Status Approved
First Submitted Date
2021/02/16
Registered Date
2021/03/12
Last Updated Date
2021/02/16
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005994 |
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Unique Protocol ID | 2020-06-029 |
Public/Brief Title | Effect of pharmacy-led medication reconciliation in the elderly patients |
Scientific Title | Effect of pharmacy-led medication reconciliation in the elderly patients |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2020-06-029 |
Approval Date | 2020-07-13 |
Institutional Review Board Name | Inha University Hospital,Institutional Review Board |
Institutional Review Board Address | 27, Inhang-ro, Jung-gu, Incheon |
Institutional Review Board Telephone | 032-890-3691 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jung Hwan LEE |
Title | Clinical professor |
Telephone | +82-32-890-3557 |
Affiliation | Inha University Hospital |
Address | 27, Inhang-ro, Jung-gu, Incheon |
Contact Person for Public Queries | |
Name | Sunmin LEE |
Title | Pharmacist |
Telephone | +82-32-890-3311 |
Affiliation | Inha University Hospital |
Address | 27, Inhang-ro, Jung-gu, Incheon |
Contact Person for Updating Information | |
Name | Sunmin LEE |
Title | Pharmacits |
Telephone | +82-32-890-3311 |
Affiliation | Inha University Hospital |
Address | 27, Inhang-ro, Jung-gu, Incheon |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-07-21 Actual | |
Target Number of Participant | 140 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Inha University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-07-21 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Inha University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inha University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | This study is an open-label, randomized controlled trial evaluating the effectiveness of multidisciplinary drug intervention in hospitalized elderly patients with chronic diseases. This study consists of an investigation through an interview with a pharmacist within 24 hours in the hospital medicine ward, drug intervention activities during hospitalization, and an investigation through an interview with a pharmacist 30 days after discharge. 1) Interview within 24 hours after admission (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed 2) Pharmacist prescription intervention activities at hospitalization: adjustment of renal function dose, confirmation of drug interaction, inappropriate prescription intervention 2)Pharmacist's prescription intervention activity at discharge: Reduction of rigimen complexity (simplification of usage, matching of medication time) 3) 30 days after discharge, re-evaluation of the survey index and self-report ADE(Adverse drug event) 4) Continuous ADE(Adverse drug event) confirmation at hospitalization and evaluation of correlation with drug intervention activities |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Health Services Research |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Open |
Allocation | RCT |
Intervention Type | Others (Pharmacist service) |
Intervention Description | 1) Interview within 24 hours after admission (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed 2) Pharmacist medication intervention activities at hospitalization: adjustment of renal function dose, confirmation of drug interaction, inappropriate prescription intervention 2)Pharmacist's prescription intervention activity at discharge: Reduction of regimen complexity (simplification of usage, matching of medication time) |
Number of Arms | 2 |
Arm 1 |
Arm Label Pharmacist intervention group |
Target Number of Participant 70 |
|
Arm Type Experimental |
|
Arm Description 1) Interview within 24 hours after admission (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed 2) Pharmacist prescription intervention activities at hospitalization: adjustment of renal function dose, confirmation of drug interaction, inappropriate prescription intervention 3)Pharmacist's prescription intervention activity at discharge: Reduction of regimen complexity (simplification of usage, matching of medication time) |
|
Arm 2 |
Arm Label Pharmacist No intervention group |
Target Number of Participant 70 |
|
Arm Type No intervention |
|
Arm Description 1) Interview within 24 hours after admission (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed |
9. Subject Eligibility
Condition(s)/Problem(s) |
Not Applicable-Education
Polypharmacy |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 65Year~No Limit |
|
Description Hospitalized in the Department of hospital Medicine (including those who come from the intensive care unit) Senior patients 65 years of age or older who are receiving five or more drug therapy (polypharmacy) for a comorbid disease • Those who agree to participate in the research among elderly patients 65 years of age or older who were admitted to the Department of hospital Medicine at Inha University Hospital from August 2020 to February 2021 • Patients with self-communication during hospitalization or good communication with a care giver • Those who can communicate over the phone for more than 30 days after discharge or those who can communicate with a care giver |
|
Exclusion Criteria |
• Those who do not agree to participate in the research • Those whose life expectancy is less than 3 months • Patients discharged within 24 hours |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Not applicable | |
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Primary Outcome(s) 1 | ||
Outcome | The difference of adverse events reported in the control and intervention groups |
|
Timepoint | Continuous evaluation during hospitalization, evaluation by phone 30 days after discharge |
|
Secondary Outcome(s) 1 | ||
Outcome | Intervention index score change after hospitalization period, readmission, discharge, 30 days after discharge (reduction in number of MRCI-K, MAI, MMAS-4, PIMS), decrease in polypharmacy, change in the expression of adverse drug reactions |
|
Timepoint | Assessment at discharge, evaluation by phone 30 days after discharge |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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