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

• ClinicalTrials.gov Identifier: NCT03927820
• Recruitment Status: Recruiting
• First Posted: April 25, 2019
• Last Update Posted: July 9, 2020
• Sponsor: Vanderbilt University Medical Center
• 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

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

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

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