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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

Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE October 18, 2018
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ideas, Concerns, Expectations. Implementing Patient-centered Communication
Official Title  ICMJE ICE - Ideas, Concerns, Expectations. Implementing Patient-centered Communication to Prevent Unnecessary Medicine
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Communication
  • Back Pain
Intervention  ICMJE Other: Workshop "ICE training"
The workshop includes training in communication skills in relation to evidence based medicine.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Workshop "ICE training"
  • No Intervention: Control Group
    This group will not get the intervention before data collection.
Publications * Schedlbauer A, Burggraf L, Hueber S, Terzakis-Snyder IA, Kühlein T, Roos M. Referrals for uncomplicated lower back pain: a cluster parallel randomised trial of patient-centred communication to improve the management of acute back pain in primary care. A study protocol. BMJ Open. 2019 Oct 28;9(10):e027718. doi: 10.1136/bmjopen-2018-027718.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date August 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03711071
Other Study ID Numbers  ICMJE 01COM180911
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE
  • German Federal Ministry of Education and Research
  • University of Erlangen-Nürnberg
Investigators  ICMJE
Study Chair: Thomas Kühlein, Prof. Dr. Institute of General Practice, Universitätsklinikum Erlangen
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP