Clinical trial NCT02233153: Elder-friendly Approaches to the Surgical Environment (EASE) Study
Official title: Elder-friendly Approaches to the Surgical Environment - Implementation of an Elder Friendly Surgical Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Surgery
Keywords: Senior
Elderly
Acute Care
Emergency Surgery
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Innovates Health Solutions
First posted: 2014-09-08
Enrollment: 723
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients \> 65 years old admitted and received acute abdominal surgery

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:

Eligibility 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

Primary outcomes:
measure: Post-Operative complications
timeFrame: During initial in-hospital stay (0-12 weeks on average)
measure: Death
timeFrame: During initial in-hospital stay (0-12 weeks on average)
Secondary outcomes:
measure: Post-discharge complications or health-events requiring re-admission
timeFrame: Within 30 days post-discharge
measure: Cost per quality-adjusted life year
timeFrame: 6 months post-discharge
Other outcomes:
measure: Health Related Quality of Life
timeFrame: 6 weeks and 6 months post-discharge
measure: Functional Status (Frailty)
timeFrame: 6 weeks post-discharge
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center, Acute Care Emergency Surgical Services
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital, Acute Care and Emergency Surgery Service
state: Alberta
Study officials:
affiliation: University of Alberta
name: Rachel G Khadaroo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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/cmaj.161403.
citation: 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.
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) pilot study. World J Emerg Surg. 2018 May 21;13:21. doi: 10.1186/s13017-018-0180-7. eCollection 2018.
citation: 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.
citation: 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.
citation: 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.