Clinical trial NCT05540158: A Mobile Integrated Health Intervention to Manage Congestive Health Failure and Chronic Obstructive Pulmonary Disease
Official title: A Mobile Integrated Health Intervention for the Management of Acute-phase Exacerbation of Congestive Health Failure and Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congestive Heart Failure
Copd
Keywords: Allied Health Personnel
Mobile Health Units
Delivery of Health Care, Integrated
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community dwelling adults in Worcester county Massachusetts who are members of the Umass Memorial accountable care organization who have a diagnosis of chronic obstructive pulmonary disease or congestive heart failure

Brief summary: Episodic and disjointed medical care for older, community-dwelling adults with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) leave them vulnerable to adverse events such as worsening disease trajectories, frequent emergency department (ED) utilization, and avoidable hospital admissions. It is imperative that an alternative means of health delivery be developed, establishing a coordinated, flexible care model to connect patients with the appropriate resources to address their acute needs and integrate with their medical homes to navigate fraught moments in their disease management.

The Mobile integrated health (MIH) care delivery model may offer a solution by providing flexible and innovative on-demand care in the comfort of patients' homes. The MIH paradigm expands the use of highly trained paramedics outside of their traditional EMS role, by dispatching them into the community to perform in-home medical evaluations and treatment(s) in consultation with an actively involved, remotely located, supervising physician. These "community paramedics" evaluate patients and render care using mobile diagnostics and a variety of medications, allowing patients to remain in place until they can be evaluated definitively on an ambulatory basis.

Utilizing a model of on-demand community paramedic visits paired with a telehealth consultation with a physician, this intervention will manage patients in place until they can access planned ambulatory follow up, decreasing the use of prehospital emergency transport services, emergency department utilizations, and hospital admissions as well as limiting transitions of care and allowing ambulatory providers to maintain longitudinal oversight of disease management

The objective of this project is to study the feasibility of the refined MIH model for the care of community dwelling patients with congestive heart failure and chronic obstructive pulmonary disease. Investigators will conduct a small pre/post pilot intervention trial enrolling 50 patients into a pilot MIH program. Primary outcomes will include participant satisfaction, patient activation, and subject retention. Investigators will also collect outcomes data including ED visits, hospitalizations, and hospital lengths of stay.


Eligibility criteria: Inclusion Criteria:

* Community Dwelling
* Residing in the catchment area of Worcester and Shrewsbury Massachusetts
* member of the UMMHC accountable care organization for at least one year prior to the implementation of the intervention
* Carry a diagnosis of congestive heart failure or chronic obstructive pulmonary disease
* Adult over eighteen
* Fluent in English
* Able to participate in a verbal interview either in-person or via zoom video conference
* Able to provide informed consent to participate in the study

Exclusion Criteria:

* Adults unable to consent
* Non-English-speaking adults
* Prisoners
* Patients under age 18 years
* Trainees, including medical students, resident physicians, and fellows will be excluded from this study.

Primary outcomes:
measure: Subject retention in study
timeFrame: 1 year after initial recruitment
measure: Subject reported acceptability of the MIH program
timeFrame: baseline, 6 months and 1 year after initial recruitment
measure: Patient activation measure
timeFrame: baseline, 6 months and 1 year after initial recruitment
measure: Brief Illness Perception Questionnaire
timeFrame: baseline, 6 months and 1 year after initial recruitment
measure: Patient satisfaction questionnaire
timeFrame: baseline, 6 months and 1 year after initial recruitment
Secondary outcomes:
measure: Healthcare Utilizations
timeFrame: 1 year prior to, and 6 months and 1 year after initial recruitment
Other outcomes:
Locations:
Study officials:
References: