Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM).

NCT04770259 | Completed DMC

• 1 other identifier: 200302001
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

Elderly people (EP) have increased, as well as life expectancy at birth. In Chile there are more than 2 million 800 thousand EP, which corresponds to 1/6 of the Chilean population. The EP have a higher disease burden and mortality when facing surgery and in the postoperative period. Thus, this population frequently has longer hospital stays due to its degree of fragility, surgical complications or decompensation of its underlying pathologies, directly affecting health care systems. An inadequate preparation of the EP prior to surgery determined that the requirements of in-hospital as well as out-of-hospital care are extended, with the consequent which entails a higher cost in health. Current research underestimates the conditions of frailty and dependence in the EP. In addition, it is not routinely evaluated prior to surgery, as well as nutritional, metabolic, cognitive status and / or delirium screening is performed. There are accelerated recovery programs, which relate their interventions to specific pathologies; however, the age of the person is not taken into account. Surgical pre-habilitation interventions in the EP usually focus their efforts on physical and cardiovascular aspects, not including an integrative pre-surgical evaluation. Based on the foregoing, a prospective, interventional, longitudinal and randomized study has been proposed in a population of the EP who will undergo elective urology and coloproctology surgeries in two university hospitals (private and public). The objective of this study is to evaluate how the implementation of a timely pre-surgical conditioning (APO) protocol for frail elderly people reduces the days of hospital stay. The APO considers the most relevant aspects of physical and cardiovascular pre-habilitation, in addition to contemplating evaluations of frailty, dependence, cognitive status, screening for delirium, nutritional and metabolic.

Conditions

Surgery; Old Age; Debility; Frail Elderly Syndrome; Post-Operative Confusion; Older Adults; Perioperative Care; Urologic Diseases; Digestive Disease; Anesthesia; Nurse-Patient Relations

Keywords

Older adults; Perioperative Care; Frail Elderly Syndrome; Pre-habilitation; length of stay in hospital

Outcome Measures

Primary Outcomes (5)

• Length of hospital stay

  Reduction of length of hospital stay in terms of days after surgery of frail elderly enrolled in the control and intervention arm.

  Average of 5 to Days of hospital stay until discharge after surgery

• Change of the degree of the frailty in the elderly patients during the perioperative process

  Change from Baseline in the degree of preoperative frailty in the elderly patients in both arms with Frail Scale 0= Robust, 1= Pre - Frail, 3-5 = Frail; Fried phenotype of frailty 0= Robust, 1= Pre - Frail, 3-5 = Frail and Clinical Frail Scale 1 to 9, 1 is very fit and 9 is a terminal patients.

  One month before surgery, the 1 day of the surgery up to 3 months after discharge.

• Change of the nutritional and metabolic status in the elderly patients during the perioperative process

  Change from Baseline in the nutritional and metabolic status in the in the elderly patients in both arms measure with the Mini Nutritional Assessment scale. 12-14 points: Normal nutritional status 8-11 points: At risk of malnutrition 0-7 points: Malnourished

  One month before surgery, the 1 day of the surgery up to 3 months after discharge.

• Assessment functional independence in the elderly patients preoperative and postoperative

  Assessment functional independence with the Barthel Index for Activities of Daily Living. 0 to 100. 0 is Totally dependent and 100 totally independent

  One month before surgery, the 1 day of the surgery up to 3 months after discharge.

• Change of the cardiorespiratory and muscular system in the elderly patients during the perioperative process

  Change from Baseline of the cardiorespiratory and muscular system in the elderly patients before and after surgery with Short Physical Performance Battery (Score 0 - 12, 0 = lower physical performance and 12 = higher physical performance); 6 Minute Walk Test (ranges from 400 to 700 m, the main predictor variables being gender, age and height) or 2 minute step Test (record the total number of times the right knee reaches the tape level in two minutes. The recommended ranges for this test based on age groups from Jones \& Rikli, 2002).

  One month before surgery, the 1 day of the after surgery up to 3 days post surgery.

Secondary Outcomes (4)

• Change of the cognitive state in the elderly patients during the perioperative process

  One month before surgery, the 1 day of the surgery up to 3 months after discharge.

