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HEALing Communities Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111939
Recruitment Status : Active, not recruiting
First Posted : October 1, 2019
Last Update Posted : August 7, 2020
Sponsor:
Collaborators:
Boston Medical Center
Columbia University
Ohio State University
University of Kentucky
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
RTI International

Brief Summary:
This study will test the impact of implementing the Communities That Helping to End Addiction Long-term (HEAL) intervention on opioid overdose deaths within 67 highly affected communities with the goal of reducing opioid overdose deaths by 40%.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder (OUD) Other: Communities That HEAL Other: Wait-list control Not Applicable

Detailed Description:
The HEALing Communities Study (HCS) is a multi-site, parallel group, cluster randomized wait-list controlled trial to test the impact of the Communities That HEAL (CTH) intervention, which is designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. The intervention will include 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence based practices to address overdose and opioid use disorder. Communities receiving the intervention will be engaged to reach individuals who are at highest risk of overdose death (e.g., out of treatment, leaving jail) and: (1) expand access to and receipt of medication for opioid use disorder (MOUD) and behavioral treatment, (2) increase the number of individuals retained in treatment beyond 6 months, (3) reduce the risk of fatal overdose through expansion of overdose education and naloxone distribution, and (4) improve prescription opioid safety. In addition, the study will determine (1) the factors that contribute to or impede successful implementation of the CTH intervention, (2) the factors that contribute to or impede sustainment of CTH intervention, and (3) the incremental costs and cost effectiveness of the CTH intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: HEALing Communities Study: Developing and Testing an Integrated Approach to Address the Opioid Crisis
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: Wave 1 - Intervention
Communities in Wave 1 will receive the CTH intervention during the first 24 months of the trial. The intervention will include 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence based practices to address overdose and opioid use disorder.
Other: Communities That HEAL
The Communities That HEAL (CTH) intervention is a community-engaged intervention designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. It includes 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence based practices to address overdose and opioid use disorder.
Other Name: CTH

Wave 2 - Wait-list comparison
Communities in Wave 2 will continue usual care during the first 24 months of the trial. At month 25, Wave 2 communities will begin receiving the CTH intervention.
Other: Wait-list control
Communities in the wait-list control condition will continue usual care during the first 24 months of the trial. At month 25, Wave 2 communities will begin receiving the CTH intervention.




Primary Outcome Measures :
  1. Number of opioid overdose deaths [ Time Frame: Months 13-24 ]
    Count of HCS community resident overdose deaths (i.e. deaths with an underlying cause of drug poisoning) where opioids were determined to be contributing (alone or in combination with other drugs) to the drug poisoning.


Secondary Outcome Measures :
  1. Number of naloxone units distributed in communities [ Time Frame: Months 13-24 ]
    Count of naloxone units distributed in the HCS communities during the measurement period as captured by the following submeasures: 1) count of naloxone units distributed by the state health agency (secondary data from state health agencies) and HCS study logs for naloxone distributed by the study and 2) the count of naloxone units sold by pharmacies (IQVIA pharmacy data)

  2. Number of individuals receiving buprenorphine products that are approved by the Food and Drug Administration (FDA) for treatment of OUD [ Time Frame: Months 13-24 ]
    Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.

  3. Incidents of high-risk opioid prescribing [ Time Frame: Months 13-24 ]
    Count of individuals with one or more of the following during the twelve month study period (months 13-24), and not in a prior specified time window (3 months): risk of continued opioid use (new opioid episode lasting at least 31 days); initiating opioid treatment with extended-release or long-acting opioid; incident high dosage (average ≥ 90 mg morphine per day); and/or incident overlapping opioid and benzodiazepine for ≥ 30 days.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The community must be located in one of the four participating states: Kentucky, Ohio, Massachusetts, or New York.
  • At least 30% of the communities selected within each state must be rural.
  • Across all the HCS communities within each state, there must be a minimum of 150 opioid-related overdose fatalities (with at least 22 opioid-related overdose fatalities experienced by the rural communities) and a rate of at least 25 opioid-related overdose fatalities per 100,000 persons, based on 2016 data.
  • The community must express willingness to address in their response strategy the implementation of MOUD, overdose prevention training, and naloxone distribution across their community.
  • The community must express willingness to develop partnerships across health care, behavioral health, and justice settings for evidence-based practices to address opioid misuse, OUD, and overdoses.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111939


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40508
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Columbia University
New York, New York, United States, 10027
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
RTI International
Boston Medical Center
Columbia University
Ohio State University
University of Kentucky
National Institute on Drug Abuse (NIDA)
Substance Abuse and Mental Health Services Administration (SAMHSA)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT04111939    
Other Study ID Numbers: 38088
1UM1DA049394 ( U.S. NIH Grant/Contract )
1UM1DA049415 ( U.S. NIH Grant/Contract )
1UM1DA049417 ( U.S. NIH Grant/Contract )
1UM1DA049412 ( U.S. NIH Grant/Contract )
1UM1DA049406 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RTI International:
opioid
Opioid Use Disorder (OUD)
overdose
addiction
Naloxone
Buprenorphine
methadone
evidence based practices
community engagement
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders