Clinical trial NCT03393351: Implementation of Shared Decision-Making in Cancer Care
Official title: Evaluation of a Program for Routine Implementation of Shared Decision-Making in Cancer Care: A Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Shared Decision-Making
Decision Making
Patient Participation
Patient Centeredness
Health Services Research
Implementation Research
Oncology
Stepped Wedge Design
Mixed Methods
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 2131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Change in uptake of shared decision-making from the patients' perspective
timeFrame: All clinics: baseline, 8 months, 16 months, 24 months
Secondary outcomes:
measure: Change in uptake of shared decision-making from external observers' perspective
timeFrame: All clinics: baseline, 8 months, 16 months, 24 months
measure: Acceptability of shared decision-making from the health care providers' perspective
timeFrame: All clinics: baseline, 8 months, 16 months, 24 months
measure: Readiness for implementing change from the health care professionals' perspective
timeFrame: All clinics: baseline, 8 months, 16 months, 24 months
measure: Appropriateness of shared decision-making from the health care professionals' perspective
timeFrame: All clinics: baseline, 8 months, 16 months, 24 months
measure: Change in penetration of shared decision-making at the clinic level
timeFrame: baseline, 3 years
measure: Change in penetration of shared decision-making in multidisciplinary team meetings
timeFrame: All clinics: baseline, 8 months, 16 months, 24 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Center for Oncology, II. Medical Clinic and Polyclinic
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Center for Surgical Sciences, Department of Gynecology
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Head and Neurocenter, Department of Oral and Maxillofacial Surgery
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Isabelle Scholl, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.