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Community Paramedicine at Home (CP@Home)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02835989
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Diabetes Mellitus Accidental Falls Social Isolation Food Insecurity Other: CP@Home Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Community Paramedicine at Home (CP @Home)
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: CP@Home Intervention

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
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.

No Intervention: Control
Usual Care



Primary Outcome Measures :
  1. Change in number of repeat EMS calls [ Time Frame: Baseline and 1 year ]
    Individual-level change in EMS call rate resulting in ambulance dispatch (pre-post intervention)


Secondary Outcome Measures :
  1. Change in number of ED presentations [ Time Frame: Baseline and 1 year ]
    Individual-level change in number of ED presentations (pre-post)

  2. Change in number of hospital admissions [ Time Frame: Baseline and 1 year ]
    Individual-level change in number of hospital admissions (pre-post)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 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)

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835989


Contacts
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Contact: Francine Marzanek, BSc BEd 9055259140 ext 28501 mlefebv@mcmaster.ca

Locations
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Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8S4K1
Contact: Francine Marzanek    9055259140    mlefebv@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Gina Agarwal, MBBS MRCGP CCFP PhD McMaster University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02835989    
Other Study ID Numbers: 2153
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Community Paramedicine
Paramedic
Emergency Medical Services
High Frequency Callers
Lift Assists
Additional relevant MeSH terms:
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Cardiovascular Diseases