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Expanding Paramedicine in the Community (EPIC)

Primary Purpose

Diabetes Mellitus (DM), Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Community Paramedicine
Usual Care
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus (DM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Residents of the region of York, Ontario, 18 years of age or older, diagnosed at any point in time with COPD, CHF, or DM and identified by the Family Health Care Team as high risk for admission.

Exclusion Criteria:

Residents of long-term care facilities or if have cognitive impairment, uncontrolled psychiatric disease or language barriers that would make it difficult to understand the consent and communicate with the paramedic during the scheduled visits, unless the individual with power of attorney for personal care consented and agreed to be at each visit.

Sites / Locations

  • Health for All and Markham Family Health Team
  • Aurora-Newmarket Family Health Team
  • Owen Sound Family Health Team
  • Stouffville Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Community Paramedicine

Arm Description

Patients randomized to the control group will continue to receive usual care from their Family Health Care Team. Usual care includes physician assessment and treatment and periodic augmentation of care in the community (CCAC or case manager, nurse practitioner) at the discretion of the treating physician.

The intervention will consist of an initial visit and 3 follow-up visits at 3 month intervals over one year by a paramedic who has received additional training in chronic disease management, in addition to routine usual care and any additional visits prompted by the patient, the paramedic or the Family Health Care Team.

Outcomes

Primary Outcome Measures

Hospital admissions per patient
The primary outcome of this trial is the one-year measurement of hospital admissions per patient.

Secondary Outcome Measures

Health Resource Utilization
The secondary outcomes will be measures of health system utilization at one year (reported as all cause and disease specific) and will include: Calls to 911 (regardless of whether patient was transported to hospital) Visits to the participating Family Health Team clinics and any after-hours clinics Length of stay in hospital
Cost Effectiveness
Cost effectiveness analysis for this model of care based on the composite outcome measures.