• Identify the appearance during the perioperative process of the delirum in the elderly patients

  1 day before surgery and every day every 12 hours post surgery until discharge

• Identify morbidity and post-operative complications

  Identify morbidity and mortality and post-operative complications one, two and three month after surgery discharge

• Identify the mortality post-operative

  One, two and three month after surgery discharge

Study Arms (2)

Control

NO INTERVENTION

The control group will have a nursing evaluation and then follow the surgeon's instructions in the current standard way until de surgery day. In that day the RN will be evaluate again these group. Then, this group will be followed within the hospital and the first, second and third month after discharge.

Intervention

EXPERIMENTAL

The intervention group will have a nursing evaluation and then will attend an evaluation by geriatarics team, kinesiology and nutrition, where a plan of physical cardiovascular, nutritional and metabolic prehabilitation is delivered. On the day of surgery, the RN will evaluate this group again. Then, this group will be followed within the hospital and the first, second and third month after discharge.

Other: Timely pre-surgical conditioning

Interventions

Timely pre-surgical conditioning OTHER

Timely pre-surgical conditioning seeks to prepare frail, pre-frail and / or dependent older patients for the surgery process. For which a work plan has been designed according to your needs and health conditions.

Intervention

Eligibility Criteria

• Age: 65 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elective surgery of urology and / or minimally invasive coloproctology under general anesthesia
• Pre-frail, frail patients.
• Patients with a moderate to severe degree of dependence

You may not qualify if:

• Emergency surgery patients.
• Patients who are hospitalized prior to surgery for urgent reasons and / or complications from another surgery.
• Patients diagnosed with delirum, dementia or similar mental illness.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (2)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 450881, Chile

Location

Hospital de La Florida

Santiago, Santiago Metropolitan, 8420525, Chile

Location

Related Publications (5)

• Edelmuth SVCL, Sorio GN, Sprovieri FAA, Gali JC, Peron SF. Comorbidities, clinical intercurrences, and factors associated with mortality in elderly patients admitted for a hip fracture. Rev Bras Ortop. 2018 Aug 2;53(5):543-551. doi: 10.1016/j.rboe.2018.07.014. eCollection 2018 Sep-Oct.

  PMID: 30245992 BACKGROUND

• Bolliger M, Kroehnert JA, Molineus F, Kandioler D, Schindl M, Riss P. Experiences with the standardized classification of surgical complications (Clavien-Dindo) in general surgery patients. Eur Surg. 2018;50(6):256-261. doi: 10.1007/s10353-018-0551-z. Epub 2018 Jul 24.

  PMID: 30546385 BACKGROUND

• Beggs T, Sepehri A, Szwajcer A, Tangri N, Arora RC. Frailty and perioperative outcomes: a narrative review. Can J Anaesth. 2015 Feb;62(2):143-57. doi: 10.1007/s12630-014-0273-z. Epub 2014 Nov 25.

  PMID: 25420470 BACKGROUND

• Ferris DK, Willet-Brown J, Martensen T, Farrar WL. Interleukin 3 stimulation of tyrosine kinase activity in FDC-P1 cells. Biochem Biophys Res Commun. 1988 Aug 15;154(3):991-6. doi: 10.1016/0006-291x(88)90237-9.

  PMID: 3261586 BACKGROUND

• Contreras V, Elgueta MF, Balde D, Astaburuaga P, Carrasco M, Pedemonte JC, Nicoletti MN, Medina Diaz R, Franco S, Agurto R, Vivanco C, Figueroa C, Alamos M, Cuzmar Benitez V, Vargas B, Barraza B, Rematal C, Cortinez LI. Prehabilitation for Chilean frail elderly people - pre-surgical conditioning protocol - to reduce the length of stay: randomized control trial. Minerva Anestesiol. 2024 Dec;90(12):1098-1107. doi: 10.23736/S0375-9393.24.18245-4.

  PMID: 39836361 DERIVED

MeSH Terms

Conditions

Frailty; Urologic Diseases; Digestive System Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Maria F Elgueta, MD

  Assistant Profesor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research associate

Model Details: randomized controlled, longitudinal.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 25, 2021
• Study Start: May 30, 2021
• Primary Completion: October 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 2 years
• Access Criteria: Certificate letter or institucional e-mail

Locations

CL (2)