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A randomised controlled feasibility trial protocol comparing face-to-face and video delivery of a specialist preoperative clinic for older people

VIGIL - Video In Geriatric Intervention cLinic

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN95833238
Enrollment
50
Registered
2022-04-06
Start date
2022-02-01
Completion date
Unknown
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm surgery Surgery

Interventions

Geriatric perioperative care outpatients clinic delivered by video or face-to-face. Patients will be referred by the vascular team where they will be screened for inclusion. Eligible patients will be

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Proposed aortic aneurysm surgery 2. Be able to read and communicate in English 3. Over 18 years old

Exclusion criteria

Exclusion criteria: 1. Emergency surgery prior to clinic attendance (within 1 week of referral) 2. Inability to participate in video consultation due to: 3. Lack of access to appropriate technology 4. Significant sensory impairment: registered blind or functional severe sight impairment e.g. unable to read study materials, or auditory e.g. unable to communicate using the telephone on screening 5. Inability to communicate on the telephone at screening e.g. advanced dementia

Design outcomes

Primary

MeasureTime frame
To assess the feasibility of delivering a video geriatric preoperative clinic, compared to a face-to-face clinic: 1. Number of patients randomised: The number of patients willing to be randomised to different modalities of delivering the clinic. Success is defined as 50 patients, partial success if 80% are randomised (40 or more patients). 2. Proportion of patients adhering to the intervention allocated 3. Proportion of patients followed up 4. Proportion of completed preoperative assessments: 4.1. Cardiac assessments including: 4.1.1. Blood pressure (in last 12 months) 4.1.2. Electricardiogram (in last 12 months) 4.1.3. Exercise capacity (completion of Duke Activity Status Index) 4.1.4. Examination for heart failure (fluid balance assessment) 4.2. Cognitive assessments including: T-MoCA (Telephone Montreal Cognitive Assessment) 4.3. Respiratory assessments including: saturations (in last 12 months) 4.4. Diabetes assessments including: HbA1c (within the last 3 months if patient has diabetes)

Secondary

MeasureTime frame
1. To assess the feasibility of measuring shared decision making 1.1. Proportion of completed shared decision making tool immediately after the clinic (collaboRATE) 1.2. Proportion of patients that convert to surgery 2. To test feasibility through process mapping of the preoperative pathway: 2.1. Process map of the perioperative pathway to determine optimal time for recruitment 2.2. Suggested time points for delivery of a video clinic 3. To test the feasibility of collecting clinical outcomes of: 3.1. For all patients surgery or not surgery: 3.1.1. Quality of life (EQ-5D at baseline and 3 months post-surgery, or matched time point if not had surgery) 3.1.2. Mortality (at discharge and 3 months post-surgery, or matched time point if not had surgery) 3.2. For those that have surgery only: 3.2.1 Length of hospital stay 3.2.2. Complications (postoperative morbidity score at inpatient days 1, 3, 5, 8)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026