Advance Care Planning
Conditions
Keywords
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
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.
Interventions
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
Sponsors
Oslo Metropolitan University
Norwegian University of Science and Technology
The Research Council of Norway
Helse Sor-Ost
Sykehuset Innlandet HF
Vestre Viken Hospital Trust
Ostfold Hospital Trust
The Hospital of Vestfold
Hospital of Southern Norway Trust
University Hospital, Akershus
Oslo University Hospital
Diakonhjemmet Hospital
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
No masking Patients and next-of-kin will not be informed about the hospital unit's allocation status. However, they may deduce this from the kind of intervention they receive. It's impossible to blind the care providers and for practical reasons we won't be able to blind the investigators or the outcomes assessors.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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-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. |
| 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 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 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 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 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. |
| 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 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 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 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 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 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. |
| 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 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. |
| 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. |
| 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 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. |
| 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 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). |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical effectiveness study 1: Clinical data about the patient from participating/attending clinician | During the intervention period (10-18 months after the start of the implementation support) | We ask the participant clinician (clinical effectiveness study 3) to report key clinical information about the patient. 14 items in the intervention units, and 15 items in the control units, with various scales/response alternatives, including free text answers (e.g. main diagnosis). |
Countries
Norway
Contacts
Primary ContactReidar Pedersen, PhD
Outcome results
None listed