ABSTRACT
BACKGROUND: The extent of human interaction needed to achieve effective and cost-effective use of mobile health (mHealth) apps for individuals with mild to moderate alcohol use disorder (AUD) remains largely unexamined. This study seeks to understand how varying levels of human interaction affect the ways in which an mHealth intervention for the prevention and treatment of AUDs works or does not work, for whom, and under what circumstances. OBJECTIVE: The primary aim is to detect the effectiveness of an mHealth intervention by assessing differences in self-reported risky drinking patterns and quality of life between participants in three study groups (self-monitored, peer-supported, and clinically integrated). The cost-effectiveness of each approach will also be assessed. METHODS: This hybrid type 1 study is an unblinded patient-level randomized clinical trial testing the effects of using an evidence-based mHealth system on participants' drinking patterns and quality of life. There are two groups of participants for this study: individuals receiving the intervention and health care professionals practicing in the broader health care environment. The intervention is a smartphone app that encourages users to reduce their alcohol consumption within the context of integrative medicine using techniques to build healthy habits. The primary outcomes for quantitative analysis will be participant data on their risky drinking days and quality of life as well as app use from weekly and quarterly surveys. Cost measures include intervention and implementation costs. The cost per participant will be determined for each study arm, with intervention and implementation costs separated within each group. There will also be a qualitative assessment of health care professionals' engagement with the app as well as their thoughts on participant experience with the app. RESULTS: This protocol was approved by the Health Sciences Minimal Risk Institutional Review Board on November 18, 2019, with subsequent annual reviews. Recruitment began on March 6, 2020, but was suspended on March 13, 2020, due to the COVID-19 pandemic restrictions. Limited recruitment resumed on July 6, 2020. Trial status as of November 17, 2021, is as follows: 357 participants were enrolled in the study for a planned enrollment of 546 participants. CONCLUSIONS: The new knowledge gained from this study could have wide and lasting benefits related to the integration of mHealth systems for individuals with mild to moderate AUDs. The results of this study will guide policy makers and providers toward cost-effective ways to incorporate technology in health care and community settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT04011644; https://clinicaltrials.gov/ct2/show/NCT04011644. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/31109.
ABSTRACT
BACKGROUND: Rates of opioid prescribing tripled in the USA between 1999 and 2015 and were associated with significant increases in opioid misuse and overdose death. Roughly half of all opioids are prescribed in primary care. Although clinical guidelines describe recommended opioid prescribing practices, implementing these guidelines in a way that balances safety and effectiveness vs. risk remains a challenge. The literature offers little help about which implementation strategies work best in different clinical settings or how strategies could be tailored to optimize their effectiveness in different contexts. Systems consultation consists of (1) educational/engagement meetings with audit and feedback reports, (2) practice facilitation, and (3) prescriber peer consulting. The study is designed to discover the most cost-effective sequence and combination of strategies for improving opioid prescribing practices in diverse primary care clinics. METHODS/DESIGN: The study is a hybrid type 3 clustered, sequential, multiple-assignment randomized trial (SMART) that randomizes clinics from two health systems at two points, months 3 and 9, of a 21-month intervention. Clinics are provided one of four sequences of implementation strategies: a condition consisting of educational/engagement meetings and audit and feedback alone (EM/AF), EM/AF plus practice facilitation (PF), EM/AF + prescriber peer consulting (PPC), and EM/AF + PF + PPC. The study's primary outcome is morphine-milligram equivalent (MME) dose by prescribing clinicians within clinics. The study's primary aim is the comparison of EM/AF + PF + PPC versus EM/AF alone on change in MME from month 3 to month 21. The secondary aim is to derive cost estimates for each of the four sequences and compare them. The exploratory aim is to examine four tailoring variables that can be used to construct an adaptive implementation strategy to meet the needs of different primary care clinics. DISCUSSION: Systems consultation is a practical blend of implementation strategies used in this case to improve opioid prescribing practices in primary care. The blend offers a range of strategies in sequences from minimally to substantially intensive. The results of this study promise to help us understand how to cost effectively improve the implementation of evidence-based practices. TRIAL REGISTRATION: NCT04044521 (ClinicalTrials.gov). Registered 05 August 2019.