- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07015112
- Original Trial
Applying a Multidisciplinary Intervention for Drug Adequacy in an Intermediate Care Hospital (AMIDA-ICH) (AMIDA-ICH)
Applying a Multidisciplinary Intervention for Drug Adequacy in a Intermediate Care Hospital (AMIDA-ICH)
The goal of this clinical trial is to learn if a multi-professional (conducted by geriatricians, clinical pharmacists, nurses) medication revision, centered on patients' goals and characteristics, can improve treatment adequacy in older adults admitted to an intermediate care hospital.
The main question it aims to answer is: does this approach reduce the average number of medications taken per patient?
Researchers will compare this multi-professional patient-centered revision to the usual standard of care (treatment revision conducted by a clinical pharmacist) to see if the patient-centered revision works in improving treatment adequacy.
Participants admitted to an intermediate care hospital will undergo a comprehensive assessment by a geriatrician, and a medication revision (conducted by a multidisciplinary team or a clinical-pharmacist alone). They will also be asked to fulfill some questionnaires on their health status and attitudes. Any possible adverse events to the medications will be recorded at discharge. Participants will be contacted again three months after discharge to check for any readmission or death.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ana M de Andrés Lázaro, Pharmacist. PhD
- Phone Number: +34932594128
- Email: amandres@perevirgili.cat
Study Locations
-
-
-
Barcelona, Spain, 08023
- Recruiting
- Parc Sanitari Pere Virgili
-
Contact:
- Ana M de Andrés Lázaro, Pharmacist, PhD
- Phone Number: +34 93 259 41 28
- Email: amandres@perevirgili.cat
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- older adults (65+ years)
- ≥ 3 or more chronic conditions requiring medical therapy
- able to speak Spanish
- capacity to provide informed consent or have a surrogate able to consent on their behalf
Exclusion Criteria:
- unable to provide informed consent
- anticipated length of hospital stay < 72h
- estimated life expectancy < 3 months
- homeless
- already enrolled in a drug trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control (usual care)
Control arm will receive usual standard of care
|
|
|
Experimental: Intervention (patient-centered medication review)
Intervention arm will receive a multidisciplinary patient-centered medication review
|
Patient-centered multidisciplinary treatment review is defined as a medication review conducted by a multidisciplinary team (geriatrician, clinical pharmacist, nurse) according to a patient-centered methodology, based on person-centered evaluation of both personal and clinical insights, diagnostic-centered evaluation (based on current guidelines), and drug-centered evaluation (based on adequacy)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of drugs
Time Frame: Baseline and after discharge, an average of 30 days
|
Median number of drugs per patient
|
Baseline and after discharge, an average of 30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AMIDA-ICH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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