Condition category
Not Applicable
Date applied
23/02/2017
Date assigned
14/03/2017
Last edited
13/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Approximately half of all Norwegians die in nursing homes. Many nursing home patients suffer from cognitive impairment (problems with memory and thinking skills). If these patients suddenly become very ill, then this combined with cognitive impairment issues may make it difficult for patients to play an active role in making end-of-life decisions. Next of kin and health personnel often do not know whether patients had previously expressed preferences about what kind of end-of-life treatment they would wish to receive. Advance care planning (ACP) is a voluntary process, in which patients can set on record choices about their care and treatment and, in particular, the end-of-life care they wish to receive. The aim of this study is to look at the effects of using ACP in nursing home patients, by getting to know patient preferences and wishes for the future before patients lose capacity to communicate.

Who can participate?
Nursing home patients aged 70 or over, their next of kin and the health personnel looking after them.

What does the study involve?
Participating nursing homes are randomly allocated to one of two groups. In the first group, staff receive training in advance care planning (ACP) conversations. Patients and/or their next of kin at these nursing homes are offered an opportunity to participate in these conversations. The conversations are concerned with patients' hopes and worries for the future, appointment of a proxy (someone to make decisions for them if they are no longer able to), their wishes for information, wishes for participation in decision-making, and wishes for life-prolonging treatment and hospitalization. Some patients, next of kin and health personnel are asked whether a researcher can observe this conversation and interview those participating directly after the conversation. In the second group, patients receive care as usual. At the start of the study and 12 months later, participants have their electronic patient records reviewed in order to make a note of any end-of-life decisions made and if these are in line with patient wishes (if known).

What are the possible benefits and risks of participating?
Advance care planning conversations may be beneficial to patients, next of kin and health personnel caring for the patient. This process of conversations may help patients cope with end-of-life challenges, enable patient and next of kin to talk about wishes, values and preferences not previously expressed and help put the patient at the centre of attention when end-of-life decisions need to be made. Ultimately, the hope is that appropriate treatment is as much in line with what the patients wants as possible. There are no notable risks involved with participating.

Where is the study run from?
Centre for Medical Ethics at the University of Oslo (Norway)

When is study starting and how long is it expected to run for?
April 2010 to March 2018

Who is funding the study?
Research Council of Norway (Norway)

Who is the main contact?
1. Professor Reidar Pedersen (scientific)
reidar.pedersen@medisin.uio.no
2. Mr Trygve Johannes Lereim Sævareid (public)
t.j.l.savareid@medisin.uio.no

Trial website

Contact information

Type

Public

Primary contact

Mr Trygve Johannes Lereim Sævareid

ORCID ID

Contact details

University of Oslo
Postboks 1130 Blindern
Oslo
0318
Norway
+47 22859204
t.j.l.savareid@medisin.uio.no

Type

Scientific

Additional contact

Prof Reidar Pedersen

ORCID ID

Contact details

University of Oslo
Postboks 1130 Blindern
Oslo
0318
Norway
+47 22844663
reidar.pedersen@medisin.uio.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

The Research Council of Norway project number: 222088

Study information

Scientific title

Implementation of advance care planning in Norwegian nursing homes - a cluster randomized controlled trial

Acronym

Study hypothesis

Research questions:
1. Does an ACP intervention influence the documentation of patient preferences to end-of-life issues?
2. Does an ACP intervention increase documentation of patient involvement when decisions are made on life-prolonging treatment and hospitalization?
3.Does an ACP intervention increase the documentation of patients hope and worry for the future?

Ethics approval

1. The Regional Ethics Committee, 15/04/2015, ref: 2014/2210/REK sør-øst
2. Norwegian Social Science Data Services, 03/03/2015, ref: 41114

Study design

Multi-centre cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Care

Intervention

Eight nursing home wards from eight nursing homes are pair-matchedusing the following data from a national survey/KOSTRA/the nursing home’s annual report: size of the municipality, size of the nursing home and ward (number of beds), number of hours with doctor present per week, and personnel position characteristics (educational backgrounds, percentage of professionals, ratio of part time/full time). One ward from each pair of wards is then randomized to be included in the intervention group and the other to the control group.

Intervention group: : The intervention consists of systematic implementation of Advance care planning (ACP) conversations. A guideline has been developed for these conversations which includes a definition of ACP, outlines aims and purposes of ACP, emphasizes voluntary participation and includes a suggested text on how to invite patients to the conversation, addresses competency to consent, notes the researchers aim of including patients with cognitive impairment in conversations, recommends setting and timing of conversation, recommends who should participate and how to prepare for and lead the conversation, recommends what questions to ask and suggests how the conversations should progress, and finally states recommendations on what to do after the conversation.
Patients at the ward, or next of kin when patients could not consent, are invited to an ACP conversation. The ACP conversation lasts no more than an hour. Each patient did not get invitation to more than one conversation during the 12 month intervention period.
A project group from each of the nursing home wards in the intervention group are educated in ACP, the guideline and how to conduct ACP conversations prior to the intervention. They also got a recommendation on how to assess competency to consent, and are told the importance of doing so. They are responsible for educating their own staff. However, the research group at the University of Oslo contributed at 3 of the 4 wards in educating staff from the wards on the project, the guideline and how to do ACP.
Each nursing home ward has one contact person from the research group they could contact if they have any queries. This researcher also contacts the local project coordinator regularly asking about development at the ward.
Local project groups are gathered three times during the 12 month intervention and then again afterwars. These gatherings consist of sharing experiences, obstacles with the implementation and how to move on.

Control group: Care as usual during the 12 month intervention. Wards in the control group do not receive education in ACP, the guideline and how to conduct ACP conversations prior to the intervention, but rather March 2nd 2017.

Intervention type

Phase

Drug names

Primary outcome measures

1. Number of patients with a documented conversation on end-of-life treatment is assessed through electronic health record review at baseline and 12 months
2. Number of patients with a documented wish regarding life-prolonging treatment and hospitalisation assessed through electronic health record review at baseline and 12 months
3. Concordance between patient wishes and treatment given will be measured based on documentation of events assessed through electronic health record review at baseline and 12 months

Secondary outcome measures

1. Documentation of: patient's hopes and worries for the future, wishes for information to oneself and next of kin, wishes for participation in end-of-life decision-making
2. Decisions on end-of-life treatment and hospitalisation
3. Concordance between patient's previously expressed wishes and actual treatment given

Overall trial start date

01/04/2010

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Nursing home resident
2. Aged 70 years and over

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

8 clusters. Cluster #1: 39, #2: 36, #3: 35, #4: 51, #5: 31, #6: 26, #7: 37, #8: 62

Participant exclusion criteria

1. Under the age of 70
2. Do not understand or speak Norwegian
3. Severe psychiatric condition

Recruitment start date

21/04/2015

Recruitment end date

29/06/2016

Locations

Countries of recruitment

Norway

Trial participating centre

Centre for Medical Ethics, University of Oslo
0318

Sponsor information

Organisation

University of Oslo

Sponsor details

Kirkeveien 166. Fredrik Holsts hus
Oslo
0450
Norway
+47 22 85 05 50
admin-etikk@helsam.uio.no

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

The Research Council of Norway

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planed publication of the following papers in Open Access, peer reviewed journals:
1. Protocol of the study, May 2017
2. Experiences with implementation of the intervention, Autumn 2017
3. Characterizations of ACP conversations after systematic implementation of ACP guideline, Autumn 2017
4. Influence of ACP intervention on documentation of the study's primary and secondary outcomes, Autumn 2017
5. Experiences based on health personnel focus groups, Spring 2018
6. Significance of ACP conversations for the stakeholders - participating patients, next of kin and health personnel, Spring 2018

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

31/03/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes