Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program

Impact of Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program on Hospitalized Older Patients: A Non-Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Geriatric
• Intervention / Treatment: Other: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program

Detailed Description

This prospective, nonrandomized controlled study was conducted in older patients who ordered proton pump inhibitor (PPI) at admission in an internal medicine service of tertiary training and research hospital. In the intervention group, clinical pharmacist-led services (including medication reconciliation and medication review) were conducted during hospitalization and at discharge by using the guidelines and potentially inappropriate medications (PIM) criteria [American Geriatric Society-AGS Beers Criteria©, 2019]. Medication Appropriateness Index (MAI), inappropriate PPI cost, and hospitalization for gastrointestinal bleeding within 1 year after discharge were calculated in both groups

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Usual care
Experimental: Clinical pharmacist-led services; Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program	Other: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program; Clinical pharmacist provided medication reconciliation and medication review during the hospital stay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	The number of patients who hospitalized for bleeding within 1 year after discharge	1 year
Cost saving during hospital stay	Medication cost for inappropriate PPI during hospital study	during hospital stay, an average of 14 days
Medication Appropriateness Index for Proton Pump Inhibitors at hospital stay	Medication Appropriateness Index (MAI); included 10 items. Each item was weighted from 1-3. The highest score per medication was 18. Higher scores of this index represent more inappropriateness of each medication.	during hospital stay, an average of 14 days
Cost saving after discharge	Medication cost for potentially inappropriate PPI after discharge	a month
Medication Appropriateness Index for Proton Pump Inhibitors at discharge	Medication Appropriateness Index (MAI); included 10 items. Each item was weighted from 1-3. The highest score per medication was 18. Higher scores of this index represent more inappropriateness of each medication.	at discharge, an average of 14 days after admission to hospital

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Betul Okuyan, Marmara University

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: October 17, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MUHSI-2019/29-78

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No