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Implementation Science
Published in: Implementation Science 1/2018

Open Access 01-12-2018 | Study protocol

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

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

Published in: Implementation Science | Issue 1/2018

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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.
Appendix
Available only for authorised users
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Metadata
Title
Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial
Authors
Isabelle Scholl
Pola Hahlweg
Anja Lindig
Carsten Bokemeyer
Anja Coym
Henning Hanken
Volkmar Müller
Ralf Smeets
Isabell Witzel
Levente Kriston
Martin Härter
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2018
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-018-0740-y

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