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Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PESRAMHIP)
Investigator (PI): Israel, Elliot
Performing Organization (PO): (Current): Brigham and Women's Hospital, Department of Medicine, Division of Pulmonary and Critical Care Medicine / (617) 732-7420
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2023
Record Source/Award ID: PCORI/PCS-1504-30283
Funding: Total Award Amount: $14,492,022
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Asthma affects more than 25 million people in the US. African American and Hispanic/Latino populations are hard hit by asthma. Asthma attacks, also known as exacerbations, often require the use of oral corticosteroid medications, an emergency room visit, or even hospitalization. They lead to days lost from work, interfere with people's performance, and account for 50 percent of asthma health care costs. Patients with asthma typically use a reliever inhaler (often called a puffer) to ease symptoms such as wheezing or being out of breath. One way to prevent exacerbations is by using another puffer called an inhaled corticosteroid, or ICS, each day. Many asthma patients do not do this, partly because they feel well enough without it and partly because they worry about overusing a medication they do not feel is necessary. A new strategy presents an alternative to using an ICS inhaler every day. With this approach, patients use the ICS inhaler at the same time they use their reliever puffer. This is called the Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) strategy. In small studies in "controlled" situations, the PARTICS strategy has been shown effective at controlling asthma and preventing exacerbations. No one knows if PARTICS will work in real-world situations. This study, the Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PESRAMHIP), aims to answer this important question: Among African American and Hispanic/Latino adults, can a PARTICS strategy in addition to provider education reduce exacerbations better than provider education alone? To answer the study question, PESRAMHIP will recruit 1,200 African American and Hispanic/Latino participants age 18 years or older with asthma who are using an ICS or who have had an exacerbation in the past year. Their doctors will receive supplemental training about how best to treat asthma. The patients will be randomly chosen to follow the PARTICS strategy in addition to receiving the education-enhanced care for asthma or just to receive provider-educated care. They will complete monthly questionnaires for 15 months. The research team will compare the number of exacerbations in both groups to determine which treatment strategy works better. The team will also look at days lost from work, symptoms, and asthma control. Two groups of patients--one of African American asthma patients, the other of Hispanic/Latino asthma patients--have been contributing to study design, implementation, recruitment, analysis, and dissemination by taking part in regularly scheduled conference calls and in-person meetings. One representative from each patient partner group will sit on the trial's executive committee. Other stakeholders who will be advising and supporting PESRAMHIP include representatives from groups that advocate for people with asthma; leaders of major allergy and pulmonary professional societies; members of family physician societies; experts from organizations involved in health care delivery; insurance professionals; government officials; and experts in clinical trial design.
MeSH Terms:
  • Adrenal Cortex Hormones /administration & dosage
  • African Americans
  • Asthma /*ethnology
  • /prevention & control /*therapy
  • Drug Administration Schedule
  • Hispanic Americans
  • Humans
  • Nebulizers and Vaporizers
  • Patient Education as Topic
  • Patient Participation
  • Randomized Controlled Trials as Topic
  • Research Design
  • Respiratory Sounds
  • Surveys and Questionnaires
Country: United States
State: Massachusetts
Zip Code: 02115
UI: 20162202
CTgovId: NCT02995733
Project Status: Ongoing
Record History: ('2019: Project extended to 2023. 2017: Project extended to 2022.',)