Implementation of Shared Decision-Making in Cancer Care

Cancer Clinical Trial

— PREPARED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393351
• Other study ID #: SCHO 1551/1-2
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2131
• Est. completion date: December 31, 2020
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Shared 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: 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.
• Usual Care
No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Scholl I, Hahlweg P, Lindig A, Bokemeyer C, Coym A, Hanken H, Müller V, Smeets R, Witzel I, Kriston L, Härter 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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