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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05061433
Other study ID # 693277
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 8, 2016
Est. completion date July 31, 2022

Study information

Verified date September 2021
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Background: Initially conceived of as a method to address healthcare needs of underserved rural populations, Mobile Integrated Healthcare and Community Paramedicine (MIH/CP) is a new model of inter-professional, community-based outpatient healthcare delivery that primarily utilizes the resources and training of Emergency Medical Services (EMS) to fill gaps in local healthcare infrastructure, expanding existing scope of practice in most cases while not detracting from acute transport capabilities. Although programs have been in existence since the early 1990s, there are few objective studies of the efficacy, safety, and cost-effectiveness of MIH/CP programs, many of which are limited-scope pilot projects. The limited data already published on these measures by established programs shows substantial Medicare charge-avoidances in patients enrolled in CHF-readmission prevention and EMS frequent user programs, and a significant reduction in Emergency Department visits overall, especially in austere environments. In summary, MIH/CP is an attempt at formalization of long-standing practices to collaborate with and supplement other healthcare system components such as primary care and home health services. Standardized, objective data collection and publication of results will be needed to support continuation and financial support of this emerging concept. Objective/Hypothesis: Using the existing resources of the MD-, RN- and Paramedic-staffed Lifespan Pediatric and Adult Critical Care Transport (LifePACT) service, investigators aim to study whether implementation of an MIH/CP pilot program tailored to the needs of an urban, underserved population in Providence, Rhode Island, will reduce the rate of 30-day hospital readmissions for patients after discharges for community-acquired pneumonia, acute MI, and COPD. In addition, investigators will study whether such a program is considered to be safe (in terms of not increasing the number of adverse events post-discharge for patients or compromising the efficacy of the LifePACT transport role) and considered satisfactory by patients (rated comparably to visits by other outpatient health care services such as VNA services).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date July 31, 2022
Est. primary completion date October 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Current inpatient/observation status for: NSTEMI; CHF; PNA (community or HCAP); COPD; Wound infection or complication, - English Speaking, - Not pregnant, - Not incarcerated, - Able to maintain clinical sobriety for informed consent and home visitation., - No unstable psychiatric conditions (Patients may be under treatment for mental health conditions as long as their symptoms are controlled)., - Accessible and reliable place of residence that is not a nursing home or "on the street" location. (Homeless patients are eligible as long as they have consistent access to a domicile that can provide shelter and privacy)., - No anticipated VNA or home care within 24-36 hours of visit, - Ages 18-80

Study Design


Intervention

Other:
Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support
MIH/CP provider and their team will offer additional support and connection to resources after patient is discharged from hospital.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rhode Island Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of hospital readmissions 30 days
Primary Incidence of adverse medical events 30 days
Primary Incidence of ED visits 30 days
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