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Mobile Integrated Healthcare and Community Paramedicine

Primary Purpose

Hospital Readmission, Pneumonia, Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hospital Readmission

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual Care

    Intervention

    Arm Description

    Participants receive standard of care.

    Initial Home Visit: MIH/CP provider team will visit the patient's home at the scheduled time following a specific General Followup Protocol involving 1. Assessment of patient understanding of recent illness and medical therapy including reinforcement of medical adherence, 2. Any other disease-specific concerns, 3. Performance of a home safety evaluation, 4. If patients have concerns relating to their ability to manage their disease process at home, 5. MIH/CP providers and an on-call social worker will provide assistance in the form of on-site, telephone, and electronic referrals or provision of appointments with appropriate services. Subsequent visits: The MIH/CP team will decide in conjunction with Medical Control and the PMD if further followup is needed, and the most appropriate followup interval., At 30 days from initial hospital discharge, the patient will be discharged from the MIH/CP program in conjunction with the PMD.

    Outcomes

    Primary Outcome Measures

    Incidence of hospital readmissions
    Incidence of adverse medical events
    Incidence of ED visits

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2021
    Last Updated
    May 31, 2022
    Sponsor
    Rhode Island Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05061433
    Brief Title
    Mobile Integrated Healthcare and Community Paramedicine
    Official Title
    Mobile Integrated Healthcare and Community Paramedicine: A Pilot Project Using LifePACT Critical Care Physician, Paramedic, and RN Staff to Increase Patient Satisfaction and Reduce Hospital Readmissions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 8, 2016 (Actual)
    Primary Completion Date
    October 10, 2020 (Actual)
    Study Completion Date
    July 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Rhode Island Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hospital Readmission, Pneumonia, Myocardial Infarction, 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
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Participants receive standard of care.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Initial Home Visit: MIH/CP provider team will visit the patient's home at the scheduled time following a specific General Followup Protocol involving 1. Assessment of patient understanding of recent illness and medical therapy including reinforcement of medical adherence, 2. Any other disease-specific concerns, 3. Performance of a home safety evaluation, 4. If patients have concerns relating to their ability to manage their disease process at home, 5. MIH/CP providers and an on-call social worker will provide assistance in the form of on-site, telephone, and electronic referrals or provision of appointments with appropriate services. Subsequent visits: The MIH/CP team will decide in conjunction with Medical Control and the PMD if further followup is needed, and the most appropriate followup interval., At 30 days from initial hospital discharge, the patient will be discharged from the MIH/CP program in conjunction with the PMD.
    Intervention Type
    Other
    Intervention Name(s)
    Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support
    Intervention Description
    MIH/CP provider and their team will offer additional support and connection to resources after patient is discharged from hospital.
    Primary Outcome Measure Information:
    Title
    Incidence of hospital readmissions
    Time Frame
    30 days
    Title
    Incidence of adverse medical events
    Time Frame
    30 days
    Title
    Incidence of ED visits
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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