NCT03521206

Brief Summary

Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future (medical) care. ACP is of particular relevance for frail older adults, particularly in the nursing home setting where an important proportion of older people die. However, the actual implementation of ACP in nursing home practice seems to be a challenge in many countries worldwide, and people often do not get the opportunity to discuss their preferences in advance. This study evaluates the effectiveness of a theory-based advance care planning training programme (ACP+ programme) for nursing homes in Flanders, Belgium, using a cluster randomised controlled trial (cRCT) design. The ACP+ programme aims to integrate ACP in routine nursing home care by training the nursing home staff and management. Residents and their family will receive in-depth information on ACP and participate in one or several ACP conversations, if they wish so. Who can participate? Nursing homes that conform to the eligibility criteria: at least 100 beds, situated in Flanders and did not participate in a similar research or implementation project over the last 4 years. What does the study involve? The researchers will perform a cluster randomized controlled trial (cRCT) to evaluate the effects of an ACP training programme in nursing homes in Flanders (Belgium), accompanied by a process evaluation. Fourteen nursing homes will be randomized to either the intervention group, which will receive the intervention (ACP+ programme), or the control group, in which no additional training regarding ACP (other than that which is part of routine practice) will be provided. The nursing homes in the control group will receive a short training on ACP, as well as all training materials used in the intervention after the last follow-up measurements. At month 0 the researchers will perform a baseline measurement in the intervention and control groups using structured questionnaires to be filled in by all care staff in the nursing home. At the end of month 8, the same questionnaires will be administered again in all nursing homes (follow-up). The process evaluation will employ structured diaries for ACP trainers, attendance lists for training sessions, audiotaping of a sample of ACP conversations and individual and group interviews with staff and management of the intervention homes. Hypotheses The primary hypothesis is that the introduction of the ACP+ programme in nursing homes will improve the knowledge and self-efficacy of nursing home care staff regarding advance care planning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

12 months

First QC Date

April 16, 2018

Last Update Submit

September 23, 2019

Conditions

Advance Care PlanningElderly CareNursing Home

Keywords

Advance directivesEffectivenessProcess evaluationCare staff

Outcome Measures

Primary Outcomes (1)

  • Change in knowledge of and self-efficacy concerning ACP

    The knowledge questions concern legal rules and regulations in Belgium around ACP-related issues (for example, the legal status of an advanced directive). The self-efficacy questions survey the respondent's self-efficacy regarding ACP.

    One questionnaire at baseline (T0), one questionnaire at follow-up (T1, 8 months after T0)

Study Arms (2)

Intervention group

EXPERIMENTAL

The ACP+ programme aims to improve or establish advance care planning (ACP) in the day-to-day routine of staff working in nursing homes. The intervention implementation period has a total duration of 8 months and is divided into: * a four-month preparation and training phase. During this phase the ACP reference persons will attend a "two-day training" given by the ACP trainers. Other staff will receive training by the reference persons on conducting ACP conversation or recognizing triggers for an ACP conversation in nursing home residents. * A four-month follow-up phase in which ACP conversations are held with residents. Additional training sessions will be organized to give more in-depth knowledge to the ACP reference persons.

Behavioral: ACP+ programme

Control group

NO INTERVENTION

The staff of nursing homes in the control group will receive no additional training next to any standard education or continuous training. After the intervention and follow-up measures are finished, all nursing homes in the control group will be offered a shortened version of the ACP+ training programme as well as all ACP+ training materials.

Interventions

ACP+ programmeBEHAVIORAL

Training program for nursing home staff.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the board of directors/the management express explicit motivation to participate in the study and agree to allocate at least a 0,10 FTE per week for at least two ACP Reference Person(s) per 30 to 40 nursing home beds, to carry out the tasks that are part of this project
  • have at least 100 beds
  • able to speak and understand Dutch.
  • work in a participating nursing home as either (head) nurse, care assistant, psychologist, physiotherapist, occupational therapist, social worker, animator, or reference person dementia/palliative care

You may not qualify if:

  • nursing homes have taken/are taking part in another research study that is evaluating palliative care services or communication strategies, currently or in the past 4 years
  • they have - or are planning to develop during the foreseen duration of the trial - an extensive ACP policy, meaning that (i) all nursing home residents or their family (in principal) regularly receive ACP conversations (two conversations or more each year) or (ii) the nursing home is judged by the researchers as having explicit and detailed ACP guidelines available (corresponding to high-quality ACP procedures and practices)
  • major organisational changes or physical changes to the facility (e.g. building activities or staff re-organisation) are planned or ongoing during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

End of Life Care Research Group

Brussels, 1090, Belgium

Location

Related Publications (4)

  • Pivodic L, Wendrich-van Dael A, Gilissen J, De Buyser S, Deliens L, Gastmans C, Vander Stichele R, Van den Block L. Effects of a theory-based advance care planning intervention for nursing homes: A cluster randomized controlled trial. Palliat Med. 2022 Jul;36(7):1059-1071. doi: 10.1177/02692163221102000.

    PMID: 35769038DERIVED

  • Gilissen J, Wendrich-van Dael A, Gastmans C, Vander Stichele R, Deliens L, Detering K, Van den Block L, Pivodic L. Differences in advance care planning among nursing home care staff. Nurs Ethics. 2021 Nov-Dec;28(7-8):1210-1227. doi: 10.1177/0969733021994187. Epub 2021 May 5.

    PMID: 33947293DERIVED

  • Gilissen J, Pivodic L, Wendrich-van Dael A, Cools W, Vander Stichele R, Van den Block L, Deliens L, Gastmans C. Nurses' self-efficacy, rather than their knowledge, is associated with their engagement in advance care planning in nursing homes: A survey study. Palliat Med. 2020 Jul;34(7):917-924. doi: 10.1177/0269216320916158. Epub 2020 May 8.

    PMID: 32383636DERIVED

  • Gilissen J, Pivodic L, Wendrich-van Dael A, Gastmans C, Vander Stichele R, Engels Y, Vernooij-Dassen M, Deliens L, Van den Block L. Implementing the theory-based advance care planning ACP+ programme for nursing homes: study protocol for a cluster randomised controlled trial and process evaluation. BMC Palliat Care. 2020 Jan 8;19(1):5. doi: 10.1186/s12904-019-0505-7.

    PMID: 31915000DERIVED

Study Officials

  • Lieve Van den Block, Prof. Dr.

    VUB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
During the data collection the investigators cannot be blinded, due to the nature of the intervention. However, during data analysis the researchers will be blinded for the unit of randomization of each nursing home, making use of encrypted data.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Seven of the 14 nursing homes will be randomized to the intervention group. The other seven nursing homes will be randomized to the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2018

First Posted

May 11, 2018

Study Start

March 1, 2018

Primary Completion

February 28, 2019

Study Completion

May 20, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)