Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 9, 2020
Sponsor:
Information provided by (Responsible Party):
Kristina Niehoff, Vanderbilt University Medical Center

Tracking Information
First Submitted Date April 23, 2019
First Posted Date April 25, 2019
Last Update Posted Date July 9, 2020
Actual Study Start Date September 9, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2019)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 23, 2019)
  • Frequency of ED visit [ Time Frame: 6 months ]
    number of ED visits 6 months post-discharge
  • frequency of hospital readmissions [ Time Frame: 6 months ]
    number of hospital readmission 6 months post-discharge
  • time to 1st ED visit (days) [ Time Frame: 6 months ]
    time until the first ED visit post-discharge
  • time to 1st readmission (days) [ Time Frame: 6 months ]
    time until the first readmission post-discharge
  • frequency of prescribed inhaler at discharge [ Time Frame: 6 months ]
    number of times the recommended inhaler was prescribed at discharge
  • frequency of short course prescription of oral steroid [ Time Frame: 6 months ]
    number of oral steroid prescriptions in the 6 months post-discharge
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
Official Title A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients admitted to the hospital
Condition
  • COPD
  • Asthma
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: Benefits investigation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 23, 2019)
1294
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kristina Niehoff, PharmD 615-322-3921 kristina.niehoff@vumc.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03927820
Other Study ID Numbers PILLAR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kristina Niehoff, Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Kristina Niehoff, PharmD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date July 2020