A randomised controlled trial of geriatric liaison intervention in frail surgical oncology patients

ISRCTN	ISRCTN46161863
DOI	https://doi.org/10.1186/ISRCTN46161863
Protocol serial number	NL810, NTR823
Sponsor	University Medical Center Groningen (UMCG) (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 05/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B L van Leeuwen
Scientific

University Medical Center Groningen (UMCG)
Department of Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 2301
Email	blvleeuwen@hetnet

Study information

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of geriatric liaison intervention in frail surgical oncology patients
Study objectives	The primary objective of this study is to show that early detection of geriatric patients at risk of preventable functional decline following a surgical procedure under general anesthesia for a solid tumor, combined with a geriatric liaison intervention will decrease the occurrence of delirium and consequent morbidity and mortality, without an increase in costs.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Frail surgical oncology geriatric patients
Intervention	The intervention entails participation of a geriatric nurse and geriatrician in the perioperative treatment of the oncogeriatric surgical patient. Multi-component interventions to achieve best-supportive care in individual treatment plans will be implemented. These will be focused on electrolyte- and fluid levels, pain management, pharmacological clearance, miction and defecation, nutrition, early mobilisation and rehabilitation, sleep, vision, hearing and cognition. The Delirium Observation Scale (DOS) will be used to screen for delirium by the nurse and the Delirium Rating Scale (DRS) will be used to measure the severity of the delirium. To ensure uniformity of geriatric intervention in participating centres a daily checklist will be used.
Intervention type	Other
Primary outcome measure(s)	The cumulative incidence of delirium (measured with the Delirium Observation Scale and the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition [DSM IV] criteria) up to ten days postoperatively.
Key secondary outcome measure(s)	1. Returning to the pre-operative living situation within 3 months postoperatively 2. The Physical Component Summary measure (PCS) of the Short Form health survey (SF-36) 3. The Mental Component Summary measure (MCS) of the SF-36 4. Complications during hospital stay including mortality 5. Care Dependence Scale at discharge 6. Direct health care and non-health care costs will be used as economic indicators
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	294
Total final enrolment	260
Key inclusion criteria	1. A score greater than three 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
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	01/01/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen (UMCG)

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/02/2016	05/01/2021	Yes	No

Editorial Notes

05/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR number has been added