Elder-friendly Approaches to the Surgical Environment (EASE) Study (EASE)

October 17, 2018 updated by: Rachel Khadaroo, University of Alberta

Elder-friendly Approaches to the Surgical Environment - Implementation of an Elder Friendly Surgical Unit

The aim of this study is to examine the impact implementing an elder-friendly surgical unit has on post-operative complications, mortality and quality of life for patients ≥ 65 years old who have undergone emergency surgical care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize that the elder-friendly surgical unit will reduce in-hospital complications and mortality in a cost-effective manner, for this at risk population.

Specific elder-friendly interventions include:

  1. Locate all elderly surgical patients on one nursing unit
  2. Interdisciplinary team-based care
  3. Elder-friendly evidence-informed practices including: comfort rounds with early mobilization, delirium prevention/management, optimal nutrition and prevention of post-operative complications
  4. Early and interdisciplinary discharge management

This is a prospective, before-after study with a concurrent control group. Four senior patient groups will be followed:

Study Type

Observational

Enrollment (Actual)

723

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Center, Acute Care Emergency Surgical Services
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital, Acute Care and Emergency Surgery Service

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients > 65 years old admitted and received acute abdominal surgery

Description

Inclusion Criteria:

  • All patients > 65 years old admitted for Acute care and Emergency Surgery
  • Received acute abdominal surgery

Exclusion Criteria:

  • Elective general surgery cases
  • Nursing home resident requiring full nursing care [dependency in 3 or more activities of daily living ]
  • Palliative surgery [surgery with the primary intention of improving quality of life or relieving symptoms caused by advancing non-curative disease]
  • Multi-system trauma
  • Patients from out of province or transferred from another inpatient service or hospital

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-Elder Friendly Surgical Intervention Group
Elder Acute Care and Emergency Surgery patients
Post-Elder Friendly Surgical Intervention Group
Elder Acute Care and Emergency Surgery patients
Other: Elder-Friendly Surgical Unit
Pre-Elder Friendly Surgical Control Group
Elder Acute Care and Emergency Surgery patients
Post-Elder Friendly Surgical Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Operative complications
Time Frame: During initial in-hospital stay (0-12 weeks on average)
Includes a) intensive care unit admission (includes respiratory failure, cardiac arrest or septic shock), b) vascular complications (myocardial infarction, stroke, deep venous thrombosis, pulmonary embolism), c) serious infections (pneumonia, intra-abdominal abscess, urinary tract infection, deep wound infection or infected decubitus ulcer) or d) protracted delirium (≥48 hours)
During initial in-hospital stay (0-12 weeks on average)
Death
Time Frame: During initial in-hospital stay (0-12 weeks on average)
During initial in-hospital stay (0-12 weeks on average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost per quality-adjusted life year
Time Frame: 6 months post-discharge
Both direct and indirect study participant costs
6 months post-discharge
Post-discharge complications or health-events requiring re-admission
Time Frame: Within 30 days post-discharge
Within 30 days post-discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life
Time Frame: 6 weeks and 6 months post-discharge
Including: EQ-5D questionnaire, SF-12 Questionnaire
6 weeks and 6 months post-discharge
Functional Status (Frailty)
Time Frame: 6 weeks post-discharge
Including: Edmonton Frail Scale, and Timed Up-and-Go Test
6 weeks post-discharge

Collaborators and Investigators

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

Sponsor

University of Alberta

Collaborators

Alberta Innovates Health Solutions

Investigators

  • Principal Investigator: Rachel G Khadaroo, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00047180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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