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

General Surgery Clinical Trial

— EASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233153
• Other study ID #: Pro00047180
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Completed
• Enrollment: 723
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Surgery

Intervention

Other:
• Elder-Friendly Surgical Unit

Locations

Country	Name	City	State
Canada	Foothills Medical Center, Acute Care Emergency Surgical Services	Calgary	Alberta
Canada	University of Alberta Hospital, Acute Care and Emergency Surgery Service	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Innovates Health Solutions

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Eamer GJ, Clement F, Pederson JL, Churchill TA, Khadaroo RG. Analysis of postdischarge costs following emergent general surgery in elderly patients. Can J Surg. 2018 Feb;61(1):19-27. — View Citation

Hanson HM, Warkentin L, Wilson R, Sandhu N, Slaughter SE, Khadaroo RG. Facilitators and barriers of change toward an elder-friendly surgical environment: perspectives of clinician stakeholder groups. BMC Health Serv Res. 2017 Aug 24;17(1):596. doi: 10.1186/s12913-017-2481-z. — View Citation

Khadaroo RG, Padwal RS, Wagg AS, Clement F, Warkentin LM, Holroyd-Leduc J. Optimizing senior's surgical care - Elder-friendly Approaches to the Surgical Environment (EASE) study: rationale and objectives. BMC Health Serv Res. 2015 Aug 21;15:338. doi: 10.1186/s12913-015-1001-2. — View Citation

Li Y, Pederson JL, Churchill TA, Wagg AS, Holroyd-Leduc JM, Alagiakrishnan K, Padwal RS, Khadaroo RG. Impact of frailty on outcomes after discharge in older surgical patients: a prospective cohort study. CMAJ. 2018 Feb 20;190(7):E184-E190. doi: 10.1503/cm — View Citation

McComb A, Warkentin LM, McNeely ML, Khadaroo RG. Development of a reconditioning program for elderly abdominal surgery patients: the Elder-friendly Approaches to the Surgical Environment-BEdside reconditioning for Functional ImprovemenTs (EASE-BE FIT) pil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health Related Quality of Life	Including: EQ-5D questionnaire, SF-12 Questionnaire	6 weeks and 6 months post-discharge
Other	Functional Status (Frailty)	Including: Edmonton Frail Scale, and Timed Up-and-Go Test	6 weeks post-discharge
Primary	Post-Operative complications	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)
Primary	Death		During initial in-hospital stay (0-12 weeks on average)
Secondary	Post-discharge complications or health-events requiring re-admission		Within 30 days post-discharge
Secondary	Cost per quality-adjusted life year	Both direct and indirect study participant costs	6 months post-discharge