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

Joseph E Glass, Jennifer F Bobb, Amy K Lee, Julie E Richards, Gwen T Lapham, Evette Ludman, Carol Achtmeyer, Ryan M Caldeiro, Rebecca Parrish, Emily C Williams, Paula Lozano, Katharine A Bradley, Joseph E Glass, Jennifer F Bobb, Amy K Lee, Julie E Richards, Gwen T Lapham, Evette Ludman, Carol Achtmeyer, Ryan M Caldeiro, Rebecca Parrish, Emily C Williams, Paula Lozano, Katharine A Bradley

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://ichgcp.net/clinical-trials-registry/NCT02675777 .

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

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

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.
    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.
    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.
    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.
    1. Rivara FP, Koepsell TD, Jurkovich GJ, Gurney JG, Soderberg R. The effects of alcohol abuse on readmission for trauma. JAMA. 1993;270(16):1962–1964.
    1. Becker U, Deis A, Sorenson TIA, Gronbaek M, Borch-Johnsen K, Muller CF. Prediction of risk of liver disease by alcohol intake, sex and age: a prospective population study. Hepatology. 1996;23(5):1025–1029.
    1. Bagnardi V, Blangiardo M, La Vecchia C, Corrao G. A meta-analysis of alcohol drinking and cancer risk. Br J Cancer. 2001;85(11):1700–1705.
    1. Bryson CL, Au DH, Sun H, Williams EC, Kivlahan DR, Bradley KA. Alcohol screening scores and medication nonadherence. Ann Intern Med. 2008;149(11):795–804.
    1. Ahmed AT, Karter AJ, Warton EM, Doan JU, Weisner CM. The relationship between alcohol consumption and glycemic control among patients with diabetes: the Kaiser Permanente Northern California Diabetes Registry. J Gen Intern Med. 2008;23(3):275–282.
    1. Dawson DA, Goldstein RB, Saha TD, Grant BF. Changes in alcohol consumption: United States, 2001-2002 to 2012-2013. Drug Alcohol Depend. 2015;148:56–61.
    1. Grant BF, Goldstein RB, Saha TD, et al. Epidemiology of DSM-5 alcohol use disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions III. JAMA Psychiatry. 2015;72(8):757–766.
    1. Buchsbaum DG, Buchanan RG, Lawton MJ, Elswick RK, Jr, Schnoll SH. A program of screening and prompting improves short-term physician counseling of dependent and nondependent harmful drinkers. Arch Intern Med. 1993;153(13):1573–1577.
    1. Glass JE, Bohnert KM, Brown RL. Alcohol screening and intervention among United States adults who attend ambulatory healthcare. J Gen Intern Med. 2016;31(7):739–745.
    1. Solberg LI, Maciosek MV, Edwards NM. Primary care intervention to reduce alcohol misuse ranking its health impact and cost effectiveness. Am J Prev Med. 2008;34(2):143–152.
    1. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA. 2014;311(18):1889–1900.
    1. Oslin DW, Lynch KG, Maisto SA, et al. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med. 2014;29(1):162–168.
    1. Watkins KE, Ober AJ, Lamp K, et al. Collaborative care for opioid and alcohol use disorders in primary care: the SUMMIT randomized clinical trial. JAMA Intern Med. 2017;177(10):1480–1488.
    1. Bouza C, Angeles M, Munoz A, Amate JM. Efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence: a systematic review. Addiction. 2004;99(7):811–828.
    1. Berglund M. A better widget? Three lessons for improving addiction treatment from a meta-analytical study. Addiction. 2005;100(6):742–750.
    1. Rosner S, Hackl-Herrwerth A, Leucht S, Lehert P, Vecchi S, Soyka M. Acamprosate for alcohol dependence. Cochrane Database Syst Rev. 2010(9):CD004332.. Accessed 31 Aug 2017.
    1. Rosner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2010:CD001867.. Accessed 31 Aug 2017.
    1. Dunn C, Deroo L, Rivara FP. The use of brief interventions adapted from motivational interviewing across behavioral domains: a systematic review. Addiction. 2001;96(12):1725–1742.
