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

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ClinicalTrials.gov Identifier: NCT06040151
Recruitment Status : Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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