Plain English Summary
Background and study aims
An advance directive (AD) is a living will, a legal document in which someone specifies what health treatment they should be given if they become unable to make decisions for themselves or communicate their wishes to others at a later date. However, programmes (or interventions) to promote Ads have only been partially successful and has too often been addressed in the context of resource allocation for professionals to the detriment of a holistic approach, that is one including patients and close relatives. To change this requires focusing on patients’ priorities according to their specific values and wishes. Advance Care Planning (ACP), centered on patient and family perspectives, pursues that goal. The aim of this study is to develop and test the feasibility, acceptability and effectiveness of a ACP nursing intervention to help with discussions about care priorities and healthcare decisions at end of life.
Who can participate?
People aged 65 or over with close relative, newly admitted in nursing home.
What does the study involve?
The study intervention includes ongoing discussions and decision-making processes involving nursing home patients, close relative and experienced specially trained nurse. During the course of three sessions, the nurse and patient discuss the patients personal needs, values and beliefs about end-of-life with the help of a card game. The nurse then repeats the process with the patients close relative, but this time the relatives is predicting how the patient would respond. Similarities and differences between the answers given by the patient and their relative is hen discussed, along with any possible implications for the future care and treatment of the patient. All participants are assessed on their care preferences, their perception of how well they communicate their wishes for end-of-life care with the nurse and thoughts on how this may affect the close relative before the start of the study and then 3 months later.
What are the possible benefits and risks of participating?
Possible benefits include starting discussions about end-of-life care with the support of a specialized nurse in a sensitive approach. Focusing on values and priorities, interviews favor personal expression and three way communication. There are no risks for participants
Where is the study run from?
Five nursing homes in Geneva (Switzerland)
When is the study starting and how long is it expected to run for?
September 2010 to December 2012
Who is funding the study?
School of Health Sciences - Geneva (Switzerland)
Who is the main contact?
Professor Laurence Séchaud
laurence.sechaud@hesge.ch
Trial website
Contact information
Type
Scientific
Primary contact
Prof Laurence Séchaud
ORCID ID
Contact details
Avenue de Champel 47
Genève
1206
Switzerland
+41 (0) 223885642
laurence.sechaud@hesge.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11-043
Study information
Scientific title
Effect estimation of an innovative nursing intervention to improve Advance Care Planning among nursing home’s residents and their relatives : a pre-post pilot trial
Acronym
Study hypothesis
To develop a new Advance care planning (ACP) nursing intervention and test its feasibility, To evaluate the acceptability, faisability and potential effects of an innovative ACP intervention with nursing home résidents (NHRs) and their close relatives.
Ethics approval
The Human Research Ethics Committee of the Canton of Geneva, 25/05/2011, ref: CER: 11-043
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
End of life care for elderly in nursing homes
Intervention
The Advance care planning (ACP) intervention includes ongoing discussions and decision-making processes individually and within the dyad with the support of an experienced nurse trained in the ACP intervention. The specificity of the intervention consisted of three interviews and the use of an alternative card game called “Go Wish".
This game is composed of 36 cards, each of which presents a statement that refers to personal needs, values, and beliefs about end of life care. First, instructions to NHRs are to sort (very, medium or low importance) the cards in three piles, then select the ten most important, rank them according to their personal priorities and discuss the reasons for their choices. Secondly, the close relatives follow the same process but on their predictions about NHRs’ choices. Finally, the dyads discuss similarities and differences in choices and the implications of the identified priorities for future NHRs’ care and treatment.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Feasibility defined as
Ability to enroll and retain dyads
1. Number of participants, close relatives recruited; timepoint: end of recruitment (31/05/2012)
2, Number of dyads retained after intervention (patients, close relatives); timepoint: six months after end of recruitment (31/11/2012)
3. Distribution of the intervention (integrity and fidelity) patients records; timepoint: six months after end of recruitment (31/11/2012)
4. Adherence to data collection plan; patients records; timepoint: six months after end of recruitment (31/11/2012)
Acceptability
5. Acceptability of the intervention for patients, close relatives; Satisfaction questionnaire; timepoint: T2= 3 months post intervention
6, Acceptability for nurses delivering the ACP intervention in terms of fidelity, resources mobilized and practice change. Satisfaction questionnaire; T2= 3 months post intervention
Secondary outcome measures
1. Quality of end of life communication with the nurse (NHR & close relative) measured with the “Quality of Patient-Clinician Communication About End of Life Care (QOC)”; timepoint: T= pre intervention (5-6 weeks after admission) and T2 post intervention (six months after admission)
2. Congruence in preferences and care options (dyad) measured with the «Statement of Treatment Preference (STP)» Timepoint: T1= pre intervention (5-6 weeks after admission) and T2 post intervention (six months after admission)
3. Perceived Burden (close relative) measured with the “Brief Burden Interview “ (BBI) Timepoint: T1= pre intervention (5-6 weeks after admission) and T2 post intervention (six months after admission)
Overall trial start date
27/09/2010
Overall trial end date
21/12/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Newly admitted in nursing home
2. ≥ 65 years old
3. Suffering from a chronic disease with a potentially fatal outcome, or from a life-threatening disease
4. Mentally competent
5. Fluent in French
6. Have a close relative who agreed to participate in the study
Participant type
Mixed
Age group
Senior
Gender
Both
Target number of participants
Minimum 40
Participant exclusion criteria
1. Serious cognitive impairment
2. Already written ADs
3. Significant motor and/or sensory deficits
Recruitment start date
15/05/2011
Recruitment end date
31/05/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
House of Petit-Saconnex Retreat (Maison de Retraite du Petit-Saconnex)
Avenue Trembley
Geneva
12-1209
Trial participating centre
Val Fleuri
Geneva
1206
Switzerland
Trial participating centre
Vessy House (Maison de Vessy)
Geneva
1234
Switzerland
Trial participating centre
La Petite Boissière Residence
Geneva
1208
Switzerland
Trial participating centre
Charmilles Residence
Geneva
1203
Switzerland
Sponsor information
Organisation
Leenaards Foundation (Switzerland)
Sponsor details
Rue du Petit Chêne 18
Lausanne
1003
Switzerland
+41 (0) 21 351 25 55
fondation@leenaards.ch
Sponsor type
Research organisation
Website
Funders
Funder type
Not defined
Funder name
School of Health Sciences - Geneva (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results manuscript ready for submission
Intention to publish date
20/06/2016
Participant level data
Available on request
Results - basic reporting
Publication summary
2014 review: http://www.ncbi.nlm.nih.gov/pubmed/23782911