gms | German Medical Science

Background: Shared decision-making (SDM) is especially important in oncology, where in many cases there is a high level of preference-sensitivity of treatment options, and where treatments often have a considerable impact on the patient’s quality of life. Many cancer patients wish to be well informed and to be actively engaged in the decision making regarding their treatment. Despite scientific evidence and a prominent position on the health policy agenda, implementation of SDM in routine practice continues to lag. As outlined in the Consolidated Framework for Implementation Research [1], it is important to first assess current practice as well as needs of different stakeholders in a pre-implementation phase. We conducted such a pilot study in 2013/2014 and identified important aspects that need to be considered for the development and evaluation of an implementation program of SDM in cancer care.

Aim: The main aim of this study is to evaluate the process and outcome of this theoretically and empirically grounded complex intervention program designed to foster implementation of SDM into routine practice.

Methods: The study will be carried out in cooperation with several clinics at a comprehensive cancer center in Germany. A stepped wedge design, a variant of the cluster randomized controlled trial feasible to evaluate interventions in routine implementation, will be used. Participating clinics will be randomized through time-delayed implementation of the multifaceted program, which will consist of the following strategies: a) SDM trainings for clinicians, b) audit & feedback, c) patient empowerment intervention, d) patient information material and decision aids, e) revision of the clinics quality management documents, and f) re-organization of multidisciplinary team meetings. A mixed methods evaluation including qualitative and quantitative process and outcome evaluation will be carried out. The process of implementation will be evaluated using qualitative methods such as interviews with stakeholders and field notes. This will allow adapting interventions if necessary. The outcome evaluation will consist of several measurement points. The primary outcome will be adoption of SDM, as measured by the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Furthermore, a range of other implementation outcomes will be assessed (acceptability, readiness for implementing change, appropriateness, and penetration).

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 of the comprehensive cancer center.

Practice implication: Insights gained from this study, using a theoretically and empirically grounded approach can be used to inform other SDM implementation studies, both nationally and internationally.