NCT04703816

Brief Summary

To determine whether the implementation of a multifaceted training program relying on the conceptual framework of the Four Habits Model improved the communication and interpersonal skills for hospital physicians during consultations compared with control physicians receiving no intervention, the investigators will conduct a prospective randomized, controlled, open-label, two parallel arms, superiority interventional trial. The unit of randomization is the physician.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

December 17, 2020

Last Update Submit

November 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Four-Habits-Coding-Scheme scale score

    The primary outcome measure is the overall 4-HCS scale score. This score is computed by summing ratings for the 4-HCS individual items, ranging from 23 (i.e., less effective) to 115 (i.e., more effective). Two physicians blinded to study arm will independently rate video-recorded medical consultations using the 4-HCS. To account for inter-rater variability, we will computed average 4-HCS overall rating scores.

    The primary outcome measure will be the mean difference in the 4-HCS score at a 3-month interval between the first (3-month period beginning on date of randomization) and second wave of consultations (3-month period beginning on date of intervention).

Secondary Outcomes (5)

  • Duration of medical consultation

    The outcome measure will be the mean difference in the duration at a 3-month interval between the first (3-month period beginning on date of randomization) and second wave of consultations (3-month period beginning on date of intervention).

  • American Board of Internal Medicine's Patient Satisfaction Rating Scale

    The outcome measure will be the mean difference in the score at a 3-month interval between the first (3-month period beginning on date of randomization) and second wave of consultations (3-month period beginning on date of intervention).

  • Therapeutic Alliance Inventory scale

    The outcome measure will be the mean difference in the score at a 3-month interval between the first (3-month period beginning on date of randomization) and second wave of consultations (3-month period beginning on date of intervention).

  • 4-HCS subscale scores

    The outcome measure will be the mean difference in the score at a 3-month interval between the first (3-month period beginning on date of randomization) and second wave of consultations (3-month period beginning on date of intervention).

  • Maslach Burnout Inventory multidimensional scale

    The outcome measure will be the mean difference in the score at a 3-month interval between the first (3-month period beginning on date of randomization) and second wave of consultations (3-month period beginning on date of intervention).

Study Arms (2)

Intervention arm

EXPERIMENTAL

Physicians in the intervention arm will receive the training program consisting of two half-day group workshops with a review of the skills needed to build effective patient relationships and a discussion of difficult consultations.

Other: Interpersonal Skills Multifaceted Training Program for the physician-patient relationship

Control arm

NO INTERVENTION

Physicians in the control group will not receive any specific intervention at this stage.

Interventions

The training program consisting of two half-day group workshops with a review of the skills needed to build effective patient relationships and a discussion of difficult consultations based on communication theory like Process-Com® and the Four Habits Model.

Also known as: The Four Habits Model
Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians:
  • Physicians board-certified in medical, surgical, or gynaecology-obstetrics specialty at Grenoble Alpes University Hospital
  • Provision of written informed consent
  • Patients:
  • Scheduled consultation in the public sector at Grenoble Alpes University Hospital
  • Patient treated in the participating physician's department
  • Initial consultation for new patient
  • Age ≥18 years old

You may not qualify if:

  • Physicians:
  • \- Problems expressing or understanding the French language for cultural or language reasons
  • Patients:
  • Problems expressing or understanding the French language for cultural or language reasons
  • Patients who are unable to provide written informed consent, because of cognitive impairment, altered mental status, or communication impairments for medical reason
  • Patient subject to a legal protection measure or unable to express their objection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble Alpes University Hospital

Grenoble, France

Location

Related Publications (4)

  • Bellier A, Chaffanjon P, Krupat E, Francois P, Labarere J. Cross-cultural adaptation of the 4-Habits Coding Scheme into French to assess physician communication skills. PLoS One. 2020 Apr 16;15(4):e0230672. doi: 10.1371/journal.pone.0230672. eCollection 2020.

    PMID: 32298278BACKGROUND
  • 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 Aug;84(2):163-9. doi: 10.1016/j.pec.2010.08.028. Epub 2010 Nov 2.

    PMID: 21050695BACKGROUND
  • Krupat E, Frankel R, Stein T, Irish J. The Four Habits Coding Scheme: validation of an instrument to assess clinicians' communication behavior. Patient Educ Couns. 2006 Jul;62(1):38-45. doi: 10.1016/j.pec.2005.04.015. Epub 2005 Jun 17.

    PMID: 15964736BACKGROUND
  • Bellier A, Labarere J, Putkaradze Z, Cavalie G, Carras S, Pelen F, Paris A, Chaffanjon P. Effectiveness of a multifaceted intervention to improve interpersonal skills of physicians in medical consultations (EPECREM): protocol for a randomised controlled trial. BMJ Open. 2022 Feb 15;12(2):e051600. doi: 10.1136/bmjopen-2021-051600.

MeSH Terms

Conditions

CommunicationSocial Skills

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this open label trial, the participating physicians will not be blinded to allocation. Only the physicians who will rate video-recorded consultations and the statistician will be blinded to study arm.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective, randomized (with a 1:1 allocation ratio), controlled, open-label, two parallel arms, superiority interventional trial. The unit of randomization is the physician. Randomization will be performed by minimization, taking into account the status (attending versus non-attending) and specialty (medical versus surgical) of the physician.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

January 11, 2021

Study Start

January 4, 2021

Primary Completion

July 1, 2021

Study Completion

October 1, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations