Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial

Isabelle Scholl, Pola Hahlweg, Anja Lindig, Carsten Bokemeyer, Anja Coym, Henning Hanken, Volkmar Müller, Ralf Smeets, Isabell Witzel, Levente Kriston, Martin Härter, Isabelle Scholl, Pola Hahlweg, Anja Lindig, Carsten Bokemeyer, Anja Coym, Henning Hanken, Volkmar Müller, Ralf Smeets, Isabell Witzel, Levente Kriston, Martin Härter

Abstract

Background: Shared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care.

Methods: We use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics' quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary.

Discussion: This study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally.

Trial registration: clinicaltrials.gov, NCT03393351 . Registered 8 January 2018.

Keywords: Cancer; Cluster randomized controlled trial; Health services research; Implementation science; Shared decision-making; Stepped wedge design.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Ethics Committee of the Medical Association Hamburg (Germany, study ID PV5368). The study will be carried out in accordance with the latest version of the Helsinki Declaration of the World Medical Association. Principles of good clinical practice will be respected. Data protection requirements will be met. For patients that are participating in data collection (i.e., audio recording of consultations, filling in SDM-Q-9), written consent will be obtained after information on aims of the study, data collection, and the use of collected data. Study participation is voluntary. A waiver of consent for HCPs was obtained from the ethics committee, as proposed by current statements on ethical designs of cluster randomized trials [78] and implementation research [79]. All participating HCPs may decline to participate in the study.

Consent for publication

Not applicable.

Competing interests

IS’s, PH’s, AL’s, LK’s, and MH’s institution receives the grant from the German Research Foundation for the study described in this study protocol (cp. funding). IS conducted one physician training in shared decision-making for which she received travel compensation from Mundipharma GmBH in 2015. MH declares that he is a co-PI in SDM training projects, one funded by the German Cancer Aid and one by Mundipharma. CB is the president of the German Society for Hematology and Oncology and receives support for clinical trials from several pharmaceutical companies (> 70 trails in his department) and holds grants, e.g., from the German Cancer Aid, Hubertus Wald Foundation and others. The authors did not receive industry funding for this paper, nor were pharmaceutical companies involved in any steps of the study or publication process. PH, AL, AC, HH, VM, RS, IW and LK declare that they have no competing interests.

Publisher’s Note

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Figures

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Fig. 1
Study design

References

    1. Bastiaens H, Van Royen P, Pavlic DR, Raposo V, Baker R. Older people’s preferences for involvement in their own care: a qualitative study in primary health care in 11 European countries. Patient Educ Couns. 2007;68:33–42. doi: 10.1016/j.pec.2007.03.025.
    1. Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012;86:9–18. doi: 10.1016/j.pec.2011.02.004.
    1. Coulter A, Jenkinson C. European patients’ views on the responsiveness of health systems and healthcare providers. Eur J Pub Health. 2005;15:355–360. doi: 10.1093/eurpub/cki004.
    1. Coulter A, Magee H. The European patient of the future. Maidenhead: Open University Press; 2003.
    1. Mühlhauser I, Steckelberg A. Evidence-based patient information: preferences of patients [German] Dtsch Arztebl. 2009;51–52:2554–2556.
    1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango) Soc Sci Med. 1997;44:681–692. doi: 10.1016/S0277-9536(96)00221-3.
    1. Härter M. Shared decision making—an approach requested by patients, physicians, and health politics prevails [German] Z Evid Fortbild Qual Gesundhwes. 2004;98:89–92.
    1. Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. BMJ. 2010;341:971–975. doi: 10.1136/bmj.c5146.
    1. Reuter K, Loh A, Härter M. Patient as partner in oncology—opportunities for shared decision-making [German] In: Koch U, Weis J, editors. Psycho-oncology—a discipline in development. Göttingen: Hogrefe; 2009. pp. 131–145.
    1. Salzburg Global Seminar Salzburg statement on shared decision making. BMJ. 2011;342:d1745. doi: 10.1136/bmj.d1745.
    1. Mulley AG, Trimble C, Elwyn G. Stop the silent misdiagnosis: patients’ preferences matter. BMJ. 2012;345 10.1136/bmj.e6572.
    1. Légaré F, Stacey D, Turcotte S, Cossi MJ, Kryworuchko J, Graham ID, et al. Interventions for improving the adoption of shared decision making by healthcare professionals. Cochrane Database Syst Rev. 2014;9:CD006732.
    1. Bundesgesetzblatt . Law for improving the rights of patients [German] Bonn: Bundesanzeiger Verlag; 2013.
    1. Härter M, Dirmaier J, Scholl I, Donner-Banzhoff N, Dierks ML, Eich W, et al. The long way of implementing patient-centered care and shared decision making in Germany. Z Evid Fortbild Qual Gesundhwes. 2017;123–124:46–51. doi: 10.1016/j.zefq.2017.05.006.
    1. Department of Health . Equity and excellence: liberating the NHS. London: The Stationery Office; 2010.
    1. Braddock CH., III The emerging importance and relevance of shared decision making to clinical practice. Med Decis Mak. 2010;30(Suppl. 5):5–7. doi: 10.1177/0272989X10381344.
    1. Hahlweg P, Härter M, Nestoriuc Y, Scholl I. How are decisions made in cancer care? A qualitative study using participant observation of current practice. BMJ Open. 2017;7:e016360. doi: 10.1136/bmjopen-2017-016360.
    1. Frerichs W, Hahlweg P, Müller E, Adis C, Scholl I. Shared decision-making in oncology—a qualitative analysis of healthcare providers’ views on current practice. PLoS One. 2016;11:e0149789. doi: 10.1371/journal.pone.0149789.
    1. Charles C, Gafni A, Whelan T. Self-reported use of shared decision-making among breast cancer specialists and perceived barriers and facilitators to implementing this approach. Health Expect. 2004;7:338–348. doi: 10.1111/j.1369-7625.2004.00299.x.
    1. Coulter A. Implementing shared decision making in the UK: a report for the Health Foundation. London: Health Foundation; 2009.
    1. Foundation for Informed Medical Desicion Making . Informing and involving patients in medical decisions: the primary care physicians’ perspective. Boston: Findings from a national survey of physicians; 2009.
    1. Vogel BA, Helmes AW, Hasenburg A. Concordance between patients’ desired and actual decision-making roles in breast cancer care. Psychooncology. 2008;17:182–189. doi: 10.1002/pon.1215.
    1. Loh A, Simon D, Kriston L, Härter M. Patient participation in medical decision-making: effects of shared decision-making from systematic reviews [German] Dtsch Arztebl. 2007;104:1483–1489.
    1. Härter M, Buchholz A, Nicolai J, Reuter K, Komarahadi F, Kriston L, et al. Shared decision making and the use of decision aids. Dtsch Arztebl Int. 2015;112:672–679.
    1. Loh A, Simon D, Wills CE, Kriston L, Niebling W, Härter M. The effects of a shared decision-making intervention in primary care of depression: a cluster-randomized controlled trial. Patient Educ Couns. 2007;67:324–332. doi: 10.1016/j.pec.2007.03.023.
    1. Bieber C, Müller KG, Blumenstiel K, Hochlehnert A, Wilke S, Hartmann M, et al. A shared decision-making communication training program for physicians treating fibromyalgia patients: effects of a randomized controlled trial. J Psychosom Res. 2008;64:13–20. doi: 10.1016/j.jpsychores.2007.05.009.
    1. Joseph-Williams N, Elwyn G, Edwards A. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns. 2014;94:291–309. doi: 10.1016/j.pec.2013.10.031.
    1. Brown R, Butow PN, Boyer MJ, Tattersall MHN. Promoting patient participation in the cancer consultation: evaluation of a prompt sheet and coaching in question-asking. Br J Cancer. 1999;80:242–248. doi: 10.1038/sj.bjc.6690346.
    1. Brown RF, Butow PN, Dunn SM, Tattersall MHN. Promoting patient participation and shortening cancer consultations: a randomised trial. Br J Cancer. 2001;85:1273–1279. doi: 10.1054/bjoc.2001.2073.
    1. Clayton J, Butow P, Tattersall M, Chye R, Noel M, Davis JM, et al. Asking questions can help: development and preliminary evaluation of a question prompt list for palliative care patients. Br J Cancer. 2003;89:2069–2077. doi: 10.1038/sj.bjc.6601380.
    1. Clayton JM, Butow PN, Tattersall MHN, Devine RJ, Simpson JM, Aggarwal G, et al. Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol. 2007;25:715–723. doi: 10.1200/JCO.2006.06.7827.
    1. Glynne-Jones R, Ostler P, Lumley-Graybow S, Chait I, Hughes R, Grainger J, et al. Can I look at my list? An evaluation of a “prompt sheet” within an oncology outpatient clinic. Clin Oncol. 2006;18:395–400. doi: 10.1016/j.clon.2006.01.005.
    1. Elwyn G, Frosch D, Volandes AE, Edwards A, Montori VM. Investing in deliberation: a definition and classification of decision support interventions for people facing difficult health decisions. Med Decis Mak. 2010;30:701–711. doi: 10.1177/0272989X10386231.
    1. Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;4:CD001431.
    1. O’Brien MA, Whelan TJ, Villasis-Keever M, Gafni A, Charles C, Roberts R, et al. Are cancer-related decision aids effective? A systematic review and meta-analysis. J Clin Oncol. 2009;27:974–985. doi: 10.1200/JCO.2007.16.0101.
    1. Elwyn G, Scholl I, Tietbohl C, Mann M, Edwards AGK, Clay C, et al. “Many miles to go...”: a systematic review of the implementation of patient decision support interventions into routine clinical practice. BMC Med Inform Decis Mak. 2013;13(Suppl. 2):14. doi: 10.1186/1472-6947-13-S2-S14.
    1. Elwyn G, Thomson R. Implementing shared decision making in the United Kingdom: lessons from the making good decisions in collaboration (MAGIC) program. In: Elwyn G, Grande SW, Hoffer Gittell J, Godfrey MM, Vidal DC, editors. Are we there yet? Case studies of implementing decision support for patients. 1. Hanover: The Dartmouth Center for Health Care Delivery Science and The Dartmouth Institute for Health Policy and Clinical Practice; 2013. pp. 23–34.
    1. Thomson R, Elwyn G. Implementation of shared decision making in practice. Emerging learning from MAGIC, a UK implementation study. 6th International Shared Decision Making Conference in Maastricht. Maastricht; 2011.
    1. Joseph-Williams N, Lloyd A, Edwards A, Stobbart L, Tomson D, Macphail S, et al. Implementing shared decision making in the NHS: lessons from the MAGIC programme. BMJ. 2017;357:j1744. doi: 10.1136/bmj.j1744.
    1. Grol R, Grimshaw J. From best evidence to best practice: effective implementation of change in patients’ care. Lancet. 2003;362:1225–1230. doi: 10.1016/S0140-6736(03)14546-1.
    1. Grol RP, Bosch MC, Hulscher ME, Eccles MP, Wensing M. Planning and studying improvement in patient care: the use of theoretical perspectives. Milbank Q. 2007;85:93–138. doi: 10.1111/j.1468-0009.2007.00478.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. Hahlweg P, Hoffmann J, Härter M, Frosch DL, Elwyn G, Scholl I. In absentia: an exploratory study of how patients are considered in multidisciplinary cancer team meetings. PLoS One. 2015;10:e0139921. doi: 10.1371/journal.pone.0139921.
    1. Hahlweg P, Didi S, Kriston L, Härter M, Nestoriuc Y, Scholl I. Process quality of decision-making in multidisciplinary cancer team meetings: a structured observational study. BMC Cancer. 2017;17:772. doi: 10.1186/s12885-017-3768-5.
    1. Müller E, Hahlweg P, Scholl I. What do stakeholders need to implement shared decision making in routine cancer care? A qualitative needs assessment. Acta Oncol (Madr) 2016;55:1484–1491. doi: 10.1080/0284186X.2016.1227087.
    1. Kühne F, Ehmcke R, Härter M, Kriston L. Conceptual decomposition of complex health care interventions for evidence synthesis: a literature review. J Eval Clin Pract. 2015;21:817–823. doi: 10.1111/jep.12384.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Br Med J (Clin Res Ed) 2008;337:978–983.
    1. Mdege ND, Man MS, Taylor 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;64:936–948. doi: 10.1016/j.jclinepi.2010.12.003.
    1. Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group Consort 2010 statement: extension to cluster randomised trials. BMJ (British Med J) 2012;345:e5661.
    1. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al. Standards for reporting implementation studies (StaRI) statement. BMJ. 2017;356:i6795. doi: 10.1136/bmj.i6795.
    1. Möhler R, Köpke S, Meyer G. Criteria for reporting the development and evaluation of complex interventions in healthcare: revised guideline (CReDECI 2) Trials. 2015;16:204. doi: 10.1186/s13063-015-0709-y.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K. Research and reporting methods annals of internal medicine SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Chaudoir SR, Dugan AG, Barr CH. Measuring factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures. Implement Sci. 2013;8:22. doi: 10.1186/1748-5908-8-22.
    1. Frosch D, Tietbohl C, Scholl I. Overcoming implementation challenges to advance shared-decision making in routine practice. In: Elwyn G, Thompson R, Edwards A, editors. Shared decision making in health care: achieving evidence-based patient choice. 3. Oxford: Oxford University Press; 2016.
    1. Körner M, Ehrhardt H, Steger A-K. Designing an interprofessional training program for shared decision making. J Interprof Care. 2013;27:146–154. doi: 10.3109/13561820.2012.711786.
    1. Körner M, Wirtz M, Michaelis M, Ehrhardt H, Steger AK, Zerpies E, et al. A multicentre cluster-randomized controlled study to evaluate a train-the-trainer programme for implementing internal and external participation in medical rehabilitation. Clin Rehabil. 2014;28:20–35. doi: 10.1177/0269215513494874.
    1. Ivers N, Jamtvedt G, Flottorp S, Young JM, Odgaard-Jensen J, French SD, O’BrienMA, Johansen M, GrimshawJ, Oxman AD. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev. 2012;13(6):CD000259.
    1. Shepherd HL, Barratt A, Trevena LJ, McGeechan K, Carey K, Epstein RM, et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: a cross-over trial. Patient Educ Couns. 2011;84:379–385. doi: 10.1016/j.pec.2011.07.022.
    1. van der Weijden T, Post H, Brand PLP, van Veenendaal H, Drenthen T, van Mierlo LAJ, et al. Shared decision making, a buzz-word in the Netherlands, the pace quickens towards nationwide implementation…. Z Evid Fortbild Qual Gesundhwes. 2017;123–124:69–74. doi: 10.1016/j.zefq.2017.05.016.
    1. Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Republished research: implementation research: what it is and how to do it. Br J Sports Med. 2014;48:731–736. doi: 10.1136/bmj.f6753.
    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. Admin Pol Ment Health. 2011;38:65–76. doi: 10.1007/s10488-010-0319-7.
    1. Kriston L, Scholl I, Hölzel L, Simon D, Loh A, Härter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010;80:94–99. doi: 10.1016/j.pec.2009.09.034.
    1. Doherr H, Christalle E, Kriston L, Härter M, Scholl I. Use of the 9-item Shared Decision Making Questionnaire (SDM-Q-9 and SDM-Q-Doc) in intervention studies—a systematic review. PLoS One. 2017;12:e0173904. doi: 10.1371/journal.pone.0173904.
    1. Barr PJ, O’Malley AJ, Tsulukidze M, Gionfriddo MR, Montori V, Elwyn G. The psychometric properties of observer OPTION (5), an observer measure of shared decision making. Patient Educ Couns. 2015;98:970–976. doi: 10.1016/j.pec.2015.04.010.
    1. Elwyn G, Tsulukidze M, Edwards A, Legare F, Newcombe R. Using a “talk” model of shared decision making to propose an observation-based measure: observer OPTION 5 item. Patient Educ Couns. 2013;93:265–271. doi: 10.1016/j.pec.2013.08.005.
    1. Kölker M, Topp J, Elwyn G, Härter M, Scholl I. Psychometric properties of the German version of Observer OPTION5. BMC Health Serv Res. 2018;18:74.
    1. McColl A, Smith H, White P, Field J. General practitioners’ perceptions of the route to evidence based medicine: a questionnaire survey. BMJ. 1998;316:361–365. doi: 10.1136/bmj.316.7128.361.
    1. Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014;9:7. doi: 10.1186/1748-5908-9-7.
    1. Lamb BW, Sevdalis N, Benn J, Vincent C, JSA G, Lamb BW, et al. Multidisciplinary cancer team meeting structure and treatment decisions: a prospective correlational study. Ann Surg Oncol. 2013;20:715–722. doi: 10.1245/s10434-012-2691-x.
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350:h1258. doi: 10.1136/bmj.h1258.
    1. Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013;14:15. doi: 10.1186/1745-6215-14-15.
    1. Frosch DL, Singer KJ, Timmermans S. Conducting implementation research in community-based primary care: a qualitative study on integrating patient decision support interventions for cancer screening into routine practice. Health Expect. 2009;14(Suppl. 1):73–84.
    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;66:752–758. doi: 10.1016/j.jclinepi.2013.01.009.
    1. Baio G, Copas A, Ambler G, Hargreaves J, Beard E, Omar RZ. Sample size calculation for a stepped wedge trial. Trials. 2015;16:354. doi: 10.1186/s13063-015-0840-9.
    1. Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005;15:1277–1288. doi: 10.1177/1049732305276687.
    1. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28:182–191. doi: 10.1016/j.cct.2006.05.007.
    1. Bundesministerium für Gesundheit [German federal ministry of health] Brochure: German National Cancer Plan—areas of activity, aims, and recommendations for implementation [German] [government document] Berlin: Bundesministerium für Gesundheit; 2012.
    1. Taljaard M, Weijer C, Grimshaw JM, Eccles MP. The Ottawa statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees. BMJ. 2013;346:f2838. doi: 10.1136/bmj.f2838.
    1. Hutton J, Eccles M, Grimshaw J. Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implement Sci. 2008;3:52. doi: 10.1186/1748-5908-3-52.
    1. Proctor E, Powell B, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8:139. doi: 10.1186/1748-5908-8-139.
    1. Härter M, Buchholz A, Nicolai J, Reuter K, Komaradhi F, Kriston L, et al. Training in shared decision making and the use of decision aids in breast and colon cancer: a cluster-randomized trial. Dtsch Arztebl. 2015;112:672–79.
    1. Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;1:CD001431.

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