A randomized controlled trial of geriatric liaison intervention in frail surgical oncology patients.
- Registration Number
- NL-OMON21719
- Lead Sponsor
- ZonMw, Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatiePostbus 93245, 2509 AE Den Haag, tel: 070-3495111, fax: 070-3495100, info@zonmw.nl >
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 294
Inclusion Criteria
1. A score greater than 3 on the Groningen Frailty Index (GFI);
2. Surgery is scheduled more than 24 hours after inclusion in the study as we feel this is the time necessary for the geriatric team to plan their perioperative measures;
3. Surgery under general anesthesia;
4. Written informed consent given according to local regulations.
Exclusion Criteria
1. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
2. Patient unable to comply with the outcome questionnaires.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The cumulative incidence of delirium (measured with the Delirium Observation Scale and the DSM IV criteria) up to 10 days postoperatively.
- Secondary Outcome Measures
Name Time Method 1. Returning to the pre-operative living situation within 3 months postoperatively;<br>2. The Physical Component Summary measure (PCS) of the SF-36;<br>3. The Mental Component Summary measure (MCS) of the SF-36;<br>4. Complications during hospital stay including mortality;<br>5. Care Dependence Scale at discharge;<br>6. Direct health care and non-health care costs will be used as economic indicators.