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

A Mobile Integrated Health Intervention for the Management of Acute-phase Exacerbation of Congestive Health Failure and Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Copd; Congestive Heart Failure
• Intervention / Treatment: Other: Mobile Integrated Health Intervention

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject retention in study	The number of subjects who participate in study for entire 1 year duration	1 year after initial recruitment
Subject reported acceptability of the MIH program	Subjects will self report their satisfaction and utilization history with MIH program using 5 point Likert scales (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree) evaluating their experiences with the MIH service. A high score indicates greater satisfaction	baseline, 6 months and 1 year after initial recruitment
Patient activation measure	Measure of a subject's knowledge, skills and confidence to manage their own health and well-being. Questions are answered on the following scale: (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree). A higher score indicates greater patient activation.	baseline, 6 months and 1 year after initial recruitment
Brief Illness Perception Questionnaire	Measures subject's self-reported perception of their chronic illness through several statements that patients agree with on a 1-10 scale, with 10 being most strongly agree.	baseline, 6 months and 1 year after initial recruitment
Patient satisfaction questionnaire	Measures subject's self-reported satisfaction with their health care. Questions are answered on the following scale: (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree). A higher score indicates greater patient satisfaction.	baseline, 6 months and 1 year after initial recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Utilizations	number of MIH, ambulatory, and emergency services utilizations	1 year prior to, and 6 months and 1 year after initial recruitment

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mobile Health Units; Delivery of Health Care, Integrated; Allied Health Personnel
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: STUDY00000126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No