PatientsPILLS@HOMENCT06040151
Evaluating Mobile-based Medication Reconciliation by Patients at Home
An observational study of Patients, run by Erasmus Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients
- What is being tested?
- Digizorg mobile app (quality evaluation study)
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 18 years or older
- Planned admission to the clinical ward of participating pilot departments in Erasmus MC
Who cannot join
- No potential subject will be excluded from participation in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Patients
- Being tested
- Digizorg mobile app (quality evaluation study)
- Keywords
- Patients with all conditions are eligible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digizorg mobile app (quality evaluation study)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Digizorg mobile app (quality evaluation study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (1/4): completion rate of digital MR by patients
The fraction of all patients who were invited to participate that participated
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
To assess to what extent digital medication reconciliation is accepted by patients
Measured: 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
To assess to what extent digital medication reconciliation is accepted by patients and pharmacy technicians
Measured: During quality evaluation of the mobile-based medication reconciliation tool, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PatientsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Abdulla, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040151
- Sponsor's protocol ID
- 10624
- Acronym
- PILLS@HOME
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mobile-based Medication Reconciliation by Patients at Home: Feasibility, Quality and Time Investments by Pharmacy Technicians
- ClinicalTrials.gov ID
- NCT06040151
- Acronym / sponsor ID
- PILLS@HOME / 10624
- Conditions
- Patients
- Keywords
- Patients with all conditions are eligible
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Users of mobile-based medication-reconciliation app | – | Device: Digizorg mobile app (quality evaluation study)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 18 years or older
- Planned admission to the clinical ward of participating pilot departments in Erasmus MC
Key exclusion criteria (1 listed)
- No potential subject will be excluded from participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Users of mobile-based medication-reconciliation app |
Primary outcome
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
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
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
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
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
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)
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martijn Brands, MD (0031205665675, m.r.brands@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.