RCT Regarding SDM Online Training and Face-to-face SDM Training

Not Applicable

Completed

• Conditions: Doctor-Patient-Communication
• Interventions: Behavioral: SDM Training

• Registration Number: NCT02674360
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-04
• Study Start: 2016-05
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

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

Exclusion Criteria

• No Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDM Online Training	SDM Training	The intervention consists of a SDM training for oncologists, which is conducted in the form of a web-based SDM online Training (intervention group I). During training, the oncologists are guided to use decision aids for breast and colon cancer patients in their consultations, which were developed and evaluated in a previous project. The SDM training has the same duration (one session à 120 minutes) in both intervention groups. Doctors in the intervention group receive decision aids for breast cancer and colorectal cancer patients during training. The training contents are based on an already developed, evaluated and published SDM manual. The SDM online training works on the modeling principle.
Face-to-Face SDM Training	SDM Training	The intervention consists of a SDM training for oncologists, which is conducted in the form of an individualized, context-based SDM individual face-to-face training at the workplace of the participants (intervention group II). During training, the oncologists are guided to use decision aids for breast and colon cancer patients in their consultations, which were developed and evaluated in a previous project. The SDM training has the same duration (one session à 120 minutes) in both intervention groups. Doctors in the intervention group receive decision aids for breast cancer and colorectal cancer patients during training. The training contents are based on an already developed, evaluated and published SDM manual. The individual training works on the coaching principle.

Primary Outcome Measures

Name	Time	Method
Change from baseline in SDM competence measured by an objective Rating (OPTION)	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 Outcome Measures

Name	Time	Method
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)	Questionnaire on the Quality of physician-patient interaction (QQPI, Bieber et al., 2010), Patient version
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)	Questionnaire on the Quality of physician-patient interaction (QQPI, Bieber et al., 2010), physician version
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)	Dyadic OPTION (Melbourne et al., 2010), patient version
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)	Physician-Perception-Scale (PPS; Janz et al., 2004)
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)	Patient Perception Scale (PPS; Janz et al., 2004)
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)	SDM-Q-9 (Kriston et al, 2010; Simon, Loh, \& Haerter, 2007)
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)	Dyadic OPTION (Melbourne et al., 2010), physician version
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)	SDM-Q-Doc (Scholl et al., 2012)

Trial Locations

Locations (2)

University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

University Hospital Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany