跳至主要内容
临床试验/NCT05540158
NCT05540158撤回不适用

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

University of Massachusetts, Worcester0 个研究点目标入组 50 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
50
主要终点
Subject retention in study

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Subject retention in study

时间窗: 1 year after initial recruitment

The number of subjects who participate in study for entire 1 year duration

Patient activation measure

时间窗: baseline, 6 months and 1 year after initial recruitment

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.

Subject reported acceptability of the MIH program

时间窗: baseline, 6 months and 1 year after initial recruitment

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

Brief Illness Perception Questionnaire

时间窗: baseline, 6 months and 1 year after initial recruitment

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.

Patient satisfaction questionnaire

时间窗: baseline, 6 months and 1 year after initial recruitment

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.

次要结局

  • Healthcare Utilizations(1 year prior to, and 6 months and 1 year after initial recruitment)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurel O'Connor

Assistant Professor

University of Massachusetts, Worcester

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