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

September 25, 2019 updated by: University of Erlangen-Nürnberg Medical School

ICE - Ideas, Concerns, Expectations. Implementing Patient-centered Communication to Prevent Unnecessary Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen, Institute of General Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
data collection up to 12 weeks post intervention aims to capture 40 consultations for acute backpain

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

German Federal Ministry of Education and Research
University of Erlangen-Nürnberg

Investigators

  • Study Chair: Thomas Kühlein, Prof. Dr., Institute of General Practice, Universitätsklinikum Erlangen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

August 15, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 10, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01COM180911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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