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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03927820

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted July 9, 2020

Study Description

Brief 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.

  • Condition or Disease:COPD
    Asthma
  • Intervention/Treatment: Other: Benefits investigation
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 1294 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
  • Actual Study Start Date: September 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: December 2021
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Patients Using Inhalers
Adult patient admitted to Vanderbilt University Medical Center (excluding surgery services) on a long acting inhaler or prescribed a long acting inhaler during admission.
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.
Outcome Measures
  • Primary Outcome Measures: 1. 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)
  • Secondary Outcome Measures: 1. Frequency of ED visit [ Time Frame: 6 months ]
    number of ED visits 6 months post-discharge
  • 2. frequency of hospital readmissions [ Time Frame: 6 months ]
    number of hospital readmission 6 months post-discharge
  • 3. time to 1st ED visit (days) [ Time Frame: 6 months ]
    time until the first ED visit post-discharge
  • 4. time to 1st readmission (days) [ Time Frame: 6 months ]
    time until the first readmission post-discharge
  • 5. frequency of prescribed inhaler at discharge [ Time Frame: 6 months ]
    number of times the recommended inhaler was prescribed at discharge
  • 6. frequency of short course prescription of oral steroid [ Time Frame: 6 months ]
    number of oral steroid prescriptions in the 6 months post-discharge
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: patients admitted to the hospital
Criteria

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

Contacts and Locations
Contacts

Contact: Kristina Niehoff, PharmD 615-322-3921 kristina.niehoff@vumc.org

Locations

United States, Tennessee
Vanderbilt Univeristy Medical Center
Nashville

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

Principal Investigator: Kristina Niehoff, PharmD Vanderbilt University Medical Center

More Information
  • Responsible Party: Vanderbilt University Medical Center
  • ClinicalTrials.gov Identifier: NCT03927820 History of Changes
  • Other Study ID Numbers: PILLAR
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: July 9, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Vanderbilt University Medical Center: inhaler pharmacy