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Implementation Science
Published in: Implementation Science 1/2015

Open Access 01-12-2015 | Study protocol

An organizational readiness intervention and randomized controlled trial to test strategies for implementing substance use disorder treatment into primary care: SUMMIT study protocol

Authors: Allison J Ober, Katherine E Watkins, Sarah B Hunter, Karen Lamp, Mimi Lind, Claude M Setodji

Published in: Implementation Science | Issue 1/2015

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Abstract

Background

Millions of people who need treatment for substance use disorders (SUD) do not receive it. Evidence-based practices for treating SUD exist, and some are appropriate for delivery outside of specialty care settings. Primary care is an opportune setting in which to deliver SUD treatment because many individuals see their primary care providers at least once a year. Further, the Patient Protection and Affordable Care Act (PPACA) increases coverage for SUD treatment and is increasing the number of individuals seeking primary care services. In this article, we present the protocol for a study testing the effects of an organizational readiness and service delivery intervention on increasing the uptake of SUD treatment in primary care and on patient outcomes.

Methods/design

In a randomized controlled trial, we test the combined effects of an organizational readiness intervention consisting of implementation tools and activities and an integrated collaborative care service delivery intervention based on the Chronic Care Model on service system (patient-centered care, utilization of substance use disorder treatment, utilization of health care services and adoption and sustainability of evidence-based practices) and patient (substance use, consequences of use, health and mental health, and satisfaction with care) outcomes. We also use a repeated measures design to test organizational changes throughout the study, such as acceptability, appropriateness and feasibility of the practices to providers, and provider intention to adopt the practices. We use provider focus groups, provider and patient surveys, and administrative data to measure outcomes.

Discussion

The present study responds to critical gaps in health care services for people with substance use disorders, including the need for greater access to SUD treatment and greater uptake of evidence-based practices in primary care. We designed a multi-level study that combines implementation tools to increase organizational readiness to adopt and sustain evidence-based practices (EBPs) and tests the effectiveness of a service delivery intervention on service system and patient outcomes related to SUD services.

Trial registration

Current controlled trials: NCT01810159
Appendix
Available only for authorised users
Literature
1.
U.S. Department of Health and Human Services. Results from the 2013 national survey on drug use and health: summary of national findings, NSDUH Series H-46, HHS Publication No. (SMA) 14–4863. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014.
2.
Yoon YH, Yi HY. Surveillance report #93: liver cirrhosis mortality in the United States, 1970–2009. National Institute on Alcohol Abuse and Alcoholism: Bethesda, MD; 2012.
3.
Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004;291(10):1238–45. doi:10.1001/jama.291.10.1238.PubMed
4.
National Drug Intelligence Center. The economic impact of illicit drug use on American society. Washington D.C: United States Department of Justice; 2011.
5.
6.
Bouchery EE, Harwood HJ, Sacks JJ, Simon CJ, Brewer RD. Economic costs of excessive alcohol consumption in the U.S., 2006. Am J Prev Med. 2011;41(5):516–24.PubMed
7.
U.S. Department of Health and Human Services. Results from the 2012 national survey on drug use and health: summary of national findings, NSDUH Series H-46, HHS Publication No. (SMA) 13–4795. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2013.
8.
Pilowsky DJ, Wu LT. Screening for alcohol and drug use disorders among adults in primary care: a review. Subst Abuse Rehabil. 2012;3(1):25–34. doi:10.2147/SAR.S30057.PubMedPubMedCentral
9.
Cherpitel CJ, Ye Y. Trends in alcohol- and drug-related emergency department and primary care visits: data from four U.S. national surveys (1995–2010). J Stud Alcohol Drugs. 2012;73(3):454–8.PubMedPubMedCentral
10.
Blackwell D, Lucas J, Clarke T. Summary health statistics for U.S. adults: national health interview survey, 2012. In: Vital Health Stat National Center for Health Statistics, editor. 2014
11.
Parthasarathy S, Mertens J, Moore C, Weisner C. Utilization and cost impact of integrating substance abuse treatment and primary care. Med Care. 2003;41(3):357–67.PubMed
12.
Drainoni ML, Farrell C, Sorensen-Alawad A, Palmisano JN, Chaisson C, Walley AY. Patient perspectives of an integrated program of medical care and substance use treatment. Aids Patient Care STDS. 2014;28(2):71–81. doi:10.1089/apc.2013.0179.PubMedPubMedCentral
13.
U.S. Department of Health and Human Services. Treatment Improvement Protocol (TIP) 49: incorporating alcohol pharmacotherapies into medical practice, HHS Publication No SMA13-4380. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2009.
14.
U.S. Department of Health and Human Services. Technical Assistance Publication (TAP) 30: buprenorphine: a guide for nurses, HHS Publication No SMA09-4376. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2009.
15.
Fudala PJ, Bridge TP, Herbert S, Williford WO, Chiang CN, Jones K, et al. Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone. N Engl J Med. 2003;349(10):949–58. doi:10.1056/NEJMoa022164.PubMed
16.
O’Malley SS, Froehlich JC. Advances in the use of naltrexone: an integration of preclinical and clinical findings. Recent Dev Alcohol. 2003;16:217–45.PubMed
17.
18.
Ball SA, Martino S, Nich C, Frankforter TL, Van Horn D, Crits-Christoph P, et al. Site matters: multisite randomized trial of motivational enhancement therapy in community drug abuse clinics. J Consult Clin Psychol. 2007;75(4):556–67. doi:10.1037/0022-006X.75.4.556.PubMedPubMedCentral
19.
Miller WR, Benefield RG, Tonigan JS. Enhancing motivation for change in problem drinking: a controlled comparison of two therapist styles. J Consult Clin Psychol. 1993;61(3):455–61.PubMed
20.
Boldt R. Obstacles to the development and use of pharmacotherapies for addiction. J Health Care Law Pol. 2010;13:1–6.
21.
Buck JA. The looming expansion and transformation of public substance abuse treatment under the affordable care act. Health Aff (Millwood). 2011;30(8):1402–10. doi:10.1377/hlthaff.2011.0480.
22.
Aspy C, Mold J, Thompson D, Blondel R, Lander P, Reilly K, et al. Integrating screening and interventions for unhealthy behaviors into primary care practices. Am J Prev Med. 2008;35(Suppl):S373–80.PubMed
23.
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.PubMed
24.
Friedmann P, McCullough D, Chin M, Saitz R. Screening and intervention for alcohol problems: a national survey of primary care physicians and psychiatrists. J Gen Intern Med. 2000;15:84–91.PubMedPubMedCentral
25.
Urada D, Teruya C, Gelberg L, Rawson R. Integration of substance use disorder services with primary care: health center surveys and qualitative interviews. Subst Abuse Treat Prev Policy. 2014;9:15. doi:10.1186/1747-597X-9-15.PubMedPubMedCentral
26.
Quest TL, Merrill JO, Roll J, Saxon AJ, Rosenblatt RA. Buprenorphine therapy for opioid addiction in rural Washington: the experience of the early adopters. J Opioid Manag. 2012;8(1):29–38.PubMedPubMedCentral
27.
