Clinical trial NCT02995733: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations; PeRson EmPowered Asthma RElief
Official title: Patient Empowered Strategy to Reduce Asthma Morbidity in Highly Impacted Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: asthma
African Americans
Hispanics
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: American Academy of Family Physicians
First posted: 2016-12-16
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Asthma Exacerbations Per Year
timeFrame: monthly through study completion an average of 15 months
Secondary outcomes:
measure: Asthma Control: Asthma Control Test (ACT) Score, Least-squares Mean Change From Baseline
timeFrame: Monthly through study completion an average of 15 months
measure: Preference Based Quality of Life: Asthma Symptom Utility Index (ASUI), Least-squares Mean Change From Baseline
timeFrame: Monthly through study completion an average of 15 months
measure: Days Per Year Lost From Work or School/ Days Unable to Carry Out Usual Activities Due to Asthma
timeFrame: Monthly through study completion an average of 15 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Grace Medical Home
state: Florida
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chicago
country: United States
facility: University of Illinois- Chicago
state: Illinois
city: Springfield
country: United States
facility: Baystate Health Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore
state: New York
city: New York
country: United States
facility: Mt. Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Brigham and Women's Hospital
name: Elliot Israel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.