Implementing a Nurse-led Advance Care Planning (ACP) Intervention in Residential Care Homes

Advanced Care Planning Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238063
• Other study ID #: UW 22-021
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: The University of Hong Kong
• Contact: Chia-Chin Lin, PhD
• Phone: 39176633
• Email: cclin[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Advanced Care Planning

Intervention

Behavioral:
• Nurse-led Advance Care Planning (ACP) Intervention
An ACP discussion between the participating resident, family members, and the trained nurse will be incorporated into the annual review. The proposed ACP intervention will be divided into three parts (three weekly sessions, 1.5 hours each): 1) preparatory, 2) discussion, and 3) follow-up sessions.

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in ACP documentation at post-intervention	ACP documentation (i.e., new documentation related to ACP and EOL care) will be extracted by reviewing participants' medical records for a new ACP documentation after the intervention.	immediately after the intervention
Primary	Change from Baseline in ACP documentation at 1-year follow-up time point.	ACP documentation (i.e., new documentation related to ACP and EOL care) will be extracted by reviewing participants' medical records for a new ACP documentation at the time that 1 year after the launch of the ACP intervention at the RCH.	1-year follow-up (i.e., 1 year after the launch of the ACP intervention)
Primary	Change from Baseline in ACP documentation at 2-year follow-up time point.	ACP documentation (i.e., new documentation related to ACP and EOL care) will be extracted by reviewing participants' medical records for a new ACP documentation at the time that 2 year after the launch of the ACP intervention at the RCH.	2-year follow-up (i.e., 2 years after the launch of the ACP intervention at the RCH).