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Doctor-Patient-CommunicationNCT02674360

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

A study testing SDM Training in people with Doctor-Patient-Communication, run by University Hospital Heidelberg at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Doctor-Patient-Communication
What is being tested?
SDM Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
2 sitesGermany
Study dates
May 2016to 31 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • No Exclusion Criteria

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University Hospital Hamburg-Eppendorf

    Hamburg, 20246

  • University Hospital Heidelberg

    Heidelberg, Baden-Wurttemberg, 69115

Other trials in Germany

About this study

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

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.

Being tested
SDM Training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SDM TrainingBehavioural

Study groups in NCT02674360
Study groupRoleWhat they receive
SDM Online TrainingActive comparatorThe 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.
Receives: Behavioral: SDM Training
Face-to-Face SDM TrainingActive comparatorThe 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.
Receives: Behavioral: SDM Training
Control GroupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: T0 (2 weeks before Training) and T1 (1 weeks after Training)

Secondary outcomes (8)

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

    Dyadic OPTION (Melbourne et al., 2010), patient version

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

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

    Patient Perception Scale (PPS; Janz et al., 2004)

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

  3. 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)

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

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

    Dyadic OPTION (Melbourne et al., 2010), physician version

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

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

    Physician-Perception-Scale (PPS; Janz et al., 2004)

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

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

    SDM-Q-Doc (Scholl et al., 2012)

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

  7. 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

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

  8. 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

    Measured: T0 (2 weeks before Training), T1 (1 weeks after Training), T2 (3 month after T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2016 (estimated)
  2. Study startMay 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02674360
Sponsor's protocol ID
DKH109956, DKH110010
Status last verified
Jun 2019
First submitted
25 Jan 2016
Last updated
11 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. doi: 10.1200/JCO.2004.09.069.

    PubMed 15284259

  • Melbourne E, Sinclair K, Durand MA, Legare F, Elwyn G. Developing a dyadic OPTION scale to measure perceptions of shared decision making. Patient Educ Couns. 2010 Feb;78(2):177-83. doi: 10.1016/j.pec.2009.07.009. Epub 2009 Aug 3.

    PubMed 19647970

  • Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.

    PubMed 19879711

  • Scholl I, Kriston L, Dirmaier J, Buchholz A, Harter M. Development and psychometric properties of the Shared Decision Making Questionnaire--physician version (SDM-Q-Doc). Patient Educ Couns. 2012 Aug;88(2):284-90. doi: 10.1016/j.pec.2012.03.005. Epub 2012 Apr 3.

    PubMed 22480628

  • Bieber C, Muller KG, Nicolai J, Hartmann M, Eich W. How does your doctor talk with you? Preliminary validation of a brief patient self-report questionnaire on the quality of physician-patient interaction. J Clin Psychol Med Settings. 2010 Jun;17(2):125-36. doi: 10.1007/s10880-010-9189-0.

    PubMed 20217195

  • Elwyn G, Edwards A, Wensing M, Hood K, Atwell C, Grol R. Shared decision making: developing the OPTION scale for measuring patient involvement. Qual Saf Health Care. 2003 Apr;12(2):93-9. doi: 10.1136/qhc.12.2.93.

    PubMed 12679504

  • Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005 Mar;8(1):34-42. doi: 10.1111/j.1369-7625.2004.00311.x.

    PubMed 15713169

  • Goss C, Fontanesi S, Mazzi MA, Del Piccolo L, Rimondini M, Elwyn G, Zimmermann C. Shared decision making: the reliability of the OPTION scale in Italy. Patient Educ Couns. 2007 Jun;66(3):296-302. doi: 10.1016/j.pec.2007.01.002. Epub 2007 Apr 11.

    PubMed 17433603

  • Muller N, Gschwendtner KM, Dwinger S, Bergelt C, Eich W, Harter M, Bieber C. Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training. Trials. 2019 Jan 7;20(1):18. doi: 10.1186/s13063-018-3112-7.

    PubMed 30616653

Questions about this trial

What is this clinical trial studying?

A study testing SDM Training in people with Doctor-Patient-Communication, run by University Hospital Heidelberg at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02674360, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.

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