Ideas, Concerns, Expectations. Implementing Patient-centered Communication

Back Pain Clinical Trial

— ICE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03711071
• Other study ID #: 01COM180911
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Communication

Intervention

Other:
• Workshop "ICE training"
The workshop includes training in communication skills in relation to evidence based medicine.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Erlangen, Institute of General Practice	Erlangen

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	German Federal Ministry of Education and Research, University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of medical referrals	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