Developing a toolkit to implement the Statin Choice Conversation Aid at scale: application of a work reduction model

Aaron L Leppin, Kasey R Boehmer, Megan E Branda, Nilay D Shah, Ian Hargraves, Sara Dick, Glyn Elwyn, Henry H Ting, Siqin Ye, Ryan Gilles, Marghoob Abbas, Alex Alexander, Victor M Montori, Aaron L Leppin, Kasey R Boehmer, Megan E Branda, Nilay D Shah, Ian Hargraves, Sara Dick, Glyn Elwyn, Henry H Ting, Siqin Ye, Ryan Gilles, Marghoob Abbas, Alex Alexander, Victor M Montori

Abstract

Background: Guidelines recommend shared decision making (SDM) for determining whether to use statins to prevent cardiovascular events in at-risk patients. We sought to develop a toolkit to facilitate the cross-organizational spread and scale of a SDM intervention called the Statin Choice Conversation Aid (SCCA) by (i) assessing the work stakeholders must do to implement the tool; and (ii) orienting the resulting toolkit's components to communicate and mitigate this work.

Methods: We conducted multi-level and mixed methods (survey, interview, observation, focus group) characterizations of the contexts of 3 health systems (n = 86, 84, and 26 primary care clinicians) as they pertained to the impending implementation of the SCCA. We merged the data within implementation outcome domains of feasibility, appropriateness, and acceptability. Using Normalization Process Theory, we then characterized and categorized the work stakeholders did to implement the tool. We used clinician surveys and IP address-based tracking to calculate SCCA usage over time and judged how stakeholder effort was allocated to influence outcomes at 6 and 18 months. After assessing the types and impact of the work, we developed a multi-component toolkit.

Results: At baseline, the three contexts differed regarding feasibility, acceptability, and appropriateness of implementation. The work of adopting the tool was allocated across many strategies in complex and interdependent ways to optimize these domains. The two systems that allocated the work strategically had higher uptake (5.2 and 2.9 vs. 1.1 uses per clinician per month at 6 months; 3.8 and 2.1 vs. 0.4 at 18 months, respectively) than the system that did not. The resulting toolkit included context self-assessments intended to guide stakeholders in considering the early work of SCCA implementation; and webinars, EMR integration guides, video demonstrations, and an implementation team manual aimed at supporting this work.

Conclusions: We developed a multi-component toolkit for facilitating the scale-up and spread of a tool to promote SDM across clinical settings. The theory-based approach we employed aimed to distinguish systems primed for adoption and support the work they must do to achieve implementation. Our approach may have value in orienting the development of multi-component toolkits and other strategies aimed at facilitating the efficient scale up of interventions.

Trial registration: ClinicalTrials.gov NCT02375815 .

Keywords: Implementation; Implementation strategies; Implementation toolkit; Scale-up; Shared decision making; Spread; Statin choice conversation aid; Statin choice decision aid; Statins.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Mayo Clinic Institutional Review Board and all participants gave consent to participate in this study. The reference number for the study is: 14–006048.

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
Study flow diagram (steps 5 and 6 are hypothetical and were not the focus of this work)
Fig. 2
Fig. 2
Conceptual rationale
Fig. 3
Fig. 3
Average monthly per clinician SCCA usage over time across the 3 health systems

