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DOI:
10.1002/bjs.10459
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Peer reviewed version
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Citation for published version (APA):
Partridge, J. S. L., Harari, D., Martin, F., Peacock, J. L., Bell, R., Mohammed, A., & Dhesi, J. K. (2017).
Randomized clinical trial of comprehensive geriatric assessment and optimization in vascular surgery. British
Journal of Surgery. https://doi.org/10.1002/bjs.10459
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Download date: 21. Aug. 2022
Randomized clinical trial of comprehensive geriatric assessment and optimization in
vascular surgery
J. S. L. Partridge
1,3
, D. Harari
1,3
, F. C. Martin
1,3
, J. L. Peacock
3
, R. Bell
2
, A. Mohammed
1
and
J. K. Dhesi
1,3
1
Proactive Care of Older People undergoing Surgery (POPS), Department of Ageing and
Health, and
2
Department of Vascular Surgery, Guy’s and St Thomas’ NHS Foundation Trust,
and
3
Division of Health and Social Care Research, King’s College London, London, UK
Correspondence to: Dr J. S. L. Partridge, Proactive Care of Older People undergoing Surgery
(POPS), Ground Floor, Bermondsey Wing, Guy’s Hospital, Great Maze Pond, London SE1
9RT, UK (e-mail: judith.partridge@gstt.nhs.uk)
Background: Increasing numbers of older patients are undergoing vascular surgery.
Inadequate preoperative assessment and optimization may contribute to increased
postoperative morbidity and mortality.
Methods: Patients aged at least 65 years scheduled for elective aortic aneurysm repair or
lower-limb arterial surgery were enrolled in an RCT of standard preoperative assessment
or preoperative comprehensive geriatric assessment and optimization. Randomization was
stratified by sex and surgical site (aorta/lower limb). Primary outcome was length of
hospital stay. Secondary outcome measures included new medical co-morbidities,
postoperative medical or surgical complications, discharge to a higher level of dependency
and 30-day readmission rate.
Results: A total of 176 patients were included in the final analysis (control 91,
intervention 85). Geometric mean length of stay was 5.53 days in the control group and
3.32 days in the intervention group (ratio of geometric means 0.60, 95 per cent c.i. 0.46 to
0.79; P < 0.001). There was a lower incidence of delirium (11 versus 24 per cent; P =
0.018), cardiac complications (8 versus 27 per cent; P = 0.001) and bladder/bowel
complications (33 versus 55 per cent; P = 0.003) in the intervention group compared with
the control group. Patients in the intervention group were less likely to require discharge to
a higher level of dependency (4 of 85 versus 12 of 91; P = 0.051).
Conclusion: In this study of patients aged 65 years or older undergoing vascular surgery,
preoperative comprehensive geriatric assessment was associated with a shorter length of
hospital stay. Patients undergoing assessment and optimization had a lower incidence of
complications and were less likely to be discharged to a higher level of dependency.
Registration number: ISRCTN23142588 (http://www.controlled-trials.com).
+A: Introduction
As the population ages the number of older people undergoing surgical procedures is
increasing
1
. Despite improved mortality and symptomatic benefits of surgery for older
people
2–4
, there continues to be an excess of adverse postoperative outcomes in older
patients
5–9
. This is likely to be explained by a combination of physiological changes, the
cumulative effect of multiple morbidities and the presence of geriatric syndromes.
Observational work within the older vascular surgical population has identified a significant
burden of undiagnosed cognitive impairment, high incidence of delirium, considerable frailty
and impaired functional status
10,11
. Vascular risk factors such as smoking, hypertension and
hypercholesterolaemia, which are common in patients undergoing vascular surgery, are also
independent risk factors for cognitive impairment, postoperative delirium and frailty
12–15
.
Furthermore, vascular risk factors increase postoperative morbidity. Such postoperative
complications can all contribute to increased mortality, poorer patient experience, prolonged
hospital stay and greater financial costs
16,17
.
Evidence is emerging to suggest that systematic structured preoperative assessment
and clinical optimization of older surgical patients may improve postoperative outcomes
18,19
.
Comprehensive geriatric assessment is an established and evidence-based method of
evaluating and optimizing physical, psychological, functional and social issues in older
patients
20,21
. The initial assessment prompts the development of an individualized care plan
that includes investigation, treatment, rehabilitation support and long-term follow-up. For
example, a patient may receive medical optimization of heart failure, assessment and
management of newly identified cognitive impairment, and provision of mobility aids or
referral to therapy-based exercise programmes. The use of comprehensive geriatric
assessment in medical inpatients and community-dwelling older people has been shown to
improve mortality at 36-month follow-up, increase the chance of living independently at
home, and also to confer a positive effect on physical and cognitive function
20
. A recent
Cochrane review and meta-analysis
21
of 22 trials showed that patients who underwent
comprehensive geriatric assessment in acute geriatric wards were more likely to be alive and
in their own homes at 12 months than patients receiving general medical care. Furthermore,
fewer patients were institutionalized at hospital discharge and cognitive decline was less
pronounced in the group that received comprehensive geriatric assessment.
Despite the evidence supporting the use of comprehensive geriatric assessment in the
medical setting, this process remains relatively understudied in the surgical population. Where
comprehensive geriatric assessment differs from other preoperative risk assessment tools is in
the individualized multidomain optimization that is prompted by the assessment process. It is
this optimization that will potentially modify perioperative risk and improve postoperative
outcomes. A systematic review and narrative synthesis
19
concluded that preoperative
comprehensive geriatric assessment is likely to have a positive impact on postoperative
outcomes in older patients undergoing elective surgery, but recommended further research to
investigate the optimal approaches and its effectiveness in this setting.
+A: Methods
A single-centre RCT was performed within an inner city teaching hospital with a tertiary
referral practice for vascular arterial surgery (ISRCTN23142588, UKCRN 13260). Eligible
and consenting patients were randomized to receive either comprehensive geriatric
assessment and optimization, or usual care. Ethics approval was given by South East London
Research Ethics Committee (12/LO/0655). Eligibility criteria were patients aged at least 65
years scheduled for elective endovascular/open aortic aneurysm repair or lower-limb arterial
bypass surgery. Patients were not eligible if they were admitted directly to the ward from the
surgical clinic or emergency department for emergency or very urgent surgery, which
precluded the opportunity for outpatient preoperative assessment and optimization.
Patients and carers were involved in the design of this study including the initial
development of the research question. Participants from an observational study that preceded
this trial advised on recruitment, randomization and follow-up. This involved discussion
about the burden of the intervention, which was felt to be minimal by the patients consulted.
All study participants will be offered a written summary of the study results.
+B: Recruitment, consent and randomization
Patients were approached by a research nurse or fellow in the vascular surgery outpatient
clinic once listed for surgery. Those satisfying the inclusion criteria were assessed for
capacity to consent to study participation. Patients lacking capacity to consent were recruited
under sections 30–34 of the Mental Capacity Act
22
. Written consent was obtained (either from
patients or consultees). Patients were approached, assessed for eligibility and consented at the
first meeting after they had read the patient information sheet.
Randomization was internet-based and was carried out independently by the King’s
Clinical Trials Unit (www.ctu.co.uk) using a 1 : 1 allocation, and was stratified according to
sex and site of surgical procedure (aorta, lower limb). According to randomized group
allocation, participants were given appointments to attend either a standard preassessment
clinic (routine care within the hospital) or to the study intervention, a comprehensive geriatric
assessment and optimization clinic.
+B: Clinical care