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Clinical Trials/NCT02674360
NCT02674360
Completed
Not Applicable

Randomized Controlled Trial Regarding (RCT) Innovative Dissemination Strategies for a Brief Shared Decision Making (SDM) Intervention for Oncologists: Web-based SDM Online Training and Individualized, Context-based Face-to-face SDM Training

University Hospital Heidelberg2 sites in 1 country161 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Doctor-Patient-Communication
Sponsor
University Hospital Heidelberg
Enrollment
161
Locations
2
Primary Endpoint
Change from baseline in SDM competence measured by an objective Rating (OPTION)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Cancer patients often report that they are not included in important treatment decisions. Numerous studies have shown that a training concerning Shared Decision Making (SDM) for physicians can improve this situation. This does not only lead to a better quality of the doctor-patient interaction, but may have a positive long term impact on treatment adherence, the psychological well-being and the coping abilities of the patients. However, previous experience regarding the implementation of SDM training programs show that it is difficult to recruit physicians for an external SDM group training due to the extensive workload of the physicians. In light of the available evidence on the effectiveness of SDM training and the low motivation by oncologists for traditional SDM group training, this study aims to develop and evaluate a brief SDM intervention. This intervention is disseminated in two different ways which both might be attractive for oncologists. On the one hand an individual face-to-face context-based SDM training is designed and conducted by a trainer at the workplace of the participating oncologists. On the other hand a web-based SDM online training is developed. Both SDM interventions are developed on the basis of an SDM manual evaluated in previous studies.

This study therefore aims to examine the effectiveness of different disseminations strategies (individualized face-to-face context-based SDM individual training vs. web-based SDM online training) compared to a control group without any training. It will be analyzed which improvements in medical SDM competence can be accomplished by the different SDM trainings. Further the effects of the training on SDM knowledge, quality of the doctor-patient interaction and SDM self-efficacy expectation will be evaluated.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
January 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Kathrin Gschwendtner

Prinicipal Investigator

University Hospital Heidelberg

Eligibility Criteria

Inclusion Criteria

  • Oncologists or physicians treating a significant percentage of breast and/or colorectal cancer patients
  • Internet access

Exclusion Criteria

  • No Exclusion Criteria

Outcomes

Primary Outcomes

Change from baseline in SDM competence measured by an objective Rating (OPTION)

Time Frame: T0 (2 weeks before Training) and T1 (1 weeks after Training)

To measure the SDM competence the OPTION scale (Observing Patient Involvement; Elwyn et al., 2003; Elwyn et al., 2005; Goss et al., 2007.) will be used. The OPTION scale is a validated instrument for measuring the process steps of Shared Decision Making. The consultations are assessed on the basis of 12 items. It shows good reliability with a value of 0.79. The Option rating is based on video recordings and anonymised transcripts. A consultation will be assessed by two blinded raters. The average value per item is used as final value. For the consultations standardized patients are deployed.

Secondary Outcomes

  • Change from baseline in quality of doctor-patient-interaction by subjective Patient rating (Questionnaire on the Quality of physician-patient interaction)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in quality of doctor-patient-interaction by subjective Physician rating (Questionnaire on the Quality of physician-patient interaction)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in SDM competence by subjective standardized patient rating (Dyadic Option)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in SDM competence by subjective physician rating (Physician-Perception-Scale)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in SDM competence by subjective standardized patient rating (Patient Perception Scale)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in SDM competence by subjective standardized patient rating (SDM-Q-9)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in SDM competence by subjective physician rating (Dyadic Option)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))
  • Change from baseline in SDM competence by subjective physician rating (SDM-Q-9)(T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1))

Study Sites (2)

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