NCT02233153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
723

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

3.1 years

First QC Date

August 22, 2014

Last Update Submit

October 17, 2018

Conditions

General Surgery

Keywords

SeniorElderlyAcute CareEmergency Surgery

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Death

    During initial in-hospital stay (0-12 weeks on average)

Secondary Outcomes (2)

  • Post-discharge complications or health-events requiring re-admission

    Within 30 days post-discharge

  • Cost per quality-adjusted life year

    6 months post-discharge

Other Outcomes (2)

  • Health Related Quality of Life

    6 weeks and 6 months post-discharge

  • Functional Status (Frailty)

    6 weeks post-discharge

Study Arms (4)

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

Interventions

Elder-Friendly Surgical UnitOTHER
Post-Elder Friendly Surgical Intervention Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foothills Medical Center, Acute Care Emergency Surgical Services

Calgary, Alberta, Canada

Location

University of Alberta Hospital, Acute Care and Emergency Surgery Service

Edmonton, Alberta, Canada

Location

Related Publications (8)

  • 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.

    PMID: 28836979BACKGROUND

  • 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.

    PMID: 26293153BACKGROUND

  • 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/cmaj.161403.

    PMID: 29565018RESULT

  • 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. doi: 10.1503/cjs.002617. Epub 2017 Dec 1.

    PMID: 29368673RESULT

  • 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) pilot study. World J Emerg Surg. 2018 May 21;13:21. doi: 10.1186/s13017-018-0180-7. eCollection 2018.

    PMID: 29942346RESULT

  • Pederson JL, Padwal RS, Warkentin LM, Holroyd-Leduc JM, Wagg A, Khadaroo RG. The impact of delayed mobilization on post-discharge outcomes after emergency abdominal surgery: A prospective cohort study in older patients. PLoS One. 2020 Nov 6;15(11):e0241554. doi: 10.1371/journal.pone.0241554. eCollection 2020.

    PMID: 33156849DERIVED

  • Khadaroo RG, Warkentin LM, Wagg AS, Padwal RS, Clement F, Wang X, Buie WD, Holroyd-Leduc J. Clinical Effectiveness of the Elder-Friendly Approaches to the Surgical Environment Initiative in Emergency General Surgery. JAMA Surg. 2020 Apr 1;155(4):e196021. doi: 10.1001/jamasurg.2019.6021. Epub 2020 Apr 15.

    PMID: 32049271DERIVED

  • Eamer GJ, Clement F, Holroyd-Leduc J, Wagg A, Padwal R, Khadaroo RG. Frailty predicts increased costs in emergent general surgery patients: A prospective cohort cost analysis. Surgery. 2019 Jul;166(1):82-87. doi: 10.1016/j.surg.2019.01.033. Epub 2019 Apr 27.

    PMID: 31036332DERIVED

Study Officials

  • Rachel G Khadaroo, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 22, 2014

First Posted

September 8, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)