Mechanical Ventilation in Internal Medicine Elderly Patients - Choosing Wisely (VentWise)

April 22, 2018 updated by: Rambam Health Care Campus
This is a prospective observational study evaluating all patients requiring mechanical ventilation. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored.

Study Overview

Status

Completed

Conditions

Detailed Description

Background The aging of the population associated with increased morbidity, on one hand, and technological advances providing life-sustaining treatments on the other, resulted in an increased number of mechanically ventilated patients in Internal Medicine wards. In a previous study the investigators found that about half of the hospitalization days in intermediate care units in Internal Medicine wards were utilized by older patients at the end of life. The mortality at 6 months from the time of admission was greater than 70%, unrelated to the type of treatment. The majority of the elderly patients surviving the acute stage were transferred to chronic long-term care hospitals. The Public Health System in Israel invests costly resources in providing care to mechanically ventilated patients in both acute and chronic care settings, in spite of unproved benefit on the quality of life and on life expectancy.

Aims of the study

  1. Identification of patients and the factors affecting the decision-making process and outcome in mechanically ventilated patients in Internal Medicine wards in acute care hospitals.
  2. Development of a predictive model to classifying mechanically ventilated patients by outcome on the basis of patient characteristics on admission and the factors involved in decision-making.
  3. Assessment of medical resource investment according to the study model groups.

Study hypothesis Identification of parameters predicting better outcome and potential for rehabilitation in elderly mechanically ventilated internal medicine patients, versus patients with poorer outcome who would need palliative care.

Methods The study is a prospective observational study carried out in five Internal Medicine wards and the Medical Intensive Care Unit at the Rambam Health Care Campus in Haifa, Israel. All patients requiring mechanical ventilation will be included. Patients' medical and demographic data will be obtained from the hospital computerized record system. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored. Mortality at 6 months will be obtained from the Israel National Population Registry. Descriptive statistical analysis will be performed, and multivariate logistic regression analysis will be applied to identify variables contributing to the need for ventilation and outcome.

Importance of the study The approval of the 2005 Dying Patient Act in Israel, allowed for withholding of certain life-sustaining interventions at end of life. However, once an intervention such as mechanical ventilation has been commenced, the Law does not permit its withdrawing, making the decision to ventilate a patient irreversible. There is thus a clear need to improve the decision-making process related to undertaking mechanical ventilation in elderly internal medicine patients. In addition, the investigators believe that the study will highlight the issue and bring the policy makers to the establishing practical tools for health care professionals. The investigators also hope that the study will incite the general public attention to address the issue of advanced directives regarding undergoing invasive treatments such as mechanical ventilation at end of life. Finally, the investigators consider that adoption of a more evidence-based approach to undertaking mechanical ventilation, and consideration of patients' advanced directives, by health care providers in both community and in-patient settings, will lead to a better utilization of health resources and improvement of end of life of care.

Study Type

Observational

Enrollment (Actual)

619

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive patients requiring mechanical ventilation over the study period.

Inclusion criteria:

Males and females Age over 18 years Admitted to internal medicine wards or medical intensive care unit

Description

Inclusion Criteria:

  • Mechanical ventilation
  • Males and females
  • Age over 18 years
  • Admitted to internal medicine wards or medical intensive care unit

Exclusion Criteria:

  • Younger than 18 years
  • Surgical and trauma patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 6 months
Data will be obtained from the Israel National Population Registry
From date of randomization until the date of first documented date of death from any cause, assessed up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of acute hospital stay
Time Frame: From date of randomization until the date of first documented discharge from the acute care hospital to the community or to a long-term care institution, assessed up to 6 months
Data will be obtained from the acute care hospital computerized record system
From date of randomization until the date of first documented discharge from the acute care hospital to the community or to a long-term care institution, assessed up to 6 months
Ongoing medical and nursing care in a long term care institution
Time Frame: From date of randomization until the date of first documented discharge from the acute care hospital to a long-term care institution, assessed up to 6 months
Data will be obtained from the acute care hospital computerized record system
From date of randomization until the date of first documented discharge from the acute care hospital to a long-term care institution, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Collaborators

Israel National Institute for Health Policy and Health Services Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 22, 2015

First Submitted That Met QC Criteria

March 1, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 22, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0399-14-RMB CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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