Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2018 Aug 6;13(1):108.
doi: 10.1186/s13012-018-0795-9.

Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)

Joseph E Glass  1   2 , Jennifer F Bobb  3 , Amy K Lee  3 , Julie E Richards  3   4 , Gwen T Lapham  3 , Evette Ludman  3 , Carol Achtmeyer  3   5 , Ryan M Caldeiro  6 , Rebecca Parrish  6 , Emily C Williams  3   4   7 , Paula Lozano  3 , Katharine A Bradley  3   8   4
Affiliations
Randomized Controlled Trial

Study protocol: a cluster-randomized trial implementing Sustained Patient-centered Alcohol-related Care (SPARC trial)

Joseph E Glass et al. Implement Sci. .

Abstract

Background: Experts recommend that alcohol-related care be integrated into primary care (PC) to improve prevention and treatment of unhealthy alcohol use. However, few healthcare systems offer such integrated care. To address this gap, implementation researchers and clinical leaders at Kaiser Permanente Washington (KPWA) partnered to design a high-quality program of evidence-based care for unhealthy alcohol use: the Sustained Patient-centered Alcohol-related Care (SPARC) program. SPARC implements systems of clinical care designed to increase both prevention and treatment of unhealthy alcohol use. This clinical care for unhealthy alcohol use was implemented using three strategies: electronic health record (EHR) decision support, performance monitoring and feedback, and front-line support from external practice coaches with expertise in alcohol-related care ("SPARC implementation intervention" hereafter). The purpose of this report is to describe the protocol of the SPARC trial, a pragmatic, cluster-randomized, stepped-wedge implementation trial to evaluate whether the SPARC implementation intervention increased alcohol screening and brief alcohol counseling (so-called brief interventions), and diagnosis and treatment of alcohol use disorders (AUDs) in 22 KPWA PC clinics.

Methods/design: The SPARC trial sample includes all adult patients who had a visit to any of the 22 primary care sites in the trial during the study period (January 1, 2015-July 31, 2018). The 22 sites were randomized to implement the SPARC program on different dates (in seven waves, approximately every 4 months). Primary outcomes are the proportion of patients with PC visits who (1) screen positive for unhealthy alcohol use and have documented brief interventions and (2) have a newly recognized AUD and subsequently initiate and engage in alcohol-related care. Main analyses compare the rates of these primary outcomes in the pre- and post-implementation periods, following recommended approaches for analyzing stepped-wedge trials. Qualitative analyses assess barriers and facilitators to implementation and required adaptations of implementation strategies.

Discussion: The SPARC trial is the first study to our knowledge to use an experimental design to test whether practice coaches with expertise in alcohol-related care, along with EHR clinical decision support and performance monitoring and feedback to sites, increase both preventive care-alcohol screening and brief intervention-as well as diagnosis and treatment of AUDs.

Trial registration: The trial is registered at ClinicalTrials.Gov: NCT02675777. Registered February 5, 2016, https://clinicaltrials.gov/ct2/show/NCT02675777 .

Keywords: Alcohol drinking; Alcohol use disorders; Prevention; Primary care, implementation, stepped-wedge, pragmatic trial.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was granted by the Kaiser Permanente Washington Health Research Institute Human Subjects Committee, approval number IRBnet 710232.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The SPARC trial: SPARC implementation intervention and alcohol-related clinical care. The SPARC implementation intervention is designed to implement improved alcohol-related clinical care including preventive screening and brief intervention for unhealthy alcohol use and increased AUD diagnosis and treatment
Fig. 2
Fig. 2
Schematic of each clinics’ four phases of the SPARC trial
Fig. 3
Fig. 3
SPARC stepped-wedge pragmatic clinical trial design. *Usual care start: January 1, 2015. **Data collection end date: July 31, 2018. Twenty-two clinics (with three paired to create 19 randomized clinical sites total) were randomized across seven waves with stratification (three waves year 1 and four waves years 2–3). Clinics in square bracket are paired as one site
See this image and copyright information in PMC

References

    1. Lim S, The Global Burden of Disease Collaborators. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380(9859):2224–60. - PMC - PubMed
    1. Jonas DE, Garbutt JC, Amick HR, et al. Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2012;157(9):645–654. - PubMed
    1. Moyer VA, Preventive Services Task Force. Screening and behavioral counseling interventions in primary care to reduce alcohol misuse: U.S. preventive services task force recommendation statement. Ann Intern Med 2013;159(3):210–8. - PubMed
    1. National Institute on Alcohol Abuse and Alcoholism . Helping patients who drink too much: a clinician’s guide (updated 2005 edition) Washington, D.C: National Institutes of Health, U.S. Department of Health and Human Services; 2005.
    1. Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009;373(9682):2223–2233. - PubMed

Publication types

Associated data