Cardiovascular DiseaseCP@HomeNCT02835989
Community Paramedicine at Home
A study testing CP@Home in people with Cardiovascular Disease and Diabetes Mellitus, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Diabetes Mellitus, Accidental Falls
- What is being tested?
- CP@Home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,826 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Individuals living in long term care facilities
- Individuals currently involved in a home visit or social navigator program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Paramedicine at Home (CP @Home)
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.
- Conditions
- Cardiovascular Disease, Diabetes Mellitus, Accidental Falls, Social Isolation, Food Insecurity
- Being tested
- CP@Home
- Keywords
- Community Paramedicine, Paramedic, Emergency Medical Services, High Frequency Callers, Lift Assists
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CP@Home |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of repeat EMS calls
Individual-level change in EMS call rate resulting in ambulance dispatch (pre-post intervention)
Measured: Baseline and 1 year
Secondary outcomes (2)
Change in number of ED presentations
Individual-level change in number of ED presentations (pre-post)
Measured: Baseline and 1 year
Change in number of hospital admissions
Individual-level change in number of hospital admissions (pre-post)
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start25 Oct 2018
- Primary completion20 Jul 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,826 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gina Agarwal, MBBS MRCGP CCFP PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835989
- Sponsor's protocol ID
- 2153
- Acronym
- CP@Home
- Status last verified
- Sep 2022
- First submitted
- 14 Jul 2016
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39587610Agarwal 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.
PubMed 30674347
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Paramedicine at Home (CP @Home)
- ClinicalTrials.gov ID
- NCT02835989
- Acronym / sponsor ID
- CP@Home / 2153
- Conditions
- Cardiovascular Disease, Diabetes Mellitus, Accidental Falls, Social Isolation, Food Insecurity
- Keywords
- Community Paramedicine, Paramedic, Emergency Medical Services, High Frequency Callers, Lift Assists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,826 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP@Home Intervention | Experimental | Other: CP@HomeThe 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. |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Individuals living in long term care facilities
- Individuals currently involved in a home visit or social navigator program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP@HomeCommunity 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. | Other | CP@Home Intervention |
Primary outcome
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)
2 secondary outcomes
Change in number of ED presentations
Time frame: Baseline and 1 year
Change in number of hospital admissions
Time frame: Baseline and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Derived from this study: PubMed 39587610Agarwal 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.
- Derived from this study: PubMed 30674347Agarwal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Agarwal, MBBS MRCGP CCFP PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CP@Home in people with Cardiovascular Disease and Diabetes Mellitus, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of repeat EMS calls (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835989, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.