A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) (PILLAR)

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 Overview

• Status: Completed
• Conditions: Asthma; COPD
• Intervention / Treatment: Other: Benefits investigation

• Study Type: Interventional
• Enrollment (Actual): 914
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Univeristy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

patients admitted to the hospital

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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.
Active Comparator: Pharmacist Intervention; 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.	Other: Benefits investigation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of ED visit	number of ED visits 6 months post-discharge	6 months
frequency of hospital readmissions	number of hospital readmission 6 months post-discharge	6 months
time to 1st ED visit (days)	time until the first ED visit post-discharge	6 months
time to 1st readmission (days)	time until the first readmission post-discharge	6 months
frequency of prescribed inhaler at discharge	number of times the recommended inhaler was prescribed at discharge	6 months
frequency of short course prescription of oral steroid	number of oral steroid prescriptions in the 6 months post-discharge	6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Kristina Niehoff, PharmD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): June 1, 2026
• Study Completion (Actual): June 1, 2026

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 24, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: inhaler; pharmacy
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Asthma
• Other Study ID Numbers: PILLAR

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