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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06040151
Other study ID # 10624
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date May 2024

Study information

Verified date September 2023
Source Erasmus Medical Center
Contact Martijn Brands, MD
Phone 0031205665675
Email m.r.brands@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Medication reconciliation (MR) is essential to limit drug-related problems that occur during care transitions in and out of care institutions. Pharmacy-led medication reconciliation has been shown to reduce medication discrepancies, preventable harm and hospital readmissions. However, these consultations are time-consuming. The Erasmus Medical Center is currently developing a mobile-based patient portal. After receiving an invitation to perform medication reconciliation in the app, patients can review their medication and allergies at home. Next, pharmacy technicians manually verify all patient-entered data on completeness and quality. The investigators hypothesize that mobile-based medication reconciliation results in increased patient insight. Yet, it is unknown if mobile-based medication reconciliation is feasible, saves time, and is of high quality. Therefore, the primary study objectives are to assess (1) the feasibility of patients performing medication reconciliation using a mobile-based patient portal, (2) the time investment of pharmacy technicians in mobile-based medication reconciliation (and related costs), in comparison to standard practice, and (3) the quality of patients' pre-verified medication lists. The secondary study objective is to assess patients' and pharmacy technicians' acceptability of performing medication reconciliation using a mobile-based patient portal. This is a prospective quality evaluation study assessing mobile-based medication reconciliation. All adult patients (18 years or older) who are admitted to (a selection of) clinical ward in Erasmus Medical Center and who are asked to complete medication reconciliation are eligible. In the patient app, patients review ('pre-verify') their medications and allergies, after which pharmacy technicians check and manually approve ('verify') all patient-entered data and determine whether a follow-up interview is needed. Feasibility is defined as the successful completion rate of digital medication reconciliation, and the need for additional interviews. Time investment by pharmacy technicians (and related costs) are determined by timing the duration of all patient-bound medication reconciliation-related tasks, both in standard care and when using mobile-based reconciliation. The quality of verification is determined by comparing patients' pre-verified medication list to pharmacy technician-verified lists. Acceptability is defined as the perceived usability of medication reconciliation by patients and by pharmacy technicians.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date May 2024
Est. primary completion date March 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - Planned admission to the clinical ward of participating pilot departments in Erasmus MC Exclusion Criteria: - No potential subject will be excluded from participation in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Digizorg mobile app (quality evaluation study)
Erasmus Medical Center is developing a state-of-the-art, mobile-based patient portal that combines up-to-date medication lists from all healthcare providers involved in a patient's care. Other functionalities include: accessing health information, viewing and planning appointments, teleconsulting, sending messages, filling in questionnaires, reporting self-measurements, and reading background information on diseases, medication, and other interventions. The patient portal will primarily be implemented in Erasmus Medical Center, and is ultimately intended for every patient, regardless of underlying condition.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility (1/4): completion rate of digital MR by patients The fraction of all patients who were invited to participate that participated During quality evaluation of the patient app, an average of 3 months
Primary Feasibility (2/4): the time it takes patients to perform digital MR (in minutes) To assess the ease-of-use of performing medication reconciliation in the patient app During quality evaluation of the patient app, an average of 3 months
Primary Feasibility (3/4): the need for live, follow-up interviews after performing digital MR The fraction of all patients who were invited to participate in digital MR who needed a live interview During quality evaluation of the patient app, an average of 3 months
Primary Feasibility (4/4): how often the helpdesk was contacted The fraction of all patients who were invited to participate in digital MR who contact the helpdesk During quality evaluation of the patient app, an average of 3 months
Primary The time investment by pharmacy technicians per patient in the digital MR process, compared to the current situation (in minutes) The time investment by pharmacy technicians per patient in the new workflow vs. the current situation, in which all patients are invited for a live interview Before launch of the patient app, during an average of 2 months, and during quality evaluation of the patient app, an average of 3 months
Primary The quality of a patient's pre-verified medication list, compared to the pharmacy technician's verified medication list The number of discrepancies between the patient-reported medication list and the pharmacy-verified medication list (the number of changes made by a pharmacy technician in the MR process) During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
Secondary Acceptability (1/2): defined as the perceived usability of mobile-based MR by patients, assessed using short in-app questionnaires (VAS 1-5) To assess to what extent digital medication reconciliation is accepted by patients During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
Secondary Acceptability (2/2): defined as the perceived usability of mobile-based MR by patients and pharmacy technicians, assessed using short qualitative interviews with both patients and pharmacy technicians To assess to what extent digital medication reconciliation is accepted by patients and pharmacy technicians During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
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