Ideas, Concerns, Expectations. Implementing Patient-centered Communication (ICE)
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|ClinicalTrials.gov Identifier: NCT03711071|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : September 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Communication Back Pain||Other: Workshop "ICE training"||Not Applicable|
The study is a cluster randomized trial recruiting general practitioner from practices in Northern Bavaria/Germany forming a research network within the recently implemented framework of PRO PRICARE (Preventing Overdiagnosis in Primary Care).
At baseline, the intervention group (24 out of 48 doctors) will take part in a one-day training session covering theoretical background and clinical implementation of ICE communication in association with frequent consultation contents.
Primary outcome measure are referrals to physiotherapists and medical specialists such as orthopaedic surgeons, neurologists and radiologists, obtained from routinely collected practice data. Secondary outcomes are patients' and doctors' satisfaction measured via structured questionnaires and semi-structured interviews. Blinding is attempted by hiding the trial purpose and treatment allocation from the participating doctors.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Cluster randomised parallel design: Randomization to ICE communication training will take place at the practice level with units of randomizations being single handed or group practices.|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||All participating doctors will be blinded towards the explicit purpose and design of the study. ICE communication training will be offered to all participants: to the doctors in the intervention group as a true intervention at the beginning of the trial, and to the doctors in the control group as a pretend intervention at the end of the trial.|
|Official Title:||ICE - Ideas, Concerns, Expectations. Implementing Patient-centered Communication to Prevent Unnecessary Medicine|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||August 15, 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Intervention Group
The Intervention Group is allocated to a Workshop of communication training before data collection covering theoretical background and clinical implementation of ICE communication in association with frequent consultation contents.
Other: Workshop "ICE training"
The workshop includes training in communication skills in relation to evidence based medicine.
No Intervention: Control Group
This group will not get the intervention before data collection.
- number of medical referrals [ Time Frame: data collection up to 12 weeks post intervention aims to capture 40 consultations for acute backpain ]referrals of patients to physiotherapists and medical specialists such as radiologists, neurologists, orthopedic surgeons
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711071
|Universitätsklinikum Erlangen, Institute of General Practice|
|Erlangen, Germany, 91054|
|Study Chair:||Thomas Kühlein, Prof. Dr.||Institute of General Practice, Universitätsklinikum Erlangen|