DOI: 10.3886/icpsr38664.v1
title: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations (PESRAMHIP), United States, 2017-2021
title: Version 1

description: Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations. PREPARE (PESRAMHIP) is a pragmatic, open-label trial of 1201 randomly assigned African American/Black and Hispanic/Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled corticosteroid strategy (PARTICS) plus usual care (intervention) or to continue usual care. Participants had one in-person visit to consent, randomize and collect baseline data followed by 15 monthly questionnaires. The primary end point of this study was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.
description: The purpose of this study to is to observe if PREPARE will address the need for pragmatic research to address the continuing burden of asthma in African American (AA) and Hispanic/Latinx (H/L) patients. In consultation with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers, results from PREPARE may demonstrate that implementing patient-activated, reliever-triggered inhaled corticosteroid strategy (PARTICS) may improve important asthma outcomes in these highly impacted populations.
description: The study design included a 1:1 randomized clinical trial. Participants agreeing to enroll had the study explained and complete informed consent facilitated by research personnel. At the enrollment visit, entry criteria was confirmed, consent was obtained, baseline questionnaires were completed, and the patient was randomized (using a central randomization algorithm) to patient-activated, reliever-triggered inhaled corticosteroid strategy (PARTICS) with continuation of their provider-educated care or continued with their provider-educated care alone.
description: This study includes variables that describe Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]) results, quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), participant-reported missed days of work, school, or usual activities, and safety.
description: Response Rates: 1229 participants came to the in-person visit for eligibility and baseline assessment. Of the 1229, 1221 were found to be eligible, 1220 agreed to consent to participate. 611 were randomized to usual care and 609 were randomized to patient-activated, reliever-triggered inhaled corticosteroid strategy (PARTICS) intervention. One site was dropped due to inability to corroborate eligibility of 19 participants they enrolled. Ten usual care and 9 PARTICS intervention participants from the dropped site were not followed or analyzed. Final cohort includes 601 PARTICS intervention and 600 usual care control participants. Of the 1201 participants: 1086 participants have &gt;14.5 months of follow up data 1142 participants have &gt;10 up to 14.5 months of follow up data 1171 participants have &gt;5 up to 10 months of follow up data 1190 participants have &gt;2 up to 5 months of follow up data
description: Presence of Common Scales: Asthma Control Test (ACT) is a self-administered tool assessing the level of asthma control. Total score ranges from 5 to 25. Scores of 20-25 indicate well-controlled asthma; 16-19 not well-controlled; 5-15 very poorly controlled. The MID is 3 points. Asthma Symptom Utility Index (ASUI) is a self-administered tool assessing preference-based quality of life.4 The summary score is a continuous scale ranging from 0 (worst possible symptoms) to 1 (no symptoms). The MID is 0.09.5. Medication Adherence Report Scale-5 (MARS-5) measures self-reported medication adherence. Mean scores are calculated from five items and range from 1-5 for each item. Higher scores indicate better adherence. Asthma-specific Beliefs About Medicines Questionnaire (BMQ) has 2 scales: Necessity Scale (measures the patient's beliefs about the necessity of using asthma medicine) and the Concerns Scale (measures the patient's concerns about negative consequences of using asthma medicine). BMQ categories: Skeptical = low necessity, high concern; Indifferent = low necessity, low concern; Ambivalent = high necessity, high concern; Accepting = high necessity, low concern. Brief Health Literacy Scale (BHLS) consists of three items and measures self-reported health literacy. One item is scored from 1 to 5, with a score of 4 or 5 indicating low/marginal health literacy; the other 2 items are scored from 1 to 4, with a score of 3 or 4 indicating low/marginal health literacy. If a participant's response on any of the 3 items indicated low/marginal health literacy, the participant was considered to have low/marginal health literacy; otherwise, health literacy was considered to be high. The short form of the Perceived Stress Scale (PSS) assesses self-reported stress in the last month. Total score ranges from 0 to 16, with higher scores indicating more perceived stress. Patient Health Questionnaire-2 (PHQ-2) screens for depression over the past 2 weeks. Total score ranges from 0-6, with scores of &gt;=3 suggesting depression. The short version of the Everyday Discrimination Scale (EDS) has 5 items with each item's score ranging from 1 to 6. The total score ranges from 5 to 30, with higher scores indicating a higher degree of perceived discrimination.
description: The sample used a randomized clinical trial. The participant criteria was as follows: INCLUSION CRITERIA: Black or Hispanic based on self-identification (Hispanic if identify as both) Male and female, ages 18-75 years Ability to provide informed consent Clinical history consistent with asthma for &gt; 1 year. Prescribed ICS as daily maintenance therapy Participant must also have an Asthma Control Test (ACT) score of 19 or less, or a history of one or more exacerbations in the past year that required patient report of systemic corticosteroid use. EXCLUSION CRITERIA: Life expectancy less than one year Known allergy to the inhaled corticosteroids (ICS) inhaler used in the study Having COPD or other chronic lung disease other than asthma; with the exception of the following: Diagnosis (Dx) of COPD in a never smoker without any other lung disease or any other disease that might cause airway obstruction such as: Cystic Fibrosis, Connective Tissue Disease, premature birth, organ transplantation, bronchiectasis, sarcoid, and obliterative bronchiolitis Dx of COPD in former smoker with normal Pulmonary function tests (PFT) done after the person quit smoking Dx of COPD in current smoker with normal PFTs done in past 24 months Dx of COPD IN CURRENT OR FORMER SMOKER with obstruction on PFTs: normal diffusing capacity in past 24 months and demonstrated reversibility of 12% or more at any time Regular systemic corticosteroid use daily or every other day for any reason--including asthma or other medical reasons Use of systemic corticosteroid, or visit to the doctor's office, emergency department (ED) or urgent care, or overnight hospitalization for an asthma exacerbation in the past month (can wait and re-check eligibility after one month) Use of biologics (injections or infusion medicines): with the exception of the following: The patient has been on a stable dose of a biologic for at least 6 months Must have had an exacerbation at least 2 months after starting on a biologic to be considered eligible OR Must have a current ACT score &lt;=19 to be considered eligible. Bronchial thermoplasty less than 6 months ago (can re-check eligibility 6 months after procedure) Another family member living in the same household already enrolled in study
description: Datasets: DS0: Study-Level Files DS1: Derived Baseline Data DS2: Baseline FeNO and EOS Data (derived) DS3: Additional Baseline Variables Data DS4: Derived Site Data DS5: Derived Monthly Data DS6: Follow-up PARTICS Treatment by Month Data DS7: Follow-up Refill Data by Month DS8: Follow-up Refill Data by Patient DS9: Follow-up Nebulizer Data by Month DS10: Nebulizer follow-up data by patient DS11: Follow-up ED/UC Data by Month DS12: ED/UC Follow-up Data by Patient DS13: Derived AEX Event-Level Data DS14: Full-study Derived Follow-up Data DS15: QVAR Change from MDI to RediHaler Data DS16: AEX Follow-up Data DS17: AEX Data Per Patient Per Study Month DS18: AEX Data Per Patient Per Calendar Month DS19: AEX Data Per Patient Per Quarter DS20: Andersen-Gill Model Dataset 0 DS21: AG Dataset 0 with TD covariate COVID Data DS22: AG Dataset 1 (Confirmed & Assumed AEXs) DS23: AG Dataset 1 with TD covariate COVID Data DS24: AG Dataset 0 with TD QVAR TX Variable DS25: AG0 Data with TD QVAR & COVID Variables DS26: ACT and ASUI Monthly Data DS27: ACT and ASUI Monthly Dataset 2 DS28: The Latest ACT Data in Follow-up DS29: ACT/ASUI Follow-up Data by Patient DS30: Monthly Data on Days Missed W/S/A DS31: Days Missed Work/School/Usual Activities DS32: Full-study Derived SAE0 Data DS33: Full-study Derived SAE1 Data
description: African American/Black and Hispanic/Latinx, adults 18-75 with uncontrolled asthma (moderate-severe), prescribed an inhaled corticosteroids (ICS) who received asthma care at one of the 19 primary care or specialty clinical sites. Smallest Geographic Unit: None
description: computer-assisted self interview (CASI); mail questionnaire; mixed mode; telephone interview; web-based surveyThe data files included in this study can be linked together by the ID variable <b>PID</b>, which is in each dataset.