Substance Use DisordersNCT03907709
Effects of In-Home Addiction Treatment for First Responders
An observational study of Substance Use Disorders, run by In-Home Addiction Treatment Institute, Inc. at 1 site in United States.
Trial summary
Retrospective analysis to evaluate impact of an in-home addiction treatment program on first responders with substance use disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- In-Home Addiction Treatment Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 28 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Approximately 15 individuals with substance use disorder who are or have served as a first responder (police officer, fire fighter, corrections officer, military police, emergency medical technician, paramedic, parole or probation officer) and were enrolled in Aware Recovery Care's In-Home Addiction Treatment program between April 2017 and March 2019.
Who may be able to join
- Client is or has been a first responder
- Client enrolled in Aware Recovery Care after April 2017
- Client discharged from Aware Recovery Care before March 2019
- Client has primary substance use disorder diagnosis
Who cannot join
- Client has never been first responder
- Client moved out of service area or lost insurance during care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an In-Home Treatment Program for First Responders With Substance Use Disorder: A Retrospective Analysis
Retrospective analysis to evaluate impact of an in-home addiction treatment program on first responders with substance use disorder.
Read the detailed description
The purpose of this retrospective study is to evaluate the effects of in-home addiction treatment on first responders with substance use disorder. Treatment engagement, hospitalizations, detox and residential addiction treatment admissions, and lethal overdoses will be measured. Although not the primary focus, recidivism and relapse will be measured.
- Conditions
- Substance Use Disorders
- Being tested
- In-Home Addiction Treatment Program
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Home Addiction Treatment ProgramBehavioural
- Treatment was delivered per treatment protocol
- Primary IHAT Care Team consisted of a licensed Care Coordinator (LPN, RN, MSW, LPC, or LMFT) and two Recovery Advisors
- Urine drug screens administered randomly
- Appointments were scheduled per protocol for 52 weeks
- Within first two weeks of care, all clients are provided an evaluation by a psychiatrist to ensure fitness for program
| Study group | Role | What they receive |
|---|---|---|
| First Responders in In-Home Addiction Treatment Program | - First responders (individual who does or has worked as a police officer, fire fighter, corrections officer, military police, emergency medical technician, paramedic, parole or probation officer) Receives: Behavioral: In-Home Addiction Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Retention in Treatment
Participation in In-Home Addiction Treatment Program using length of stay reports
Measured: Measured throughout 365 day duration of anticipated length of stay
Brief Addiction Monitor questionnaire
Measure change in client report of symptoms related to substance use disorder
Measured: Conducted monthly throughout 365 day anticipated length of stay in program
Positive Outcomes Measures Survey
Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no/not applicable response scale
Measured: Completed at week 3 or 4, Week 30, Week 35, Week 44, and Week 50 throughout 52 week anticipated length of program participation
Secondary outcomes (3)
Relapse rates
Occurrence of substance use measured through urine drug screening and breathalyzer tests
Measured: Randomly administered throughout 365 day anticipated length of program participation
Hospitalization
Occurrence of Emergency Room and Inpatient hospital admissions
Measured: Measured throughout 365 day anticipated length of program participation
Detox and Residential Admissions
Occurrence of residential treatment and detox admission
Measured: Measured throughout 365 day anticipated length of program participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start8 Apr 2019
- Primary completion28 May 2020 (estimated)
- Study completion28 Jul 2020 (estimated)
Why it stopped: Resource allocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- In-Home Addiction Treatment Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Kaiser, MS Ed, LPN, Principal investigator, In-Home Addiction Treatment Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907709
- Sponsor's protocol ID
- IHATI-2019-1
- Status last verified
- Aug 2019
- First submitted
- 5 Apr 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an In-Home Treatment Program for First Responders With Substance Use Disorder: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03907709
- Acronym / sponsor ID
- IHATI-2019-1
- Conditions
- Substance Use Disorders
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Resource allocation
- Enrolment
- 15 participants (actual)
- Lead sponsor
- In-Home Addiction Treatment Institute, Inc.University, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 28 May 2020 (estimated)
- Study completion
- 28 Jul 2020 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Retrospective analysis to evaluate impact of an in-home addiction treatment program on first responders with substance use disorder.
Detailed description
The purpose of this retrospective study is to evaluate the effects of in-home addiction treatment on first responders with substance use disorder. Treatment engagement, hospitalizations, detox and residential addiction treatment admissions, and lethal overdoses will be measured. Although not the primary focus, recidivism and relapse will be measured.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First Responders in In-Home Addiction Treatment Program | – | Behavioral: In-Home Addiction Treatment Program- First responders (individual who does or has worked as a police officer, fire fighter, corrections officer, military police, emergency medical technician, paramedic, parole or probation officer) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Approximately 15 individuals with substance use disorder who are or have served as a first responder (police officer, fire fighter, corrections officer, military police, emergency medical technician, paramedic, parole or probation officer) and were enrolled in Aware Recovery Care's In-Home Addiction Treatment program between April 2017 and March 2019.
Key inclusion criteria (4 listed)
- Client is or has been a first responder
- Client enrolled in Aware Recovery Care after April 2017
- Client discharged from Aware Recovery Care before March 2019
- Client has primary substance use disorder diagnosis
Key exclusion criteria (2 listed)
- Client has never been first responder
- Client moved out of service area or lost insurance during care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Home Addiction Treatment Program* Treatment was delivered per treatment protocol * Primary IHAT Care Team consisted of a licensed Care Coordinator (LPN, RN, MSW, LPC, or LMFT) and two Recovery Advisors * Urine drug screens administered randomly * Appointments were scheduled per protocol for 52 weeks * Within first two weeks of care, all clients are provided an evaluation by a psychiatrist to ensure fitness for program | Behavioural | First Responders in In-Home Addiction Treatment Program |
Primary outcome
Rate of Retention in Treatment
Time frame: Measured throughout 365 day duration of anticipated length of stay
Participation in In-Home Addiction Treatment Program using length of stay reports
Brief Addiction Monitor questionnaire
Time frame: Conducted monthly throughout 365 day anticipated length of stay in program
Measure change in client report of symptoms related to substance use disorder
Positive Outcomes Measures Survey
Time frame: Completed at week 3 or 4, Week 30, Week 35, Week 44, and Week 50 throughout 52 week anticipated length of program participation
Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no/not applicable response scale
3 secondary outcomes
Relapse rates
Time frame: Randomly administered throughout 365 day anticipated length of program participation
Hospitalization
Time frame: Measured throughout 365 day anticipated length of program participation
Detox and Residential Admissions
Time frame: Measured throughout 365 day anticipated length of program participation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Kaiser, MS Ed, LPN principal investigator
In-Home Addiction Treatment Institute, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorders, run by In-Home Addiction Treatment Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Retention in Treatment (time frame: Measured throughout 365 day duration of anticipated length of stay). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.