Hospital ReadmissionNCT05061433
Mobile Integrated Healthcare and Community Paramedicine
A study testing Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support in people with Hospital Readmission and Pneumonia, run by Rhode Island Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hospital Readmission, Pneumonia, Myocardial Infarction
- What is being tested?
- Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2016to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).,
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- 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
Who cannot join
None listed.
About this study
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
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.
Read more
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
- Being tested
- Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support
- Medical subject headings
- Pneumonia, Myocardial Infarction, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) SupportOther
MIH/CP provider and their team will offer additional support and connection to resources after patient is discharged from hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital readmissions
Measured: 30 days
Incidence of adverse medical events
Measured: 30 days
Incidence of ED visits
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start8 Feb 2016
- Primary completion10 Oct 2020
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital ReadmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061433
- Sponsor's protocol ID
- 693277
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05061433
- Acronym / sponsor ID
- 693277
- Conditions
- Hospital Readmission, Pneumonia, Myocardial Infarction, COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 8 Feb 2016 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants receive standard of care. |
| Intervention | Experimental | Other: Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) SupportInitial 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) SupportMIH/CP provider and their team will offer additional support and connection to resources after patient is discharged from hospital. | Other | Intervention |
Primary outcome
Incidence of hospital readmissions
Time frame: 30 days
Incidence of adverse medical events
Time frame: 30 days
Incidence of ED visits
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support in people with Hospital Readmission and Pneumonia, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital readmissions (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.