Completed

NCT Number: NCT02674360

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

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.

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Key information

Conditions

Doctor-Patient-Communication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

No Exclusion Criteria

Treatment and study plan

SDM Training

Behavioral

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 SDM competence by subjective standardized patient rating (Dyadic Option)

Time frame: 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 standardized patient rating (Patient Perception Scale)

Time frame: 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)

Time frame: 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)

Time frame: 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 (Physician-Perception-Scale)

Time frame: 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 physician rating (SDM-Q-9)

Time frame: 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)

Time frame: 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)

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2019
First posted: Feb 4, 2016
Registry last updated: Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Who can participate

Treatment and study plan

SDM Training

Primary outcomes

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

Secondary outcomes

Change from baseline in SDM competence by subjective standardized patient rating (Dyadic Option)

Change from baseline in SDM competence by subjective standardized patient rating (Patient Perception Scale)

Change from baseline in SDM competence by subjective standardized patient rating (SDM-Q-9)

Change from baseline in SDM competence by subjective physician rating (Dyadic Option)

Change from baseline in SDM competence by subjective physician rating (Physician-Perception-Scale)

Change from baseline in SDM competence by subjective physician rating (SDM-Q-9)

Change from baseline in quality of doctor-patient-interaction by subjective Patient rating (Questionnaire on the Quality of physician-patient interaction)

Change from baseline in quality of doctor-patient-interaction by subjective Physician rating (Questionnaire on the Quality of physician-patient interaction)