Effects of In-Home Addiction Treatment for First Responders

August 5, 2019 updated by: In-Home Addiction Treatment Institute, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • North Haven, Connecticut, United States, 06473
        • Aware Recovery Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Client has never been first responder
  • Client moved out of service area or lost insurance during care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Measured throughout 365 day duration of anticipated length of stay
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
Conducted monthly throughout 365 day anticipated length of stay in program
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
Completed at week 3 or 4, Week 30, Week 35, Week 44, and Week 50 throughout 52 week anticipated length of program participation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relapse rates
Time Frame: Randomly administered throughout 365 day anticipated length of program participation
Occurrence of substance use measured through urine drug screening and breathalyzer tests
Randomly administered throughout 365 day anticipated length of program participation
Hospitalization
Time Frame: Measured throughout 365 day anticipated length of program participation
Occurrence of Emergency Room and Inpatient hospital admissions
Measured throughout 365 day anticipated length of program participation
Detox and Residential Admissions
Time Frame: Measured throughout 365 day anticipated length of program participation
Occurrence of residential treatment and detox admission
Measured throughout 365 day anticipated length of program participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
In-Home Addiction Treatment Institute, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara Kaiser, MS Ed, LPN, In-Home Addiction Treatment Institute, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IHATI-2019-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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