Modified Essential Frailty Toolset in Older Adults Undergoing Major Elective Surgery

NCT07452263 | Recruiting

• 1 other identifier: UI-Frailty-VRN25/2024
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists. The Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study. We therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI \<22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g/L for men and 120 g/L for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution. This study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.

Conditions

Frailty in Adult Surgery; Frailty Syndrome; Elective Surgeries; Readmission Rates; Postoperative Complication

Keywords

Frailty; Postoperative Outcomes; Major elective surgery; Surgical Frailty; Readmission; Complications

Outcome Measures

Primary Outcomes (2)

• 90-day Readmission

  Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. Readmissions to the same hospital on the same day for the same principal diagnosis are not counted in the outcome.

  From the day of surgery to postoperative day 90.

• Surgical Complications

  Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).

  From the same day after surgery to postoperative day 30.

Secondary Outcomes (3)

• Prolonged length of hospital stay

  Postoperative day 0 through discharge from the index hospitalization (up to 180 days).

• 180-day mortality

  Up to 180 days after the primary surgery

• Non-home discharge

  From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.

Study Arms (1)

Frailty screening cohort undergoing major elective surgery

Patients ≥ 70 years undergoing major elective surgery who are triaged to present for preoperative assessment at the admissions department at Landspitali University Hospital in Iceland. Patients who screen positive on the mEFT (≥3 points) will be considered frail. Those who do not screen positive (≤2 points) will be part of the control group (non-frail).

Procedure: Major elective surgery

Interventions

Major elective surgery PROCEDURE

Any major elective surgery at Landspítali University Hospital

Frailty screening cohort undergoing major elective surgery

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

he study population will consist of all patients ≥70 years who have present for preoperative assessment at the admissions department at Landspitali before undergoing major surgery, University Hospital of Iceland.

You may qualify if:

• Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.
• Patients assigned to undergo major surgery

You may not qualify if:

• Cardiac surgery
• Not undergoing planned surgery

Sponsors & Collaborators

• University of Iceland: lead

Study Sites (1)

Landspitali University hospital

Reykjavik, Hofudborgarsvaedid, 101, Iceland

RECRUITING

Related Publications (1)

• Rabelo LG, Bjornsdottir A, Jonsdottir AB, Einarsson SG, Karason S, Sigurdsson MI. Frailty assessment tools and associated postoperative outcomes in older patients undergoing elective surgery: A prospective pilot study. Acta Anaesthesiol Scand. 2023 Feb;67(2):150-158. doi: 10.1111/aas.14162. Epub 2022 Nov 9.

  PMID: 36307919 BACKGROUND

MeSH Terms

Conditions

Frailty; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martin I Sigurdsson, MD, PhD

CONTACT

+354-824-8282; mingi@hi.is

Luis G Rabelo, MD

CONTACT

+3548203587; lgr2@hi.is

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 5, 2026
• Study Start: January 20, 2025
• Primary Completion: May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)