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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. Identifier: NCT02835989
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : October 25, 2019
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE July 14, 2016
First Posted Date  ICMJE July 18, 2016
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE October 25, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Change in number of ED presentations [ Time Frame: Baseline and 1 year ]
    Individual-level change in number of ED presentations (pre-post)
  • Change in number of hospital admissions [ Time Frame: Baseline and 1 year ]
    Individual-level change in number of hospital admissions (pre-post)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Community Paramedicine at Home
Official Title  ICMJE Community Paramedicine at Home (CP @Home)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Diabetes Mellitus
  • Accidental Falls
  • Social Isolation
  • Food Insecurity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: CP@Home
  • No Intervention: Control
    Usual Care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: July 14, 2016)
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Francine Marzanek, BSc BEd 9055259140 ext 28501
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02835989
Other Study ID Numbers  ICMJE 2153
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gina Agarwal, MBBS MRCGP CCFP PhD McMaster University
PRS Account McMaster University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP