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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02674360
Enrollment
161
Registered
2016-02-04
Start date
2016-05-31
Completion date
2019-01-31
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doctor-Patient-Communication

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.

Interventions

BEHAVIORALSDM Training

Sponsors

Universitätsklinikum Hamburg-Eppendorf
CollaboratorOTHER
University Hospital Heidelberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 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 (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)
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 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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026