Clinical trial NCT04770259: Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM).
Official title: Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 87
Sex: ALL
Minimum age (years): 65
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled, longitudinal.
Primary purpose: TREATMENT

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.

Detailed description: 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: Red de Salud UC-Christus and Hospital Clinico La Florida. Both based on Santiago de Chile.

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.

PM will be screened according to: co-morbidities, degree of frailty and dependence. This procedure will be carried out by a trained register nurse (RN) from the team at each center, who through a random system will enter 50% of the patients to the APO protocol (intervention) and the other 50% to the standard protocol of each institution. After that the RN will measure nutritional and cognitive status, drugs and alcohol consume and will take the protocol blood samples in the first evaluation two to three days after receiving an order for surgery for the physician.

The APO considers the evaluations for a geriatric team, physical therapist team and nutritionist team in order to find out the most relevant aspects of physical, cardiovascular geriatric syndromes, cognitive status, nutritional and metabolic status.

physical therapist team and nutritionist team they will prepare to the EP to surgery with physical, cardiovascular and dietary protocols adjusted to the patient, for the time of 4 to 5 weeks before surgery.

Upon admission of hospitalization for surgery, the RN in each of the two hospitals will evaluate the state of frail and dependence, nutritional and cognitive status, drugs and alcohol consume and delirium status in which the patients of both groups arrive.

The analgesia and anesthesia of all patients in both groups, control and intervention, will be standardized to reduce confounding associated with intra- and postoperative anesthesia and analgesia.

The registered nurse will follow the patient throughout the in-hospital process and via telemedicine or face-to-face will interview patients one month, second month and third month after discharge in search of possible problems associated with the peri-operative process.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Length of hospital stay
timeFrame: Average of 5 to Days of hospital stay until discharge after surgery
measure: Change of the degree of the frailty in the elderly patients during the perioperative process
timeFrame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
measure: Change of the nutritional and metabolic status in the elderly patients during the perioperative process
timeFrame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
measure: Assessment functional independence in the elderly patients preoperative and postoperative
timeFrame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
measure: Change of the cardiorespiratory and muscular system in the elderly patients during the perioperative process
timeFrame: One month before surgery, the 1 day of the after surgery up to 3 days post surgery.
Secondary outcomes:
measure: Change of the cognitive state in the elderly patients during the perioperative process
timeFrame: One month before surgery, the 1 day of the surgery up to 3 months after discharge.
measure: Identify the appearance during the perioperative process of the delirum in the elderly patients
timeFrame: 1 day before surgery and every day every 12 hours post surgery until discharge
measure: Identify morbidity and post-operative complications
timeFrame: Identify morbidity and mortality and post-operative complications one, two and three month after surgery discharge
measure: Identify the mortality post-operative
timeFrame: One, two and three month after surgery discharge
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital de La Florida
state: Región Metropolitana
Study officials:
affiliation: Assistant Profesor
name: Maria F Elgueta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.