Limits...
Expanding Paramedicine in the Community (EPIC): study protocol for a randomized controlled trial.

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 - Trials (2014)

Bottom Line: Secondary outcomes will include measures of health system utilization, overall health status, and cost-effectiveness of the intervention over the same time period.The results of this study will be used to inform decisions around the implementation of community paramedic programs.If successful in preventing hospitalizations, it has the ability to be scaled up to other regions, both nationally and internationally.

View Article: PubMed Central - PubMed

Affiliation: Rescu, Li Ka Shing Knowledge Institute, St, Michael's Hospital, 30 Bond St, Toronto, ON M5B 1W8, Canada. DrennanI@smh.ca.

ABSTRACT

Background: The incidence of chronic diseases, including diabetes mellitus (DM), heart failure (HF) and chronic obstructive pulmonary disease (COPD) is on the rise. The existing health care system must evolve to meet the growing needs of patients with these chronic diseases and reduce the strain on both acute care and hospital-based health care resources. Paramedics are an allied health care resource consisting of highly-trained practitioners who are comfortable working independently and in collaboration with other resources in the out-of-hospital setting. Expanding the paramedic's scope of practice to include community-based care may decrease the utilization of acute care and hospital-based health care resources by patients with chronic disease.

Methods/design: This will be a pragmatic, randomized controlled trial comparing a community paramedic intervention to standard of care for patients with one of three chronic diseases. The objective of the trial is to determine whether community paramedics conducting regular home visits, including health assessments and evidence-based treatments, in partnership with primary care physicians and other community based resources, will decrease the rate of hospitalization and emergency department use for patients with DM, HF and COPD. The primary outcome measure will be the rate of hospitalization at one year. Secondary outcomes will include measures of health system utilization, overall health status, and cost-effectiveness of the intervention over the same time period. Outcome measures will be assessed using both Poisson regression and negative binomial regression analyses to assess the primary outcome.

Discussion: The results of this study will be used to inform decisions around the implementation of community paramedic programs. If successful in preventing hospitalizations, it has the ability to be scaled up to other regions, both nationally and internationally. The methods described in this paper will serve as a basis for future work related to this study.

Trial registration: ClinicalTrials.gov: NCT02034045. Date: 9 January 2014.

Show MeSH

Related in: MedlinePlus

Patient block stratified randomization procedure.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4289358&req=5

Fig1: Patient block stratified randomization procedure.

Mentions: Eligible patients will be contacted by their family physician and given multiple opportunities to provide their consent to participate. Enrollment will employ a modified Dillman method [17] with prepaid postage response cards. All patients will be consented using exactly the same process prior to randomization. See Additional files 3 and 4.A block stratified randomization procedure will be used to randomize eligible, consenting patients to treatment or control groups (1:1 ratio). Randomization will occur using a computer generated randomized number sequence allocated by block based on disease, using variable block sizes to avoid substantial imbalances in the number of patients assigned to each group (FigureĀ 1) and to ensure the three disease groups are represented in the intervention or control (usual care) group. Stratification will balance differences in disease characteristics, which may influence the primary outcomes. Should patients have multiple diagnoses, patients with HF will be categorized HF regardless of the other diagnoses and patients with both COPD and DM will be categorized as COPD. Categorization is based on the prevalence of disease previously noted in a subset of patients in which the number of patients diagnosed as having HF was markedly reduced. A preliminary feasibility sample of cases from within the two family health care teams identified 548 patients: 74 COPD patients, 417 DM patients, and 31 HF patients. One patient had all 3 conditions, 17 had diabetes and HF, 1 had HF and COPD and finally 7 patients had both diabetes and COPD. Informed consent will be obtained from all patients prior to enrollment in the EPIC study. Patient recruitment will occur over a 1-year period. Based upon the preliminary feasibility sample and the sample size calculation required to detect a 15% difference in our primary outcome, this will be sufficient time to enroll the required number of patients.Figure 1


Expanding Paramedicine in the Community (EPIC): study protocol for a randomized controlled trial.

