Implementation of Shared Decision-Making in Cancer Care

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Shared decision-making program; Other: Usual Care

• Registration Number: NCT03393351
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-08
• Study Start: 2018-03-05
• Primary Completion: 2020-09-12
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2131

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Shared decision-making program	Shared decision-making program	-
Usual care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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)
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
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
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.

Trial Locations

Locations (3)

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