Advanced Care Planning for the Severely Ill Home-dwelling Elderly

University of Oslo

Status: Enrolling

Conditions: Advance Care Planning

Treatments: Other: Implementation support program

Study type: Interventional

Funder types: Other

Identifiers

NCT05681585

NSD 805491

Details and patient eligibility

About

This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design.

Twelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Of the twelve clusters, half will receive implementation support and training immediately, and the other half will receive similar support after the intervention period. The study includes 1) assessment of implementation outcomes (fidelity) in the participating units,2) health service and clinical outcomes including a) questionnaires to all staff in the units before and after the implementation period, questionnaires to attending clinicians and qualitative interviews with health personnel and local unit leaders b) questionnaires to patients and their relatives, patients records and data from central health registers and qualitative interviews with patients and relatives. Furthermore we will assess barriers and facilitators for advance care planning in 1) a wider health service context, and 2) at the national, regional and municipal level, and do economic analyses.

Full description

Background:

Severely ill elderly patients and their relatives are often poorly involved in treatment and care decisions. Advance care planning is a well-documented tool to comply with the ethical and legal imperative to involve both the patient and their next of kin in the planning of current and future treatment and care. The overall aim of this project is to improve health services, user involvement and quality of life for severely ill elderly people living at home, and their relatives, in an efficient, sustainable and coordinated way, through better implementation of Advance care planning (ACP).

Setting: Twelve hospital wards providing care to acutely admitted elderly home-dwelling patients, either pure geriatric units or mixed units with specialists in geriatric medicine.

Research questions:

1. What is the current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in the participating clinical units?
2. What are the most important facilitators and barriers among all relevant stakeholders - to implementing ACP at the a) clinical, b) health care service- and c) national, regional and municipal level?
3. What are the most important moral dilemmas and conflicting interests related to ACP, and how can these be resolved?
4. What are the benefits and disadvantages with the implementation support and ACP experienced by the patients, among next of kin, health personnel and implementation teams?
5. Does the implementation support program - compared to no such support - improve a) the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians?
6. Is the implementation support program associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives?
7. Is higher level of implementation (fidelity) of ACP associated with improved outcomes for patients, relatives, the staff and the services?
8. Is the implementation support program for ACP a cost-effective intervention?

Hypotheses:

1. The current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in participating clinical units is low.
2. There are important facilitators for and barriers to implementing ACP among all stakeholders at the a) clinical, b) health care service- and c) national and other higher levels.
3. There are important moral dilemmas and conflicting interests related to ACP, and they can be dealt with through systematic approaches and ethics reflection.
4. Patients, among next of kin, health personnel and implementation teams experience both benefits and disadvantages with the implementation support and ACP.
5. The implementation support program - compared to no such support - will improve a) improve the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians.
6. The implementation support program is associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives
7. Higher level of implementation (fidelity) of ACP is associated with improved outcomes for patients, relatives, the staff and the services
8. Outcomes for patients, relatives and the public health- and welfare services justify the costs of the implementation support program and of ACP in routine care.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion and exclusion criteria for patients and relatives the quantitative and triadic sub-study:

Inclusion criteria for patients:

• Home-dwelling
• 70 years or older
• Acutely admitted to the participating unit
• Sufficient language proficiency in Norwegian to answer the questionnaire
• Clinical frailty score of 4 or more
• The physician responsible for the patient's medical care answers "no" to "Surprise question" from Gold Standards Framework proactive identification guidance
• Both patient and a close relative (preferably the closest relative) would participate in ACP together if offered
• Both patient and the close relative consent to participate in the research project

Exclusion criteria for patients:

• The patient is not competent to consent to research participation

• The patient is expected to die within 24 hours

• The patient has participated in ACP prior to the current hospital admission

• In the intervention arm

  • ACP is not conducted with patient, next of kin and physician before hospital discharge
  • The clinician that participated in the ACP conversation has not consented to research participation

• In the control arm

  • The patient would not have been able to participate in ACP during hospitalization
  • An attending clinician has not consented to research participation

Inclusion criteria for relatives:

• A close relative of a patient who fulfill all inclusion criteria and no exclusion criteria; and who would be willing to participate in ACP together with the patient if offered
• 18 years or older
• Sufficient language proficiency in Norwegian to answer the questionnaire
• Both patient and the close relative consent to participate in the research project

Exclusion criteria for relatives:

• The relative is not competent to consent to research participation

• In the intervention arm

  • ACP is not carried out with the patient, next of kin and attending clinician before hospital discharge

• In the control arm

  • The relative would not have been able to participate in ACP during hospitalization

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Intervention arm

Other group

Description:

Clusters (medical/geriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period.

Treatment:

Other: Implementation support program

Control arm

No Intervention group

Description:

Clusters (medical/geriatric hospital units) in the control arm receives no implementation support program during the trial period. These units will receive the implementation support program after the trial period.