Evaluation of a Programme for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial

• Applicant: Dr. Isabelle Scholl
• Subject Area: Public Health, Healthcare Research, Social and Occupational Medicine
• Term: from 2013 to 2020
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 232160533

Patient participation has become increasingly important in health care. Many patients want to play an active role in their own health care. An approach which takes these needs of patients into account is the model of shared decision-making (SDM), in which the patient and the clinician work together actively and equally and share information in order to come to a shared medical decision. Several interventions strategies to increase the adoption of SDM exist and studies have shown their effectiveness. Furthermore, SDM has been promoted on the health policy level in Germany. Nevertheless, SDM has not been implemented into routine practice. In a DFG-funded pilot study, the applicant developed a programme for routine implementation of SDM in oncology, which is both theoretically and empirically grounded. The Consolidated Framework for Implementation Research (CFIR), a theoretical framework for advancing implementation science in health services research, was used for theoretical grounding. Empirical grounding was achieved through an analysis of the current state (including participant observation of care) and a needs assessment (including focus groups and interviews with different stakeholders). A range of important aspects were revealed through these analyses and were used to develop a multifaceted implementation programme. The main aim of this study is to evaluate the process and outcome of this theoretically and empirically grounded multifaceted implementation programme designed to foster implementation of shared decision-making (SDM) into routine clinical practice in cancer care. The study will be carried out in cooperation with three clinics at the University Cancer Centre Hamburg (UCCH). 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 programme, 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-organisation 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).

• DFG Programme: Research Grants
• International Connection: Australia, USA
• Co-Investigators: Professor Dr. Martin Christian Härter; Professor Dr. Levente Kriston
• Cooperation Partners: Professor Dr. Glyn Elwyn; Dr. Dominick Frosch; Dr. Heather Shepherd