NCT06040151

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

July 12, 2023

Last Update Submit

September 13, 2023

Conditions

Keywords

Patients with all conditions are eligible

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Acceptability (1/2): defined as the perceived usability of mobile-based MR by patients, assessed using short in-app questionnaires (VAS 1-5)

    During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months

  • 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

    During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months

Study Arms (1)

Users of mobile-based medication-reconciliation app

Adult patients (18 years or older) who are asked to complete medication reconciliation before a planned admission to the clinical ward of selected pilot departments in Erasmus Medical Center

Device: Digizorg mobile app (quality evaluation study)

Interventions

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.

Users of mobile-based medication-reconciliation app

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients (18 years or older) who are asked to complete medication reconciliation before a planned admission to the clinical ward of selected pilot departments in Erasmus MC are eligible to participate in this study.

You may qualify if:

  • years or older
  • Planned admission to the clinical ward of participating pilot departments in Erasmus MC

You may not qualify if:

  • No potential subject will be excluded from participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Martijn Brands, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Alan Abdulla, Principal Investigator

Study Record Dates

First Submitted

July 12, 2023

First Posted

September 15, 2023

Study Start

October 1, 2023

Primary Completion

March 1, 2024

Study Completion

May 1, 2024

Last Updated

September 15, 2023

Record last verified: 2023-09