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On-site Supportive Communication Training in Doctor-patient Communication

Primary Purpose

Communication Programs, Communication, Manual, Communication Research

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
On-site supportive communication training
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Communication Programs

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Medical doctors Employed at the Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark or Aalborg University Hospital, or Zealand University Hospital, Roskilde/Naestved. Work in the outpatient clinics at the participating departments Exclusion Criteria: Doctors whose employment contracts will expire during the study and who do not plan to continue working at the department. Doctors who are not willing to sign the informed consent form.

Sites / Locations

  • Department of Oncology, University Hospital of Southern Denmark - Vejle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Each oncologist will have a total of three intervention days with a psychologist sitting in and observing the doctor-patient consultations and subsequently providing feedback.

Oncologists in the control group will conduct consultations as usual.

Outcomes

Primary Outcome Measures

Difference in rate of "Excellent" scores on the Communication Assessment Tool between the intervention and the control group.
Patients rate the doctor's communication skills right after the consultation.

Secondary Outcome Measures

Change in oncologists' rating of own communication efficacy according to the "Self-efficacy in Health Communication" tool from before to after on-site communication training.
The Self-efficacy in Health Communication tool consists of 12 questions eliciting the healthcare professionals' perceived self-efficacy in communication with patients using a 10-point scale from "very uncertain" (1) to "very certain" (10).
Change in oncologists' rating of burnout according to part 2 and 3 of the Copenhagen Burnout Inventory tool from before to after on-site communication training.
The reply options in relation to burnout range from 1 (To a very high degree/always), to 5 (To a very low degree/never-almost never)
Change in oncologists' rating of job satisfaction from before to after on-site communication training.
Job satisfaction is measured in Denmark every other year at the nation-wide employee satisfaction survey, which survey offers a large amount of comparable data. Five items directly concerning job satisfaction will be extracted from the survey.

Full Information

First Posted
April 24, 2023
Last Updated
May 12, 2023
Sponsor
Vejle Hospital
Collaborators
Zealand University Hospital, Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05842083
Brief Title
On-site Supportive Communication Training in Doctor-patient Communication
Official Title
On-site Supportive Communication Training in Doctor-patient Communication: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
Collaborators
Zealand University Hospital, Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this randomized, controlled clinical trial is to test a new concept for communication skills training (on-site supportive communication training (on-site SCT) in cancer care. The study aims to determine the impact of on-site SCT on patients' rating of oncologists' communication abilities. Oncologists participating in the study will be randomly allocated to the intervention or control group. In the intervention group each doctor will have a total of three intervention days at intervals of 3-4 weeks. On an intervention day, a psychologist will sit in and observe doctor-patient consultations. After the first consultations, 30 minutes are allocated for feedback to the doctor by the psychologist. After the last consultation of the day, 60 minutes are allocated for thorough feedback and establishment of learning goals to focus on until the next intervention day. Doctor's in the control group will conduct communication as usual. Researchers will compare the control and intervention groups to see if patients' rating of doctors' interpersonal and communication skills increase when the doctors have participated in on-site SCT. The 15-item Communication Assessment Tool (CAT) will be used. It will also be investigated whether on-site SCT increases the doctors' rating of themselves in relation to communication efficacy and job satisfaction and decrease their experience of burnout.
Detailed Description
Oncologists carry a heavy responsibility when delivering information to cancer patients and helping them navigate through decisions about life-altering treatments, survivorship, and end-of-life care. Comprehensive person-centered psychosocial cancer care should be adapted to the individual patient, which is obviously a challenging task (Dilworth, et al. 2014). Individualized and empathic communication, on the other hand, is of substantial importance to patient satisfaction, adherence to treatment, empowerment, and the ability to navigate in the disease trajectory (Gattellari, et al. 2001; Stewart 1995; Vogel, et al. 2009). The quality of the communication in medical care has been shown to influence health outcomes, as it increases the risk of unnecessary treatment and is linked to insufficient pain relief and higher anxiety levels (Thorne, et al. 2005). Therefore, considerable effort has been dedicated to interventions that may improve the communication skills of healthcare professionals involved in cancer care (Moore, et al. 2018). The primary purpose has been to improve the quality of the doctor-patient-communication including the doctors' interpersonal skills. Previous papers have suggested direct feedback on observed situations as an ideal method for improving communication skills (Anderson 2012; Burgess, et al. 2020), but to the best of our knowledge, no randomized clinical trials have used patient feedback during on-site training. Studies on communication skills training courses with recorded consultations/role-play have shown significant effect on key communication skills (Fallowfield, et al. 2002) and increased self-efficacy (Ammentorp, et al. 2007). Two studies have demonstrated long-term maintenance of acquired skills (Finset, et al. 2003; Gulbrandsen, et al. 2013). Until now, no effect on burnout has been demonstrated (Bragard, et al. 2010a; Bragard, et al. 2010b). Clinical supervision and training aims to develop clinical practice and provide a protected space to allow an educational and reflective process to occur. Although there is still no empirical definition of the term supervision (Milne 2007), in 2004 Bernard and Goodyear defined it as "an intervention provided by a more senior member of a profession to a more junior member or members of that same profession"(Bernard 2004). On this premise, psychologists cannot formally supervise doctors and other terms must be used. In this project we therefore use the term "on-site supportive communication training" (on-site SCT) when referring to the intervention given by the psychologists. Psychologists have a long tradition of working with communication, creating a reflective learning space, making observations and providing feedback. It is therefore highly relevant to use dedicated psychologists to investigate the effect of on-site SCT on the doctors' communication and on their experienced level of self-efficacy, satisfaction and burn-out.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Communication Programs, Communication, Manual, Communication Research, Oncology, Doctor Patient Relation, Job Stress, Burnout, Satisfaction, Patient, Efficacy, Self

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Oncologists will be randomized between the intervention and usual practice.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Each oncologist will have a total of three intervention days with a psychologist sitting in and observing the doctor-patient consultations and subsequently providing feedback.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Oncologists in the control group will conduct consultations as usual.
Intervention Type
Behavioral
Intervention Name(s)
On-site supportive communication training
Intervention Description
On-site supportive communication training
Primary Outcome Measure Information:
Title
Difference in rate of "Excellent" scores on the Communication Assessment Tool between the intervention and the control group.
Description
Patients rate the doctor's communication skills right after the consultation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in oncologists' rating of own communication efficacy according to the "Self-efficacy in Health Communication" tool from before to after on-site communication training.
Description
The Self-efficacy in Health Communication tool consists of 12 questions eliciting the healthcare professionals' perceived self-efficacy in communication with patients using a 10-point scale from "very uncertain" (1) to "very certain" (10).
Time Frame
6 months
Title
Change in oncologists' rating of burnout according to part 2 and 3 of the Copenhagen Burnout Inventory tool from before to after on-site communication training.
Description
The reply options in relation to burnout range from 1 (To a very high degree/always), to 5 (To a very low degree/never-almost never)
Time Frame
6 months
Title
Change in oncologists' rating of job satisfaction from before to after on-site communication training.
Description
Job satisfaction is measured in Denmark every other year at the nation-wide employee satisfaction survey, which survey offers a large amount of comparable data. Five items directly concerning job satisfaction will be extracted from the survey.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medical doctors Employed at the Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark or Aalborg University Hospital, or Zealand University Hospital, Roskilde/Naestved. Work in the outpatient clinics at the participating departments Exclusion Criteria: Doctors whose employment contracts will expire during the study and who do not plan to continue working at the department. Doctors who are not willing to sign the informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerstin Kiis Antonsen, MD
Phone
+4528944763
Email
kerstin.kiis.antonsen@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Henrik Jensen, MD, PhD
Phone
+4579406802
Email
Lars.Henrik.Jensen@rsyd.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerstin Kiis Antonsen, MD
Organizational Affiliation
University Hospital of Southern Denmark - Vejle Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, University Hospital of Southern Denmark - Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerstin Kiis Antonsen, MD
Phone
+4528944763
Email
kerstin.kiis.antonsen@rsyd.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24519814
Citation
Dilworth S, Higgins I, Parker V, Kelly B, Turner J. Patient and health professional's perceived barriers to the delivery of psychosocial care to adults with cancer: a systematic review. Psychooncology. 2014 Jun;23(6):601-12. doi: 10.1002/pon.3474. Epub 2014 Feb 11.
Results Reference
background
PubMed Identifier
11352412
Citation
Gattellari M, Butow PN, Tattersall MH. Sharing decisions in cancer care. Soc Sci Med. 2001 Jun;52(12):1865-78. doi: 10.1016/s0277-9536(00)00303-8.
Results Reference
background
PubMed Identifier
7728691
Citation
Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.
Results Reference
background
PubMed Identifier
19796910
Citation
Vogel BA, Leonhart R, Helmes AW. Communication matters: the impact of communication and participation in decision making on breast cancer patients' depression and quality of life. Patient Educ Couns. 2009 Dec;77(3):391-7. doi: 10.1016/j.pec.2009.09.005. Epub 2009 Oct 1.
Results Reference
background
PubMed Identifier
16200515
Citation
Thorne SE, Bultz BD, Baile WF; SCRN Communication Team. Is there a cost to poor communication in cancer care?: a critical review of the literature. Psychooncology. 2005 Oct;14(10):875-84; discussion 885-6. doi: 10.1002/pon.947.
Results Reference
background
PubMed Identifier
30039853
Citation
Moore PM, Rivera S, Bravo-Soto GA, Olivares C, Lawrie TA. Communication skills training for healthcare professionals working with people who have cancer. Cochrane Database Syst Rev. 2018 Jul 24;7(7):CD003751. doi: 10.1002/14651858.CD003751.pub4.
Results Reference
background
PubMed Identifier
23730434
Citation
Anderson PA. Giving feedback on clinical skills: are we starving our young? J Grad Med Educ. 2012 Jun;4(2):154-8. doi: 10.4300/JGME-D-11-000295.1.
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PubMed Identifier
33272265
Citation
Burgess A, van Diggele C, Roberts C, Mellis C. Feedback in the clinical setting. BMC Med Educ. 2020 Dec 3;20(Suppl 2):460. doi: 10.1186/s12909-020-02280-5.
Results Reference
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PubMed Identifier
11879860
Citation
Fallowfield L, Jenkins V, Farewell V, Saul J, Duffy A, Eves R. Efficacy of a Cancer Research UK communication skills training model for oncologists: a randomised controlled trial. Lancet. 2002 Feb 23;359(9307):650-6. doi: 10.1016/S0140-6736(02)07810-8.
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PubMed Identifier
17337337
Citation
Ammentorp J, Sabroe S, Kofoed PE, Mainz J. The effect of training in communication skills on medical doctors' and nurses' self-efficacy. A randomized controlled trial. Patient Educ Couns. 2007 Jun;66(3):270-7. doi: 10.1016/j.pec.2006.12.012. Epub 2007 Mar 2.
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PubMed Identifier
14502593
Citation
Finset A, Ekeberg O, Eide H, Aspegren K. Long term benefits of communication skills training for cancer doctors. Psychooncology. 2003 Oct-Nov;12(7):686-93. doi: 10.1002/pon.691.
Results Reference
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PubMed Identifier
23414658
Citation
Gulbrandsen P, Jensen BF, Finset A, Blanch-Hartigan D. Long-term effect of communication training on the relationship between physicians' self-efficacy and performance. Patient Educ Couns. 2013 May;91(2):180-5. doi: 10.1016/j.pec.2012.11.015. Epub 2013 Feb 12.
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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On-site Supportive Communication Training in Doctor-patient Communication

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