COPDPILLARNCT03927820
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
A study testing Benefits investigation in people with COPD and Asthma, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Benefits investigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 914 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient admitted to Vanderbilt University Medical Center (VUMC) (excluding surgery services)
- on a long acting inhaler or prescribed a long acting inhaler during admission.
Who cannot join
- Diagnosis of cystic fibrosis
- Diagnosis of graft versus host disease (GVHD)
- no medication insurance
- discharge to any post-acute care facility or inpatient hospice
- death during hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Univeristy Medical Center
Nashville, Tennessee, 37232
About this study
The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.
- Being tested
- Benefits investigation
- Keywords
- inhaler, pharmacy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benefits investigationOther
The study pharmacist will review the prescribed inhaler for 1) insurance coverage and 2) clinical appropriateness. The pharmacist will conduct a benefits investigation at time of hospital admission. The benefits investigation involves running test claims for inhalers to determine the most cost-effective inhaler for the patient's insurance plan. The study pharmacist will utilize clinical practice guidelines to assess appropriateness of the prescribed inhaler. Based on this review, the study pharmacist will submit a pharmacy consult to the inpatient pharmacist on the patient's healthcare team who will pend the inhaler orders (changing the patient's prescribed inhaler, if necessary) for the prescriber to send to the Meds to Beds discharge pharmacy. The Meds to Beds pharmacist will counsel the patient on inhaler use techniques prior to discharge.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Intervention | Active comparator | Patients randomized to the intervention arm received usual care plus inhaler review by study pharmacist who made recommendations for inhaler changes based on clinical guideline and insurance formulary compliance. Recommendations were sent to the patient's team for final approval prior to discharge. Receives: Other: Benefits investigation |
| Usual Care | No intervention | Patients randomized to the usual care arm received care by the primary team which includes an inpatient pharmacist who does not have access to benefits investigation technology. The study pharmacist was not involved to review inhalers for optimization prior to discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to either hospital readmission or ER visit
Combined time (days) to either hospital readmission or emergency department visit after hospitalization (all outcomes measured at 6 months post-discharge with a 3 month interim analysis)
Measured: 6 months
Secondary outcomes (6)
Frequency of ED visit
number of ED visits 6 months post-discharge
Measured: 6 months
frequency of hospital readmissions
number of hospital readmission 6 months post-discharge
Measured: 6 months
time to 1st ED visit (days)
time until the first ED visit post-discharge
Measured: 6 months
time to 1st readmission (days)
time until the first readmission post-discharge
Measured: 6 months
frequency of prescribed inhaler at discharge
number of times the recommended inhaler was prescribed at discharge
Measured: 6 months
frequency of short course prescription of oral steroid
number of oral steroid prescriptions in the 6 months post-discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start9 Sep 2019
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tate Davis, Vanderbilt University Medical Center
- Investigators
- Kristina Niehoff, PharmD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927820
- Sponsor's protocol ID
- PILLAR
- Acronym
- PILLAR
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2019
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parrott TD, Wallace MD, Eble SH, Niehoff KM, Gao Y, Choi L, Prigmore HL, Dear ML, Rice TW, Sevin CM, Choma NN, Zuckerman AD. A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmission (PILLAR): A Randomized Controlled Trial. CHEST Pulm. 2026 Feb 12;4(2):100231. doi: 10.1016/j.chpulm.2025.100231. eCollection 2026 Jun.
PubMed 42548423
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
- ClinicalTrials.gov ID
- NCT03927820
- Acronym / sponsor ID
- PILLAR / PILLAR
- Keywords
- inhaler, pharmacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Intervention | Active comparator | Other: Benefits investigationPatients randomized to the intervention arm received usual care plus inhaler review by study pharmacist who made recommendations for inhaler changes based on clinical guideline and insurance formulary compliance. Recommendations were sent to the patient's team for final approval prior to discharge. |
| Usual Care | No intervention | –Patients randomized to the usual care arm received care by the primary team which includes an inpatient pharmacist who does not have access to benefits investigation technology. The study pharmacist was not involved to review inhalers for optimization prior to discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient admitted to Vanderbilt University Medical Center (VUMC) (excluding surgery services)
- on a long acting inhaler or prescribed a long acting inhaler during admission.
Key exclusion criteria (5 listed)
- Diagnosis of cystic fibrosis
- Diagnosis of graft versus host disease (GVHD)
- no medication insurance
- discharge to any post-acute care facility or inpatient hospice
- death during hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benefits investigationThe study pharmacist will review the prescribed inhaler for 1) insurance coverage and 2) clinical appropriateness. The pharmacist will conduct a benefits investigation at time of hospital admission. The benefits investigation involves running test claims for inhalers to determine the most cost-effective inhaler for the patient's insurance plan. The study pharmacist will utilize clinical practice guidelines to assess appropriateness of the prescribed inhaler. Based on this review, the study pharmacist will submit a pharmacy consult to the inpatient pharmacist on the patient's healthcare team who will pend the inhaler orders (changing the patient's prescribed inhaler, if necessary) for the prescriber to send to the Meds to Beds discharge pharmacy. The Meds to Beds pharmacist will counsel the patient on inhaler use techniques prior to discharge. | Other | Pharmacist Intervention |
Primary outcome
Time to either hospital readmission or ER visit
Time frame: 6 months
Combined time (days) to either hospital readmission or emergency department visit after hospitalization (all outcomes measured at 6 months post-discharge with a 3 month interim analysis)
6 secondary outcomes
Frequency of ED visit
Time frame: 6 months
frequency of hospital readmissions
Time frame: 6 months
time to 1st ED visit (days)
Time frame: 6 months
time to 1st readmission (days)
Time frame: 6 months
frequency of prescribed inhaler at discharge
Time frame: 6 months
frequency of short course prescription of oral steroid
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Derived from this study: PubMed 42548423Parrott TD, Wallace MD, Eble SH, Niehoff KM, Gao Y, Choi L, Prigmore HL, Dear ML, Rice TW, Sevin CM, Choma NN, Zuckerman AD. A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmission (PILLAR): A Randomized Controlled Trial. CHEST Pulm. 2026 Feb 12;4(2):100231. doi: 10.1016/j.chpulm.2025.100231. eCollection 2026 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Niehoff, PharmD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benefits investigation in people with COPD and Asthma, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to either hospital readmission or ER visit (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.