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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02233153
Recruitment Status : Completed
First Posted : September 8, 2014
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Alberta Innovates Health Solutions
Information provided by (Responsible Party):
Rachel Khadaroo, University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment
General Surgery Other: Elder-Friendly Surgical Unit

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:

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Study Type : Observational
Actual Enrollment : 723 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Elder-friendly Approaches to the Surgical Environment - Implementation of an Elder Friendly Surgical Unit
Actual Study Start Date : April 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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)

  2. Death [ Time Frame: During initial in-hospital stay (0-12 weeks on average) ]

Secondary Outcome Measures :
  1. Post-discharge complications or health-events requiring re-admission [ Time Frame: Within 30 days post-discharge ]
  2. Cost per quality-adjusted life year [ Time Frame: 6 months post-discharge ]
    Both direct and indirect study participant costs


Other Outcome Measures:
  1. Health Related Quality of Life [ Time Frame: 6 weeks and 6 months post-discharge ]
    Including: EQ-5D questionnaire, SF-12 Questionnaire

  2. Functional Status (Frailty) [ Time Frame: 6 weeks post-discharge ]
    Including: Edmonton Frail Scale, and Timed Up-and-Go Test



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients > 65 years old admitted and received acute abdominal surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233153


Locations
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Canada, Alberta
Foothills Medical Center, Acute Care Emergency Surgical Services
Calgary, Alberta, Canada
University of Alberta Hospital, Acute Care and Emergency Surgery Service
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Alberta Innovates Health Solutions
Investigators
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Principal Investigator: Rachel G Khadaroo, MD University of Alberta
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rachel Khadaroo, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02233153    
Other Study ID Numbers: Pro00047180
First Posted: September 8, 2014    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rachel Khadaroo, University of Alberta:
Senior
Elderly
Acute Care
Emergency Surgery