Expanding Paramedicine in the Community

NCT02034045 | Completed

• 1 other identifier: EPIC - RCT
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hospital admissions per patient

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

  maximum 2 years

Secondary Outcomes (2)

• Health Resource Utilization

  maximum 2 years

• Cost Effectiveness

  maximum 2 years

Other Outcomes (1)

• Trial Fidelity and Safety

  maximum 2 years

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Community Paramedicine

EXPERIMENTAL

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

Interventions

Community Paramedicine OTHER

Community Paramedicine

Usual Care OTHER

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (4)

Health for All and Markham Family Health Team

Markham, Ontario, Canada

Location

Aurora-Newmarket Family Health Team

Newmarket, Ontario, Canada

Location

Owen Sound Family Health Team

Owen Sound, Ontario, Canada

Location

Stouffville Medical Centre

Stouffville, Ontario, Canada

Location

Related Publications (3)

• 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.

  PMID: 34495549 DERIVED

• 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.

  PMID: 25909892 DERIVED

• 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.

  PMID: 25467772 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurie Morrison, MD, MSc, FRCPC

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 13, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

CA (4)