Clinical trial NCT04861792: Michigan SPARC Trial
Official title: The Michigan Sustained Patient-centered Alcohol-Related Care (MI-SPARC) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol
Drinking
Alcohol Use Disorder (AUD)
Keywords: Alcohol misuse
Unhealthy alcohol use
Alcoholism
Alcohol dependence
Alcohol abuse
Risky drinking
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ) - Funder
name: Altarum Institute
name: NORC at the University of Chicago
First posted: 2021-04-27
Enrollment: 9590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Originally the SPARC trial was a stepped-wedge cluster-randomized design to evaluate the Michigan SPARC quality improvement intervention compared to usual care. We converted the trial into a program evaluation due to COVID making randomization impossible (e.g., a randomly assigned, unpredictable time to implement was unacceptable in a pandemic, COVID markedly limited primary care practices interest in the trial, and some practices that enrolled closed during the project). The originally planned random assignment to receive the AUD decision aid was not possible due to the small number of participating practices during the pandemic and the need to provide all sites the decision aid to maximize engagement in the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Unhealthy alcohol use is a major contributor to morbidity and mortality in the US. Although effective prevention for unhealthy alcohol use and medication treatment for alcohol use disorders (AUDs) can be provided in primary care (PC), they have historically not been included in routine services. As a result, most patients do not receive evidence-based prevention or treatment for unhealthy alcohol use. Several efforts have successfully implemented alcohol-related preventive care-referred to as screening and brief intervention (SBI), but efforts to increase treatment of AUDs with medications have been less successful. Moreover, implementation efforts have usually neglected smaller PC practices, in which most PC is provided.

The Michigan SPARC trial is a partnership between Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle, bringing extensive expertise implementing evidence-based alcohol-related care, and Altarum Institute in Ann Arbor, Michigan, bringing demonstrated success engaging over 500 small to medium Michigan-based PC practices in effective quality improvement (QI) efforts. The project builds on Altarum's innovative approach to implementing new or improved clinical care using practice facilitators to provide continuing medical education and maintenance of certification (CME/MOC) programs to PC providers, along with ongoing support for QI using evidence-based implementation strategies. The KPWHRI team recently finished the highly successful AHRQ-funded Sustained Patient-centered Alcohol-Related Care (SPARC) trial using similar implementation strategies in KP Washington, including use of electronic health records and performance monitoring and feedback, and also developed a patient decision aid to support shared decision-making between patients with high-risk drinking and/or AUDs and their PC providers.

The Michigan SPARC trial combines Altarum's expertise in QI in small-medium PC practices in Michigan with KPWHRI's expertise implementing evidence-based prevention and treatment of unhealthy alcohol use-specifically alcohol SBI and medication treatment for AUDs.

Specific Aims of the Michigan SPARC trial had to be markedly modified due to the trial beginning in March 2020 at the same time as the COVID pandemic. A trial was not possible. The revised aims were to describe alcohol screening, brief intervention, AUD diagnosis and initiation of medication treatment for AUD, before and after the Michigan SPARC model was implemented, in small to medium PC practices in Michigan.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 years and older
* Seen in primary care at a study practice during the practice's study period

Exclusion Criteria:

• None

Primary outcomes:
measure: Prevention - Screening and brief intervention
timeFrame: For Aim 1 the period up to 6 months before the launch date will be compared to the 6 month period after the launch date.
measure: Treatment - Prescription of AUD medications
timeFrame: For Aim 1 the period up to 6 months before the launch date will be compared to the 6 month period after the launch date.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Altarum Institute
state: Michigan
Study officials:
References: