NCT05061433

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

June 1, 2022

Status Verified

September 1, 2021

Enrollment Period

4.7 years

First QC Date

September 21, 2021

Last Update Submit

May 31, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Incidence of hospital readmissions

    30 days

  • Incidence of adverse medical events

    30 days

  • Incidence of ED visits

    30 days

Study Arms (2)

Usual Care

NO INTERVENTION

Participants receive standard of care.

Intervention

EXPERIMENTAL

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.

Other: Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support

Interventions

MIH/CP provider and their team will offer additional support and connection to resources after patient is discharged from hospital.

Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PneumoniaMyocardial InfarctionPulmonary Disease, Chronic Obstructive

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisLung Diseases, ObstructiveChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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

September 21, 2021

First Posted

September 29, 2021

Study Start

February 8, 2016

Primary Completion

October 10, 2020

Study Completion

July 31, 2022

Last Updated

June 1, 2022

Record last verified: 2021-09