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

Copd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05540158
• Other study ID #: STUDY00000126
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: Laurel O'Connor, MD
• Phone: 5084211400
• Email: laurel.connor[@]umassmed.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Copd
• Heart Failure
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject retention in study	The number of subjects who participate in study for entire 1 year duration	1 year after initial recruitment
Primary	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
Primary	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
Primary	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
Primary	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	Healthcare Utilizations	number of MIH, ambulatory, and emergency services utilizations	1 year prior to, and 6 months and 1 year after initial recruitment