Validity of Frailty Screening Tools as a Measure for Postoperative Outcomes

NCT07367828 | Recruiting

• 1 other identifier: VRN 25/2024
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is a common geriatric syndrome defined as a clinical state of decreased physiologic reserve resulting in increased vulnerability to stressors. It is associated with several unfavorable postoperative complications independent of age such as readmission, length of hospital stay and mortality. To address these concerns, medical societies have acknowledged a need for routine screening to identify elderly patients who are at high risk for major complications before undergoing surgery. In the absence of a golden standard for frailty assessment, there are multiple assessment tools available. However, the challenge with many frailty tools is that they can be time-consuming, and require expertise and clinical training.This poses a challenge for screening a large elderly population before surgery. Some frailty assessment tools, such as PRISMA7 (The Program of Research to Integrate Services for the Maintenance of Autonomy), timed up and go (TUG) and the clock drawing test (CDT), have been demonstrated to be quick, simple and easy to use with minimal training. The PRISMA-7 is a frailty screening questionnaire that consists of seven dichotomous items considering age, gender, health problems that affect activities of daily living (ADLs), assistance from others with ADLs, having to count on someone if needed, and the use of mobility aids. The TUG test is used for assessing fall risk and frailty in older patients. It is measured by the time it takes an individual to stand up from a seated position, walk three meters and return back to a seated position. There is no standard cut-off for TUG, however, a cut-off of \> 10 seconds has been used to identify frailty. Cognitive impairment in older surgical patients may predispose patients to executive dysfunction that many elderly patients experience postoperatively and has shown to be a risk factor for surgical complications. Some studies suggest a strong relationship between cognitive impairment and physical frailty resulting in cognitive frailty when evaluating older adults.The CDT has shown to be a valuable screening tool for cognitive concerns. When administering the CDT, a patient receives instructions to draw a clock. Performing the test requires auditory comprehension, planning, sustained attention, visual-spatial skills and executive skills. The prevalence of surgical frailty in Iceland has not been researched thoroughly enough to provide an accurate estimate. This is important to reveal the number of senior surgical patients at high risk of adverse postoperative outcomes who could benefit from a preoperative intervention. However, there is a lack of consensus on an optimal frailty assessment to screen patients for identifying frail patients prior to surgery, and more research is needed to evaluate which group of patients would benefit the most from prehabilitation. The scientific value of this study is to elucidate the extent of frailty risk and its associated postoperative outcomes in older surgical patients undergoing elective surgery. We opt to find a convenient screening routine prior to surgery to identify patients at risk of frailty. Therefore, the study aims to validate three frailty screening methods and to assess a positive screening result as an independent risk factor for adverse postoperative outcomes in a cohort of elderly surgical patients undergoing elective surgery. We hypothesize that elderly patients at risk of frailty have a higher rate of surgical complications than patients not at risk of frailty. Patients aged ≥ 70 years who undergo elective surgery will be prospectively examined at the Department of Anesthesiology and Critical Care of Landspítali. The screening assessments to be evaluated are the Program of Research to Integrate Services for the Maintenance of Autonomy (PRISMA-7), a combination of Timed Up \& Go (TUG), Clock Drawing Test (CDT) and the FRAIL questionnaire, and a combination of PRISMA-7, TUG and CDT. Additional clinical data and outcomes will be obtained from the electronic medical records of Landspítali. The postoperative outcomes measured will be 180-day mortality, surgical complications, 90-day readmission, delirium, non-home discharge and length of hospital stay. Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).

Conditions

Frailty in Adult Surgery; Frailty Syndrome; Elective Surgery

Keywords

Frailty; Postoperative Outcomes; Major elective surgery; Surgical Frailty; Intermediate elective surgery

Outcome Measures

Primary Outcomes (2)

• Moderate and severe surgical complications (Clavien-Dindo ≥2)

  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).

  Time frame: From the same day after surgery to postoperative day 30.

• 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. A patient´s readmission on the same day of discharge is considered a single continuous admission, unless it is clear the reason for readmission is not related to the initial admission or surgery. In which case it would be considered a separate readmission.

  From the day of surgery to postoperative day 90.

Secondary Outcomes (4)

• Length of hospital stay

  From the day of primary surgery until discharge from the index hospitalization (same-day discharge counted as 0 days), assessed up to 180 days postoperatively.

• Postoperative delirium during primary hospitalization

  From the day of surgery (postoperative day 0) until first documented postoperative delirium or discharge from the index hospitalization, whichever occurs first, assessed up to 180 days postoperatively.

• Short-term mortality

  Up to 1 year 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

The study will consist of a cohort of surgical patients ≥ 70 years undergoing Intermediate/major elective surgery who present for preoperative assessment at the anesthesia outpatient clinic at Landspitali - The National University Hospital in Iceland. Patients who screen positive on the CDT (≤ 2/3 points) and TUG (≥ 11 seconds) will be considered frail. Those who do not screen positive on both of these tests will be part of the control group (non-frail).

Procedure: Intermediate/major elective surgery

Interventions

Intermediate/major elective surgery PROCEDURE

Any intermediate/major elective surgery at Landspítali -The National University Hospital in Iceland

Frailty screening cohort

Eligibility Criteria

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

Study Population

The study population will consist of all patients ≥70 years who present for preoperative assessment with an anesthesiologist at Landspitali before undergoing intermediate/major surgery, The National University Hospital of Iceland.

You may qualify if:

• Patients ≥ 70 years who present for preoperative work-up at the anesthesia department at Landspitali.
• Patients assigned to undergo intermediate/major surgery

You may not qualify if:

• Not undergoing planned surgery

Sponsors & Collaborators

• University of Iceland: lead
• Landspitali University Hospital: collaborator

Study Sites (1)

Landspitali - The national university hospital in Iceland.

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

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, B.Sc

CONTACT

+354-820-3587; lgr2@hi.is

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 26, 2026
• Study Start: January 20, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)