A prospective observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a ShorT stay (23-hour) Aneurysm Repair (STAR) pathway. Outcomes will be collected for up to 1 year.
The STAR study is a prospective multicentre observational cohort study to assess the eligibility, uptake, viability, acceptability, safety, and cost of a short stay (23-hour) aneurysm pathway for infrarenal AAA patients. The study will take place at least at five sites in the United Kingdom. Over a 12-month recruitment period, all patients with AAA referred to or diagnosed at each of the units will be assessed for inclusion in the STAR pathway if suitable for EVAR. The study anticipates the assessment of over 200 AAA patients with the aim of recruiting up to 100 patients into the study to undergo EVAR using the STAR pathway. Patients may be enrolled into the study to undergo EVAR using the STAR pathway provided all inclusion and no exclusion criteria are met. Subjects will be evaluated through to hospital discharge, receive a telephone call at 48 hours, return for follow-up visits at one month, and telephone follow-ups at three- and six months post treatment. Patients recruited into the study will have their routine clinical data collected at 12 months when they return for follow-up visits.
Study Type
OBSERVATIONAL
Enrollment
100
Imperial College London
London, United Kingdom
Eligibility
Proportion of patients suitable for a short stay pathway (assessed in 200 patients)
Time frame: 12 months
Uptake
Proportion of patients who will accept admission to this pathway (assessed in all eligible patients)
Time frame: 12 months
Viability
Proportion of patients admitted to the short-stay pathway that can be discharged at 23-hours
Time frame: 12 months
Treatment satisfaction
Treatment satisfaction will be measured using the validated Aneurysm TSQ questionnaire
Time frame: 18 months
Patient well-being and stress
Well-being (W-B16) questionnaires will be used to measure depressed and anxious mood, energy, positive well-being, and stress at baseline, at 2-4 days and 30 days post-op
Time frame: 18 months
Quality of life measure
EQ-5D-5L health status questionnaires will be administered at baseline, 3- and 6-months post-op
Time frame: 18 months
Safety: Adverse events, readmissions and mortality
Rate of device-related and other adverse events, readmission, mortality (at 30, 90 days and 6- and 12- months) of patients
Time frame: 24 months
Costs up to 6 months
Inpatient micro-costing, surveys, as well as health resource use after discharged will be measured as any increase in social care and/or informal care
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Qualitative data
Describing the experiences, worries and concerns of patients, families and GPs as well as staff involved in the implementation of STAR, thus identifying the key barriers and drivers to implementation of a 23-hour pathway
Time frame: 12 months
Creation of a 'STAR tool-kit'
This may be used for implementation of a short-stay pathway in a wider group, to ensure sustainability. The toolkit will be produced if there are a significant proportion eligible and accepting the pathway and the pathway is viable without perceived safety issues
Time frame: 12 months