Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief (PREPARE)

Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations

Asthma imposes a significant burden in the US in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions. Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. The Investigators call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. These studies have been performed in pre-selected populations, which represent less than 5% of asthma patients. The previous studies have been done with repeated education and adherence checks in both the intervention and control arms.

The investigators have consulted with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if we demonstrated that implementing PARTICS improves important asthma outcomes such as reducing exacerbations. The Investigators have designed a study with the stakeholders to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard of care through the Asthma IQ system. The Investigators propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The Investigators aim to determine whether PARTICS can reduce asthma morbidity in AA and H/L.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: PARTICS using QVAR

Detailed Description

Asthma imposes a significant burden on the US population in terms of morbidity, costs to society, individual suffering, loss of productivity and mortality. African Americans (AA) and Hispanic/Latinos (H/L) bear a disproportionate share of that morbidity. Despite introduction of national guidelines for asthma treatment, the gap between these groups and whites has been stable or widening. The need for pragmatic research to address the continuing burden is widely recognized. Patients use asthma reliever inhalers to provide immediate relief of symptoms. Controller inhalers (inhaled corticosteroids (ICS)) are intended to be used regularly to prevent symptoms and attacks. Guidelines suggest that they be used daily, on a fixed basis, in all but the mildest asthma. However, adherence by patients and implementation of evidence-based guideline recommendations by clinicians has been poor. Gap analysis suggests that it is difficult to improve adherence to the current recommendations without complex and resource-intensive interventions.

Studies have examined symptom-activated use of ICS triggered by use of a reliever medication. We call this approach PARTICS - Patient Activated Reliever-Triggered Inhaled CorticoSteroid. Explanatory, non-real world studies suggest that PARTICS can produce up to 50% reductions in asthma attacks compared with usual care, while reducing ICS use by half or more. However, these studies have been performed in pre- selected populations, which represent less than 5% of patients with asthma. They have been done with repeated education and adherence checks in both the intervention and control arms.

The investigators have consulted with AA and H/L patients, health care providers, leaders of professional societies, advocacy groups, health policy leaders, pharmacists, and pharmaceutical manufacturers. All groups have indicated that asthma decision making would be changed if it was demonstrated that implementing PARTICS improves important asthma outcomes such as reducing rates of exacerbations. Together with our partners and stakeholders, the investigators have designed a study to determine whether PARTICS can improve outcomes that are important to patients when superimposed on a background provider-educated standard care through the Asthma IQ system. The investigators therefore propose a study entitled PREPARE: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations. The aim is to determine whether a PARTICS strategy can reduce asthma morbidity in AA and H/L. The primary outcome will be asthma exacerbations which have been shown to be important to patient and healthcare stakeholders. The secondary outcomes will include additional outcomes important to patients (i.e. days lost from work or school, asthma control, & asthma quality of life). The investigators have broad input and involvement from multiple stakeholder groups in study design, implementation, and commitments for dissemination. AA and H/L patients and their advocates have been involved and will continue to play a central role in all phases of the study.

• Study Type: Interventional
• Enrollment (Actual): 1220
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00926
    • University of Puerto Rico
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Colorado
    • Denver, Colorado, United States, 80209
      • Denver Health and Hospital Authority
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32827
      • Grace Medical Home
    • Orlando, Florida, United States, 32827
      • University of Central Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois- Chicago
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Health Center
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore
    • New York, New York, United States, 10029
      • Mt. Sinai
  • North Carolina
    • Chapel Hill, North Carolina, United States, 25799
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 > 1 year.
• Prescribed ICS as daily maintenance therapy
• Participant must also have an 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 ICS inhaler used in the study

• Having COPD or other chronic lung disease other than asthma; with the exception of the following:

  • 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 PFTs 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 and,
  • 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 <=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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PARTICS; addition of PARTICS strategy - Patient Activated Reliever-Triggered Inhaled CorticoSteroid (PARTICS) using QVAR . Patient will use inhaled corticosteroid at time of rescue inhaler use	Drug: PARTICS using QVAR; Patient takes inhaled corticosteroid at the time of rescue inhaler use; Other Names: Patient Activated Reliever-Triggered Inhaled CorticoSteroid
No Intervention: Usual Care; Provider-enhanced usual care arm; no change in asthma management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Asthma Exacerbations Per Year	Our primary outcome, the rate of asthma exacerbations per year, is defined as the number of exacerbations, emergency room visits, or hospitalizations requiring oral or parenteral corticosteroids, per patient per year	monthly through study completion an average of 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline	Asthma control represents the degree to which impairment (impact of asthma on patient's daily life) is minimized and the goals of therapy are met. The Asthma Control Test is a participant-administered tool for assessing the level of asthma control. Total scores range from 5 to 25, with a score of 20 to 25 indicating well-controlled asthma, a score of 16 to 19 indicating asthma that was not well controlled, and a score of 5 to 15 indicating very poorly controlled asthma. The minimal clinically important difference is 3 points	Monthly through study completion an average of 15 months
Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline	The ideal outcome measure for any comparative effectiveness analysis captures the risks and benefits for each of the interventions from the patient's point of view. The use of a preference-based instrument, the Asthma Symptom Utility Index (ASUI), captures this important information. The Asthma Symptom Utility Index is a participant-administered tool for assessing preference-based quality of life. Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The minimal clinically important difference is 0.09.	Monthly through study completion an average of 15 months
Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma	Defined as days not able to work or go to school because of asthma symptoms OR days not able to carry out usual activities due to asthma	Monthly through study completion an average of 15 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; American Academy of Family Physicians

Publications and helpful links

General Publications

• Cardet JC, Shenoy K, Baydur A, Carroll JK, Celedon JC, Cui J, Dara P, Ericson B, Forth VE, Fagan M, Fuhlbrigge AL, Gupta R, Hart MK, Hernandez ML, Hernandez PA, Kruse J, Maher NE, Manning BK, Pinto-Plata VM, Robles J, Rodriguez-Louis J, Shields JB, Telon Sosa BS, Wechsler ME, Israel E. Caribbean Latinx with moderate-severe asthma bear greater asthma morbidity than other Latinx. J Allergy Clin Immunol. 2022 Nov;150(5):1106-1113.e10. doi: 10.1016/j.jaci.2022.05.026. Epub 2022 Jun 30.
• Israel E, Cardet JC, Carroll JK, Fuhlbrigge AL, She L, Rockhold FW, Maher NE, Fagan M, Forth VE, Yawn BP, Arias Hernandez P, Kruse JM, Manning BK, Rodriguez-Louis J, Shields JB, Ericson B, Colon-Moya AD, Madison S, Coyne-Beasley T, Hammer GM, Kaplan BM, Rand CS, Robles J, Thompson O, Wechsler ME, Wisnivesky JP, McKee MD, Jariwala SP, Jerschow E, Busse PJ, Kaelber DC, Nazario S, Hernandez ML, Apter AJ, Chang KL, Pinto-Plata V, Stranges PM, Hurley LP, Trevor J, Casale TB, Chupp G, Riley IL, Shenoy K, Pasarica M, Calderon-Candelario RA, Tapp H, Baydur A, Pace WD. Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma. N Engl J Med. 2022 Apr 21;386(16):1505-1518. doi: 10.1056/NEJMoa2118813. Epub 2022 Feb 26.
• Cardet JC, Busse PJ, Carroll JK, Casale TB, Coyne-Beasley T, Dixon-Williams S, Fagan M, Forth VE, Fuhlbrigge AL, Hernandez ML, Kaelber D, Kaplan B, Lorenzi M, Madison S, Maher NE, Majewski K, Manning B, McKee MD, Nazario S, Pace WD, Pencina MJ, Rand CS, Rodriguez-Louis J, She L, Shields J, Teng JE, Wechsler ME, Wisnivesky JP, Yawn BP, Israel E. Adherence to adding inhaled corticosteroids to rescue therapy in a pragmatic trial with adults with asthma: A pilot study. Ann Allergy Asthma Immunol. 2020 May;124(5):487-493.e1. doi: 10.1016/j.anai.2019.12.027. Epub 2020 Jan 8.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: December 15, 2016
• First Posted (Estimate): December 16, 2016

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: asthma; African Americans; Hispanics
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2016P001839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes