A Mobile Integrated Health Intervention to Manage Congestive Health Failure and Chronic Obstructive Pulmonary Disease

NCT ID: NCT05540158

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-12-31

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.

Conditions

Congestive Heart Failure; Copd

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mobile Integrated Health Intervention

Subjects will have access to "on-demand" mobile integrated health program for acute symptoms. Subjects will be educated on the nature and capabilities of the MIH community paramedics and will be able to call a hotline for unscheduled visits 24 hours a day, 7 days a week if they wish to be evaluated for acute symptoms or changes in their condition. All visits entail focused history and physical exam with community paramedic, portable diagnostics as indicated, and telehealth visit with a physician

Intervention Type: OTHER

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.

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

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Laurel O'Connor

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STUDY00000126

Identifier Type: -

Identifier Source: org_study_id