Condition category
Not Applicable
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
27/06/2014
Prospective/Retrospective
Prospectively 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

Dr A.H. Blankenstein

ORCID ID

Contact details

Vrije University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448198
ah.blankenstein@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR565

Study information

Scientific title

Acronym

COMPACT

Study hypothesis

GPs play a central role in providing palliative care (PC) in the Netherlands. Good GP-patient communication is essential for the delivery of high quality care. Communication in PC is difficult, involving a mix of physical, psychosocial, and spiritual issues. Because of barriers in communication, not all of the patient’s problems are clarified. Consequently, GPs will not take subsequent actions, and the quality of life of the patient may be unnecessarily impaired.

We developed the AAA assessment tool that enables GPs to identify the gaps in their PC communication skills and to formulate learning goals. Tailored communication exercises are offered, and finally the tool is used for self-evaluation of learned AAA skills. The effectiveness of this tool will be evaluated in a controlled clinical trial with outcome measures on GP and patient level.

It is hypothesised that, compared to existing PC courses, a training course on communication in PC guided by the AAA assessment tool will increase GPs’ competence in identifying and meeting the needs of PC patients more. As a result, patients will suffer less and be more satisfied with the PC they receive from their GPs.

Ethics approval

Received from the local medical ethics committee

Study design

Parallel group controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

Palliative care

Intervention

Based on the literature and preliminary studies, three key elements for GP-patient communication in PC were identified: Availability, Active listening, and Anticipating (AAA). Existing GP training programmes on communication in PC are in need of a tool for identifying GPs’ individual learning goals. The AAA assessment tool will enable GPs to gain insight in the quality of their communication skills in PC; this will increase the effectiveness of the learning process by helping to focus on the aspects GPs want to improve.

All participating GPs will attend a PC Peer Group Training Course, only the intervention group will attend the course with the AAA assessment tool integrated in the course. In the intervention group the AAA assessment tool will be implemented in the existing Peer Group Course as follows:
1. At the start, a consultation with a simulated PC patient is video-recorded and (a few weeks later) the GP receives feedback according to the AAA assessment tool. GPs will be invited to identify their gaps and to formulate personal learning goals, based on the received feedback.
2. During the residential course education modules on the AAA items will be offered: individual GPs participate in the module(s) that focus on their gaps.
3. During the peer group sessions GPs will apply the AAA assessment tool to give feedback on cases presented (orally, transcribed, or audio/video-taped) by their peers. This tailor-made intervention will focus on the aspects each individual GP wants to improve.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The first research question, on effectiveness of the AAA assessment tool, will be measured by analysis of video-recorded consultations with simulated patients: the GP-patient communication in PC will be determined by the Roter Interaction Analysis System (RIAS).
This primary outcome will also be measured according to a study-specific ‘AAA’ rating scale.

Twice during the project GPs will be video-taped (consultation with a simulated patient); the first time will be during the first 2-day course (before the start of the intervention); the second time will be during the third 2-day course (one year later).

Secondary outcome measures

Effects at patient level will be measured by questionnaires to real PC patients:
1. Satisfaction about the communication with their GP will be measured with the Dutch version of the Patient Satisfaction Questionnaire III
2. Disease-related quality of life will be measured with the Palliative Care Outcome Scale and the EORTC QLQ-C15-PAL
3. Feelings of being at peace and comfortable will be measured according to a study-specific ‘rest & peace’ rating scale
4. Implementation of AAA items by GPs will be measured by a study-specific 'AAA Patient Questionnaire'

Twice during the project GPs will be asked to recruit the first two consecutive patients for whom they currently provide PC, and who are eligible for participation. The first time will be during the three months before the start of the course; the second time will be between the second and third 2-day course.

Overall trial start date

01/03/2006

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Incurable cancer with a life-expectancy of less than six months
2. Over 18 years of age
3. Ability to speak, read and write Dutch
4. Absence of overt psychopathology or serious cognitive dysfunction that would impede their ability to take part in the study
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

640

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/03/2006

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4448180
emgo@vumc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/

Funders

Funder type

Industry

Funder name

OZ Health Insurance NV (OZ Zorgverzekeringen NV) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Comprehensive Cancer Centre South (IKZ Eindhoven) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer (The Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Janivo Foundation (The Netherlands)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23819723
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24951633

Publication citations

  1. Results

    Slort W, Blankenstein AH, Schweitzer BP, Knol DL, Deliens L, Aaronson NK, van der Horst HE, Effectiveness of the ACA (Availability, Current issues and Anticipation) training programme on GP-patient communication in palliative care; a controlled trial., BMC Fam Pract, 2013, 14, 93, doi: 10.1186/1471-2296-14-93.

  2. Results

    Slort W, Blankenstein AH, Schweitzer BP, Knol DL, van der Horst HE, Aaronson NK, Deliens L, Effectiveness of the palliative care 'Availability, Current issues and Anticipation' (ACA) communication training programme for general practitioners on patient outcomes: A controlled trial., Palliat Med, 2014, 28, 8, 1036-1045, doi: 10.1177/0269216314538302.

Additional files

Editorial Notes