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 - Trials (2014)

Patient block stratified randomization procedure.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4289358&req=5

Fig1: Patient block stratified randomization procedure.
Mentions: Eligible patients will be contacted by their family physician and given multiple opportunities to provide their consent to participate. Enrollment will employ a modified Dillman method [17] with prepaid postage response cards. All patients will be consented using exactly the same process prior to randomization. See Additional files 3 and 4.A block stratified randomization procedure will be used to randomize eligible, consenting patients to treatment or control groups (1:1 ratio). Randomization will occur using a computer generated randomized number sequence allocated by block based on disease, using variable block sizes to avoid substantial imbalances in the number of patients assigned to each group (FigureĀ 1) and to ensure the three disease groups are represented in the intervention or control (usual care) group. Stratification will balance differences in disease characteristics, which may influence the primary outcomes. Should patients have multiple diagnoses, patients with HF will be categorized HF regardless of the other diagnoses and patients with both COPD and DM will be categorized as COPD. Categorization is based on the prevalence of disease previously noted in a subset of patients in which the number of patients diagnosed as having HF was markedly reduced. A preliminary feasibility sample of cases from within the two family health care teams identified 548 patients: 74 COPD patients, 417 DM patients, and 31 HF patients. One patient had all 3 conditions, 17 had diabetes and HF, 1 had HF and COPD and finally 7 patients had both diabetes and COPD. Informed consent will be obtained from all patients prior to enrollment in the EPIC study. Patient recruitment will occur over a 1-year period. Based upon the preliminary feasibility sample and the sample size calculation required to detect a 15% difference in our primary outcome, this will be sufficient time to enroll the required number of patients.Figure 1

Bottom Line: Secondary outcomes will include measures of health system utilization, overall health status, and cost-effectiveness of the intervention over the same time period.The results of this study will be used to inform decisions around the implementation of community paramedic programs.If successful in preventing hospitalizations, it has the ability to be scaled up to other regions, both nationally and internationally.

View Article: PubMed Central - PubMed

Affiliation: Rescu, Li Ka Shing Knowledge Institute, St, Michael's Hospital, 30 Bond St, Toronto, ON M5B 1W8, Canada. DrennanI@smh.ca.

ABSTRACT

Background: The incidence of chronic diseases, including diabetes mellitus (DM), heart failure (HF) and chronic obstructive pulmonary disease (COPD) is on the rise. The existing health care system must evolve to meet the growing needs of patients with these chronic diseases and reduce the strain on both acute care and hospital-based health care resources. Paramedics are an allied health care resource consisting of highly-trained practitioners who are comfortable working independently and in collaboration with other resources in the out-of-hospital setting. Expanding the paramedic's scope of practice to include community-based care may decrease the utilization of acute care and hospital-based health care resources by patients with chronic disease.

Methods/design: This will be a pragmatic, randomized controlled trial comparing a community paramedic intervention to standard of care for patients with one of three chronic diseases. The objective of the trial is to determine whether community paramedics conducting regular home visits, including health assessments and evidence-based treatments, in partnership with primary care physicians and other community based resources, will decrease the rate of hospitalization and emergency department use for patients with DM, HF and COPD. The primary outcome measure will be the rate of hospitalization at one year. Secondary outcomes will include measures of health system utilization, overall health status, and cost-effectiveness of the intervention over the same time period. Outcome measures will be assessed using both Poisson regression and negative binomial regression analyses to assess the primary outcome.

Discussion: The results of this study will be used to inform decisions around the implementation of community paramedic programs. If successful in preventing hospitalizations, it has the ability to be scaled up to other regions, both nationally and internationally. The methods described in this paper will serve as a basis for future work related to this study.

Trial registration: ClinicalTrials.gov: NCT02034045. Date: 9 January 2014.

Show MeSH
Related in: MedlinePlus