Advanced Care Planning for the Severely Ill Home-dwelling Elderly

Study Overview
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Brief Summary
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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
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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: What is the current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in the participating clinical units? 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? What are the most important moral dilemmas and conflicting interests related to ACP, and how can these be resolved? 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? 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? 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? Is higher level of implementation (fidelity) of ACP associated with improved outcomes for patients, relatives, the staff and the services? Is the implementation support program for ACP a cost-effective intervention? Hypotheses: The current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in participating clinical units is low. 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. There are important moral dilemmas and conflicting interests related to ACP, and they can be dealt with through systematic approaches and ethics reflection. Patients, among next of kin, health personnel and implementation teams experience both benefits and disadvantages with the implementation support and ACP. 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. 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 Higher level of implementation (fidelity) of ACP is associated with improved outcomes for patients, relatives, the staff and the services 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.

Official Title
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Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial

Conditions
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Advance Care Planning

Intervention / Treatment
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* Other: Implementation support program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a cluster RCT, with a complex intervention containing implementation interventions and strategies, and a clinical intervention (ACP). Twelve clusters were recruited and stratified into two strata according to number of beds and randomized to intervention or control arms (allocation ratio of 1:1). The six hospital units in the intervention arm will receive a comprehensive implementation support program, whereas the control units receive no support in the intervention period. A similar number of patients, relatives and attending clinician will be recruited from both arms in triads for the quantitative sub-study. Data for each patient will be supplemented by health record and register data. Patients, relatives, staff and implementation teams will be recruited from the intervention units to qualitative interviews. All health personnel in the participating units will be recruited to answer a questionnaire twice. We will also interview key stakeholders in a wider context.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention arm<br>Clusters (medical/geriatric hospital units) in the intervention arm receives a comprehensive implementation support program during the trial period. | Other: Implementation support program<br>* The intervention consists of: I Implementation strategies: 1.1 Ensuring leadership commitment 1.2 Responsive evaluation 1.3 Whole ward approach 1.4 Train the trainer model 1.5 Sustainability after the study II Implementation interventions 2.1 Implementation team 2.2 ACP coordinator 2.3 Training and supervision: Kick-off, training of resource persons and health care personnel including practical exercises, network conferences 2.4 Toolkit and shared resources: ACP guideline, teaching material, information leaflets, documentation templates etc. 2.5 Structured fidelity measurements of the implementation level of a) the implementation interventions and b) the clinical intervention, with tailored feedback and supervision III Clinical intervention: Advance Care Planning 3.1 Routine information and invitation to Advance Care Planning to all eligible patients 3.2 Written information to patients and relatives 3.3 Documentation and collaboration with other health care levels<br>|
| No Intervention: Control arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning | Change in fidelity (sum score) measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high). | Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Clinical effectiveness study 1: Patient-reported outcome | Quality of communication and decision-making when the patient is approaching the end of life. 4 items, scale 0-9. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported outcome | 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. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 3: Clinician outcome | 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 | During the intervention period (10-18 months after the start of the implementation support) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 1 | Change in fidelity subscale - Organizational implementation - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high). | Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 2 | Change in fidelity subscale - Quality of ACP - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high). | Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 3 | Change in fidelity subscale - Penetration - measured by the fidelity scale for Advanced Care Planning. Rated from 1 (low) to 5 (high). | Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm. | 
| Clinical effectiveness study 1: Patient-reported seondary outcome 1 | Communication about preferences for information and involvement, providers' current compliance with these preferences, and trust in future compliance. 5 items, rated 0-9. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 1: Patient-reported seondary outcome 2 | 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 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 1: Patient-reported seondary outcome 3 | 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 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 1: Patient-reported seondary outcome 4 | 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 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 1: Patient-reported seondary outcome 5 | 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 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 1: Patient-reported seondary outcome 6 | General life satisfaction (ref. OECD. (2013). OECD guidelines on measuring subjective well-being). 1 item, rated 0-10. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 1: Patient registry data 1 - Number of hospital admissions | Retrieved from national registries | From 18 months before to 18 months after inclusion (or until death) | 
| Clinical effectiveness study 1: Patient registry data 2 - Other use of health care services and use of medication | Retrieved from national registries | From 18 months before to 18 months after inclusion (or until death) | 
| Clinical effectiveness study 1: Patient registry data 3 - Time before death (for patients dying before 18 months after inclusion) | Retrieved from national registries | From inclusion to 18 months after inclusion | 
| Clinical effectiveness study 1: Patient health records data | 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. | From 18 months before to 18 months after inclusion (or until death) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 1 | 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 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 2 | 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. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 3 | 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. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 4 | 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 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 5 | Next-of-kin's tasks and burdens. 7 items with various scales/response alternatives. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 6 | Informal carer's care-related quality of life (ref. CarerQoL-7D (Brouwer et al. 2006)). 7 items, rated 0-2 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 2: Relative-reported seondary outcome 7 | General life satisfaction (ref. OECD. (2013). OECD guidelines on measuring subjective well-being). 1 item, rated 0-10. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 3: Clinician secondary outcome 1 | Self-confidence in matching involvement of patient and next-of-kin and future decision-making to patient's preferences. 4 items, rated 0-10 | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 3: Clinician secondary outcome 2 | 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. | During the intervention period (10-18 months after the start of the implementation support) | 
| Clinical effectiveness study 4: All staff - 1 | Patients' and relatives' preferences for information and involvement. 7 questions. | Baseline and 18 months in both intervention and control arm | 
| Clinical effectiveness study 4: All staff - 2 | Whether information, involvement and health care provided is concordant with the patients' and relatives' preferences, and reasons for discordance. 9 questions. | Baseline and 18 months in both intervention and control arm | 
| Clinical effectiveness study 4: All staff - 3 | Decision making authority - clinical realities and ideals. 16 questions. | Baseline and 18 months in both intervention and control arm | 
| Clinical effectiveness study 4: All staff - 4 | Self-efficacy in ACP-relevant information and involvement tasks.17 questions. | Baseline and 18 months in both intervention and control arm | 
| Clinical effectiveness study 4: All staff - 5 | Self-confidence in ACP-relevant information and involvement tasks. 7 questions. | Baseline and 18 months in both intervention and control arm. | 
| Economic sub-study: Increased costs related to implementing and practicing ACP | 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. | Measured before baseline and then throughout the implementation period (0-18 months). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation science, Decision-making processes, Hospital, Geriatric, Next of kin, Clinical ethics, Qualitative methods, Cluster randomized clinical trial, Complex intervention, Health services for the aged, End of life