Evaluating Mobile-based Medication Reconciliation by Patients at Home (PILLS@HOME)

September 13, 2023 updated by: Alan Abdulla, Erasmus Medical Center

Evaluating Mobile-based Medication Reconciliation by Patients at Home: Feasibility, Quality and Time Investments by Pharmacy Technicians

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (1/4): completion rate of digital MR by patients
Time Frame: During quality evaluation of the patient app, an average of 3 months
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)
Time Frame: During quality evaluation of the patient app, an average of 3 months
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
Time Frame: During quality evaluation of the patient app, an average of 3 months
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
Time Frame: During quality evaluation of the patient app, an average of 3 months
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)
Time Frame: 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 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
Time Frame: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability (1/2): defined as the perceived usability of mobile-based MR by patients, assessed using short in-app questionnaires (VAS 1-5)
Time Frame: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
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
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
Time Frame: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 10624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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