Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial

Sara J Becker, Cara M Murphy, Bryan Hartzler, Carla J Rash, Tim Janssen, Mat Roosa, Lynn M Madden, Bryan R Garner, Sara J Becker, Cara M Murphy, Bryan Hartzler, Carla J Rash, Tim Janssen, Mat Roosa, Lynn M Madden, Bryan R Garner

Abstract

Background: Opioid-related overdoses and harms have been declared a public health emergency in the United States, highlighting an urgent need to implement evidence-based treatments. Contingency management (CM) is one of the most effective behavioral interventions when delivered in combination with medication for opioid use disorder, but its implementation in opioid treatment programs is woefully limited. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) was funded by the National Institute on Drug Abuse to identify effective strategies for helping opioid treatment programs improve CM implementation as an adjunct to medication. Specific aims will test the impact of two different strategies on implementation outcomes (primary aim) and patient outcomes (secondary aims), as well as test putative mediators of implementation effectiveness (exploratory aim).

Methods: A 3-cohort, cluster-randomized, type 3 hybrid design is used with the opioid treatment programs as the unit of randomization. Thirty programs are randomized to one of two conditions. The control condition is the Addiction Technology Transfer Center (ATTC) Network implementation strategy, which consists of three core approaches: didactic training, performance feedback, and on-going consultation. The experimental condition is an enhanced ATTC strategy, with the same core ATTC elements plus two additional theory-driven elements. The two additional elements are Pay-for-Performance, which aims to increase implementing staff's extrinsic motivations, and Implementation & Sustainment Facilitation, which targets staff's intrinsic motivations. Data will be collected using a novel, CM Tracker tool to document CM session delivery, session audio recordings, provider surveys, and patient surveys. Implementation outcomes include CM Exposure (number of CM sessions delivered per patient), CM Skill (ratings of CM fidelity), and CM Sustainment (number of patients receiving CM after removal of support). Patient outcomes include self-reported opioid abstinence and opioid-related problems (both assessed at 3- and 6-months post-baseline).

Discussion: There is urgent public health need to improve the implementation of CM as an adjunct to medication for opioid use disorder. Consistent with its hybrid type 3 design, Project MIMIC is advancing implementation science by comparing impacts of these two multifaceted strategies on both implementation and patient outcomes, and by examining the extent to which the impacts of those strategies can be explained by putative mediators.

Trial registration: This clinical trial has been registered with clinicaltrials.gov (NCT03931174). Registered April 30, 2019. https://ichgcp.net/clinical-trials-registry/NCT03931174?term=project+mimic&draw=2&rank=1.

Keywords: Addiction; Addiction technology transfer center; Contingency management; Implementation; Motivational incentives; Opioid use.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Conceptual overview of Project MIMIC (maximizing implementation of motivational incentives in clinics). Project MIMIC is a type 3 hybrid effectiveness-implementation trial guided by the Eploration, Preparation, Implementation, and Sustainment framework
Fig. 2
Fig. 2
Overview of implementation strategies by phase of the Exploration, Preparation, Implementation, and Sustainment (EPIS) model. The exploration phase occurred in prior work with opioid treatment programs, as documented in Becker et al. 2020, BMC Health Affairs
Fig. 3
Fig. 3
Study activities occurring in each cohort of Project MIMIC

References

    1. Substance Abuse and Mental Health Services Administration. Key substance use and mental health indicators in the United States: results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. 2020.
    1. Centers for Disease Control and Prevention. NCHS releases new monthly provisional estimates on drug overdose deaths [STATCAST]. 2019. . Accessed 9 Nov 2019.
    1. Manchikanti L, Helm S, 2nd, Fellows B, Janata JW, Pampati V, Grider JS, et al. Opioid epidemic in the United States. Pain Phys. 2012;15(3 Suppl):ES9–38. doi: 10.36076/ppj.2012/15/ES9.
    1. Jones CM, McCance-Katz EF. Co-occurring substance use and mental disorders among adults with opioid use disorder. Drug Alcohol Depend. 2019;197:78–82. doi: 10.1016/j.drugalcdep.2018.12.030.
    1. Jiang R, Lee I, Lee TA, Pickard AS. The societal cost of heroin use disorder in the United States. PloS ONE. 2017;12(5):e0177323. doi: 10.1371/journal.pone.0177323.
    1. Barnett PG, Rodgers JH, Bloch DA. A meta-analysis comparing buprenorphine to methadone for treatment of opiate dependence. Addiction. 2001;96(5):683–690. doi: 10.1046/j.1360-0443.2001.9656834.x.
    1. Mattick RP, Breen C, Kimber J, Davoli M. Methadone maintenance therapy versus no opioid replacement therapy for opioid dependence. Cochrane Database Syst Rev. 2009 doi: 10.1002/14651858.CD002209.pub2.
    1. Connock M, Juarez-Garcia A, Jowett S, et al. Methadone and buprenorphine for the management of opioid dependence: a systematic review and economic evaluation. 2007. In: NIHR Health Technology Assessment programme: Executive Summaries. Southampton (UK): NIHR Journals Library; 2003. Available from: . Accessed 1 Aug 2021.
    1. Ling W, Casadonte P, Bigelow G, Kampman KM, Patkar A, Bailey GL, et al. Buprenorphine implants for treatment of opioid dependence: a randomized controlled trial. JAMA. 2010;304(14):1576–1583. doi: 10.1001/jama.2010.1427.
    1. Resnick R, Galanter M, Pycha C, Cohen A, Grandison P, Flood N. Buprenorphine: an alternative to methadone for heroin dependence treatment. Psychopharmacol Bull. 1992;28(1):109–113.
    1. Hser YI, Saxon AJ, Huang D, Hasson A, Thomas C, Hillhouse M, et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2014;109(1):79–87. doi: 10.1111/add.12333.
    1. Farré M, Mas A, Torrens M, Moreno V, Camí J. Retention rate and illicit opioid use during methadone maintenance interventions: a meta-analysis. Drug Alcohol Depend. 2002;65(3):283–90. doi: 10.1016/S0376-8716(01)00171-5.
    1. Bell J, Trinh L, Butler B, Randall D, Rubin G. Comparing retention in treatment and mortality in people after initial entry to methadone and buprenorphine treatment. Addiction. 2009;104(7):1193–1200. doi: 10.1111/j.1360-0443.2009.02627.x.
    1. National Institute on Drug Abuse. In: U.S. Department of Health and Human Services, editor. 2016–2020 NIDA STRATEGIC PLAN advancing addiction science. National Institutes of Health. 2015.
    1. US Department of Health and Human Services. HEAL Initiative Research Plan 2019. 2019. . Accessed 31 Jan 2019.
    1. Downey KK, Helmus TC, Schuster CR. Treatment of heroin-dependent poly-drug abusers with contingency management and buprenorphine maintenance. Exp Clin Psychopharmacol. 2000;8(2):176. doi: 10.1037/1064-1297.8.2.176.
    1. Griffith JD, Rowan-Szal GA, Roark RR, Simpson DD. Contingency management in outpatient methadone treatment: a meta-analysis. Drug Alcohol Depend. 2000;58(1–2):55–66. doi: 10.1016/S0376-8716(99)00068-X.
    1. Rawson RA, Huber A, McCann M, Shoptaw S, Farabee D, Reiber C, et al. A comparison of contingency management and cognitive-behavioral approaches during methadone maintenance treatment for cocaine dependence. Arch Gen Psychiatry. 2002;59(9):817–824. doi: 10.1001/archpsyc.59.9.817.
    1. Sindelar JL, Olmstead TA, Peirce JM. Cost-effectiveness of prize-based contingency management in methadone maintenance treatment programs. Addiction. 2007;102(9):1463–1471. doi: 10.1111/j.1360-0443.2007.01913.x.
