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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared decision-making program | Experimental |
| |
| Usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared decision-making program | Other | 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:
Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | All clinics: baseline, 8 months, 16 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria for participating patients:
Exclusion Criteria for participating patients:
Inclusion Criteria for participating health care professionals:
Exclusion Criteria for participating health care professionals:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Scholl, Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic | Hamburg | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29580249 | Background | Scholl I, Hahlweg P, Lindig A, Bokemeyer C, Coym A, Hanken H, Muller V, Smeets R, Witzel I, Kriston L, Harter M. Evaluation of a program for routine implementation of shared decision-making in cancer care: study protocol of a stepped wedge cluster randomized trial. Implement Sci. 2018 Mar 27;13(1):51. doi: 10.1186/s13012-018-0740-y. | |
| 37553560 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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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.
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| Usual Care | Other | No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany. |
|
| 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. | 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 | 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 | 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 | 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) | All clinics: baseline, 8 months, 16 months, 24 months |
| 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 |
| Hahlweg P, Lindig A, Frerichs W, Zill J, Hanken H, Muller V, Peters MC, Scholl I. Major influencing factors on routine implementation of shared decision-making in cancer care: qualitative process evaluation of a stepped-wedge cluster randomized trial. BMC Health Serv Res. 2023 Aug 8;23(1):840. doi: 10.1186/s12913-023-09778-w. |
| 34965881 | Derived | Scholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Harter M, Kriston L. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4. |