    1. Glasner-Edwards S, Rawson R. Evidence-based practices in addiction treatment: review and recommendations for public policy. Health Policy. 2010;97(2–3):93–104.
    1. National Institute for Health and Clinical Effectiveness . Alcohol-use disorders: diagnosis, assessment and managment of harmful drinking and alcohol dependence. 2011.
    1. VA Office of Quality and Performance . VA/DoD clinical practice guideline for the management of substance use disorders, version 2.0. 2009.
    1. National Quality Forum. National Voluntary Consensus Standards for the Treatment of Substance Use Conditions: Evidence-Based Treatment Practices. Washington, DC: Robert Wood Johnson Foundation; 2007.
    1. Anderson P, Kaner E, Wutzke S, et al. Attitudes and managing alcohol problems in general practice: an interaction analysis based on findings from a WHO collaborative study. Alcohol. 2004;39(4):351–356.
    1. Williams EC, Johnson ML, Lapham GT, et al. Strategies to implement alcohol screening and brief intervention in primary care settings: a structured literature review. Psychol Addict Behav. 2011;25(2):206–214.
    1. Harris AH, Oliva E, Bowe T, Humphreys KN, Kivlahan DR, Trafton JA. Pharmacotherapy of alcohol use disorders by the Veterans Health Administration: patterns of receipt and persistence. Psychiatr Serv. 2012;63(7):679–685.
    1. Harris AH. Too few patients medicated for alcohol dependence. Health Aff (Millwood) 2012;31(1):249.
    1. Mark TL, Kassed CA, Vandivort-Warren R, Levit KR, Kranzler HR. Alcohol and opioid dependence medications: prescription trends, overall and by physician specialty. Drug Alcohol Depend. 2009;99(1–3):345–349.
    1. Rubinsky AD, Chen C, Batki SL, Williams EC, Harris AH. Comparative utilization of pharmacotherapy for alcohol use disorder and other psychiatric disorders among U.S. Veterans Health Administration patients with dual diagnoses. J Psychiatr Res. 2015;69:150–157.
    1. Williams EC, Gupta S, Rubinsky AD, et al. Variation in receipt of pharmacotherapy for alcohol use disorders across racial/ethnic groups: a national study in the U.S. Veterans Health Administration. Drug Alcohol Depend. 2017;178:527–533.
    1. McGlynn EA, Asch SM, Adams JL, et al. The quality of health care delivered to adults in the United States. N Engl J Med. 2003;348(26):2635–2645.
    1. Turner BJ, Mathias CW. Increasing prevalence of alcohol use disorders: meeting the challenge in primary care : commentary on Williams et al., barriers to and facilitators of alcohol use disorder pharmacotherapy in primary care: a qualitative study in five VA clinics. J Gen Intern Med. 2018;33(3):236–237.
    1. Bradley KA, Williams EC, Achtmeyer CE, Volpp B, Collins BJ, Kivlahan DR. Implementation of evidence-based alcohol screening in the Veterans Health Administration. Am J Manag Care. 2006;12(10):597–606.
    1. Lapham GT, Achtmeyer CE, Williams EC, Hawkins EJ, Kivlahan DR, Bradley KA. Increased documented brief alcohol interventions with a performance measure and electronic decision support. Med Care. 2012;50(2):179–187.
    1. Bradley KA, Williams EC. Implementation of SBI in clinical settings using quality improvement principles. In: Ries RK, Miller SC, Fiellin DA, Saitz R, editors. Principles of addiction medicine. 5. Philadelphia, PA: Lippincott Williams & Wilkins; 2013. pp. 291–292.
    1. Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O. Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q. 2004;82(4):581–629.
    1. Williams EC, Achtmeyer CE, Young JP, et al. Local implementation of alcohol screening and brief intervention at five Veterans Health Administration primary care clinics: perspectives of clinical and administrative staff. J Subst Abus Treat. 2016;60:27–35.
    1. Bradley KA, Johnson ML, Williams EC. Commentary on Nilsen et al.: the importance of asking patients-the potential value of patient report of brief interventions. Addiction. 2011;106(10):1757–1759.
    1. Chavez LJ, Williams EC, Lapham GT, Rubinsky AD, Kivlahan DR, Bradley KA. Changes in patient-reported alcohol-related advice following Veterans Health Administration implementation of brief alcohol interventions. J Stud Alcohol Drugs. 2016;77(3):500–508.
    1. Hawkins EJ, Kivlahan DR, Williams EC, Wright SM, Craig T, Bradley KA. Examining quality issues in alcohol misuse screening. Subst Abus. 2007;28(3):53–65.
    1. Bradley KA, Lapham GT, Hawkins EJ, et al. Quality concerns with routine alcohol screening in VA clinical settings. J Gen Intern Med. 2011;26(3):299–306.
    1. Williams EC, Achtmeyer CE, Thomas RM, et al. Factors underlying quality problems with alcohol screening prompted by a clinical reminder in primary care: a multi-site qualitative study. J Gen Intern Med. 2015;30(8):1125–1132.
    1. Williams EC, Rubinsky AD, Chavez LJ, et al. An early evaluation of implementation of brief intervention for unhealthy alcohol use in the US Veterans Health Administration. Addiction. 2014;109(9):1472–1481.
    1. Williams EC, Lapham GT, Bobb JF, et al. Documented brief intervention not associated with resolution of unhealthy alcohol use one year later among VA patients living with HIV. J Subst Abus Treat. 2017;78:8–14.
    1. Bradley KA, Chavez LJ, Lapham GT, et al. When quality indicators undermine quality: bias in a quality indicator of follow-up for alcohol misuse. Psychiatr Serv. 2013;64(10):1018–1025.
    1. Berger D, Lapham GT, Shortreed SM, et al. Increased Rates of Documented Alcohol Counseling in Primary Care: More Counseling or Just More Documentation? J Gen Intern Med. 2018;33(3):268-74.
    1. Buchsbaum DG, Buchanan RG, Poses RM, Schnoll SH, Lawton MJ. Physician detection of drinking problems in patients attending a general medicine practice. J Gen Intern Med. 1992;7(5):517–521.
    1. Anton RF, O'Malley SS, Ciraulo DA, et al. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006;295(17):2003-17.
    1. Bradley KA, Bobb JF, Ludman EJ, et al. Alcohol-Related Nurse Care Management in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2018;178(5):613-21.
    1. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33.
    1. Saitz R, Cheng DM, Winter M, et al. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial. JAMA. 2013;310(11):1156–1167.
    1. Bradley KA, Kivlahan DR. Bringing patient-centered care to patients with alcohol use disorders. JAMA. 2014;311(18):1861–1862.
    1. Willenbring ML, Olson DH. A randomized trial of integrated outpatient treatment for medically ill alcoholic men. Arch Intern Med. 1999;159(16):1946–1952.
    1. Wallhed Finn S, Hammarberg A, Andreasson S. Treatment for alcohol dependence in primary care compared to outpatient specialist treatment—a randomized controlled trial. Alcohol Alcohol. 2018;53(4):376–385.
    1. National Council for Behavioral Health. Implementing Care for Alcohol & Other Drug Use in Medical Setting: An Extension of SBIRT. Washington DC: National Council for Behavioral Health; 2018.
    1. Maust DT, Mavandadi S, Klaus J, Oslin DW. Missed opportunities: fewer service referrals after positive alcohol misuse screens in VA primary care. Psychiatric services (Washington, DC) 2011;62(3):310–312.
    1. Williams EC, Lapham G, Achtmeyer CE, Volpp B, Kivlahan DR, Bradley KA. Use of an electronic clinical reminder for brief alcohol counseling is associated with resolution of unhealthy alcohol use at follow-up screening. J Gen Intern Med. 2010;25(Suppl 1):11–17.
    1. Bobb JF, Lee AK, Lapham GT, et al. Evaluation of a Pilot Implementation to Integrate Alcohol-Related Care within Primary Care. Int J Environ Res Public Health. 2017;14(9).
    1. Baskerville NB, Liddy C, Hogg W. Systematic review and meta-analysis of practice facilitation within primary care settings. Ann Fam Med. 2012;10(1):63–74.
    1. Damiani G, Pinnarelli L, Colosimo SC, et al. The effectiveness of computerized clinical guidelines in the process of care: a systematic review. BMC Health Serv Res. 2010;10(1):2.
