Advanced Care Planning for the Severely Ill Home-dwelling Elderly
ConditionAdvance Care Planning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity of Oslo
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Home-dwelling
70 years or older
Acutely admitted to the participating unit
Sufficient language proficiency in Norwegian to answer the questionnaire
Trial design
Design model
Parallel
Treatments tested in this trial
Implementation support program
Other interventionThe 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
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Intervention armOther 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.2
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.
Time frame
During the intervention period (10-18 months after the start of the implementation support)3
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.
Time frame
During the intervention period (10-18 months after the start of the implementation support)4
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
Time frame
During the intervention period (10-18 months after the start of the implementation support)Secondary outcomes
1
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).
Time frame
Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.2
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).
Time frame
Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.3
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).
Time frame
Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.4
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.
Time frame
During the intervention period (10-18 months after the start of the implementation support)Other outcomes
1
Clinical effectiveness study 1: Clinical data about the patient from participating/attending clinician
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).
Time frame
During the intervention period (10-18 months after the start of the implementation support)Sponsors and contacts
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University of Oslo
Lead sponsor
Oslo Metropolitan University
Collaborator
Norwegian University of Science and Technology
Collaborator
The Research Council of Norway
Collaborator
Helse Sor-Ost
Collaborator
Sykehuset Innlandet HF
Collaborator
Vestre Viken Hospital Trust
Collaborator
Ostfold Hospital Trust
Collaborator
The Hospital of Vestfold
Collaborator
Hospital of Southern Norway Trust
Collaborator
University Hospital, Akershus
Collaborator
Oslo University Hospital
Collaborator
Diakonhjemmet Hospital
Collaborator
Source ClinicalTrials.gov