both the ETM and UC groups, all inpatient, residential, outpatient, and pharmacy care will be measured from VA utilization and cost files.
In summary, Mental Health Operations is committed to eradicating the dangerous, costly pattern of Veterans obtaining inpatient detox services but not receiving the SUD treatment they need. Telehealth interventions, a promising way to improve treatment access and outcomes by SUD patients, have not been utilized with the challenging population of detox inpatients before. In accordance with others in this CREATE, this project will help to accomplish Mental Health Operations' goal of implementing the Uniform Handbook by increasing Veterans' access to, engagement in, and benefit from, SUD treatment services, particularly among Veterans who are using VA medical services and need SUD services but are not receiving them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Telephone Monitoring | Experimental | Detox inpatients in the ETM condition will be expected to complete one 15-minute telephone call per week for 12 weeks. |
|
| Usual Care | No Intervention | Patients in the usual care condition will receive the care they would receive in the absence of a research project. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Telephone Monitoring | Behavioral | Detox inpatients in the ETM condition will be expected to complete one session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Who Had an Additional Inpatient Detoxification | Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no. | 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Timko, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enhanced Telephone Monitoring | Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care). |
| FG001 | Usual Care | Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Telephone Monitoring | Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care). |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percent of Participants Who Had an Additional Inpatient Detoxification | Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no. | Of 298 baseline participants, 266 participated in follow-up at 6 months. | Posted | Count of Participants | Participants | 6-month follow-up |
|
6 months
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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 | Enhanced Telephone Monitoring | Detox inpatients in the ETM condition will be expected to complete one 50-minute individual session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incapacitation | General disorders | Systematic Assessment | Too incapacitated by poor health to complete follow-up assessment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Timko, Research Career Scientist | Department of Veterans Affairs | 6504935000 | 23336 | Christine.Timko@va.gov |
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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 | Oct 1, 2014 | Feb 7, 2019 | Prot_SAP_000.pdf |
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|
| Incapacitated |
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Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Married | Count of Participants | Participants |
|
| Years education | Mean | Standard Deviation | years |
|
| Employed | Count of Participants | Participants |
|
| Homeless | Count of Participants | Participants |
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| Detoxification, lifetime | Count of Participants | Participants |
|
| Attended 12-step meeting (past 3 months) | Count of Participants | Participants |
|
| Number of meetings (past 3 months) | Mean | Standard Deviation | meetings |
|
| Treatment, lifetime | Count of Participants | Participants |
|
| Treatment, 30 days | Count of Participants | Participants |
|
| ASI, Alcohol severity | ASI composite scores were produced from sets of items that were standardized and summed to provide internally consistent evaluations of patient status in the problem areas (McLellan et al., 2006). They range from 0 to 1, with higher scores indicating poorer outcomes. Alcohol Severity is a composite score for the ASI alcohol dimension which measures the severity of the problem in that area over the past 30 days. | Mean | Standard Deviation | units on a scale |
|
| ASI, Drugs severity | ASI composite scores were produced from sets of items that were standardized and summed to provide internally consistent evaluations of patient status in the problem areas (McLellan et al., 2006). They range from 0 to 1, with higher scores indicating poorer outcomes. Drug Severity is a composite score for the ASI drug dimension which measures the severity of the problem in that area over the past 30 days. | Mean | Standard Deviation | units on a scale |
|
| ASI, Psychiatric | ASI composite scores were produced from sets of items that were standardized and summed to provide internally consistent evaluations of patient status in the problem areas (McLellan et al., 2006). They range from 0 to 1, with higher scores indicating poorer outcomes. Psychiatric is a composite score for the ASI psychiatric dimension which measures the severity of the problem in that area over the past 30 days. | Mean | Standard Deviation | units on a scale |
|
| Days used alcohol (past 30 days) | Mean | Standard Deviation | days |
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| Days used opioids (past 30 days) | Mean | Standard Deviation | days |
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| Serious ideas suicide (past 30 days) | Count of Participants | Participants |
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| Attempted suicide (past 30 days) | Count of Participants | Participants |
|
| BAM, Alcohol and drug use | Brief Addiction Monitor (which is required in VA for measurement based substance use disorder care) yields two composite scores referring to the past 30 days. Alcohol and drug use is the sum of three items, i.e., number of days drank alcohol; had at least 5 drinks (if a man) or at least 4 drinks (if a woman); and used any illegal/street drugs or abused any prescription medications (for each, 0=0 days, to 4=16-30 days, i.e. higher the mean, more days used substances). | Mean | Standard Deviation | units on a scale |
|
| BAM, Risk factors | Brief Addiction Monitor (which is required in VA for measurement based substance use disorder care) yields two composite scores referring to the past 30 days. Risk factors is the sum of five items, e.g., physical health (0=excellent, 4=poor); number of nights having trouble falling or staying asleep (0=0, 4=16-30 days); in any situations or with any people that might increase risk for using alcohol or drugs (0=0, 4=16-30 days, higher the mean, worse the outcome/higher risk for substance use). | Mean | Standard Deviation | units on a scale |
|
| Self-efficacy, Confidence | Self-efficacy was assessed with the Brief Situational Confidence Questionnaire (Breslin, Sobell, Sobell, & Agrawal, 2000). Eight items asked patients to rate their level of confidence (0% 'not at all confident' to 100% 'totally confident') in resisting drinking and using drugs as a response to different types of situations (e.g., unpleasant emotions, social pressure to drink/use), and then responses were averaged such that higher scores indicate more self-efficacy (Cronbach's alpha = .91, .92, and .91 at baseline and 3 and 6 months, respectively). | Mean | Standard Deviation | units on a scale |
|
Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project.
|
|
| 2 |
| 148 |
| 0 |
| 148 |
| 0 |
| 148 |
| EG001 | Usual Care | Detox inpatients in the usual care condition will receive the care they would receive in the absence of a research project. | 3 | 150 | 1 | 150 | 0 | 150 |
|
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