HEALing Communities Study
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|ClinicalTrials.gov Identifier: NCT04111939|
Recruitment Status : Active, not recruiting
First Posted : October 1, 2019
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Disorder (OUD)||Other: Communities That HEAL Other: Wait-list control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|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|
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.
- 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.
- 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)
- 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.
- 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.
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
|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|
|New York, New York, United States, 10027|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|