GeriatricNCT05113667
Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
A study testing Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program in people with Geriatric, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy stewardship program in hospitalized older patients. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Geriatric
- What is being tested?
- Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years old or greater
- Admitted to the hospital with any reason
- Ordered at least one PPI dose within 48 hours of admission
Who cannot join
- Transferred to another ward (including an intensive care unit)
- Having active gastrointestinal bleeding
- Having active malignity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Geriatric
- Being tested
- Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship ProgramOther
Clinical pharmacist provided medication reconciliation and medication review during the hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Clinical pharmacist-led services | Experimental | Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program Receives: Other: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriateness of Proton Pump Inhibitors Usage
The rate of appropriateness use of proton pump inhibitors based on the guidelines at hospital stay
Measured: 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
Measured: at discharge, an average of 14 days after admission to hospital
Secondary outcomes (5)
Clinical outcome
The number of patients who hospitalized for bleeding within 1 year after discharge
Measured: 1 year
Cost saving during hospital stay
Medication cost for inappropriate PPI during hospital study
Measured: 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.
Measured: during hospital stay, an average of 14 days
Cost saving after discharge
Medication cost for potentially inappropriate PPI after discharge
Measured: 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.
Measured: at discharge, an average of 14 days after admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start1 Sep 2019
- Primary completion28 Feb 2020
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Okuyan, Marmara University
- Investigators
- Betul Okuyan, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113667
- Sponsor's protocol ID
- MUHSI-2019/29-78
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2021
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35449351
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program on Hospitalized Older Patients: A Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05113667
- Acronym / sponsor ID
- MUHSI-2019/29-78
- Conditions
- Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy stewardship program in hospitalized older patients.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical pharmacist-led services | Experimental | Other: Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship ProgramClinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 years old or greater
- Admitted to the hospital with any reason
- Ordered at least one PPI dose within 48 hours of admission
Key exclusion criteria (3 listed)
- Transferred to another ward (including an intensive care unit)
- Having active gastrointestinal bleeding
- Having active malignity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship ProgramClinical pharmacist provided medication reconciliation and medication review during the hospital stay. | Other | Clinical pharmacist-led services |
Primary outcome
Appropriateness of Proton Pump Inhibitors Usage
Time frame: during hospital stay, an average of 14 days
The rate of appropriateness use of proton pump inhibitors based on the guidelines at hospital stay
Potentially Inappropriate Proton Pump Inhibitors Usage
Time frame: at discharge, an average of 14 days after admission to hospital
The rate of potentially inappropriate use of proton pump inhibitors based on American Geriatric Society Beers Criteria© 2019
5 secondary outcomes
Clinical outcome
Time frame: 1 year
Cost saving during hospital stay
Time frame: during hospital stay, an average of 14 days
Medication Appropriateness Index for Proton Pump Inhibitors at hospital stay
Time frame: during hospital stay, an average of 14 days
Cost saving after discharge
Time frame: a month
Medication Appropriateness Index for Proton Pump Inhibitors at discharge
Time frame: at discharge, an average of 14 days after admission to hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Derived from this study: PubMed 35449351Dumlu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betul Okuyan principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program in people with Geriatric, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriateness of Proton Pump Inhibitors Usage (time frame: during hospital stay, an average of 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05113667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.