Ideas, Concerns, Expectations. Implementing Patient-centered Communication (ICE)
Primary Purpose
Communication, Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Workshop "ICE training"
Sponsored by
About this trial
This is an interventional other trial for Communication focused on measuring patient-centered-communication, Primary Care, over investigation, communication, consultation, shared-decision making, medical education, low back pain
Eligibility 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
Sites / Locations
- Universitätsklinikum Erlangen, Institute of General Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
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.
This group will not get the intervention before data collection.
Outcomes
Primary Outcome Measures
number of medical referrals
referrals of patients to physiotherapists and medical specialists such as radiologists, neurologists, orthopedic surgeons
Secondary Outcome Measures
Full Information
NCT ID
NCT03711071
First Posted
October 10, 2018
Last Updated
September 25, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Federal Ministry of Education and Research, University of Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT03711071
Brief Title
Ideas, Concerns, Expectations. Implementing Patient-centered Communication
Acronym
ICE
Official Title
ICE - Ideas, Concerns, Expectations. Implementing Patient-centered Communication to Prevent Unnecessary Medicine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
German Federal Ministry of Education and Research, University of Erlangen-Nürnberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication, Back Pain
Keywords
patient-centered-communication, Primary Care, over investigation, communication, consultation, shared-decision making, medical education, low back pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will not get the intervention before data collection.
Intervention Type
Other
Intervention Name(s)
Workshop "ICE training"
Intervention Description
The workshop includes training in communication skills in relation to evidence based medicine.
Primary Outcome Measure Information:
Title
number of medical referrals
Description
referrals of patients to physiotherapists and medical specialists such as radiologists, neurologists, orthopedic surgeons
Time Frame
data collection up to 12 weeks post intervention aims to capture 40 consultations for acute backpain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kühlein, Prof. Dr.
Organizational Affiliation
Institute of General Practice, Universitätsklinikum Erlangen
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinikum Erlangen, Institute of General Practice
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31662352
Citation
Schedlbauer A, Burggraf L, Hueber S, Terzakis-Snyder IA, Kuhlein 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.
Results Reference
derived
Learn more about this trial
Ideas, Concerns, Expectations. Implementing Patient-centered Communication
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