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

Primary Purpose

Surgery, Old Age; Debility, Frail Elderly Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Timely pre-surgical conditioning
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Older adults, Perioperative Care, Frail Elderly Syndrome, Pre-habilitation, length of stay in hospital

Eligibility Criteria

65 Years - 105 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pontificia Universidad Catolica de ChileRecruiting
  • Hospital de La FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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
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
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).

Secondary Outcome Measures

Change of the cognitive state in the elderly patients during the perioperative process
Change of the cognitive state in the elderly patients during the perioperative process with Mini Cog test (0-2 points indicates positive screen for dementia and 3-5 points indicates negative screen for dementia); AD8 (0 to 8, and over 2 is positive for dementia), and/or MoCA test (scores range between 0 and 30. A score of 26 or over is considered to be normal).
Identify the appearance during the perioperative process of the delirum in the elderly patients
Identify the appearance during the perioperative process of the delirum in the elderly patients with Confusion assessment method (CAM), CAM=negative is delirium absent and CAM=positive is delirum present, the same for CAM-Intensive Care Unit (CAM-ICU) CAM-ICU=negative is delirium absent and CAM-ICU=positive is delirum present.
Identify morbidity and post-operative complications
Identify post-operative complications with Claven-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V).
Identify the mortality post-operative
Identify the mortality post-operative in the frail elderly enrolled in the controls and intervention arm. Proportion of deaths from a certain of frail elderly patients after surgery compared to the total number of elderly people after surgery

Full Information

First Posted
February 15, 2021
Last Updated
March 27, 2023
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04770259
Brief Title
Pre-surgical Protocol for Frail Elderly People in Order to Reduce Hospitalization Days (APOPM).
Acronym
APOPM
Official Title
Generation of a Pre-surgical Conditioning Protocol for Frail Elderly People in Order to Reduce Hospitalization Days.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled, longitudinal.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Timely pre-surgical conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Reduction of length of hospital stay in terms of days after surgery of frail elderly enrolled in the control and intervention arm.
Time Frame
Average of 5 to Days of hospital stay until discharge after surgery
Title
Change of the degree of the frailty in the elderly patients during the perioperative process
Description
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.
Time Frame
One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Title
Change of the nutritional and metabolic status in the elderly patients during the perioperative process
Description
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
Time Frame
One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Title
Assessment functional independence in the elderly patients preoperative and postoperative
Description
Assessment functional independence with the Barthel Index for Activities of Daily Living. 0 to 100. 0 is Totally dependent and 100 totally independent
Time Frame
One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Title
Change of the cardiorespiratory and muscular system in the elderly patients during the perioperative process
Description
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).
Time Frame
One month before surgery, the 1 day of the after surgery up to 3 days post surgery.
Secondary Outcome Measure Information:
Title
Change of the cognitive state in the elderly patients during the perioperative process
Description
Change of the cognitive state in the elderly patients during the perioperative process with Mini Cog test (0-2 points indicates positive screen for dementia and 3-5 points indicates negative screen for dementia); AD8 (0 to 8, and over 2 is positive for dementia), and/or MoCA test (scores range between 0 and 30. A score of 26 or over is considered to be normal).
Time Frame
One month before surgery, the 1 day of the surgery up to 3 months after discharge.
Title
Identify the appearance during the perioperative process of the delirum in the elderly patients
Description
Identify the appearance during the perioperative process of the delirum in the elderly patients with Confusion assessment method (CAM), CAM=negative is delirium absent and CAM=positive is delirum present, the same for CAM-Intensive Care Unit (CAM-ICU) CAM-ICU=negative is delirium absent and CAM-ICU=positive is delirum present.
Time Frame
1 day before surgery and every day every 12 hours post surgery until discharge
Title
Identify morbidity and post-operative complications
Description
Identify post-operative complications with Claven-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V).
Time Frame
Identify morbidity and mortality and post-operative complications one, two and three month after surgery discharge
Title
Identify the mortality post-operative
Description
Identify the mortality post-operative in the frail elderly enrolled in the controls and intervention arm. Proportion of deaths from a certain of frail elderly patients after surgery compared to the total number of elderly people after surgery
Time Frame
One, two and three month after surgery discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Contreras, MSN
Phone
223549217
Email
vecontre@uc.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Maria F Elgueta, MD
Phone
223543270
Email
panchielgueta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria F Elgueta, MD
Organizational Affiliation
Assistant Profesor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidad Catolica de Chile
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
450881
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Contreras, MSN
Phone
223549217
Email
vecontre@uc.cl
First Name & Middle Initial & Last Name & Degree
Maria F Elgueta, MD
First Name & Middle Initial & Last Name & Degree
Paula Astaburuaga, MD
First Name & Middle Initial & Last Name & Degree
Marcela Carrasco, MD
First Name & Middle Initial & Last Name & Degree
Leticia Clede, MD
First Name & Middle Initial & Last Name & Degree
Juan C Pedemonte, MD
First Name & Middle Initial & Last Name & Degree
Detlef Balde, MD
First Name & Middle Initial & Last Name & Degree
Natalia Calderon, RN
Facility Name
Hospital de La Florida
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8420525
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Astaburuaga, MD
Phone
223549217
Email
paulaastaburuaga@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Timely pre-surgical conditioning protocol for frail older people.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Certificate letter or institucional e-mail
Citations:
PubMed Identifier
30245992
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.
Results Reference
background
PubMed Identifier
30546385
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.
Results Reference
background
PubMed Identifier
25420470
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.
Results Reference
background
PubMed Identifier
3261586
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.
Results Reference
background

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

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