Full Information

First Posted
January 9, 2014
Last Updated
April 8, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02034045
Brief Title
Expanding Paramedicine in the Community
Acronym
EPIC
Official Title
The Expanding Paramedicine in the Community (Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Initiatives aimed at reducing Emergency Department (ED) wait times and improved community health initiatives are major priorities in Canada. Three of the most common chronic diseases worldwide are Diabetes Mellitus (DM), Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). These diseases are on the rise and currently cost the Canadian health care system billions of dollars every year including the cost of hospitalizations and ED visits. The existing health care system does not have the resources and manpower to effectively care for these patients in the future. Paramedics are currently employed to provide Emergency Medical Services in remote, rural and urban settings in Canada. They are highly trained health care practitioners that are mobile in the community and currently work in a physician medically delegated act model and therefore are positioned to take on new collaborative roles to deliver patient care in the community setting. Increased community paramedic care could decrease the utilization of the health care system resources for patients with chronic disease. Using a randomized control trial design we will attempt to answer the question of whether whether non-emergency community paramedics conducting home visits to undertake assessments and evidence-based treatments of patients in partnership with family doctors will decrease the rate of patient hospitalization.
Detailed Description
Imagine if we could leverage existing infrastructure to enhance how we better manage and support patients with chronic disease in the community? Three of the most common chronic diseases worldwide are Diabetes Mellitus (DM), Congestive Heart Failure (CHF) and Chronic Obstructive Pulmonary Disease (COPD). These diseases are on the rise and currently cost the Canadian health care system billions of dollars every year including the cost of unnecessary hospitalizations and ED visits. The current structure of the health care system does not have the capacity to effectively care for these patients in the future. Paramedics are currently employed 24-7 to provide Emergency Medical Services (EMS) in urban, rural and settings across Canada. They are highly trained health care practitioners that are connected to and mobile in the community and currently work in a medically delegated act model with physicians where they regularly rely on independent judgment giving them a significant advantage in assessing patients. The evidence already tells us that collaborative Chronic Care Models can improve patient outcomes and decrease overall health care utilization. What if we leveraged this incredible resource to enhance patient care in the community setting? We hypothesize that training paramedics in chronic disease management and having them conduct home visits to assess and treat patients under medical delegation of the patients' primary care physicians will reduce the rate of acute care hospitalization and, ED visits, EMS utilization, and Family Health Team (FHT) utilization for COPD, DM and CHF patients. So how do we find out if it works? We propose a randomized controlled trial (Level 1 evidence) to rigorously study the effectiveness of community paramedicine model versus standard care. The primary study question is whether non-emergency community paramedics conducting home visits to undertake assessments and evidence-based treatments of patients under the medical delegation of primary care physicians will decrease the rate of hospitalization for chronic disease patients. Our intervention will be applied in select Ontario Family Health Team (FHT) patients diagnosed with COPD, CHF and DM. We plan to randomize 695 patients: patients randomized to the intervention group will be assessed and treated during home visits by community paramedics. Patients randomized to the control group will continue to receive usual care from the participating Family Health Teams. The number of hospitalizations, hospital length of stay, ED visits, EMS utilization and cost-effectiveness will be compared using existing administrative databases. We have been doing a feasibility trial since March of 2013 to confirm our recruitment and data collection approaches. The intent of the Partnerships for Health System Improvement (PHSI) program is to strengthen Canada's health care system through collaborative, applied and policy-relevant research. Our project has been developed in strong partnership with Centennial College; Central Community Care Access Centre; York Region Emergency Medical Services; Health For All Family Health Team; Markham Family Health Team; Rescu, Li Ka Shing Knowledge Institute, St. Michael's Hospital; and the Sunnybrook Centre for Prehospital Medicine. We have also partnered directly with the Primary Care Branch of the Ministry of Health and Long Term Care to ensure a fruitful integrated knowledge translation plan at the policy level. By engaging all of the key stakeholders upfront we have already created the necessary linkages to make this health system innovation possible. If found to be effective, the simplicity of the community paramedicine model allows it to be scalable in various ways for EMS services across the country. It could also be expanded to include management of several other conditions. Funding is only getting tighter and health care capacities will be increasingly challenged in the coming years - innovation in how we use existing resources is the future of health system improvement. Community paramedicine is a perfect example of this type of innovation and our project will provide the evidence needed by decision makers and knowledge users to significantly impact primary care policy making for the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus (DM), Congestive Heart Failure (CHF), Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
467 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Patients randomized to the control group will continue to receive usual care from their Family Health Care Team. Usual care includes physician assessment and treatment and periodic augmentation of care in the community (CCAC or case manager, nurse practitioner) at the discretion of the treating physician.
Arm Title
Community Paramedicine
Arm Type
Experimental
Arm Description
The intervention will consist of an initial visit and 3 follow-up visits at 3 month intervals over one year by a paramedic who has received additional training in chronic disease management, in addition to routine usual care and any additional visits prompted by the patient, the paramedic or the Family Health Care Team.
Intervention Type
Other
Intervention Name(s)
Community Paramedicine
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Hospital admissions per patient
Description
The primary outcome of this trial is the one-year measurement of hospital admissions per patient.
Time Frame
maximum 2 years
Secondary Outcome Measure Information:
Title
Health Resource Utilization
Description
The secondary outcomes will be measures of health system utilization at one year (reported as all cause and disease specific) and will include: Calls to 911 (regardless of whether patient was transported to hospital) Visits to the participating Family Health Team clinics and any after-hours clinics Length of stay in hospital
Time Frame
maximum 2 years
Title
Cost Effectiveness
Description
Cost effectiveness analysis for this model of care based on the composite outcome measures.
Time Frame
maximum 2 years
Other Pre-specified Outcome Measures:
Title
Trial Fidelity and Safety
Description
Measures of intervention compliance and safety (ie. Completed assessments and visits, protocol violations identified by physician review of EMR)
Time Frame
maximum 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Residents of the region of York, Ontario, 18 years of age or older, diagnosed at any point in time with COPD, CHF, or DM and identified by the Family Health Care Team as high risk for admission. Exclusion Criteria: Residents of long-term care facilities or if have cognitive impairment, uncontrolled psychiatric disease or language barriers that would make it difficult to understand the consent and communicate with the paramedic during the scheduled visits, unless the individual with power of attorney for personal care consented and agreed to be at each visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Morrison, MD, MSc, FRCPC
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health for All and Markham Family Health Team
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Aurora-Newmarket Family Health Team
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Owen Sound Family Health Team
City
Owen Sound
State/Province
Ontario
Country
Canada
Facility Name
Stouffville Medical Centre
City
Stouffville
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
34495549
Citation
Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
Results Reference
derived
PubMed Identifier
25909892
Citation
Heinelt M, Drennan IR, Kim J, Lucas S, Grant K, Spearen C, Tavares W, Al-Imari L, Philpott J, Hoogeveen P, Morrison LJ. Prehospital Identification of Underlying Coronary Artery Disease by Community Paramedics. Prehosp Emerg Care. 2015;19(4):548-53. doi: 10.3109/10903127.2015.1005261. Epub 2015 Apr 24.
Results Reference
derived
PubMed Identifier
25467772
Citation
Drennan IR, Dainty KN, Hoogeveen P, Atzema CL, Barrette N, Hawker G, Hoch JS, Isaranuwatchai W, Philpott J, Spearen C, Tavares W, Turner L, Farrell M, Filosa T, Kane J, Kiss A, Morrison LJ. Expanding Paramedicine in the Community (EPIC): study protocol for a randomized controlled trial. Trials. 2014 Dec 2;15:473. doi: 10.1186/1745-6215-15-473.
Results Reference
derived

Learn more about this trial

Expanding Paramedicine in the Community

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