NCT03927820

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
914

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

6.7 years

First QC Date

April 23, 2019

Last Update Submit

August 22, 2025

Conditions

Keywords

inhalerpharmacy

Outcome Measures

Primary Outcomes (1)

  • Time to either hospital readmission or ER visit

    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)

    6 months

Secondary Outcomes (6)

  • Frequency of ED visit

    6 months

  • frequency of hospital readmissions

    6 months

  • time to 1st ED visit (days)

    6 months

  • time to 1st readmission (days)

    6 months

  • frequency of prescribed inhaler at discharge

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Pharmacist Intervention

ACTIVE COMPARATOR

Patients randomized to the intervention arm received usual care plus inhaler review by study pharmacist who made recommendations for inhaler changes based on clinical guideline and insurance formulary compliance. Recommendations were sent to the patient's team for final approval prior to discharge.

Other: Benefits investigation

Usual Care

NO INTERVENTION

Patients randomized to the usual care arm received care by the primary team which includes an inpatient pharmacist who does not have access to benefits investigation technology. The study pharmacist was not involved to review inhalers for optimization prior to discharge.

Interventions

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.

Pharmacist Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Univeristy Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthma

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kristina Niehoff, PharmD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

April 23, 2019

First Posted

April 25, 2019

Study Start

September 9, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations