NCT05113667

Brief Summary

To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy stewardship program in hospitalized older patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 17, 2021

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Appropriateness of Proton Pump Inhibitors Usage

    The rate of appropriateness use of proton pump inhibitors based on the guidelines at hospital stay

    during hospital stay, an average of 14 days

  • Potentially Inappropriate Proton Pump Inhibitors Usage

    The rate of potentially inappropriate use of proton pump inhibitors based on American Geriatric Society Beers Criteria© 2019

    at discharge, an average of 14 days after admission to hospital

Secondary Outcomes (5)

  • Clinical outcome

    1 year

  • Cost saving during hospital stay

    during hospital stay, an average of 14 days

  • Medication Appropriateness Index for Proton Pump Inhibitors at hospital stay

    during hospital stay, an average of 14 days

  • Cost saving after discharge

    a month

  • Medication Appropriateness Index for Proton Pump Inhibitors at discharge

    at discharge, an average of 14 days after admission to hospital

Study Arms (2)

Clinical pharmacist-led services

EXPERIMENTAL

Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program

Other: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program

Control group

NO INTERVENTION

Usual care

Interventions

Clinical pharmacist provided medication reconciliation and medication review during the hospital stay.

Clinical pharmacist-led services

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old or greater
  • Admitted to the hospital with any reason
  • Ordered at least one PPI dose within 48 hours of admission

You may not qualify if:

  • Transferred to another ward (including an intensive care unit)
  • Having active gastrointestinal bleeding
  • Having active malignity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Dumlu HI, Sancar M, Ozdemir A, Okuyan B. Impact of a clinical pharmacist-led stewardship program for the appropriate use of acid suppression therapy in older hospitalized patients: a non-randomized controlled study. Int J Clin Pharm. 2022 Aug;44(4):914-921. doi: 10.1007/s11096-022-01394-8. Epub 2022 Apr 21.

Study Officials

  • Betul Okuyan

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 17, 2021

First Posted

November 9, 2021

Study Start

September 1, 2019

Primary Completion

February 28, 2020

Study Completion

August 31, 2021

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations