Evaluation of the Paramedic Evaluation for Acute COPD Exacerbation (PEACE) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intervention Acceptability
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a serious lung condition that affects millions of people in the United States. Each year, it leads to about 150,000 deaths, nearly 900,000 emergency room visits, and 700,000 hospital stays. When COPD symptoms suddenly get worse-called an exacerbation-it can seriously harm a person's quality of life and often requires emergency care. Treating these flare-ups early can help prevent hospital visits, but right now, there aren't many good ways to make sure people get care quickly.
Mobile Integrated Health (MIH) programs send specially trained paramedics, guided remotely by doctors, to care for patients in their homes. This approach could help people with COPD get faster, more effective care without needing to go to the hospital.
In this project, the investigators are testing a new program called PEACE (Paramedic Evaluation for Acute COPD Exacerbation). The PEACE program sends community paramedics to patients' homes-when needed and in partnership with their regular doctors-to manage worsening COPD symptoms early. The study team will adapt the PEACE program to meet the needs of adults living at home with moderate to severe COPD, gather feedback from patients and healthcare providers, and run a small pilot study to see if the program is practical and helpful.
详细描述
Evidence-based strategies to ensure that patients with COPD have reliable, timely, equitable access to treatment are lacking. This deficit is particularly evident in communities impacted by determinants of health that adversely impact preventive health behavior and care access.
On-demand Mobile Integrated Health (MIH) teams, comprised of community paramedics supported by centralized physicians, have been developed to care for patients outside of conventional hospital settings. These teams empower physicians to provide enhanced remote care by collecting essential clinical information about patients in their living environment, performing diagnostic testing, and administering therapy in the home. MIH programs decrease emergency medical services utilization and improve patient satisfaction in select populations, but the impact of MIH programs on the outcomes of patients with COPD exacerbation has not been evaluated.
In this project, the study team will implement and refine an MIH intervention for patients living with COPD. The Paramedic Evaluation for Acute COPD Exacerbation (PEACE) intervention will dispatch community paramedics to execute a home-based evaluation and treatment strategy in collaboration with a supervising physician and the patient's ambulatory medical team during and after acute COPD exacerbation to promote wellness and recovery. This intervention is intended to improve clinical outcomes and reduce acute care costs by eliminating barriers to care, generating actionable clinical data that can facilitate appropriate diagnosis, accelerating treatment, and simplifying care coordination. Our central hypothesis, based on preliminary data and input from key informants, is that an intervention that facilitates community-based management of COPD exacerbation will be acceptable and highly adoptable by patients and clinicians.
The Practical Robust Implementation and Sustainability Model (PRISM) implementation framework will be used to describe factors impacting project implementation, with the embedded Expanded RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model guiding outcomes measurements. Leveraging our prototypical intervention design, the study team will test and Refine the prototype PEACE intervention in real clinical practice with a cohort of patients who are at high risk of COPD exacerbation. The study team will use a mixed-methods approach to evaluate the usability and acceptability of each operational and clinical component of PEACE. Measures will include a systematic assessment of protocol adherence, survey instruments, and qualitative interviews to explore contextual factors impacting intervention performance. The study team will confirm our findings and adapt the protocols informed by a working group comprised of clinicians and community partners. Up to 25 patient participants will be enrolled in the intervention, plus up to 11 clinician participants will be enrolled to participate in usability/acceptability ratings and qualitative evaluations/focus groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD
- •At least one COPD exacerbation resulting in ED utilization in the six months prior to enrollment
- •COPD GOLD Score letter designation of B, C, or D
- •Receives care in the UMass Memorial Medical Center Pulmonary Clinic or Benedict Family Health Clinic
- •Over 18 years of age
- •Speaks English
- •Resides in the geographical catchment area allowed by the UMass Memorial Medical Center MIH Program's license
排除标准
- •No prior diagnosis of COPD
- •Under 18 years of age
- •Does not speak English
- •Cannot provide informed consent
结局指标
主要结局
Intervention Acceptability
时间窗: from enrollment until completion of study activities at 1 year
Using the healthcare intervention acceptability qualitative framework, investigators will measure intervention acceptability from both patient and clinician perspectives. This validated framework assesses participants' affective attitudes, sense of intervention coherence, self-efficacy, the perceived ethicality of the intervention, intervention burden and anticipated cost, opportunity cost, and perceived effectiveness.
Protocol Fidelity
时间窗: From enrollment until study completion at 1 year
Investigators will evaluate adherence to each component of the PEACE protocol by having two independent physician-reviewers audit the EHR and video recordings from every PEACE encounter to ensure that procedures were completed correctly and within the expected timeframe. Particular attention will be focused on visits with operational or clinical "failures," defined as any clinical or operational deviation from intervention protocol or any unexpected ED visit or hospitalization within 72 hours of a PEACE referral.
Sample Retention
时间窗: From enrollment until completion of study activities at 1 year
Investigators will track the number of subjects who completed the entire study compared to the number of subjects initially enrolled. The investigators will also evaluate loss to follow-up rate, perceived reason for discontinuation and completeness of post-intervention data collection.
PEACE Referrals
时间窗: 6 and 12 months after enrollment
Investigators will track the total number of PEACE referrals requested during the study period
Recruitment Rate
时间窗: At enrollment
Ratio of patients enrolled to total patients approached
Reason for Recruitment Refusal
时间窗: At enrollment
Reason that approached patients did not enroll in the study
次要结局
- PEACE Disposition(6 and 12 months after enrollment)
- Unanticipated ED Visits(From enrollment to completion of study activities at 1 year)
- Hospitalizations(From enrollment until completion of study activities at 1 year)
- Exacerbation Relapse Rate(From enrollment until completion of study activities at 1 year)
- COPD-related Medication changes(From enrollment to completion of study activities at 1 year)
研究者
Laurel O'Connor
Associate Professor of Emergency Medicine
University of Massachusetts, Worcester