NCT04861792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,590

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

April 21, 2021

Last Update Submit

March 23, 2023

Conditions

AlcoholDrinkingAlcohol Use Disorder (AUD)

Keywords

Alcohol misuseUnhealthy alcohol useAlcoholismAlcohol dependenceAlcohol abuseRisky drinking

Outcome Measures

Primary Outcomes (2)

  • Prevention - Screening and brief intervention

    The proportion of PC patients who screen positive for unhealthy alcohol use and have BI documented in their EHR.

    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.

  • Treatment - Prescription of AUD medications

    The proportion of PC patients who are diagnosed with AUD at a visit who also receive a prescription for medications to treat AUD and are seen for follow-up within 14 days.

    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.

Study Arms (2)

Usual Care

NO INTERVENTION

Patients seen before the intervention launch date.

Quality Improvement Intervention

EXPERIMENTAL

Patients seen after the intervention launch date.

Behavioral: Michigan SPARC Quality Improvement Intervention

Interventions

Michigan SPARC Quality Improvement InterventionBEHAVIORAL

Practice facilitation, electronic health record (EHR) support, performance monitoring and feedback combined with alcohol-related continuing medical education (CME) and maintenance of certification (MOC) and tools to support alcohol related care including a decision aid for shared decision making about alcohol use disorder (AUD).

Quality Improvement Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altarum Institute

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 27, 2021

Study Start

May 1, 2021

Primary Completion

March 13, 2023

Study Completion

March 13, 2023

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Deidentified data will be shared in the following ways: External Evaluator. The Michigan SPARC investigators are committed to working with AHRQ's external evaluator (NORC) on the cross-grant evaluation. Other data sharing. We will also make de-identified data available, upon request, after Michigan SPARC trial results are completed and published. No PC practices will be identified in the dataset. Data will be available to investigators who propose a cogent analysis not already part of planned secondary analyses. Proposals must include a biosketch of the Investigator(s), as well as research question(s), sample, measures, methods and statistical issues. Proposals will be reviewed by the Multiple PIs and the leaders of the Michigan SPARC Data and Evaluation team. For approved projects, a data sharing agreement will be developed and subsequently data will be made available.

Locations

US(1)