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Completed

NCT Number: NCT02233153

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

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.

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Key information

Conditions

General Surgery

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Center, Acute Care Emergency Surgical Services, Calgary, Alberta, Canada

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About this study

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:

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elder-Friendly Surgical Unit

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Innovates Health Solutions

Registry information

Official study title

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

Acronym: EASE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2014
Registry last updated
Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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