A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) (PILLAR)
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ClinicalTrials.gov Identifier: NCT03927820 |
Recruitment Status :
Recruiting
First Posted : April 25, 2019
Last Update Posted : July 9, 2020
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Sponsor:
Vanderbilt University Medical Center
Information provided by (Responsible Party):
Kristina Niehoff, Vanderbilt University Medical Center
Tracking Information | |||||
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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 |
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)
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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 |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | patients admitted to the hospital | ||||
Condition |
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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.
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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
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Kristina Niehoff, Vanderbilt University Medical Center | ||||
Study Sponsor | Vanderbilt University Medical Center | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Vanderbilt University Medical Center | ||||
Verification Date | July 2020 |