ClinicalTrials.gov
ClinicalTrials.gov Menu

Expanding Paramedicine in the Community (EPIC)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02034045
Recruitment Status : Unknown
Verified April 2016 by St. Michael's Hospital, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : January 13, 2014
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus (DM) Congestive Heart Failure (CHF) Chronic Obstructive Pulmonary Disease (COPD) Other: Community Paramedicine Other: Usual Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Expanding Paramedicine in the Community (Study)
Study Start Date : June 2013
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Active Comparator: Usual Care
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.
Other: Usual Care
Experimental: Community Paramedicine
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.
Other: Community Paramedicine



Primary Outcome Measures :
  1. Hospital admissions per patient [ Time Frame: maximum 2 years ]
    The primary outcome of this trial is the one-year measurement of hospital admissions per patient.


Secondary Outcome Measures :
  1. Health Resource Utilization [ Time Frame: maximum 2 years ]

    The secondary outcomes will be measures of health system utilization at one year (reported as all cause and disease specific) and will include:

    1. Calls to 911 (regardless of whether patient was transported to hospital)
    2. Visits to the participating Family Health Team clinics and any after-hours clinics
    3. Length of stay in hospital

  2. Cost Effectiveness [ Time Frame: maximum 2 years ]
    Cost effectiveness analysis for this model of care based on the composite outcome measures.


Other Outcome Measures:
  1. Trial Fidelity and Safety [ Time Frame: maximum 2 years ]
    Measures of intervention compliance and safety (ie. Completed assessments and visits, protocol violations identified by physician review of EMR)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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): NCT02034045


Locations
Canada, Ontario
Health for All and Markham Family Health Team
Markham, Ontario, Canada
Aurora-Newmarket Family Health Team
Newmarket, Ontario, Canada
Owen Sound Family Health Team
Owen Sound, Ontario, Canada
Stouffville Medical Centre
Stouffville, Ontario, Canada
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Laurie Morrison, MD, MSc, FRCPC St. Michael's Hospital, Toronto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02034045     History of Changes
Other Study ID Numbers: EPIC - RCT
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases