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

• ClinicalTrials.gov Identifier: NCT06040151
• Recruitment Status: Not yet recruiting
• First Posted: September 15, 2023
• Last Update Posted: September 15, 2023
• Sponsor: Erasmus Medical Center
• Information provided by (Responsible Party): Alan Abdulla, Erasmus Medical Center

Tracking Information

• First Submitted Date: July 12, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: September 15, 2023
• Estimated Study Start Date: October 2023
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

• 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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2023)

• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Patients

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.

Study Groups/Cohorts

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

Intervention: Device: Digizorg mobile app (quality evaluation study)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 13, 2023): 39
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided

Contacts

Contact: Martijn Brands, MD; 0031205665675; m.r.brands@erasmusmc.nl

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06040151
• Other Study ID Numbers: 10624
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Alan Abdulla, Erasmus Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Erasmus Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Erasmus Medical Center
• Verification Date: September 2023