Doctor-Patient-Communication Clinical Trial
Official title:
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
| Verified date | June 2019 |
| Source | University Hospital Heidelberg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 161 |
| Est. completion date | January 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Hamburg-Eppendorf | Hamburg | |
| Germany | University Hospital Heidelberg | Heidelberg | Baden-Wuerttemberg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Heidelberg | Universitätsklinikum Hamburg-Eppendorf |
Germany,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in SDM competence measured by an objective Rating (OPTION) | 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. | T0 (2 weeks before Training) and T1 (1 weeks after Training) | |
| Secondary | Change from baseline in SDM competence by subjective standardized patient rating (Dyadic Option) | Dyadic OPTION (Melbourne et al., 2010), patient version | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in SDM competence by subjective standardized patient rating (Patient Perception Scale) | Patient Perception Scale (PPS; Janz et al., 2004) | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in SDM competence by subjective standardized patient rating (SDM-Q-9) | SDM-Q-9 (Kriston et al, 2010; Simon, Loh, & Haerter, 2007) | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in SDM competence by subjective physician rating (Dyadic Option) | Dyadic OPTION (Melbourne et al., 2010), physician version | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in SDM competence by subjective physician rating (Physician-Perception-Scale) | Physician-Perception-Scale (PPS; Janz et al., 2004) | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in SDM competence by subjective physician rating (SDM-Q-9) | SDM-Q-Doc (Scholl et al., 2012) | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in quality of doctor-patient-interaction by subjective Patient rating (Questionnaire on the Quality of physician-patient interaction) | Questionnaire on the Quality of physician-patient interaction (QQPI, Bieber et al., 2010), Patient version | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) | |
| Secondary | Change from baseline in quality of doctor-patient-interaction by subjective Physician rating (Questionnaire on the Quality of physician-patient interaction) | Questionnaire on the Quality of physician-patient interaction (QQPI, Bieber et al., 2010), physician version | T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1) |