    1. Ivers N, Jamtvedt G, Flottorp S, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012;(6):CD000259.
    1. Kirchner JE, Ritchie MJ, Pitcock JA, Parker LE, Curran GM, Fortney JC. Outcomes of a partnered facilitation strategy to implement primary care-mental health. J Gen Intern Med. 2014;29(Suppl 4):904–912.
    1. Evans M. A ReThink of the way we drink. 2015.
    1. Mdege ND, Man MS, Taylor Nee Brown CA, Torgerson DJ. Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol. 2011;64(9):936–948.
    1. National Committee for Quality Assurance . HEDIS 2018. Washington, DC: National Committee for Quality Assurance; 2018.
    1. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–191.
    1. Hughes JP, Granston TS, Heagerty PJ. Current issues in the design and analysis of stepped wedge trials. Contemp Clin Trials. 2015;45(Pt A):55–60.
    1. Beebe J. Rapid Assessment Process: An Introduction. Lanham: Altmira Press; 2001.
    1. Agency for Healthcare Research and Quality . AHRQ Academy | Integrating Behavioral Health and Primary Care Homepage. 2018.
    1. Whitlock EP. Alcohol screening in primary care. BMJ. 2003;327:E263–E264.
    1. Washington Health Alliance . Washington Health Alliance survey. 2018.
    1. Lim SS, Vos T, Flaxman AD, et al. 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):2224–2260.
    1. Collaborators USBoD, Mokdad AH, Ballestros K et al. The state of US health, 1990-2016: burden of diseases, injuries, and risk factors among US states. JAMA. 2018;319(14):1444–1472.
    1. Institute of Medicine . Broadening the base of treatment for alcohol problems: a report of the committee for the study of treatment and rehabilitation for alcoholism. Washington DC: National Academy Press; 1990.
    1. Institute of Medicine (US) Committee on Crossing the Quality Chasm: Adaptation to Mental Health and Addictive Disorders . Improving the quality of health care for mental and substance-use conditions: quality chasm series. Washington, DC: National Academies Press; 2006.
    1. Samet JH, Larson MJ, Horton NJ, Doyle K, Winter M, Saitz R. Linking alcohol- and drug-dependent adults to primary medical care: a randomized controlled trial of a multi-disciplinary health intervention in a detoxification unit. Addiction. 2003;98(4):509–516.
    1. Samet JH, Rollnick S, Barnes H. Beyond CAGE. A brief clinical approach after detection of substance abuse. Arch Intern Med. 1996;156(20):2287–2293.
    1. Watkins KE, Pincus HA, Tanielian TL. Evidence-based care models for recognizing and treating alcohol problems in primary care settings. Santa Monica, CA: RAND Corporation; 2001.
    1. Watkins K, Pincus HA, Tanielian TL, Lloyd J. Using the chronic care model to improve treatment of alcohol use disorders in primary care settings. J Stud Alcohol. 2003;64(2):209–218.
    1. Bradley KA, DeBenedetti AF, Volk RJ, Williams EC, Frank D, Kivlahan DR. AUDIT-C as a Brief Screen for Alcohol Misuse in Primary Care. Alcoholism: Clin Exp Res. 2007;31(7):1208–1217.
    1. Johnson JA, Lee A, Vinson D, Seale JP. Use of AUDIT-Based Measures to Identify Unhealthy Alcohol Use and Alcohol Dependence in Primary Care: A Validation Study. Alcoholism: Clin Exp Res. 2013;37:E253-E259.
    1. Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005;58(2):163–171.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9. J Gen Intern Med. 2001;16(9):606-613.
    1. Posner K, Brown GK, Stanley B, et al. The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults. Am J Psychiatry. 2011;168(12):1266-1277.
    1. Lapham GT, Lee AK, Caldeiro RM, et al. Frequency of Cannabis Use Among Primary Care Patients in Washington State. J the Am Board Fam Med. 2017;30(6):795-805.
    1. Humeniuk R, Ali R, Babor TF, et al. Validation of the alcohol, smoking and substance involvement screening test (ASSIST). Addiction. 2008;103(6):1039-1047.
    1. Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. A Single-Question Screening Test for Drug Use in Primary Care. Arch Int Med. 2010;170(13).

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