NCT02835989

Brief Summary

Community Paramedicine @Home (CP@Home) is a novel community paramedicine health assessment program for high users of Emergency Medical Services (EMS). Individuals who have been identified as active callers to EMS, individuals who have called EMS for lift-assists, and direct paramedic referrals are referred into the community paramedicine home visit program. The program will focus on in-home chronic disease management, community health service connections, and EMS usage education. Aside from chronic disease management, aspects of the program include health-related quality of life, social isolation and other social determinants of health. Participants in the program will have up to 3 one-on-one home visits from a community paramedic to ultimately reduce repeat EMS calls and improve their overall health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,826

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
2.3 years until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

July 14, 2016

Last Update Submit

September 21, 2022

Conditions

Keywords

Community ParamedicineParamedicEmergency Medical ServicesHigh Frequency CallersLift Assists

Outcome Measures

Primary Outcomes (1)

  • Change in number of repeat EMS calls

    Individual-level change in EMS call rate resulting in ambulance dispatch (pre-post intervention)

    Baseline and 1 year

Secondary Outcomes (2)

  • Change in number of ED presentations

    Baseline and 1 year

  • Change in number of hospital admissions

    Baseline and 1 year

Study Arms (2)

CP@Home Intervention

EXPERIMENTAL

The experimental group will receive the CP@Home program. The main elements of this program include BP assessment, diabetes risk assessment, falls risk assessment, heart failure risk assessment, neurologic assessment, psychiatric assessment, depression screening, health-related quality of life analysis (including pain, mobility, anxiety/depression, ADLs), social isolation screening, and food and income security. The program is targeted at referrals to appropriate community resources, identification and referral of high-risk patients to their family physician (FP), as well as regular communication of participants' health information to their physician. The intervention will be implemented by community paramedics from the local paramedic service who have undergone a structured training program (4 hours of online, interactive training modules, including case studies and the observation of an intervention visits led by another paramedic) to assure intervention fidelity.

Other: CP@Home

Control

NO INTERVENTION

Usual Care

Interventions

CP@HomeOTHER

Community paramedics (CPs) will be assigned to visiting the participants for a first time the week following the initial EMS call. Participants will complete the informed consent process with a CP on their first visit. This visit will also include a full assessment and risk analysis that will take approximately 90 minutes and will be located in the participant's home. As a result of the initial visit, the CP will make all relevant clinical referrals and decisions based on predetermined @Home algorithms. A second visit will be made to the participant 2-4 weeks following the initial call for a streamlined follow-up and reassessment during a 30 minute period. A final visit will be made 6-8 weeks following the initial call for a final evaluation of their situation. It is anticipated the patient will be discharged from the CP@Home program at this point. If the patient calls EMS following the third visit, if they meet the inclusion criteria, they will be re-entered into the CP@Home program.

CP@Home Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • or more EMS calls in the last 6 months from intervention start date AND active caller in the last 30 days OR
  • Any call for a lift assist to EMS in the past 30 days OR
  • Paramedic referral into program (identified by paramedic through usual practice)

You may not qualify if:

  • Individuals living in long term care facilities
  • Individuals currently involved in a home visit or social navigator program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4K1, Canada

Location

Related Publications (2)

  • Agarwal G, Angeles R, Brar J, Pirrie M, Marzanek F, McLeod B, Thabane L. Effectiveness of the community paramedicine at home (CP@home) program for frequent users of emergency medical services in Ontario: a randomized controlled trial. BMC Health Serv Res. 2024 Nov 25;24(1):1462. doi: 10.1186/s12913-024-11952-7.

  • Agarwal G, Pirrie M, McLeod B, Angeles R, Tavares W, Marzanek F, Thabane L. Rationale and methods of an Evaluation of the Effectiveness of the Community Paramedicine at Home (CP@home) program for frequent users of emergency medical services in multiple Ontario regions: a study protocol for a randomized controlled trial. Trials. 2019 Jan 23;20(1):75. doi: 10.1186/s13063-018-3107-4.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusSocial Isolation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Gina Agarwal, MBBS MRCGP CCFP PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 18, 2016

Study Start

October 25, 2018

Primary Completion

July 20, 2020

Study Completion

December 31, 2021

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations