Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02995733 |
| Other study ID # |
2016P001839 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 27, 2017 |
| Est. completion date |
April 30, 2021 |
Study information
| Verified date |
December 2022 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