References

    1. Goff DC, Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association task force on practice guidelines. Circulation. 2014;129(25 Suppl 2):S49–S73. doi: 10.1161/01.cir.0000437741.48606.98.
    1. Stone Neil J., Robinson Jennifer G., Lichtenstein Alice H., Bairey Merz C. Noel, Blum Conrad B., Eckel Robert H., Goldberg Anne C., Gordon David, Levy Daniel, Lloyd-Jones Donald M., McBride Patrick, Schwartz J. Sanford, Shero Susan T., Smith Sidney C., Watson Karol, Wilson Peter W. F. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. Circulation. 2013;129(25 suppl 2):S1–S45. doi: 10.1161/01.cir.0000437738.63853.7a.
    1. Montori VM, Breslin M, Maleska M, Weymiller AJ. Creating a conversation: insights from the development of a decision aid. PLoS Med. 2007;4(8):e233. doi: 10.1371/journal.pmed.0040233.
    1. Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med. 2007;167(10):1076–1082. doi: 10.1001/archinte.167.10.1076.
    1. Mann DM, Ponieman D, Montori VM, Arciniega J, McGinn T. The statin choice decision aid in primary care: a randomized trial. Patient Educ Couns. 2010;80(1):138–140. doi: 10.1016/j.pec.2009.10.008.
    1. Perestelo-Pérez L, Rivero-Santana A, Boronat M, Sánchez-Afonso JA, Pérez-Ramos J, Montori VM, Serrano-Aguilar P. Effect of the statin choice encounter decision aid in Spanish patients with type 2 diabetes: a randomized trial. Patient Educ Couns. 2016;99(2):295–299. doi: 10.1016/j.pec.2015.08.032.
    1. Branda ME, LeBlanc A, Shah ND, Tiedje K, Ruud K, Van Houten H, Pencille L, Kurland M, Yawn B, Montori VM. Shared decision making for patients with type 2 diabetes: a randomized trial in primary care. BMC Health Serv Res. 2013;13(1):301. doi: 10.1186/1472-6963-13-301.
    1. Ballard AY, Kessler M, Scheitel M, Montori VM, Chaudhry R. Exploring differences in the use of the statin choice decision aid and diabetes medication choice decision aid in primary care. BMC medical informatics and decision making. 2017;17(1):118. doi: 10.1186/s12911-017-0514-5.
    1. Inselman J, Branda M, Castaneda-Guarderas A, Gionfriddo MR, Zeballos-Palacios CL, Morris MM, Shah ND, Montori VM, LeBlanc A. Uptake and documentation of the use of an encounter decision aid in usual practice: a retrospective analysis of the use of the statin/aspirin choice decision aid. Med Decis Mak. 2016;36(4):557–561. doi: 10.1177/0272989X15618175.
    1. Writing Committee M, Drozda JP, Jr, Ferguson TB, Jr, Jneid H, Krumholz HM, Nallamothu BK, Olin JW, Ting HH, Measures ACAFOP, Heidenreich PA, et al. 2015 ACC/AHA focused update of secondary prevention lipid performance Measures: a report of the American College of Cardiology/American Heart Association task force on performance Measures. Circ Cardiovasc Qual Outcomes. 2016;9(1):68–95. doi: 10.1161/HCQ.0000000000000014.
    1. Centers for Disease C Prevention: CDC grand rounds: the million hearts initiative. MMWR Morb Mortal Wkly Rep. 2012;61(50):1017–1021.
    1. Perla RJ, Bradbury E, Gunther-Murphy C. Large-scale improvement initiatives in healthcare: a scan of the literature. J Healthc Qual. 2013;35(1):30–40. doi: 10.1111/j.1945-1474.2011.00164.x.
    1. Simmons R, Fajans P, Ghiron L. Scaling up health service delivery: from pilot innovations to policies and programmes. Geneva: World Health Organization; 2007.
    1. Simmons R, Shiffman J: Scaling up health service innovations: a framework for action. Scaling up health service delivery 2007, 1:30.
    1. Norton WE, McCannon CJ, Schall MW, Mittman BS. A stakeholder-driven agenda for advancing the science and practice of scale-up and spread in health. Implement Sci. 2012;7(1):118. doi: 10.1186/1748-5908-7-118.
    1. Barker PM, Reid A, Schall MW. A framework for scaling up health interventions: lessons from large-scale improvement initiatives in Africa. Implement Sci. 2016;11:12. doi: 10.1186/s13012-016-0374-x.
    1. Massoud MR, Donohue KL, McCannon CJ. Technical Report. Bethesda, MD: University Research Co. LLC; 2010. Options for Large-scale Spread of Simple, HIgh-impact Interventions.
    1. Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8(1):139. doi: 10.1186/1748-5908-8-139.
    1. DiCenso A, Virani T, Bajnok I, Borycki E, Davies B, Graham I, Harrison M, Logan J, McCleary L, Power M. A toolkit to facilitate the implementation of clinical practice guidelines in healthcare settings. Hospital quarterly. 2002;5(3):55–60.
    1. Murray E, May C, Mair F. Development and formative evaluation of the e-health implementation toolkit (e-HIT) BMC medical informatics and decision making. 2010;10(1):61. doi: 10.1186/1472-6947-10-61.
    1. DeWalt DA, Broucksou KA, Hawk V, Brach C, Hink A, Rudd R, Callahan L. Developing and testing the health literacy universal precautions toolkit. Nurs Outlook. 2011;59(2):85–94. doi: 10.1016/j.outlook.2010.12.002.
    1. University of Wisconsin Health Innovation Program: HIPxChange Toolkit Database. 2017. In. . Accessed 7 July 2017.
    1. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Admin Pol Ment Health. 2009;36(1):24–34. doi: 10.1007/s10488-008-0197-4.
    1. Prior M, Guerin M, Grimmer-Somers K. The effectiveness of clinical guideline implementation strategies–a synthesis of systematic review findings. J Eval Clin Pract. 2008;14(5):888–897. doi: 10.1111/j.1365-2753.2008.01014.x.
    1. Davies P, Walker AE, Grimshaw JM. A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implement Sci. 2010;5(1):14. doi: 10.1186/1748-5908-5-14.
    1. Grimshaw JM, Eccles MP, Lavis JN, Hill SJ, Squires JE. Knowledge translation of research findings. Implement Sci. 2012;7(1):50. doi: 10.1186/1748-5908-7-50.
    1. Grimshaw J, Thomas R, MacLennan G, Fraser C, Ramsay C, Vale Le, emsp14, al, Whitty P, Eccles M et al: Effectiveness and efficiency of guideline dissemination and implementation strategies. Health Technol Assess. 2004;8(6):1–72.
    1. Eccles M, Grimshaw J, Walker A, Johnston M, Pitts N. Changing the behavior of healthcare professionals: the use of theory in promoting the uptake of research findings. J Clin Epidemiol. 2005;58(2):107–112. doi: 10.1016/j.jclinepi.2004.09.002.
    1. Group ICEtBR Designing theoretically-informed implementation interventions. Implement Sci. 2006;1(1):4. doi: 10.1186/1748-5908-1-4.
    1. Bradley Elizabeth H, Curry Leslie A, Taylor Lauren A, Pallas Sarah Wood, Talbert-Slagle Kristina, Yuan Christina, Fox Ashley, Minhas Dilpreet, Ciccone Dana Karen, Berg David, Pérez-Escamilla Rafael. A model for scale up of family health innovations in low-income and middle-income settings: a mixed methods study. BMJ Open. 2012;2(4):e000987. doi: 10.1136/bmjopen-2012-000987.
    1. Stetler CB, Legro MW, Wallace CM, Bowman C, Guihan M, Hagedorn H, Kimmel B, Sharp ND, Smith JL. The role of formative evaluation in implementation research and the QUERI experience. J Gen Intern Med. 2006;21(Suppl 2):S1–S8. doi: 10.1007/s11606-006-0267-9.
    1. Senge PM, Scharmer CO: Community action research: learning as a community of practitioners, consultants and researchers. Handbook of Action Research: Concise Paperback Edition 2006:195–206.
    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. May C. Towards a general theory of implementation. Implement Sci. 2013;8:18. doi: 10.1186/1748-5908-8-18.
    1. Lloyd A, Joseph-Williams N, Edwards A, Rix A, Elwyn G. Patchy 'coherence': using normalization process theory to evaluate a multi-faceted shared decision making implementation program (MAGIC) Implement Sci. 2013;8:102. doi: 10.1186/1748-5908-8-102.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health Ment Health Serv Res. 2011;38(2):65–76. doi: 10.1007/s10488-010-0319-7.
    1. Legare F, Ratte S, Gravel K, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: update of a systematic review of health professionals' perceptions. Patient Educ Couns. 2008;73(3):526–535. doi: 10.1016/j.pec.2008.07.018.
    1. May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, et al. Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009;4:29. doi: 10.1186/1748-5908-4-29.
    1. Mintzberg H, Waters JA. Of strategies, deliberate and emergent. Strateg Manag J. 1985;6(3):257–272. doi: 10.1002/smj.4250060306.
    1. Naldemirci O, Wolf A, Elam M, Lydahl D, Moore L, Britten N. Deliberate and emergent strategies for implementing person-centred care: a qualitative interview study with researchers, professionals and patients. BMC Health Serv Res. 2017;17(1):527. doi: 10.1186/s12913-017-2470-2.
    1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322–1327. doi: 10.2105/AJPH.89.9.1322.
    1. Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013;93(1):102–107. doi: 10.1016/j.pec.2013.05.009.
    1. Wyatt KD, Branda ME, Anderson RT, Pencille LJ, Montori VM, Hess EP, Ting HH, LeBlanc A. Peering into the black box: a meta-analysis of how clinicians use decision aids during clinical encounters. Implement Sci. 2014;9:26. doi: 10.1186/1748-5908-9-26.
    1. May CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, Treweek S, Rapley T. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit. BMC Health Serv Res. 2011;11:245. doi: 10.1186/1472-6963-11-245.
    1. Grant A, Dreischulte T, Guthrie B. Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing. Implement Sci. 2017;12(1):4. doi: 10.1186/s13012-016-0531-2.
    1. Weiner BJ, Lewis MA, Clauser SB, Stitzenberg KB. In search of synergy: strategies for combining interventions at multiple levels. J Natl Cancer Inst Monogr. 2012;2012(44):34–41. doi: 10.1093/jncimonographs/lgs001.
    1. Alexander JA, Hearld LR. Methods and metrics challenges of delivery-system research. Implement Sci. 2012;7:15. doi: 10.1186/1748-5908-7-15.
    1. Rogers EM: Diffusion of innovations: Simon and Schuster; 2010.
    1. Weiner BJ. A theory of organizational readiness for change. Implement Sci. 2009;4:67. doi: 10.1186/1748-5908-4-67.
    1. The SHARE Approach []. Accessed 20 July 2017.
    1. Legare F, Elwyn G, Fishbein M, Fremont P, Frosch D, Gagnon MP, Kenny DA, Labrecque M, Stacey D, St-Jacques S, et al. Translating shared decision-making into health care clinical practices: proof of concepts. Implement Sci. 2008;3:2. doi: 10.1186/1748-5908-3-2.
    1. Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. Bmj. 2010;341:c5146. doi: 10.1136/bmj.c5146.

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