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An Intervention for Elderly in Emergency Services

Primary Purpose

Stroke, Ischemic Attack, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Factors associated with the use of emergency departments
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Frailty, emergency services, elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults 70 and over.
  • Both sexes
  • Affiliation force in the IMSS
  • Attending spontaneously or referred to the emergency department of hospitals in the study.
  • Agree to participate in the study phase in observational or intervention by signed written informed consent

Exclusion Criteria:

  1. Adults 70 and older whose income is service by:

    a. A very serious acute condition with imminent risk to life and requires immediate emergency care, cataloged by the Triage system marked by the IMSS as Red or (state the patient's functional impairment characterized by high and low, with imminent risk life or the integrity and function of some of their organs and requires immediate medical attention since his arrival to the emergency room) or require emergency care (patient condition characterized by acute and severe functional impairment, life-threatening or the integrity and function of some of their organs and requires medical attention within the next 10 minutes after arrival at the emergency department).

    • An automobile accident
    • Burn-grade II or III
    • Partial or total unconsciousness
    • Severe cognitive impairment
  2. Individuals who do not agree to participate in the study

Sites / Locations

  • XXI Century National Medical

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Basal phase

Arm Description

Integrated measurement of all variables involved impact and frequency of prior use of health services and specifically to the emergency room, service access, patient characteristics, features for the classification of frailty, cognitive impairment and depression, why consultation, triage scale level on admission to the service and to the service variables in terms of length of stay, diagnosis and medical management, and related services with internal consultants percentage of inpatients discharged or deceased, in further analysis the researchers undertake group estimating frequency of use and the identification of factors associated with the use of emergency departments and adverse events

Outcomes

Primary Outcome Measures

Change in hand grip strength (HS) as a physical performance test
A standardized technique and digital dynamometers (Exacta TM) wil lbe used, and the best result of two tests in the dominant hand will be used for analysis. No cut-off points will be applied; instead the variable will be assessed as a continuous one with kilograms as the units of measure.

Secondary Outcome Measures

Evaluation of individual and institutional impact
Evaluate the impact of a scheme based on internal consultation geriatricians and home visiting nurses oriented elders 70 and over, in terms of individual outcomes and health services: a. Individual Impacts: a.1 Primary: • Fragility

Full Information

First Posted
October 10, 2012
Last Updated
February 3, 2015
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT01706133
Brief Title
An Intervention for Elderly in Emergency Services
Official Title
Elderly in Emergency Services: Effectiveness of an Intervention to Improve Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
-Can a scheme based on inter geriatricians visiting nurse consultants and reduce negative impacts on the health of elderly over 70 years ?
Detailed Description
- Usual care as the comparison group Usual care or standard refers to those processes or services that the elderly claimant receives the IMSS services network, after the acute phase of their illness has been stabilized and is defined that can be discharged from the emergency department, following clinical and therapeutic recommendations for improving their health. Elders risk population for emergency The aging population brings a major change in health conditions and social conditions around the elderly, the analysis of the elderly population is considered according to functionality and risks of old age, when it comes to care services emergency, care becomes more critical as the elderly are older, have been identified adults of 70 and over as more vulnerable to health services, especially for the emergency services as they do not exhibit classic patterns to acute events of prevalent diseases. Functionality and dependence The commitment of the functionality in adults older than 65 may be present in 5% of cases, while in over 70 years this figure rises to 50% or more. Functional impairment may be a "marker" of the effect of systemic disease on the patient and is also an indicator of severity of disease because it measures the ability of independence The accumulation of normal aging characteristics define a threshold, which once pierced, tends to increase the propensity for loss of functional abilities due to aging. However, not everyone ages the same way, since factors such as inherited genetic capital, especially the accumulation of risks associated with lifestyle and work activities, and the opportunity to identify the disease in its period latency coupled with the accessibility and use of health services, can delay or exacerbate the loss of functionality and increase the dependency of the elderly. Quality of life of older Frailty in the elderly is a state of increased susceptibility due to less booking multiple physiological systems resulting in lower resilience, negative energy balance, sarcopenia, decreased strength and reduced exercise tolerance. Frailty is associated with adverse health outcomes such as institutionalization, falls, reduced performance status and increased mortality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Attack, Diabetes Mellitus, Hypertension, Fragility
Keywords
Frailty, emergency services, elderly

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
1400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Basal phase
Arm Type
No Intervention
Arm Description
Integrated measurement of all variables involved impact and frequency of prior use of health services and specifically to the emergency room, service access, patient characteristics, features for the classification of frailty, cognitive impairment and depression, why consultation, triage scale level on admission to the service and to the service variables in terms of length of stay, diagnosis and medical management, and related services with internal consultants percentage of inpatients discharged or deceased, in further analysis the researchers undertake group estimating frequency of use and the identification of factors associated with the use of emergency departments and adverse events
Intervention Type
Other
Intervention Name(s)
Factors associated with the use of emergency departments
Intervention Description
Participants who were assigned to the intervention will be evaluated jointly by the medical service by a medical specialist in geriatrics and a nurse trained in gerontology and geriatrics. The doctor will monitor the apparition and / or aggravation of any geriatric syndromes already established by the specialty in geriatrics, namely, polypharmacy, delirium, dementia, depression, risk of falls, etc.. The nurse will monitor and follow up in four areas I. medical issues (pressure ulcers, infusion, mobility); II. Mental and emotional state and coping strategies with hospitalization; III. functionality, and IV. Atmosphere (A. Service status, architectural difficulties for mobility, bathing etc. B. Support Network, caregiver, and C. hardship)
Primary Outcome Measure Information:
Title
Change in hand grip strength (HS) as a physical performance test
Description
A standardized technique and digital dynamometers (Exacta TM) wil lbe used, and the best result of two tests in the dominant hand will be used for analysis. No cut-off points will be applied; instead the variable will be assessed as a continuous one with kilograms as the units of measure.
Time Frame
Basal and Six months
Secondary Outcome Measure Information:
Title
Evaluation of individual and institutional impact
Description
Evaluate the impact of a scheme based on internal consultation geriatricians and home visiting nurses oriented elders 70 and over, in terms of individual outcomes and health services: a. Individual Impacts: a.1 Primary: • Fragility
Time Frame
Six Months
Other Pre-specified Outcome Measures:
Title
Quantify hospital readmissions
Description
Estimate the readmission to hospital adverse events in adults older than 70 years, underwent surgery and its comparison group from discharge from service
Time Frame
One Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 70 and over. Both sexes Affiliation force in the IMSS Attending spontaneously or referred to the emergency department of hospitals in the study. Agree to participate in the study phase in observational or intervention by signed written informed consent Exclusion Criteria: Adults 70 and older whose income is service by: a. A very serious acute condition with imminent risk to life and requires immediate emergency care, cataloged by the Triage system marked by the IMSS as Red or (state the patient's functional impairment characterized by high and low, with imminent risk life or the integrity and function of some of their organs and requires immediate medical attention since his arrival to the emergency room) or require emergency care (patient condition characterized by acute and severe functional impairment, life-threatening or the integrity and function of some of their organs and requires medical attention within the next 10 minutes after arrival at the emergency department). An automobile accident Burn-grade II or III Partial or total unconsciousness Severe cognitive impairment Individuals who do not agree to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen García-Peña, PhD
Organizational Affiliation
Epidemiological Research Unit and Health Services. XXI Century National Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sergio Sánchez García, PhD
Organizational Affiliation
Epidemiological Research Unit and Health Services. XXI Century National Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Teresa Juarez Cedillo, PhD
Organizational Affiliation
Epidemiological Research Unit and Health Services. XXI Century National Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rogelio Moncada Tobias, Doctor
Organizational Affiliation
Emergency Service. General Hospital Zone No.2
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nubia Franco Alvarez, Doctor
Organizational Affiliation
Internal Medicine. General Hospital Zone No. 2
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
José García González, Master
Organizational Affiliation
Department of Nephrology. Regional General Hospital No. 1
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ulises Pérez Zepeda, Master
Organizational Affiliation
Institute of Geriatrics
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leslie Viridiana Robles Jiménez, Doctor
Organizational Affiliation
National Institute of Psychiatry
Official's Role
Study Chair
Facility Information:
Facility Name
XXI Century National Medical
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06725
Country
Mexico

12. IPD Sharing Statement

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An Intervention for Elderly in Emergency Services

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