Gueorguieva R, Wu R, Donovan D, Rounsaville BJ, Couper D, Krystal JH, et al. Naltrexone and combined behavioral intervention effects on trajectories of drinking in the COMBINE study. Drug Alcohol Depend. 2009;107(2–3):221–9. doi:10.1016/j.drugalcdep.2009.10.017.PubMedPubMedCentral
28.
West SL, Garbutt JC, Carey TS, Lux LJ, Jackman AM, Tolleson-Rinehart S, et al. Pharmacotherapy for alcohol dependence. Evid Rep Technol Assess (Summ). 1999;3:1–5.PubMed
29.
Fixsen DL, Naoom SF, Blase KA, Friedman RM, Wallace F. Implementation research: a synthesis of the literature. University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementation Research Network (FMHI Publication #231); 2005.
30.
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4:50. doi:10.1186/1748-5908-4-50.PubMedPubMedCentral
31.
Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, et al. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2011;69(2):123–57. doi:10.1177/1077558711430690.PubMedPubMedCentral
32.
Weiner BJ, Amick H, Lee SY. Conceptualization and measurement of organizational readiness for change: a review of the literature in health services research and other fields. Med Care Res Rev. 2008;65(4):379–436. doi:10.1177/1077558708317802.PubMed
33.
Weiner BJ, Lewis MA, Linnan LA. Using organization theory to understand the determinants of effective implementation of worksite health promotion programs. Health Educ Res. 2009;24(2):292–305. doi:10.1093/her/cyn019.PubMed
34.
Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, et al. Quality improvement in chronic illness care: a collaborative approach. Jt Comm J Qual Improv. 2001;27(2):63–80.PubMed
35.
Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A. Improving chronic illness care: translating evidence into action. Health Aff (Millwood). 2001;20(6):64–78.
36.
Unutzer J, Katon W, Callahan CM, Williams Jr JW, Hunkeler E, Harpole L, et al. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002;288(22):2836–45.PubMed
37.
Katon W, Unutzer J, Wells EA, Jones L. Collaborative depression care: history, evolution and ways to enhance dissemination and sustainability. Gen Hosp Psychiatry. 2010;32:456–64.PubMed
38.
Unutzer J, Katon WJ, Fan MY, Schoenbaum MC, Lin EH, Della Penna RD, et al. Long-term cost effects of collaborative care for late-life depression. Am J Manag Care. 2008;14(2):95–100.PubMedPubMedCentral
39.
McGregor M, Lin EH, Katon WJ. TEAMcare: an integrated multicondition collaborative care program for chronic illnesses and depression. J Ambul Care Manage. 2011;34(2):152–62. doi:10.1097/JAC.0b013e31820ef6a4.PubMedPubMedCentral
40.
Katon WJ. Collaborative care: evidence-based models that improve primary care depressive outcomes. CNS Spectr. 2009;14(12 Suppl 14):10–3.PubMed
41.
Ell K, Katon W, Xie B, Lee PJ, Kapetanovic S, Guterman J, et al. One-year postcollaborative depression care trial outcomes among predominantly Hispanic diabetes safety net patients. Gen Hosp Psychiatry. 2011;33(5):436–42. doi:10.1016/j.genhosppsych.2011.05.018.PubMedPubMedCentral
42.
Katon W, Guico-Pabia CJ. Improving quality of depression care using organized systems of care: a review of the literature. Prim Care Companion CNS Disord. 2011;13(1). doi:10.4088/PCC.10r01019blu.
43.
Blasinsky M, Goldman HH, Unutzer J. Project IMPACT: a report on barriers and facilitators to sustainability. Adm Policy Ment Health. 2006;33(6):718–29. doi:10.1007/s10488-006-0086-7.PubMed
44.
Schackman BR, Leff JA, Polsky D, Moore BA, Fiellin DA. Cost-effectiveness of long-term outpatient buprenorphine-naloxone treatment for opioid dependence in primary care. J Gen Intern Med. 2012;27(6):669–76. doi:10.1007/s11606-011-1962-8.PubMedPubMedCentral
45.
Myles J, FL, Raybould T. A double-blind randomised controlled trial of buprenorphine/naloxone (suboxone) versus methadone/lofexidine for the detoxification of opiate-dependent addicts. Drug Alcohol Depend. 2000;60 Suppl 1:S156.
46.
Tofighi B, Grossman E, Williams AR, Biary R, Rotrosen J, Lee JD. Outcomes among buprenorphine-naloxone primary care patients after Hurricane Sandy. Addict Sci Clin Pract. 2014;9:3. doi:10.1186/1940-0640-9-3.PubMedPubMedCentral
47.
Mauger S, Fraser R, Gill K. Utilizing buprenorphine-naloxone to treat illicit and prescription-opioid dependence. Neuropsychiatr Dis Treat. 2014;10:587–98. doi:10.2147/NDT.S39692.PubMedPubMedCentral
48.
Doolittle B, Becker W. A case series of buprenorphine/naloxone treatment in a primary care practice. Subst Abus. 2011;32(4):262–5. doi:10.1080/08897077.2011.599256.PubMed
49.
Balhara YP. Time to include buprenorphine-naloxone combination in the WHO model list of essential medicines. J Opioid Manag. 2014;9(4):237.
50.
Lee JD, Grossman E, Huben L, Manseau M, McNeely J, Rotrosen J, et al. Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. J Subst Abuse Treat. 2012;43(4):458–62.PubMed
51.
Garbutt JC, Kranzler HR, O’Malley SS, Gastfriend DR, Pettinati HM, Silverman BL. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617–25.PubMed
52.
