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

• ClinicalTrials.gov Identifier: NCT03711071
• Recruitment Status: Active, not recruiting
• First Posted: October 18, 2018
• Last Update Posted: September 26, 2019
• Sponsor: University of Erlangen-Nürnberg Medical School
• 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: October 10, 2018
• First Posted Date: October 18, 2018
• Last Update Posted Date: September 26, 2019
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: August 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ideas, Concerns, Expectations. Implementing Patient-centered Communication
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Communication
• Back Pain

Intervention

Other: Workshop "ICE training"

The workshop includes training in communication skills in relation to evidence based medicine.

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 16, 2018): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Actual Primary Completion Date: August 15, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03711071
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: University of Erlangen-Nürnberg Medical School
• 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

• PRS Account: University of Erlangen-Nürnberg Medical School
• Verification Date: September 2019