A Hybrid III stepped wedge cluster randomized trial testing an implementation strategy to facilitate the use of an evidence-based practice in VA Homeless Primary Care Treatment Programs

Molly M Simmons, Sonya Gabrielian, Thomas Byrne, Megan B McCullough, Jeffery L Smith, Thom J Taylor, Tom P O'Toole, Vincent Kane, Vera Yakovchenko, D Keith McInnes, David A Smelson, Molly M Simmons, Sonya Gabrielian, Thomas Byrne, Megan B McCullough, Jeffery L Smith, Thom J Taylor, Tom P O'Toole, Vincent Kane, Vera Yakovchenko, D Keith McInnes, David A Smelson

Abstract

Background: Homeless veterans often have multiple health care and psychosocial needs, including assistance with access to housing and health care, as well as support for ongoing treatment engagement. The Department of Veterans Affairs (VA) developed specialized Homeless Patient Alignment Care Teams (HPACT) with the goal of offering an integrated, "one-stop program" to address housing and health care needs of homeless veterans. However, while 70% of HPACT's veteran enrollees have co-occurring mental health and substance use disorders, HPACT does not have a uniform, embedded treatment protocol for this subpopulation. One wraparound intervention designed to address the needs of homeless veterans with co-occurring mental health and substance use disorders which is suitable to be integrated into HPACT clinic sites is the evidence-based practice called Maintaining Independence and Sobriety through Systems Integration, Outreach, and Networking-Veterans Edition, or MISSION-Vet. Despite the promise of MISSION-Vet within HPACT clinics, implementation of an evidence-based intervention within a busy program like HPACT can be difficult. The current study is being undertaken to identify an appropriate implementation strategy for MISSION-Vet within HPACT. The study will test the implementation platform called Facilitation and compared to implementation as usual (IU). The aims of this study are as follows: (1) Compare the extent to which IU or Facilitation strategies achieve fidelity to the MISSION-Vet intervention as delivered by HPACT homeless provider staff. (2) Compare the effects of Facilitation and IU strategies on the National HPACT Performance Measures. (3) Compare the effects of IU and Facilitation on the permanent housing status. (4) Identify and describe key stakeholders' (patients, providers, staff) experiences with, and perspectives on, the barriers to, and facilitators of implementing MISSION.

Design: Type III Hybrid modified stepped wedge implementation comparing IU to Facilitation across seven HPACT teams in three sites in the greater Los Angeles VA system. This is a cluster randomized trial.

Discussion: Integrating MISSION-Vet within HPACT has the potential to improve the health of thousands of veterans, but it is crucial to implement the intervention appropriately in order for it to succeed. The lessons learned in this protocol could assist with a larger roll-out of MISSION within HPACT. This protocol is registered with clinicaltrials.gov and was assigned the number NCT 02942979.

Trial registration: ClinicalTrials.gov NCT02942979.

Keywords: Co-occurring disorders; Facilitation; Step wedge design; Vulnerable populations.

Figures

Fig. 1
Fig. 1
Project timeline

References

    1. O’Toole TP, Conde‐Martel A, Gibbon JL, Hanusa BH, Fine MJ. Health care of homeless veterans. J Gen Intern Med. 2003;18(11):929–33. doi: 10.1046/j.1525-1497.2003.21209.x.
    1. Smith JL, Williams JW, Owen RR, Rubenstein LV, Chaney E. Developing a national dissemination plan for collaborative care for depression: QUERI Series. Implement Sci. 2008;3:59. doi: 10.1186/1748-5908-3-59.
    1. O’Toole TP, Johnson EE, Aiello R, Kane V, Pape L. Tailoring care to vulnerable populations by incorporating social determinants of health: the Veterans Health Administration’s “Homeless Patient Aligned Care Team” Program. Prev Chronic Dis. 2016;31(13):150567. doi: 10.5888/pcd13.150567.
    1. O’Toole TP, Bourgault C, Johnson EE, Redihan SG, Borgia M, Aiello R, Kane V. New to care: demands on a health system when homeless veterans are enrolled in a medical home model. Am J Public Health. 2013;103(S2):S374–9. doi: 10.2105/AJPH.2013.301632.
    1. O’Toole TP. Primary care at the Providence VA Medical Center: challenges, opportunities and innovations. Med Health Rhode Island. 2010;93(1):11.
    1. Smelson D, Kalman D, Losonczy MF, Kline A, Sambamoorthi U, Hill LS, Castles-Fonseca K, Ziedonis D. A brief treatment engagement intervention for individuals with co-occurring mental illness and substance use disorders: results of a randomized clinical trial. Community Ment Health J. 2012;48(2):127–32. doi: 10.1007/s10597-010-9346-9.
    1. Smelson D, Losonczy M, Castles-Fonseca K, Stewart P, Kaune M, Ziedonis D. Preliminary outcomes from a booster case management program for individuals with a co-occuring substance abuse and a persistent psychiatric disorder. J Dual Diagn. 2005;3(1):47–59. doi: 10.1300/J374v01n03_05.
    1. Smelson D, Losonczy M, Castles-Fonseca K, Sussner B, Rodrigues S, Kaune M, Ziedonis D. Preliminary outcomes from a community linkage intervention for individuals with co-occurring substance abuse and serious mental illness. J Dual Diagn. 2005;1(3):47–59. doi: 10.1300/J374v01n03_05.
    1. Smelson D, Losonczy M, Ziedonis D, Castles-Fonseca K, Kaune M. Six month outcomes from a booster case management program for individuals with a cooccurring substance abuse and a persistent psychiatric disorder. Eur J Psychiatry Clin Neurosci. 2007;21:143–52.
    1. Smelson D, Kalman D, Losonczy MF, Kline A, Sambamoorthi U, St Hill L, Castles-Fonseca K, Ziedonis D. A brief treatment engagement intervention for individuals with co-occurring mental illness and substance use disorders: results of a randomized clinical trial. Community Ment Health J. 2012;48(2):6. doi: 10.1007/s10597-010-9346-9.
    1. Smelson DA, Kline A, Kuhn J, Rodrigues S, O’Connor K, Fisher W, Kane V. A wraparound treatment engagement intervention for homeless veterans with co-occurring disorders. Psychiatr Serv. 2013;10(2):7.
    1. Cividin TM, Ottoson JM. Linking reasons for continuing professional education participation with post-program application. J Contin Educ Health Prof. 1997;17(1):10. doi: 10.1002/chp.4750170107.
    1. Ottoson JM. After the applause: exploring multiple influences on application following an adult education program. Adult Educ Q. 1997;47(2):16. doi: 10.1177/074171369704700203.
    1. Ennett S, Ringwalt C, Thorne J, Rohrbach L, Vincus A, Simons-Rudolph A, Jones S. A comparison of current practice in school-based substance use prevention programs with meta-analysis findings. Prev Sci. 2003;4(1):15. doi: 10.1023/A:1021777109369.
    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):904–12. doi: 10.1007/s11606-014-3027-2.
    1. Kirchner J, Ritchie M, Dollar K, Gundlach P, Smith J. Implementation facilitation training manual: using external and internal facilitation to improve care in the Veterans Health Administration. 2014.
    1. Curran GM, et al. Effectiveness-Implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact. Med Care. 2012;50(3):217–26.
    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):217–26. doi: 10.1097/MLR.0b013e3182408812.
    1. Bauer MS, Miller C, Kim B, Lew R, Weaver K, Coldwell C, Henderson K, Holmes S, Seibert MN, Stolzmann K, Elwy AR, Kirchner J. Partnering with health system operations leadership to develop a controlled implementation trial. Implement Sci. 2016;11(22):016–0385.
    1. Harvey, G. and A. Kitson, Implementing evidence-based practice in healthcare: a facilitation guide. New York: Routledge; 2015.
    1. Susser E, Valencia E, Conover S, Felix A, Tsai W-Y, Wyatt RJ. Preventing recurrent homelessness among mentally ill men: a “ critical time” intervention after discharge from a shelter. Am J Public Health. 1997;87(2):256–62. doi: 10.2105/AJPH.87.2.256.
    1. Ziedonis DM, Stern R. Dual recovery therapy for schizophrenia and substance abuse. Psychiatr Ann. 2001;31(4):255–64. doi: 10.3928/0048-5713-20010401-09.
    1. Ziedonis D, Brady K. Dual diagnosis in primary care: detecting and treating both the addiction and mental illness. Med Clin N Am. 1997;81(4):1017–36. doi: 10.1016/S0025-7125(05)70561-7.
    1. Ziedonis DM, Smelson D, Rosenthal RN, Batki SL, Green AI, Henry RJ, Montoya I, PARKS J, Weiss RD. Improving the care of individuals with schizophrenia and substance use disorders: consensus recommendations. J Psychiatr Pract. 2005;11(5):315. doi: 10.1097/00131746-200509000-00005.
    1. Millner W, Rollnick S. Motivational interviewing: preparing people for change. New York: Guilford Press; 2002.
    1. Marlatt G, Gordon J. Relapse prevention: maintenance strategies in addictive behaviour change. New York: Guilford; 1985.
    1. Bond GR, McHugo GJ, Becker DR, Rapp CA, Whitley R. Fidelity of supported employment: lessons learned from the national evidence-based practice project. Psychiatr Rehabil J. 2008;31(4):300. doi: 10.2975/31.4.2008.300.305.
    1. Najavits LM. Expanding the boundaries of PTSD treatment. JAMA. 2012;308(7):714–6. doi: 10.1001/2012.jama.10368.
    1. Smelson DA, Ziedonis D, Williams J, Losonczy MF, Williams J, Steinberg ML, Kaune M. The efficacy of olanzapine for decreasing cue-elicited craving in individuals with schizophrenia and cocaine dependence: a preliminary report. J Clin Psychopharmacol. 2006;26(1):9–12. doi: 10.1097/01.jcp.0000194624.07611.5e.
    1. Smelson DA, Sawh L, Kane V, Kuhn J, Ziedonis DM. MISSION-VET Treatment Manual. 2011.
    1. Smelson DA, Sawh L, Rodrigues S, Munoz EC, Marzilli A, Tripp J, Ziedonis DM. The MISSION-VET Consumer Workbook. 2011.
    1. Smelson DA, Zaykowski H, Guevermont N, Siegfriedt J, Sawh L, Modzelewski D, Tsemberis S, Kane V. Integrating permanent supportive housing and co-occurring disorders treatment for individuals who are homeless. J Dual Diagn. 2016;12(2):193–201. doi: 10.1080/15504263.2016.1174010.
    1. Ajzen IFM. Attitude-behavior relations: a theoretical analysis and review of empirical research. Psychol Bull. 1977;84(5):31. doi: 10.1037/0033-2909.84.5.888.
    1. Rosenheck RA. Organizational process: a missing link between research and practice. Psychiatr Serv. 2001;52(12):6. doi: 10.1176/appi.ps.52.12.1607.
    1. Stetler CB, Legro MW, Rycroft-Malone J, Bowman C, Curran G, Guihan M, Hagedorn H, Pineros S, Wallace CM. Role of “external facilitation” in implementation of research findings: a qualitative evaluation of facilitation experiences in the Veterans Health Administration. Implement Sci. 2006;1:23. doi: 10.1186/1748-5908-1-23.
    1. Stetler CB, McQueen L, Demakis J, Mittman BS. An organizational framework and strategic implementation for system-level change to enhance research-based practice: QUERI Series. Implement Sci. 2008;3:30. doi: 10.1186/1748-5908-3-30.
    1. Owen RR, Drummond KL, Viverito KM, Marchant K, Pope SK, Smith JL, Landes RD. Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation. Implement Sci. 2013;8:120. doi: 10.1186/1748-5908-8-120.
    1. Hagedorn H, Hogan M, Smith JL, Bowman C, Curran GM, Espadas D, Kimmel B, Kochevar L, Legro MW, Sales AE. Lessons learned about implementing research evidence into clinical practice. J Gen Intern Med. 2006;21(S2):S21–4.
    1. Association D-AP. Diagnostic and statistical manual of mental disorders. Arlington: American Psychiatric Publishing; 2013.
    1. World Health Organization. The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization; 1992.
    1. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–91. doi: 10.1016/j.cct.2006.05.007.
    1. Gray MJ, Elhai JD, Schmidt LO. Trauma professionals’ attitudes toward and utilization of evidence-based practices. Behav Modif. 2007;31(6):732–48. doi: 10.1177/0145445507302877.
    1. Jameson JP, Chambless DL, Blank MB. Empirically supported treatments in rural community mental health centers: a preliminary report on current utilization and attitudes toward adoption. Community Ment Health J. 2009;45(6):463–7. doi: 10.1007/s10597-009-9230-7.
    1. Walrath CM, Sheehan AK, Holden EW, Hernandez M, Blau G. Evidence-based treatments in the field: a brief report on provider knowledge, implementation, and practice. J Behav Health Serv Res. 2006;33(2):244–53. doi: 10.1007/s11414-005-9008-9.
    1. Aarons GA, McDonald EJ, Sheehan AK, Walrath-Greene CM. Confirmatory factor analysis of the Evidence-Based Practice Attitude Scale in a geographically diverse sample of community mental health providers. Adm Policy Ment Health. 2007;34(5):465–9. doi: 10.1007/s10488-007-0127-x.
    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;4:50. doi: 10.1186/1748-5908-4-50.
    1. Boyatzis, R.E., Transforming qualitative information: thematic analysis and code development. Thousand Oaks: Sage Publishing; 1998.
    1. Champely S. pwr: basic functions for power analysis. The R Foundation: Vienna; 2009.
    1. RDevelopment, C., TEAM 2009: R: A language and environment for statistical computing. Vienna, Austria. 2012. Internet: .
    1. Woertman W, de Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–8. doi: 10.1016/j.jclinepi.2013.01.009.
    1. O’Connell M, Kasprow W, Rosenheck RA. National dissemination of supported housing in the VA: model adherence versus model modification. Psychiatr Rehabil J. 2010;33(4):308–19. doi: 10.2975/33.4.2010.308.319.
    1. Tsai J, Kasprow WJ, Rosenheck RA. Latent homeless risk profiles of a national sample of homeless veterans and their relation to program referral and admission patterns. Am J Public Health. 2013;103(2):9. doi: 10.2105/AJPH.2011.300422.
    1. Smelson DA, Kline A, Hills S, Mizzeli A, Trip J. The MISSION Consumer Workbook. 2007.
    1. Hemming KLR, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Statist Med. 2015;34(2):16. doi: 10.1002/sim.6325.
    1. Handley MA, Schillinger D, Shiboski S. Quasi-experimental designs in practice-based research settings: design and implementation considerations. J Am Board Fam Med. 2011;24(5):589–96. doi: 10.3122/jabfm.2011.05.110067.
    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):13. doi: 10.1016/j.jclinepi.2010.12.003.
    1. Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006;6:54. doi: 10.1186/1471-2288-6-54.
    1. King GGE, Ravishankar N, Moore RT, Lakin J, Vargas M, Tellez-Rojo M, Hernandez Avila JE, Hernandez Avila M, Hernandez Llamas H. A “politically robust” experimental design for public policy evaluation, with application to the Mexican Universal Health Insurance Program. J Policy Anal Manage. 2007;26(3):28. doi: 10.1002/pam.20279.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj