Clinical trial NCT06238063: Implementing a Nurse-led Advance Care Planning (ACP) Intervention in Residential Care Homes
Official title: Implementing a Nurse-led Advance Care Planning (ACP) Intervention to Improve ACP Uptake in Residential Care Homes: An Implementation Science and Mixed Methods Pragmatic Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advanced Care Planning
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 164
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this cluster randomized controlled trial is to examine the effectiveness of a nurse-led advance care planning (ACP) intervention on improving ACP discussion uptake in residential care homes (RCHs). The main question it aims to answer is: The effectiveness of nurse-led advance care planning (ACP) interventions implemented on eligible residents in residential care homes on improving ACP discussion uptake in this population.

Compared to participants in the control group who will only receive usual care with no ACP intervention, residents and their family members in the intervention group will be invited to attend the ICP meeting with ACP discussion. The ACP discussion will be guided by the established protocol, which was developed by the expert panel and delivered by trained nurses.

Detailed description: Targeted issue: The lack of ACP discussion and poor dyadic congruence pose challenges to the provision of good EOL care in Hong Kong RCHs.

Population: RCHs in Hong Kong with nurse-to-resident ratios ≥1:3 will be targeted to ensure adequate staffing to carry out ACP. Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin. Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention.

Intervention: a nurse-led advance care planning (ACP) intervention

Main study aim: To implement a nurse-led ACP intervention for improving ACP uptake in RCH residents in Hong Kong to bridge the evidence-practice gap.

Study method: This implementation science study will use a mixed methods approach, including a pair-matched cluster-RCT and qualitative interviews, and relevant outcomes will be followed for up to 2 years. RCHs will be randomized into two groups: a nurse-led ACP intervention group and a control group with usual care only.The ACP documentation (i.e., new documentation related to ACP and EOL care) in medical records of all RCH residents in the intervention and control groups will be audited by the research team at baseline (T0), post-intervention (T1; after the ACP intervention), 1-year follow-up (T2; 1 year after the launch of the ACP intervention at the RCH), and 2-year follow-up (T3; 2 years after the launch of the ACP intervention at the RCH).

Eligibility criteria: Inclusion Criteria:

* Eligible participants have to be age 65 or older and be able to communicate in Cantonese or Mandarin.
* Participants will also be invited to identify family members involved in making decisions about their care to participate in the intervention. For residents who have moderate or severe cognitive impairment (as determined by a score of less than 19 in the Hong Kong version of the Montreal Cognitive Assessment), the participation of family members is mandatory.

Exclusion Criteria:

* They have a moderate or severe significant cognitive impairment but do not have family members, or
* They have prior ACP experience (e.g., AD completed).

Primary outcomes:
measure: Change from Baseline in ACP documentation at post-intervention
timeFrame: immediately after the intervention
measure: Change from Baseline in ACP documentation at 1-year follow-up time point.
timeFrame: 1-year follow-up (i.e., 1 year after the launch of the ACP intervention)
measure: Change from Baseline in ACP documentation at 2-year follow-up time point.
timeFrame: 2-year follow-up (i.e., 2 years after the launch of the ACP intervention at the RCH).
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Chia-Chin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References: