Trial Outcomes & Findings for HEALing Communities Study (NCT NCT04111939)

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

Months 19-30

Results posted on

2025-05-29

Participant Flow

Unit of analysis: Communities

Participant milestones

Participant milestones
Measure	Wave 1 - Intervention Communities in Wave 1 will receive the CTH intervention during the first 30 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. 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.	Wave 2 - Wait-list Comparison Communities in Wave 2 will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention. Wait-list control: Communities in the wait-list control condition will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.
Overall Study STARTED	0 34	0 33
Overall Study COMPLETED	0 34	0 33
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HEALing Communities Study

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Months 19-30

Population: Communities randomized to intervention and actual number of participants is unknown.

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.

Outcome measures

Outcome measures
Measure	Wave 1 - Intervention n=34 Communities Communities in Wave 1 will receive the CTH intervention during the first 30 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. 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.	Wave 2 - Wait-list Comparison n=33 Communities Communities in Wave 2 will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention. Wait-list control: Communities in the wait-list control condition will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.
Number of Opioid Overdose Deaths	47.2 Opioid-related overdose deaths Interval 41.8 to 53.2	51.7 Opioid-related overdose deaths Interval 44.9 to 59.6

SECONDARY outcome

Timeframe: Months 19-30

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 19-30

Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 19-30

Count of individuals with one or more of the following during the twelve month study period (months 19-30), 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 44 months

Population: AEs and SAEs were assessed at the community level.

The mean rate of emergency medical service (EMS) runs for a suspected opioid overdose per 1000 adults to assess potential adverse events and serious adverse events in the community. This is community level data of EMS runs (suspected opioid overdose events in the community areas), but not deaths. We had to use a surrogate measure (EMS runs: not the same as deaths, some may have died but others may have been saved) since the decedent/death certificate data had too long of a lag. AE Criterion: ORO (opioid-related overdose) rate for a single month increased \> 3 standard deviations (SDs) above the moving avg of the previous 3 months. SAE Criterion: ORO rate for a single month increased \> 4 SDs above the moving avg of the previous 3 months. The SD was determined from the monthly rates of the communities for the latest available 12-month period prior to the start of the intervention using a pooled estimate across communities. We did not monitor at the individual participant level.

Outcome measures

Outcome measures
Measure	Wave 1 - Intervention n=34 Communities Communities in Wave 1 will receive the CTH intervention during the first 30 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. 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.	Wave 2 - Wait-list Comparison n=33 Communities Communities in Wave 2 will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention. Wait-list control: Communities in the wait-list control condition will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.
Adverse Event Incidence Per 1000 Community Members	0.0007659 Events per 1000 members	0.0008748 Events per 1000 members

Adverse Events

Wave 1 - Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wave 2 - Wait-list Comparison

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Charles Knott

RTI International

Phone: 9195416294

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place