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

Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Unknown status
CT.gov ID
NCT03991598
Collaborator
Université du Québec a Montréal (Other), University of Toronto (Other), Laval University (Other), Hopital du Sacre-Coeur de Montreal (Other), Ottawa Hospital Research Institute (Other), Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Other), Alberta Health Services, Calgary (Other), Sunnybrook Research Institute (Other), Washington University School of Medicine (Other), McMaster University (Other), Mount Sinai Hospital, Canada (Other), The Ottawa Hospital (Other), Université de Montréal (Other), University of Ottawa (Other), Canadian Institutes of Health Research (CIHR) (Other)
1,500
6
2
36
250
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a step-wedge clinical trial.This is a step-wedge clinical trial.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Connecting Emergency Departments With Community Services to Prevent Mobility Losses in Pre-frail & Frail Seniors (CEDeComS)
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention

EDs 1 to 7 will then be randomly phased-in INT every 3 months.

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

No Intervention: control

During the first 6 months and throughout CTRL time

Outcome Measures

Primary Outcome Measures

  1. Changes in Cumulative Incidence of Functional Decline at 3 and 6 months after the intial ED visit (Baseline) [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]

    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)

Secondary Outcome Measures

  1. Changes in mean SPPB scores at 3 and 6 months after the initial ED visit (baseline) [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]

    The SPPB (Short Physical Portable Battery) combines walking, balance and strength items. Scores range from 0 to 12 (best).

  2. Changes in mean SOF Frailty index scores at 3 and 6 months after the initial ED visit (from Baseline) [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]

    The SOF index is a Frailty measure. Scores range from 0/3 (robust senior) to 3/3 (frail senior)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alberta Health Services Calgary Alberta Canada T2N 2T9
2 Alberta Health Services Edmonton Alberta Canada TG2 2C8
3 Sunnybrook Health Science Center Toronto Ontario Canada M4N 3M5
4 Ottawa Hospital Research Institute Ottawa Ontaro Canada K1Y 4E9
5 Hôpital Sacré-Coeur Montréal Quebec Canada H4J 1C5
6 CHU-Québec Quebec City Quebec Canada G1J 1Z4

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Marcel ME Emond, Md, Ph.D, Centre de recherche du CHU de Québec

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie-Josée Sirois, Ph.D Independent Researcher - Mid Career Investigator, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier:
NCT03991598
Other Study ID Numbers:
  • MP-20-2017-3235
  • 364485
First Posted:
Jun 19, 2019
Last Update Posted:
Jun 19, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie-Josée Sirois, Ph.D Independent Researcher - Mid Career Investigator, CHU de Quebec-Universite Laval
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 19, 2019