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

Completed

• Conditions: General Surgery
• Interventions: Other: Elder-Friendly Surgical Unit

• Registration Number: NCT02233153
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-08
• Primary Completion: 2017-05
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 723

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Elder Friendly Surgical Intervention Group	Elder-Friendly Surgical Unit	Elder Acute Care and Emergency Surgery patients

Primary Outcome Measures

Name	Time	Method
Post-Operative complications	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)
Death	During initial in-hospital stay (0-12 weeks on average)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

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

University of Alberta Hospital, Acute Care and Emergency Surgery Service; 🇨🇦 Edmonton, Alberta, Canada