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Ideas, Concerns, Expectations. Implementing Patient-centered Communication (ICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03711071
Recruitment Status : Active, not recruiting
First Posted : October 18, 2018
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
University of Erlangen-Nürnberg
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
Exploring patients' ideas, concerns and expectation (ICE) is a communication tool to promote patient centredness and shared decision making during a consultation. This study evaluates whether offering ICE training to doctors can decrease overdiagnosis in the management of acute backache.

Condition or disease Intervention/treatment Phase
Communication Back Pain Other: Workshop "ICE training" Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18
  • first time seeing doctor because of the defined high frequent consultation issue referring on recommendation of the National Guideline

Exclusion Criteria:

  • not first time seeing the doctor during the recommended time of the National Guideline

Information from the National Library of Medicine

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


Locations
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Germany
Universitätsklinikum Erlangen, Institute of General Practice
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
German Federal Ministry of Education and Research
University of Erlangen-Nürnberg
Investigators
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Study Chair: Thomas Kühlein, Prof. Dr. Institute of General Practice, Universitätsklinikum Erlangen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03711071    
Other Study ID Numbers: 01COM180911
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
patient-centered-communication
Primary Care
over investigation
communication
consultation
shared-decision making
medical education
low back pain
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations