ClinicalTrials.gg
Status unknownNCT05061433Updated Jun 1, 2022

Mobile Integrated Healthcare and Community Paramedicine

An interventional study of Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support in Hospital Readmission, Pneumonia and Myocardial Infarction, sponsored by Rhode Island Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-01.

Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Feb 2016, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Hospital Readmission
  • Pneumonia
  • Myocardial Infarction
  • COPD
03

In context

Pneumonia

2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.

This study's enrollment of 44 is below the median of 107 across 1,263 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Rhode Island Hospital is the lead sponsor of 191 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • No intervention
    Usual Care

    Participants receive standard of care.

  • Experimental
    Intervention

    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

  • OtherMobile 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.

06

What researchers measure

Primary outcomes

  1. Incidence of hospital readmissions

    Time frame: 30 days

  2. Incidence of adverse medical events

    Time frame: 30 days

  3. Incidence of ED visits

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2016 to primary completion in Oct 2020, 56 months.

Of 293 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 56 months is above that.

Counting every sponsor, half of 303 studies reached it within 21 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2021
First posted
Sep 29, 2021
StartActual
Feb 8, 2016
Primary completionActual
Oct 10, 2020
CompletionEst.
Jul 31, 2022
Last update
Jun 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05061433
Responsible party
Sponsor
First posted
Sep 29, 2021
Start date
Feb 8, 2016
Primary completion
Oct 10, 2020
Completion
Jul 31, 2022 (estimated)
Last update
Jun 1, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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