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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Doctor-Patient-Communication

Intervention / Treatment
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* Behavioral: SDM Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Oncologists or physicians treating a significant percentage of breast and/or colorectal cancer patients Internet access Exclusion Criteria: No Exclusion Criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SDM Online Training<br>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. | Behavioral: SDM Training<br> <br> |
| Active Comparator: Face-to-Face SDM Training<br>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. | Behavioral: SDM Training<br> <br> |
| No Intervention: Control Group<br>The Control Group receives no SDM Training. All participants of the Control Group will be offered to participate in the SDM Online Training after T2. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |