Clinical trial NCT03711071: Ideas, Concerns, Expectations. Implementing Patient-centered Communication
Official title: ICE - Ideas, Concerns, Expectations. Implementing Patient-centered Communication to Prevent Unnecessary Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Communication
Back Pain
Keywords: patient-centered-communication
Primary Care
over investigation
communication
consultation
shared-decision making
medical education
low back pain
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: University of Erlangen-Nürnberg
First posted: 2018-10-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: number of medical referrals
timeFrame: data collection up to 12 weeks post intervention aims to capture 40 consultations for acute backpain
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Institute of General Practice
Study officials:
affiliation: Institute of General Practice, Universitätsklinikum Erlangen
name: Thomas Kühlein, Prof. Dr.
role: STUDY_CHAIR
References:
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.