In this hybrid Type 1 effectiveness-implementation pilot randomized controlled trial, 60 caregivers will be randomized into either the CSNAT-I group or usual care. Preliminary effectiveness outcomes include caregiver burden, distress, and health-related quality of life. Preliminary implementation outcomes include feasibility, fidelity, appropriateness, acceptability, cost of the intervention, as well as barriers and facilitators to intervention implementation. Quantitative data will be analyzed using descriptive analysis and linear mixed effects model, while qualitative data using thematic analysis. The CSNAT-I is expected to be preliminarily effective in improving caregiver outcomes and implementable in Hong Kong palliative care context, which will serve as the foundation for a large trial before integration into daily practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
CSNAT-I will be conducted in five stages, including an introduction of the CSNAT, family caregivers' consideration of needs, prioritize needs, a shared care plan, and a shared review for effectiveness and subsequent actions .
Caregiver burden
13-item Caregiver Strain Index (CSI), each item with 1 ("yes") or 0("no") responses. The total score ranges from 0 to 13 and a higher score represents greater caregiver burden.
Time frame: From enrollment to the end of intervention at 4 weeks
Caregiver distress
The Depression, Anxiety, and Stress Scale (DASS), 4-point Likert scale ranging from 0('did not apply to me at all") to 3('applied to me very much'). The scale has 3 subscales, and the subscale score is obtained by summing up the item scores. A possible score range of 0 to 21 is each subscale. A higher score indicates greater depression, anxiety and stress.
Time frame: From enrollment to the end of intervention at 4 weeks
Health-related quality of life
Quality of Life in Life-Threatening Illness-Family Carer (QOLLTI-F), assesses seven dimensions, encompassing environment, patient condition, your own condition, your outlook, quality of care, relationships, and financial worries. The rating scale of each tool ranges from 0 to 10, and the total score is 160 respectively, with a higher total score indicating better QOL.
Time frame: From enrollment to the end of intervention at 4 weeks
Reach
eligibility rate, consent rate, participation rate, and reasons for non-participation will be used to measure reach of the intervention. All data will be collected from the study screening log.
Time frame: Through study completion, an average of 6 months
Implementation
Fidelity, appropriateness and acceptability of the intervention, enablers and barriers to intervention implementation as well as the cost of the implementation. Fidelity of the intervention will be measured through the intervention delivery log. The appropriate and acceptability of the intervention, enablers and barriers to the intervention implementation will be collected using a self-designed questionnaire completed by participants. The cost of the implementation of the study will be calculated based on the time of interventionists for each intervention case multiplied by hourly salary determined by the hospital authority
Time frame: Through study completion, an average of 6 months.
Enablers and barriers to access, effectiveness, implementation, adoption, and maintenance
We will explore enablers and barriers to access, effectiveness, implementation, adoption, and maintenance through meetings with hospital administration staff, health-related representatives and researchers before the completion of the study
Time frame: Up to 6 months
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