Clinical trial NCT03991598: Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors
Official title: Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors (CEDeComS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Functional Status
Keywords: Frail
Prefrail
Mobile decline
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Université du Québec a Montréal
name: University of Toronto
name: Laval University
name: Hopital du Sacre-Coeur de Montreal
name: Ottawa Hospital Research Institute
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Alberta Health Services, Calgary
name: Sunnybrook Research Institute
name: Washington University School of Medicine
name: McMaster University
name: Mount Sinai Hospital, Canada
name: The Ottawa Hospital
name: Université de Montréal
name: University of Ottawa
name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-06-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a step-wedge clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: About 18% of independent people over 65 who are evaluated in Emergency Departments for minor injuries (fractures, sprains) present some mobility decline up to 3 to 6 months postinjury. People at risk of decline are prefrail or frail; this condition could be explained by muscle proprieties loss. Exercise is a proven method that can help limit frailty and allow to restore mobility.

The aim of our study is to evaluate whether a suitable exercise program of one hour, twice a week for 12 weeks will limit functional losses \& fragility in injured older adults after their emergency department visit.

Detailed description: Yearly, around 400 000 Canadian community-dwelling seniors sustain injuries that are not life threatening but limit their mobility and normal activities. Up to 65 % of these seniors seek care in Emergency Departments (EDs) and 2/3 are discharged from EDs with varying degrees of minor injuries. Since 2010 and using multicenter large Canadian cohorts (n=3000), our CIHR CETI\* emerging team has shown that minor injuries trigger a downward spiral of mobility decline in 16% of seniors who are still independent at the time of injury, unmasking early impairments and a prefrail or frail status. As there are no ED management guidelines designed to prevent these prefrail (35%) and frail (13%) injured seniors from losing their mobility and function, they do deteriorate within 6 months post-ED discharge. This is unfortunate because there is compelling evidence of the effectiveness of community and home-based mobility interventions showing that simple, targeted interventions can prevent frailty and functional limitations.

In that context, identification of seniors at risk in EDs is crucial to implement effective interventions. The CETI has validated a simple Clinical Decision Rule (CETI-CDR) that screens and orients seniors at high, moderate and low risk of functional decline to appropriate post-ED follow-ups. The latter include effective community-based mobility interventions available across all Canadian communities. An ongoing pilot study (n=120) in two EDs is showing the feasibility and effectiveness (functional decline prevention) of interventions and patient satisfaction. The investigators thus propose to implement the CEDeComS intervention, which involves the CETI-CDR combined with rapid linkage to community mobility programs directly from EDs.

The Main Objectives of this study are to 1) evaluate the effectiveness of the CEDeComS compared to usual care, on improving seniors' health outcomes, 2) determine the cost-effectiveness of the intervention.

Eligibility criteria: Inclusion Criteria:

* Consultation at Emergency Department (ED) for an injury
* Injury happened in the 14 days prior to ED visit
* 65 years old and over
* Discharge from ED within 48 hours
* Independant in basic Activities of Daily Living (ADL)

Exclusion Criteria:

* Hospitalization related to the trauma
* Major surgery related to the trauma
* Not independant in ADL
* Living in a long-term care home
* Important cognitive impairment
* Not speaking French or English
* Unable to consent
* No trauma

Primary outcomes:
measure: Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline)
timeFrame: Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
Secondary outcomes:
measure: Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline)
timeFrame: Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
measure: Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline)
timeFrame: Outcome measures are assessed at three time points : Baseline T0: time of the Emergency Department (ED) consultation by participants T1: 3 months post-ED consultation; T2: 6 months post-ED consultation
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Health Services
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Science Center
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontaro
city: Montréal
country: Canada
facility: Hôpital Sacré-Coeur
state: Quebec
city: Quebec City
country: Canada
facility: CHU-Québec
state: Quebec
Study officials:
affiliation: Centre de recherche du CHU de Québec
name: Marcel ME Emond, Md, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sirois MJ, Carmichael PH, Daoust R, Eagles D, Griffith L, Lang E, Lee J, Perry JJ, Veillette N, Emond M; Canadian Emergency Team Initiative on Mobility in Aging. Functional Decline After Nonhospitalized Injuries in Older Patients: Results From the Canadian Emergency Team Initiative Cohort in Elders. Ann Emerg Med. 2022 Aug;80(2):154-164. doi: 10.1016/j.annemergmed.2022.01.041. Epub 2022 Mar 16.