Condition category
Not Applicable
Date applied
23/04/2007
Date assigned
12/06/2007
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Pål Gulbrandsen

ORCID ID

Contact details

Helse Øst Health Services Research Centre
Mail drawer 95
Akershus University Hospital
Lørenskog
1478
Norway
+47 (0)67 929461
pal.gulbrandsen@ahus.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Helse Øst RHF (Regional Authorities for Hospital Care, Eastern Norway) 2007 - 015

Study information

Scientific title

Acronym

4HN

Study hypothesis

The “Four Habits Model” describes the four patterns of behaviour used by clinicians during medical interviews (Frankel and Stein, 2001). Hypothesis: A 20-hour intensive course in effective clinical communication according to the "Four Habits" approach will significantly alter the communication skills of participating physicians.

Frankel and Stein, Getting the most out of the clinical encounter: the four habits model, J Med Pract Manage, 2001 Jan-Feb;16(4):184-91

Ethics approval

The Regional Ethics Committee for Medical Research of East Norway gave approval on the 13th April 2007 (ref: 1.2007.356)

Study design

Randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Clinical communication

Intervention

Participating physicians are given a 20-hour intensive course in clinical communication using the "Four habits" approach. 40 physicians will attend the training course in June 2007, and the other 40 physicians will attend the course in January 2008. For all physicians, two consultations/meetings will be recorded before the June course, four consultations/meetings will be recorded between the June and the January courses, and two consultations/meetings will be recorded after the January course for evaluation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The videotaped consultations/meetings were assessed using the “Four Habits Coding Scheme” (Krupat et al, 2006).

Krupat E, Frankel R, Stein T, Irish J. The Four Habits Coding Scheme: validation of an instrument to assess clinicians’ communication behavior. Pat Educ Couns 2006; 62: 38-45.

Secondary outcome measures

1. Change in Habit 1 through 4 behaviours according to which habit the physicians particularly commit themselves to improve (physicians may want to implement all habits, but are prompted to give priority to one of them)
2. Changes in Habits in 20% of physicians with the lowest scores
3. Changes in Habits across age groups, gender, specialties, seniors/juniors
4. Change in physician communication specific self-efficacy
5. Change in patient satisfaction

Overall trial start date

13/04/2007

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Physicians under 60 years doing full or part-time clinical work in somatic departments of Akershus University Hospital. Altogether 8 real consultations or meetings with patients/relatives of patients per physician are recruited consecutively.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64 physicians (512 consultations)

Participant exclusion criteria

None for physicians.

For consultations:
1. Anticipated consultation duration less than 5 minutes
2. Consultations or meetings with patients or relatives where they are in a particularly vulnerable situation and where videotaping would be inappropriate (e.g. when conveying serious messages)

Recruitment start date

13/04/2007

Recruitment end date

31/03/2010

Locations

Countries of recruitment

Norway

Trial participating centre

Helse Øst Health Services Research Centre
Lørenskog
1478
Norway

Sponsor information

Organisation

Regional Authorities for Hospital Care, Eastern Norway (Helse Øst RHF)

Sponsor details

PO Box 404
Hamar
2301
Norway
+47 (0)62 585500
postmottak@helse-ost.no

Sponsor type

Government

Website

http://www.helse-ost.no

Funders

Funder type

Government

Funder name

Regional Authorities for Hospital Care, Eastern Norway (Helse Øst RHF) (ref: 2007 - 015)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results of substudy on self-efficacy among doctors in hospitals after a course in clinical communication in http://www.ncbi.nlm.nih.gov/pubmed/19935933 [in Norwegian]
2. 2010 results on confirmation of informed consent by SMS in http://www.ncbi.nlm.nih.gov/pubmed/20133410
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21050695

Publication citations

  1. Results on confirmation of informed consent by SMS

    Gulbrandsen P, Jensen BF, Post-recruitment confirmation of informed consent by SMS., J Med Ethics, 2010, 36, 2, 126-128, doi: 10.1136/jme.2009.033456.

  2. Results

    Fossli Jensen B, Gulbrandsen P, Dahl FA, Krupat E, Frankel RM, Finset A, Effectiveness of a short course in clinical communication skills for hospital doctors: results of a crossover randomized controlled trial (ISRCTN22153332)., Patient Educ Couns, 2011, 84, 2, 163-169, doi: 10.1016/j.pec.2010.08.028.

  3. Gulbrandsen P, Jensen BF, Finset A, [Self-efficacy among doctors in hospitals after a course in clinical communication]., Tidsskr. Nor. Laegeforen., 2009, 129, 22, 2343-2346, doi: 10.4045/tidsskr.09.0261.

Additional files

Editorial Notes