Kranzler H, Wesson D, Billot L. Drug abuse sciences: naltrexone depot study group. Naltrexone depot for treatment of alcohol dependence: a multicenter, randomized, placebo-controlled clinical trial. Alcohol Clin Exp Res. 2004;28:1051–9.PubMed
53.
Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: long-term safety and effectiveness. Addiction. 2013;108(9):1628–37.PubMed
54.
Hartung DM, McCarty D, Fu R, Wiest K, Chalk M, Gastfriend DR. Extended-release naltrexone for alcohol and opioid dependence: a meta-analysis of healthcare utilization studies. J Subst Abuse Treat. 2014;47(2):113–21.PubMedPubMedCentral
55.
Miller WR, Sanchez VC. Motivation of young adults for treatment and lifestyle change. In: Howard G, editor. Issues in alcohol use and misuse by young adults. Notre Dame, IN: University of Notre Dame Press; 1994. p. 55–82.
56.
Miller WR, Zweben A, DiClemente CC, Rychtarik RG. Motivational enhancement therapy: a clinical research guide for therapists treating individuals with alcohol abuse and dependence. Rockville, MD: National Institutes of Health; 1994. Report No.: NIH Publication No. 94–3723.
57.
58.
Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. doi:10.1007/s10488-010-0319-7.PubMed
59.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26. doi:10.1097/MLR.0b013e3182408812.PubMedPubMedCentral
60.
Smith PC, Schmidt SM, Allensworth-Davies D, Saitz R. A single-question screening test for drug use in primary care. Arch Intern Med. 2010;170(13):1155–60.PubMedPubMedCentral
61.
WHO ASSIST Working Group. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST): development, reliability and feasibility. Addiction. 2002;97(9):1183–94.
62.
Rodgers R, Hunter J, Rogers D. Influence of top management commitment on management program success. J Appl Psychol. 1993;78:151–5.
63.
Kraft JM, Mezoff JS, Sogolow ED, Neumann MS, Thomas PA. A technology transfer model for effective HIV/AIDS interventions: science and practice. AIDS Educ Prev. 2000;12(5 Suppl):7–20.PubMed
64.
Beidas R, Kendall P. Training therapists in evidence-based practice: a critical review of studies from a systems-contextual perspective. Clin Psychol. 2010;17:1–30.
65.
Hunter S, Chinman M, Ebener P, Imm P, Wandersman A, Ryan G. Technical assistance as a prevention capacity-building tool: a demonstration using the getting to outcomes framework. Health Educ Behav. 2009;36:810–28.PubMed
66.
Deming W. Out of the crisis, 1986. Cambridge, MA: Massachusetts Institute of Technology Center for Advanced Engineering Study iii; 1991.
67.
Berwick DM. Developing and testing changes in delivery of care. Ann Intern Med. 1998;128(8):651–6.PubMed
68.
Moore G, Benbasat I. Development of an instrument to measure the perceptions of adopting an information technology innovation. Inform Syst Res. 1991;2(3):192–222.
69.
Rogers E. Diffusion of innovations. 4th ed. New York: The Free Press; 1995.
70.
The National Center on Addiction and Substance Abuse (CASA). Missed opportunity: survey of primary care providers and patients on substance abuse. Columbia University; 2000.
71.
Chappel JN, Veach TL, Krug RS. The substance abuse attitude survey: an instrument for measuring attitudes. J Stud Alcohol Drugs. 1985;46(1):48–52.
72.
Aarons GA. Mental health provider attitudes toward adoption of evidence-based practice: the evidence-based practice attitude scale (EBPAS). Ment Health Serv Res. 2004;6(2):61–74.PubMedPubMedCentral
73.
Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the patient assessment of chronic illness care (PACIC). Med Care. 2005;43(5):436–44.PubMed
74.
Bonomi AE, Wagner EH, Glasgow RE, VonKorff M. Assessment of chronic illness care (ACIC): a practical tool to measure quality improvement. Health Serv Res. 2002;37(3):791–820. doi:10.1111/1475-6773.00049.PubMedPubMedCentral
75.
Sobell LC, Maisto SA, Sobell MB, Cooper AM. Reliability of alcohol abusers’ self-reports of drinking behavior. Behav Res Ther. 1979;17:157–60.PubMed
76.
Gillespie W, Holt JL, Blackwell RL. Measuring outcomes of alcohol, marijuana, and cocaine use among college students: a preliminary test of the shortened inventory of problems–alcohol and drugs (SIP-AD). J Drug Issues. 2007;37:549–68.
77.
Ware Jr J, Kosinski M, Turner-Bowker D, Gandek B. How to score version 2 of the SF-12® health survey (with a supplement documenting version 1). Lincoln, RI: Quality Metric Incorporated; 2002.
78.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13.PubMedPubMedCentral
79.
Spitzer R, Kroenke K, Williams J, Lowe B. A brief measure for assessing generalized anxiety disorder. Arch Inern Med. 2006;166:1092–7.
80.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197–207.PubMed
Metadata
Title
An organizational readiness intervention and randomized controlled trial to test strategies for implementing substance use disorder treatment into primary care: SUMMIT study protocol
Authors
Allison J Ober
Katherine E Watkins
Sarah B Hunter
Karen Lamp
Mimi Lind
Claude M Setodji
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-015-0256-7

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