Operationalizing and selecting outcome measures for the HEALing Communities Study.
BACKGROUND
The Helping to End Addiction Long-termSM (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.


METHODS
Priority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites.


RESULTS
The research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing.


CONCLUSIONS
The HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.
['Slavova|Svetla|S|', 'LaRochelle|Marc R|MR|', 'Root|Elisabeth D|ED|', 'Feaster|Daniel J|DJ|', 'Villani|Jennifer|J|', 'Knott|Charles E|CE|', 'Talbert|Jeffery|J|', 'Mack|Aimee|A|', 'Crane|Dushka|D|', 'Bernson|Dana|D|', 'Booth|Austin|A|', 'Walsh|Sharon L|SL|']
D000701:Analgesics, Opioid D002047:Buprenorphine D002986:Clinical Trials as Topic D055317:Evidence-Based Practice D006801:Humans D009270:Naloxone D000083682:Opiate Overdose D009293:Opioid-Related Disorders D017063:Outcome Assessment, Health Care D010818:Practice Patterns, Physicians' D011634:Public Health D012107:Research Design
HEALing Communities Study Overdose Naloxone Opioid use disorder Helping to End Addiction Long-term(SM) High-risk prescribing