Implementation support program: 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
Study 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.
Eligibility
Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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