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

• ClinicalTrials.gov Identifier: NCT03393351
• Recruitment Status: Completed
• First Posted: January 8, 2018
• Last Update Posted: June 4, 2021
• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Information provided by (Responsible Party): Isabelle Scholl, Universitätsklinikum Hamburg-Eppendorf

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Other: Shared decision-making program; Other: Usual Care	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2131 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention 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)
• Primary Purpose: Health Services Research
• Official Title: Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial
• Actual Study Start Date: March 5, 2018
• Actual Primary Completion Date: September 12, 2020
• Actual Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in uptake of shared decision-making from the patients' perspective [ Time Frame: 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 :

1. Change in uptake of shared decision-making from external observers' perspective [ Time Frame: 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.
2. Acceptability of shared decision-making from the health care providers' perspective [ Time Frame: 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.
3. Readiness for implementing change from the health care professionals' perspective [ Time Frame: All clinics: baseline, 8 months, 16 months, 24 months ]
   As measured by an adapted version of the Organizational Readiness for Implementing Change (ORIC) measure
4. Appropriateness of shared decision-making from the health care professionals' perspective [ Time Frame: 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
5. Change in penetration of shared decision-making at the clinic level [ Time Frame: 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
6. Change in penetration of shared decision-making in multidisciplinary team meetings [ Time Frame: 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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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, Germany

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

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

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Härter 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.

• Responsible Party: Isabelle Scholl, Head of Research Group, Prinicipal Investigator, Universitätsklinikum Hamburg-Eppendorf
• ClinicalTrials.gov Identifier: NCT03393351
• Other Study ID Numbers: SCHO 1551/1-2
• First Posted: January 8, 2018
• Last Update Posted: June 4, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Isabelle Scholl, Universitätsklinikum Hamburg-Eppendorf:

Shared Decision-Making; Decision Making; Patient Participation; Patient Centeredness; Health Services Research; Implementation Research; Oncology; Stepped Wedge Design; Mixed Methods