    1. McGovern MP, Fox TS, Xie H, Drake RE. A survey of clinical practices and readiness to adopt evidence-based practices: dissemination research in an addiction treatment system. J Subst Abuse Treat. 2004;26(4):305–312. doi: 10.1016/j.jsat.2004.03.003.
    1. Becker SJ, Scott K, Murphy CM, Pielech M, Moul SA, Yap KR, et al. User-centered design of contingency management for implementation in opioid treatment programs: a qualitative study. BMC Health Serv Res. 2019;19(1):466. doi: 10.1186/s12913-019-4308-6.
    1. Kirby KC, Benishek LA, Dugosh KL, Kerwin ME. Substance abuse treatment providers’ beliefs and objections regarding contingency management: implications for dissemination. Drug Alcohol Depend. 2006;85(1):19–27. doi: 10.1016/j.drugalcdep.2006.03.010.
    1. Hartzler B, Rabun C. Community opioid treatment perspectives on contingency management: perceived feasibility, effectiveness, and transportability of social and financial incentives. J Subst Abuse Treat. 2013;45(2):242–248. doi: 10.1016/j.jsat.2013.01.014.
    1. Hartzler B, Donovan DM, Tillotson CJ, Mongoue-Tchokote S, Doyle SR, McCarty D. A multilevel approach to predicting community addiction treatment attitudes about contingency management. J Subst Abuse Treat. 2012;42(2):213–221. doi: 10.1016/j.jsat.2011.10.012.
    1. Walker R, Rosvall T, Field CA, Allen S, McDonald D, Salim Z, et al. Disseminating contingency management to increase attendance in two community substance abuse treatment centers: lessons learned. J Subst Abuse Treat. 2010;39(3):202–209. doi: 10.1016/j.jsat.2010.05.010.
    1. Ducharme LJ, Knudsen HK, Roman PM, Johnson JA. Innovation adoption in substance abuse treatment: exposure, trialability, and the clinical trials network. J Subst Abuse Treat. 2007;32(4):321–329. doi: 10.1016/j.jsat.2006.05.021.
    1. Becker SJ, Kelly LM, Kang AW, Escobar KI, Squires DD. Factors associated with contingency management adoption among opioid treatment providers receiving a comprehensive implementation strategy. Subst Abuse. 2019;40(1):56–60. doi: 10.1080/08897077.2018.1455164.
    1. Petry NM, DePhilippis D, Rash CJ, Drapkin M, McKay JR. Nationwide dissemination of contingency management: the Veterans Administration initiative. Am J Addict. 2014;23(3):205–210. doi: 10.1111/j.1521-0391.2014.12092.x.
    1. Kirchner JWT, Powell BJ, Smith JL, Proctor EK. Implementation strategies. In: Brownson RC, Colditz GA, Proctor EK, editors. Dissemination and implementation research in health: translating science to practice. 2. New York: Oxford University Press; 2018.
    1. McCance-Katz EF. The substance abuse and mental health services administration (SAMHSA): new directions. Psychiatr Serv. 2018;69(10):1046–1048. doi: 10.1176/appi.ps.201800281.
    1. Squires DD, Gumbley SJ, Storti SA. Training substance abuse treatment organizations to adopt evidence-based practices: the addiction technology transfer center of New England science to service laboratory. J Subst Abuse Treat. 2008;34(3):293–301. doi: 10.1016/j.jsat.2007.04.010.
    1. Mello MJ, Becker SJ, Bromberg J, Baird J, Zonfrillo MR, Spirito A. Implementing alcohol misuse SBIRT in a national cohort of pediatric trauma centers—a type III hybrid effectiveness-implementation trial. Implement Sci. 2018;13(1):1–10. doi: 10.1186/s13012-018-0725-x.
    1. Miller WR, Yahne CE, Moyers TB, Martinez J, Pirritano M. A randomized trial of methods to help clinicians learn motivational interviewing. J Consult Clin Psychol. 2004;72(6):1050. doi: 10.1037/0022-006X.72.6.1050.
    1. Sholomskas DE, Syracuse-Siewert G, Rounsaville BJ, Ball SA, Nuro KF, Carroll KM. We don't train in vain: a dissemination trial of three strategies of training clinicians in cognitive-behavioral therapy. J Consult Clin Psychol. 2005;73(1):106. doi: 10.1037/0022-006X.73.1.106.
    1. Becker SJ, Squires DD, Strong DR, Barnett NP, Monti PM, Petry NM. Training opioid addiction treatment providers to adopt contingency management: a prospective pilot trial of a comprehensive implementation science approach. Subst Abuse. 2016;37(1):134–140. doi: 10.1080/08897077.2015.1129524.
    1. Helseth SA, Janssen T, Scott K, Squires DD, Becker SJ. Training community-based treatment providers to implement contingency management for opioid addiction: time to and frequency of adoption. J Subst Abuse Treat. 2018;95:26–34. doi: 10.1016/j.jsat.2018.09.004.
    1. Garner BR, Godley SH, Dennis ML, Hunter BD, Bair CM, Godley MD. Using pay for performance to improve treatment implementation for adolescent substance use disorders: results from a cluster randomized trial. Arch Pediatr Adolesc Med. 2012;166(10):938–944. doi: 10.1001/archpediatrics.2012.802.
    1. Garner BR, Lwin AK, Strickler GK, Hunter BD, Shepard DS. Pay-for-performance as a cost-effective implementation strategy: results from a cluster randomized trial. Implement Sci. 2018;13(1):1–11. doi: 10.1186/s13012-018-0774-1.
    1. Garner BR, Gotham HJ, Chaple M, Martino S, Ford JH, Roosa MR, et al. The implementation and sustainment facilitation strategy improved implementation effectiveness and intervention effectiveness: results from a cluster-randomized, type 2 hybrid trial. Implement Res Pract. 2020 doi: 10.1177/2633489520948073.
    1. Hinde JM, Garner BR, Watson CJ, Ramanan R, Ball EL, Tueller SJ. The implementation & sustainment facilitation (ISF) strategy: cost and cost-effectiveness results from a 39-site cluster randomized trial integrating substance use services in community-based HIV service organizations. 2021 [manuscript submitted for publication].
    1. Moullin JC, Dickson KS, Stadnick NA, Becan JE, Wiley T, Phillips J, et al. Exploration, preparation, implementation, sustainment (EPIS) framework. In: Nilsen P, Birken S, et al., editors. Handbook on implementation science. Cheltenham: Edward Elgar Publishing; 2020.
    1. Williams NJ, Wolk CB, Becker-Haimes EM, Beidas RS. Testing a theory of strategic implementation leadership, implementation climate, and clinicians’ use of evidence-based practice: a 5-year panel analysis. Implement Sci. 2020;15(1):1–15. doi: 10.1186/s13012-019-0962-7.
    1. Brookman-Frazee L, Chlebowski C, Suhrheinrich J, Finn N, Dickson KS, Aarons GA, et al. Characterizing shared and unique implementation influences in two community services systems for autism: applying the EPIS framework to two large-scale autism intervention community effectiveness trials. Adm Policy Ment Health. 2020;47(2):176–187. doi: 10.1007/s10488-019-00931-4.
    1. MacKinnon DP. Integrating mediators and moderators in research design. Res Soc Work Pract. 2011;21(6):675–681. doi: 10.1177/1049731511414148.
    1. 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.
    1. 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. doi: 10.1097/MLR.0b013e3182408812.
    1. Foy R, Sales A, Wensing M, Aarons GA, Flottorp S, Kent B, et al. Implementation science: a reappraisal of our journal mission and scope. Implement Sci. 2015;10(51):1–7.
    1. Garner BR, Hunter SB, Funk RR, Griffin BA, Godley SH. Toward evidence-based measures of implementation: examining the relationship between implementation outcomes and client outcomes. J Subst Abuse Treat. 2016;67:15–21. doi: 10.1016/j.jsat.2016.04.006.
    1. Substance Abuse Mental Health Services Administration. Federal guidelines for opioid treatment programs (Vol HHS Publication No. (SMA) PEP 15-FEDGUIDEOTP). 2015.
    1. Petry NM, Alessi SM, Rash CJ, Barry D, Carroll KM. A randomized trial of contingency management reinforcing attendance at treatment: do duration and timing of reinforcement matter? J Consult Clin Psychol. 2018;86(10):799. doi: 10.1037/ccp0000330.
    1. Stitzer ML, Petry NM, Peirce J. Motivational incentives research in the national drug abuse treatment clinical trials network. J Subst Abuse Treat. 2010;38(Suppl 1):S61–S69. doi: 10.1016/j.jsat.2009.12.010.
    1. DePhilippis D, Petry NM, Bonn-Miller MO, Rosenbach SB, McKay JR. The national implementation of Contingency Management (CM) in the Department of Veterans Affairs: attendance at CM sessions and substance use outcomes. Drug Alcohol Depend. 2018;185:367–373. doi: 10.1016/j.drugalcdep.2017.12.020.
    1. Petry NM. A comprehensive guide to the application of contingency management procedures in clinical settings. Drug Alcohol Depend. 2000;58(1–2):9–25. doi: 10.1016/S0376-8716(99)00071-X.
    1. Hartzler B. Building a bonfire that remains stoked: sustainment of a contingency management intervention developed through collaborative design. Subst Abuse Treat Prev Policy. 2015;10(1):1–9. doi: 10.1186/s13011-015-0027-0.
    1. Scott K, Jarman S, Moul S, Murphy CM, Yap K, Garner BR, et al. Implementation support for contingency management: preferences of opioid treatment program leaders and staff. Implement Sci Commun. 2021 doi: 10.1186/s43058-021-00149-2.
    1. National Association of Social Workers. Apply to the NASW CE approval program. .
    1. American Academy of Child and Adolescent Psychiatry. Frequently asked questions. . Accessed 1 Aug 2021.
    1. Petry NM, Alessi SM, Ledgerwood DM, Sierra S. Psychometric properties of the contingency management competence scale. Drug Alcohol Depend. 2010;109(1–3):167–174. doi: 10.1016/j.drugalcdep.2009.12.027.
    1. Ledgerwood D, Petry N. Rating contingency management sessions that reinforce abstinence using the contingency management competence scale. University of Connecticut Health Center. 2010.
    1. Garner BR, Ball EL, Dave L, Jesrani R, Nofziger J, Toro A et al., editors. Contingency management tracker: a research tool and implementation strategy in one. Addiction Health Services Research Conference; Providence, RI. 2020.
    1. Petry NM, Alessi SM, Ledgerwood DM. A randomized trial of contingency management delivered by community therapists. J Consult Clin Psychol. 2012;80(2):286. doi: 10.1037/a0026826.
    1. Petry NM, Weinstock J, Alessi SM. A randomized trial of contingency management delivered in the context of group counseling. J Consult Clin Psychol. 2011;79(5):686–696. doi: 10.1037/a0024813.
    1. Petry NM, Alessi SM, Olmstead TA, Rash CJ, Zajac K. Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? Psychol Addict Behav. 2017;31(8):897. doi: 10.1037/adb0000287.
    1. Rash CJ, Stitzer M, Weinstock J. Contingency management: New directions and remaining challenges for an evidence-based intervention. J Subst Abuse Treat. 2017;72:10–18. doi: 10.1016/j.jsat.2016.09.008.
    1. Garner BR, Hunter BD, Godley SH, Godley MD. Training and retaining staff to competently deliver an evidence-based practice: the role of staff attributes and perceptions of organizational functioning. J Subst Abuse Treat. 2012;42(2):191–200. doi: 10.1016/j.jsat.2011.10.016.
    1. Garner BR, Hunter BD, Modisette KC, Ihnes PC, Godley SH. Treatment staff turnover in organizations implementing evidence-based practices: turnover rates and their association with client outcomes. J Subst Abuse Treat. 2012;42(2):134–142. doi: 10.1016/j.jsat.2011.10.015.
    1. Garner BR, Hunter BD. Examining the temporal relationship between psychological climate, work attitude, and staff turnover. J Subst Abuse Treat. 2013;44(2):193–200. doi: 10.1016/j.jsat.2012.05.002.
    1. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, et al. RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health. 2019;7:64. doi: 10.3389/fpubh.2019.00064.
    1. Sobell LC, Sobell MB. Timeline follow-back. In: Litten RZ, Allen JP, editors. Measuring alcohol consumption. Berlin: Springer; 1992. pp. 41–72.
    1. Dennis ML, Funk R, Godley SH, Godley MD, Waldron H. Cross-validation of the alcohol and cannabis use measures in the Global Appraisal of Individual Needs (GAIN) and Timeline Followback (TLFB; Form 90) among adolescents in substance abuse treatment. Addiction. 2004;99:120–128. doi: 10.1111/j.1360-0443.2004.00859.x.
    1. Dennis ML, Titus JC, White MK, Unsicker JI, Hodgkins D. Global appraisal of individual needs: administration guide for the GAIN and related measures. Bloomington: Chestnut Health Systems; 2003.
    1. Jacobs SR, Weiner BJ, Bunger AC. Context matters: measuring implementation climate among individuals and groups. Implement Sci. 2014;9(1):1–14. doi: 10.1186/1748-5908-9-1.
    1. Garner BR. The relationship between several mechanism of change measures and an independently rated measure of implementation integrity. Society for Implementation Research Collaboration Conference; Seattle, WA. 2017.
    1. Fisher L, Dixon D, Herson J, Frankowski R, Hearron M. Intention to treat in clinical trials. In: Peace K, editor. Statistical issues in drug research and development. New York: Marcel Dekker; 1990. pp. 331–350.
    1. Gupta SK. Intention-to-treat concept: a review. Perspect Clin Res. 2011;2(3):109. doi: 10.4103/2229-3485.83221.
    1. National Research Council Panel on Handling Missing Data in Clinical Trials . The prevention and treatment of missing data in clinical trials. Washington, DC: National Academies Press; 2011.
    1. Carpenter JR, Kenward MG, White IR. Sensitivity analysis after multiple imputation under missing at random: a weighting approach. Stat Methods Med Res. 2007;16(3):259–275. doi: 10.1177/0962280206075303.
    1. Raudenbush SW, Bryk AS. Hierarchical linear models: applications and data analysis methods. Newbury Park: Sage; 2002.
    1. Preacher KJ, Zhang Z, Zyphur MJ. Multilevel structural equation models for assessing moderation within and across levels of analysis. Psychol Methods. 2016;21(2):189. doi: 10.1037/met0000052.
    1. Cohen J. Statistical power analysis for the behavioral sciences. 2. New Jersey: Lawrence Erlbaum; 1988.
    1. Brown RD, Hauenstein NM. Interrater agreement reconsidered: an alternative to the rwg indices. Organ Res Methods. 2005;8(2):165–184. doi: 10.1177/1094428105275376.
    1. Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 doi: 10.1037/0022-3514.51.6.1173.
    1. Spybrook J, Bloom H, Congdon R, Hill C, Martinez A, Raudenbush SW. Optimal design plus empirical evidence: documentation for the “optimal design” software version 3.0. 2011.
    1. Weiner BJ, Belden CM, Bergmire DM, Johnston M. The meaning and measurement of implementation climate. Implement Sci. 2011;6(1):1–12. doi: 10.1186/1748-5908-6-78.
    1. 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(1):1–15. doi: 10.1186/1748-5908-4-50.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi