Implementation of Shared Decision-Making in Cancer Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Shared decision-making program
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria for participating health care professionals: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared decision-making program<br> | Other: Shared decision-making program<br>* 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: shared decision-making trainings for health care professionals, individual coaching for physicians, patient activation strategy, provision of patient information material and decision aids, revision of the clinics quality management documents, and 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.<br>|
| Active Comparator: Usual care<br> | Other: Usual Care<br>* No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed Methods, Shared Decision-Making, Decision Making, Patient Participation, Patient Centeredness, Health Services Research, Implementation Research, Oncology, Stepped Wedge Design