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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927820
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Tate Davis, Vanderbilt University Medical Center

Study Description
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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 Intervention/treatment
COPD Asthma Other: Benefits investigation

Study Design
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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 9, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022
Groups and Cohorts
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Group/Cohort 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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927820


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

Locations
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United States, Tennessee
Vanderbilt Univeristy Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kristina Niehoff         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Kristina Niehoff, PharmD Vanderbilt University Medical Center
More Information
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Responsible Party: Tate Davis, Clinical Pharmacist, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03927820    
Other Study ID Numbers: PILLAR
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tate Davis, Vanderbilt University Medical Center:
inhaler
pharmacy