This study aims to evaluate a theoretically and empirically grounded implementation program designed to foster shared decision-making in routine cancer care. The intervention program consists of several components (e.g. training for health care professionals, patient empowerment strategies) that will be rolled out in three clinics at a comprehensive cancer center in Germany.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
2,131
The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components: 1. shared decision-making trainings for health care professionals, 2. individual coaching for physicians, 3. patient activation strategy, 4. provision of patient information material and decision aids, 5. revision of the clinics quality management documents, and 6. critical reflection of current organization of multidisciplinary team meetings. Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3.
No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.
University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic
Hamburg, Germany
University Medical Center Hamburg-Eppendorf, Center for Surgical Sciences, Department of Gynecology
Hamburg, Germany
University Medical Center Hamburg-Eppendorf, Head and Neurocenter, Department of Oral and Maxillofacial Surgery
Hamburg, Germany
Change in uptake of shared decision-making from the patients' perspective
Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9)
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Change in uptake of shared decision-making from external observers' perspective
Action to employ shared decision-making as measured by the German version of the Observer OPTION 5 scale using audio-recorded medical encounters. The Observer OPTION 5 scale measures the extent to which clinicians involve patients in decision-making. Each of the 5 items is assessed on a scale ranging from 0 to 4 with higher values indicating more involvement of patients in decision-making. A sum score is calculated (ranging from 0 to 20) and rescaled to be between 0 to 100, for ease of interpretation.
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Acceptability of shared decision-making from the health care providers' perspective
Perception that shared decision-making is agreeable, palatable, or satisfactory as measured by an adapted version of the acceptability survey developed by McColl et al.
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Readiness for implementing change from the health care professionals' perspective
As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure
Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Appropriateness of shared decision-making from the health care professionals' perspective
Perceived fit, relevance, or compatibility of shared decision-making for the given practice setting as measured by an adapted version of the IcanSDM measure
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Time frame: All clinics: baseline, 8 months, 16 months, 24 months
Change in penetration of shared decision-making at the clinic level
Integration of shared decision-making within a setting and its subsystems as measured by routine data from patient experience surveys of the clinics
Time frame: baseline, 3 years
Change in penetration of shared decision-making in multidisciplinary team meetings
Integration of shared decision-making within a setting and its subsystems as measured by an adapted version of the Metric for the Observation of Decision Making in Multidisciplinary Team Meetings (MDT-MODe)
Time frame: All clinics: baseline, 8 months, 16 months, 24 months