Mobile Integrated Healthcare and Community Paramedicine

NCT ID: NCT05061433

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-08
• Study Completion Date: 2022-07-31

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).

Conditions

Hospital Readmission; Pneumonia; Myocardial Infarction; COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants receive standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

693277

Identifier Type: -

Identifier Source: org_study_id