Effectiveness of the AAA-training programme on GP-patient communication in palliative care: a controlled clinical trial

ISRCTN	ISRCTN56722368
DOI	https://doi.org/10.1186/ISRCTN56722368
Secondary identifying numbers	NTR565

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 27/06/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.H. Blankenstein
Scientific

Vrije University Medical Centre
EMGO-Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4448198
Email	ah.blankenstein@vumc.nl

Study information

Study design	Parallel group controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	GP practice
Study type	Quality of life
Scientific title
Study acronym	COMPACT
Study objectives	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 patients 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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2006
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	640
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/03/2006
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Centre

Amsterdam
1081 BT
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

EMGO Institute
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4448180
Email	emgo@vumc.nl
Website	http://www.vumc.nl/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Industry

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

No information available

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

No information available

Pfizer (The Netherlands)
Government organisation / For-profit companies (industry)

Alternative name(s): Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location: United States of America

Janivo Foundation (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/07/2013		Yes	No
Results article	results	01/09/2014		Yes	No