Operationalizing and selecting outcome measures for the HEALing Communities Study

Svetla Slavova, Marc R. LaRochelle, Elisabeth D. Root, Daniel J. Feaster, Jennifer Villani, Charles E. Knott, Jeffery Talbert, Aimee Mack, Dushka Crane, Dana Bernson, Austin Booth, Sharon L. Walsh

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

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.

Original languageEnglish
Article number108328
JournalDrug and Alcohol Dependence
Volume217
DOIs
StatePublished - Dec 1 2020

Bibliographical note

Funding Information:
This research was supported by the National Institutes of Health through the NIH HEAL Initiative under award numbers UM1DA049394, UM1DA049406, UM1DA049412, UM1DA049415, UM1DA049417. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or its NIH HEAL Initiative.

Funding Information:
This research was supported by the National Institutes of Healththrough the NIH HEAL Initiative under award numbers UM1DA049394,UM1DA049406,UM1DA049412,UM1DA049415,UM1DA049417. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or its NIH HEAL Initiative.

Funding Information:
We would like to acknowledge the support for this study from the following agencies: Kentucky Cabinet for Health and Family Services [Office of Inspector General, Office of Health Data and Analytics, Office of Vital Statistics, Department for Medicaid Services, Department for Public Health, Department for Behavioral Health, Developmental and Intellectual Disabilities], Kentucky Board of EMS, New York State (NYS) Department of Health, NYS Office of Health Insurance Programs, NYS Bureau of Vital Records, NYS Bureau of Narcotic Enforcement, Office of Primary Care and Health Systems Management, NYS Statewide Planning and Research Cooperative System, NYS Bureau of All Payer Systems and Informatics, Office of Quality and Patient Safety, NYS Bureau of Emergency Medical Services and Trauma Systems, NYS Office of Alcoholism and Substance Abuse Services, NYS Office of Drug User Health, RecoveryOhio, the Ohio Department of Medicaid, the Ohio Department of Health, and the Ohio Department of Mental Health and Addiction Services, Ohio Department of Public Safety, Ohio Department of Rehabilitation and Corrections, Ohio Department of Administrative Services (InnovateOhio Platform), the Massachusetts Department of Public Health, MassHealth (Massachusetts Medicaid), and the Biostatistics Epidemiology Data Analytics Center (BEDAC) at Boston University. We also would like to thank the following colleagues and collaborators for their support for the study and contribution to the HCS measure: Thomas Clarke, Eric Friedlander, Rick Massati, Alisha Nelson, Aimee Shadwick, Adam Meier, Katie Marks, Angela Taylor, Peter Rock, Patrick Ward, Zhengyan Huang, Sarah Hargrove, Trish Freeman, Michelle Lofwall, Laura Fanucchi, Candace Brancato, Rachel Mauk, Emelie Bailey, Gregory Young, John Meyers, Rachel Baker, Alexandra Bontempo, Peter Brodie, Lindsay Cogan, Kitty Gelberg, Danielle Green, Yi Han, Steve Hansen, Glynnis Hunt, Melissa Kamal, Kimberly Leonard, Patricia Lincourt, Stephanie Mack, Yali Meng, Trang Nguyen, Vivian Nwudu, Alison Pinkelski, Elizabeth Schady, Loretta Santilli, Joshua Vinciguerra, Valerie White, Cortney Miller, Alexander Walley, Greg Patts, Sharon Coleman, Amy Bettano, Leonard Young, Danielle Valerio, Netrali Dalvi, Adam Stoler, Madelyn Murphy, Neshe Gafuri, Rosa Ergas, Megha Parikh, John McCarthy, Dalia Khoury. We would like to acknowledge the Justice Community Opioid Innovation Network (JCOIN) and Christy Scott and Michael Dennis for permission to use items from their Jail Interview Protocol (© Chestnut Health Systems). Finally, IQVIA data are not reported in this paper, but are mentioned as a data source; consequently, the manuscript was reviewed and approved by IQVIA.

Publisher Copyright:
© 2020 Elsevier B.V.

Keywords

  • HEALing Communities Study
  • Helping to End Addiction Long-term
  • High-risk prescribing
  • Naloxone
  • Opioid use disorder
  • Overdose

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology
  • Psychiatry and Mental health
  • Pharmacology (medical)

Fingerprint

Dive into the research topics of 'Operationalizing and selecting outcome measures for the HEALing Communities Study'. Together they form a unique fingerprint.

Cite this