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

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ClinicalTrials.gov Identifier: NCT03393351
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Isabelle Scholl, 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 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
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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:

  1. shared decision-making trainings for health care professionals,
  2. individual coaching for physicians,
  3. patient activation strategy,
  4. provision of patient information material and decision aids,
  5. revision of the clinics quality management documents, and
  6. 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.




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)



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393351


Contacts
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Contact: Isabelle Scholl, Dr. +49 (0)40-7410-57135 i.scholl@uke.de
Contact: Pola Hahlweg, Dr. +49 (0)40-7410-56851 p.hahlweg@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic Recruiting
Hamburg, Germany
Contact: Carsten Bokemeyer, Prof. Dr.         
Contact: Mascha Binder, Prof. Dr.         
University Medical Center Hamburg-Eppendorf, Center for Surgical Sciences, Department of Gynecology Recruiting
Hamburg, Germany
Contact: Barbara Schmalfeldt, Prof. Dr.         
Contact: Volkmar Müller, Prof. Dr.         
University Medical Center Hamburg-Eppendorf, Head and Neurocenter, Department of Oral and Maxillofacial Surgery Recruiting
Hamburg, Germany
Contact: Henning Hanken, PD Dr. Dr.         
Contact: Ralf Smeets, Prof. Dr. Dr.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Isabelle Scholl, Dr. Universitätsklinikum Hamburg-Eppendorf
Publications:
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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    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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