Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors

Elderly Clinical Trial

— CEDeComS  

Official title:

Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors (CEDeComS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991598
• Other study ID #: MP-20-2017-3235
• Secondary ID: 364485
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 2020

Study information

• Verified date: June 2019
• Source: CHU de Quebec-Universite Laval
• Contact: Marie-Josée MJ Sirois, Ph.D
• Phone: 418-649-0252
• Email: marie-josee.sirois[@]rea.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Emergencies
• Functional Status

Intervention

Other:
• Exercise program
Exercise program in communities / Exercise program at home

Locations

Country	Name	City	State
Canada	Alberta Health Services	Calgary	Alberta
Canada	Alberta Health Services	Edmonton	Alberta
Canada	Hôpital Sacré-Coeur	Montréal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontaro
Canada	CHU-Québec	Quebec City	Quebec
Canada	Sunnybrook Health Science Center	Toronto	Ontario

Sponsors (16)

Lead Sponsor

Collaborator

CHU de Quebec-Universite Laval

Alberta Health Services, Calgary, Canadian Institutes of Health Research (CIHR), Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Hopital du Sacre-Coeur de Montreal, Laval University, McMaster University, Mount Sinai Hospital, Canada, Ottawa Hospital Research Institute, Sunnybrook Research Institute, The Ottawa Hospital, Université de Montréal, Universite du Quebec a Montreal, University of Ottawa, University of Toronto, Washington University School of Medicine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline)	Proportions of participants showing, at 3 or 6 months post-ED visit, a loss =2/28 on the OARS scale, compared to Baseline. (OARS: Older American Resource and Services multidimensional functional scale, which includes 7 basic ADLs and 7 instrumental ADLs items)	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	Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline)	The SPPB (Short Physical Portable Battery) combines walking, balance and strength items. Scores range from 0 to 12 (best).	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	Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline)	The SOF index is a Frailty measure. Scores range from 0/3 (robust senior) to 3/3 (frail senior)	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