Ideas, Concerns, Expectations. Implementing Patient-centered Communication

NCT ID: NCT03711071

Last Updated: 2019-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Communication Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Workshop "ICE training"

Intervention Type OTHER

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

Control Group

This group will not get the intervention before data collection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Workshop "ICE training"

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Kühlein, Prof. Dr.

Role: STUDY_CHAIR

Institute of General Practice, Universitätsklinikum Erlangen

Locations

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Universitätsklinikum Erlangen, Institute of General Practice

Erlangen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 31662352 (View on PubMed)

Other Identifiers

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01COM180911

Identifier Type: -

Identifier Source: org_study_id

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