Cancer
Conditions
Keywords
Shared Decision-Making, Decision Making, Patient Participation, Patient Centeredness, Health Services Research, Implementation Research, Oncology, Stepped Wedge Design, Mixed Methods
Brief summary
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.
Interventions
OTHERShared decision-making program
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.
OTHERUsual Care
No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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 receive the multifaceted implementation program in a randomized sequence.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for participating patients: * diagnosed with neoplasms (ICD 10: C00-D49, excluding D10-D36) * admitted for inpatient or outpatient treatment at the participating clinics * age \> 18 years * German-speaking
Exclusion criteria
for participating patients: * severe cognitive impairment Inclusion Criteria for participating health care professionals: * physician or nurse working at the participating clinics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in uptake of shared decision-making from the patients' perspective | All clinics: baseline, 8 months, 16 months, 24 months | Action to employ shared decision-making as measured by the German version of the 9-item Shared Decision Making Questionnaire (SDM-Q-9) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of shared decision-making from the health care providers' perspective | All clinics: baseline, 8 months, 16 months, 24 months | 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. |
| Readiness for implementing change from the health care professionals' perspective | All clinics: baseline, 8 months, 16 months, 24 months | As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure |
| Change in uptake of shared decision-making from external observers' perspective | All clinics: baseline, 8 months, 16 months, 24 months | 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. |
| Change in penetration of shared decision-making at the clinic level | baseline, 3 years | Integration of shared decision-making within a setting and its subsystems as measured by routine data from patient experience surveys of the clinics |
| Change in penetration of shared decision-making in multidisciplinary team meetings | All clinics: baseline, 8 months, 16 months, 24 months | 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) |
| Appropriateness of shared decision-making from the health care professionals' perspective | All clinics: baseline, 8 months, 16 months, 24 months | Perceived fit, relevance, or compatibility of shared decision-making for the given practice setting as measured by an adapted version of the IcanSDM measure |
Countries
Germany
Outcome results
None listed