Implementation of Shared Decision-Making in Cancer Care (PREPARED)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Shared decision-making program; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 2131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Other: Usual Care; No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.
Experimental: Shared decision-making program	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Isabelle Scholl, Dr., Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2018
• Primary Completion (Actual): September 12, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Decision Making; Health Services Research; Oncology; Patient Participation; Mixed Methods; Shared Decision-Making; Implementation Research; Stepped Wedge Design; Patient Centeredness
• Other Study ID Numbers: SCHO 1551/1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No