- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835989
Community Paramedicine at Home (CP@Home)
Community Paramedicine at Home (CP @Home)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S4K1
- McMaster University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Usual Care
|
|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in number of ED presentations
Time Frame: Baseline and 1 year
|
Individual-level change in number of ED presentations (pre-post)
|
Baseline and 1 year
|
|
Change in number of hospital admissions
Time Frame: Baseline and 1 year
|
Individual-level change in number of hospital admissions (pre-post)
|
Baseline and 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gina Agarwal, MBBS MRCGP CCFP PhD, McMaster University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2153
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Disease
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruitingCardiovascular Disease (CVD) | Gender Incongruence | Cardiovascular (CV) Risk | Cardiovascular Health Status | Cardiovascular Disease Prevention | Cardiovascular Disease Acute | Cardiovascular Disease Risk FactorItaly
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedCardiovascular Disease | Inflammatory DiseaseUnited States
-
University College DublinBeacon Hospital, IrelandRecruitingCoronary Artery Disease (CAD) | Cardiovascular Diseases (CVD) | Cardiovascular Disease Prevention | Cardiovascular Disease Risk FactorIreland
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Istituti Clinici Scientifici Maugeri SpAA.R.C.A Associazioni Regionali Cardiologi AmbulatorialiRecruiting
-
AmgenRecruitingCardiovascular DiseaseItaly, Germany, United States, China, Japan, Spain, Denmark, Australia, France, Canada, Netherlands
-
University of ReadingBiotechnology and Biological Sciences Research Council; Royal Berkshire NHS...Not yet recruiting
-
Nanjing Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingCardiovascular DiseaseFrance
Clinical Trials on CP@Home
-
PfizerTerminatedObesityUnited States, Australia, Canada, Brazil, Slovakia, Czech Republic, Argentina, Germany, Mexico, United Kingdom, Sweden
-
Janssen Pharmaceutical K.K.Completed
-
Siemens Molecular ImagingTerminatedBreast CancerUnited States
-
PfizerTerminatedObesityAustralia, United States, Korea, Republic of, Spain, France, United Kingdom, Germany, Sweden, Argentina, Chile, Mexico
-
PfizerTerminatedObesityUnited States, Canada
-
University of California, San FranciscoCalifornia Breast Cancer Research ProgramCompleted
-
Institute for Clinical and Experimental MedicineRecruitingMyocardial Infarction | Shock, Cardiogenic | Remodeling, VentricularCzechia
-
PfizerCompletedTibial FracturesUnited States, Australia, Canada, Spain, Turkey, Croatia, India, Bosnia and Herzegovina, Japan, Russian Federation, South Africa
-
Tasca TherapeuticsRecruitingNon-Small Cell Lung Cancer | Bladder Cancer | Colorectal Carcinoma | Solid Tumor Malignancies | Pancreatic Cancer, Advanced or Metastatic | Head and Neck (HNSCC) | Small Cell Lung Cancer ( SCLC )United States
-
Abramson Cancer Center of the University of PennsylvaniaCompletedAdvanced Solid TumorsUnited States