Advanced Care Planning for the Severely Ill Home-dwelling Elderly
- Conditions
- Advance Care Planning
- Interventions
- Other: Implementation support program
- Registration Number
- NCT05681585
- Lead Sponsor
- University of Oslo
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention arm Implementation support program Clusters (medical/geriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period.
- Primary Outcome Measures
Name Time Method Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. Change in fidelity (sum score) measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).
Clinical effectiveness study 1: Patient-reported outcome During the intervention period (10-18 months after the start of the implementation support) Quality of communication and decision-making when the patient is approaching the end of life. 4 items, scale 0-9.
Clinical effectiveness study 2: Relative-reported outcome During the intervention period (10-18 months after the start of the implementation support) Quality of communication and decision-making for the patient and the next-of-kin when approaching the end of life. 4 items, rated 0-9.
Clinical effectiveness study 3: Clinician outcome During the intervention period (10-18 months after the start of the implementation support) Congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively
- Secondary Outcome Measures
Name Time Method Clinical effectiveness study 1: Patient-reported seondary outcome 3 During the intervention period (10-18 months after the start of the implementation support) Self-efficacy in communicating with next-of-kin and health care professionals about future deterioration, preferences for life-prolonging treatment in such a situation, and health care when approaching the end of life. 9 items, rated 0-3
Clinical effectiveness study 1: Patient-reported seondary outcome 6 During the intervention period (10-18 months after the start of the implementation support) General life satisfaction (ref. OECD. (2013). OECD guidelines on measuring subjective well-being). 1 item, rated 0-10.
Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 2 Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. Change in fidelity subscale - Quality of ACP - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).
Clinical effectiveness study 1: Patient registry data 1 - Number of hospital admissions From 18 months before to 18 months after inclusion (or until death) Retrieved from national registries
Clinical effectiveness study 1: Patient health records data From 18 months before to 18 months after inclusion (or until death) Documentation concerning ACP and other similar conversations, palliative care plan, the patient's life stance or religious beliefs, and life prolonging treatment and palliative care given and any decisions to limit such treatment or care, and similarly for hospital admittance.
Clinical effectiveness study 2: Relative-reported seondary outcome 2 During the intervention period (10-18 months after the start of the implementation support) Self-efficacy in communicating with the patient and health care professionals about future deterioration, the patient's preferences for life-prolonging treatment in such a situation, and health care when the patient is approaching the end of life. 9 items, rated 0-3.
Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 1 Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. Change in fidelity subscale - Organizational implementation - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).
Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 3 Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. Change in fidelity subscale - Penetration - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high).
Clinical effectiveness study 1: Patient-reported seondary outcome 2 During the intervention period (10-18 months after the start of the implementation support) Satisfaction with information and involvement concerning health care provided during admittance and that will be provided after discharge, and with information about the patient's state of health, discharge, prognosis and future health care needs. 10 items, rated 0-9
Clinical effectiveness study 2: Relative-reported seondary outcome 7 During the intervention period (10-18 months after the start of the implementation support) General life satisfaction (ref. OECD. (2013). OECD guidelines on measuring subjective well-being). 1 item, rated 0-10.
Clinical effectiveness study 4: All staff - 1 Baseline and 18 months in both intervention and control arm Patients' and relatives' preferences for information and involvement. 7 questions.
Clinical effectiveness study 4: All staff - 2 Baseline and 18 months in both intervention and control arm Whether information, involvement and health care provided is concordant with the patients' and relatives' preferences, and reasons for discordance. 9 questions.
Clinical effectiveness study 2: Relative-reported seondary outcome 1 During the intervention period (10-18 months after the start of the implementation support) Satisfaction with information and involvement concerning the patient's health care provided during admittance and that will be provided after discharge, with information about the patient's state of health, discharge, prognosis, future health care needs, and with the providers' understanding of the next-of-kin's situation. 11 items, rated 0-9
Clinical effectiveness study 2: Relative-reported seondary outcome 3 During the intervention period (10-18 months after the start of the implementation support) Problem causing admittance solved, satisfaction with arrival, stay, and discharge at the hospital, trust in necessary health care for the patient in the future, and make sure that the patient receives needed health care in the time to come. 6 items, ratet 0-9.
Clinical effectiveness study 1: Patient-reported seondary outcome 1 During the intervention period (10-18 months after the start of the implementation support) Communication about preferences for information and involvement, providers' current compliance with these preferences, and trust in future compliance. 5 items, rated 0-9.
Clinical effectiveness study 1: Patient-reported seondary outcome 4 During the intervention period (10-18 months after the start of the implementation support) Problem causing admittance solved, satisfaction with arrival, stay, and discharge at the hospital, and trust in necessary health care in the future. 5 items, rated 0-9
Clinical effectiveness study 1: Patient-reported seondary outcome 5 During the intervention period (10-18 months after the start of the implementation support) Concrete preferences for information and who should participate in important decisions about health care, and assessment of the amount of information given. 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively
Clinical effectiveness study 1: Patient registry data 2 - Other use of health care services and use of medication From 18 months before to 18 months after inclusion (or until death) Retrieved from national registries
Clinical effectiveness study 1: Patient registry data 3 - Time before death (for patients dying before 18 months after inclusion) From inclusion to 18 months after inclusion Retrieved from national registries
Clinical effectiveness study 2: Relative-reported seondary outcome 5 During the intervention period (10-18 months after the start of the implementation support) Next-of-kin's tasks and burdens. 7 items with various scales/response alternatives.
Clinical effectiveness study 4: All staff - 5 Baseline and 18 months in both intervention and control arm. Self-confidence in ACP-relevant information and involvement tasks. 7 questions.
Clinical effectiveness study 2: Relative-reported seondary outcome 4 During the intervention period (10-18 months after the start of the implementation support) Next-of-kin's concrete preferences for information and assessment of the amount of information given, the patient's preference for information and who should participate in important decisions about health care. 4 items, scales: 0-9, 0-2, 0-9, 7 alternative answers, respectively
Clinical effectiveness study 3: Clinician secondary outcome 1 During the intervention period (10-18 months after the start of the implementation support) Self-confidence in matching involvement of patient and next-of-kin and future decision-making to patient's preferences. 4 items, rated 0-10
Clinical effectiveness study 4: All staff - 3 Baseline and 18 months in both intervention and control arm Decision making authority - clinical realities and ideals. 16 questions.
Clinical effectiveness study 4: All staff - 4 Baseline and 18 months in both intervention and control arm Self-efficacy in ACP-relevant information and involvement tasks.17 questions.
Economic sub-study: Increased costs related to implementing and practicing ACP Measured before baseline and then throughout the implementation period (0-18 months). Increased costs related to implementing and practicing ACP in the clinical units in the intervention arm. Compared to normal costs before baseline. Differences in costs will be compared to the primary outcomes (differences measured as percentage point) and selected secondary outcomes.
Clinical effectiveness study 2: Relative-reported seondary outcome 6 During the intervention period (10-18 months after the start of the implementation support) Informal carer's care-related quality of life (ref. CarerQoL-7D (Brouwer et al. 2006)). 7 items, rated 0-2
Clinical effectiveness study 3: Clinician secondary outcome 2 During the intervention period (10-18 months after the start of the implementation support) Self-efficacy in communicating about future deterioration, preferences for life-prolonging treatment in such a situation, for future care (at home or in a nursing home), and for health care when approaching the end of life, with the patient, next-of-kin, and other providers. 16 items, rated 0-3.
Trial Locations
- Locations (12)
Innlandet Hospital Trust, Gjøvik
🇳🇴Gjøvik, Norway
Vestre Viken Hospital Trust, Drammen
🇳🇴Drammen, Norway
Hospital of Southern Norway, Arendal
🇳🇴Arendal, Norway
Innlandet Hospital Trust, Elverum
🇳🇴Elverum, Norway
Akershus University Hospital
🇳🇴Lørenskog, Norway
Vestre Viken Hospital Trust, Bærum
🇳🇴Oslo, Bærum Kommune, Norway
Vestre Viken Hospital Trust, Kongsberg
🇳🇴Kongsberg, Norway
Hospital of Southern Norway, Kristiansand
🇳🇴Kristiansand, Norway
Diakonhjemmet Hospital
🇳🇴Oslo, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
Østfold Hospital Trust
🇳🇴Sarpsborg, Norway
Vestfold Hospital Trust
🇳🇴Tønsberg, Norway