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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Patients with complex, long-lasting conditions such as chronic kidney disease (CKD) often take multiple medications and frequently have serious medication problems, arising from poor communication between doctors and patients. Prescription errors or misunderstandings can cause harm and lead to emergency room visits or even hospitalizations. To address these issues, medication reconciliation is now used by hospitals as a way to confirm the medication list of patients on admission to and discharge from hospital. However, a similar process does not exist outside the hospital setting. In recent years patients have become more proactive in undertaking activities with a direct bearing on their health. Such activities may include maintaining an accurate list of their medications. The rapid growth of the digital health arena has led to the development of a large number of commercially available mobile medication management apps for patients. These digital tools are 'stand-alone' products that are not integrated with the patients' pharmacy or health record system. They rely on patients to enter the list of their medications and update it as necessary. Moreover, few have a function to communicate medication changes or problems with their healthcare providers. Recently, an integrated smartphone, eKidneyCare, app system was developed with a medication management feature to help patients maintain an accurate mobile medication list. Patients' current medication information in the pharmacy database is uploaded onto their by a pharmacist and changes are tracked regularly through a bi-directional communication system. Updates to the medication list occur seamlessly by the pharmacist, and patients and their physicians are notified about any medication errors or serious adverse events. This study will determine whether our eKidneyCare app with its medication management feature will decrease medication errors and improve patient safety compared to the more traditional way of managing medications.
Background: Patients who have complicated conditions such as chronic kidney disease (CKD) are at high risk for problems related to their medications. Often these problems occur because doctors and patients do not communicate the right type of medication information to each other. This causes many prescribing errors and can lead to patient harm, emergency visits, or hospitalizations. To address this communication problem, hospitals now use a process called "medication reconciliation" to confirm the medications patients are taking when they enter and leave the hospital. However, the way that medication reconciliation is currently being done, patients are not actively engaged or given tools to effectively communicate the medications they are taking, changes that have been made, and what they are having trouble with. Directly engaging patients in this process might help solve this problem, and mobile technologies on smartphones may be a solution. Our study team has developed a mobile application (app) called eKidneyCare, which has a specific medication component to help patients communicate their medication information to all their doctors. This app can feed medication information from the clinic's medical record to the patient's smartphone, and any changes made to the medication list can be entered by the patient and sent back to the central server to notify their doctors.
Study Design: We propose to conduct an open-label randomized controlled trial to assess the medication related effectiveness and stakeholders' satisfaction of the eKidneyCare mobile app compared to commercially available mobile apps like My MedRec for 12 months. This study will be conducted in the renal clinics at University Health Network who oversee the clinical management of advanced stage 4 to 5 CKD patients and end stage renal disease. On average, patients of this clinic are aged 65 years or more and take 10-15 medications per day.
Objectives and Hypotheses Primary 1) To evaluate the effect of the eKidneyCare mobile app compared to a commercially available stand alone mobile app (My MedRec) on unintentional medication discrepancies in CKD patients. The use of the eKidneyCare app will have a greater reduction medication discrepancy rates by enhancing patient self-care through bidirectional communication of information.
Secondary
This study will evaluated if this app will decrease errors related to medications. It is hypothesized that if patients use this app to report their medications to their doctors, fewer errors will occur, which should eventually lead to reduced patient harm and healthcare use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eKidneyCare | Experimental | The eKidneyCare mobile app has an active interface with the renal clinic pharmacy system to allow for updated medication profiles to be sent directly to the patient's smartphone for the renal clinic pharmacy information system. |
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| My MedRec (Commercial App) | Active Comparator | My MedRec is a commercially available mobile app which allows a user to have a personal health record along with keeping track of their medications. The My MedRec mobile app allows users to track blood pressure and medication information through manual data entry with the app. It is a stand alone mobile app which stores specified medical information on the native smartphone device and does not connect to any other servers or databases. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | Usual standard CKD care involves an outpatient clinic visit every 3 to 4 months (at minimum every 6 months) for a clinical assessment by their renal clinical care team. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Discrepancy | The change in unintentional medication discrepancy rate from baseline to the last (12 months) visit. | One year (12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinic Blood Pressure | Mean change in systolic and diastolic BP measured by clinic BP Tru automated machine | 6, 12 months |
| Ambulatory Blood Pressure | Mean change in systolic and diastolic BP measured by average 7 day home ambulatory BP readings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie W Ong, BScPHM, MSc | UHN | Principal Investigator |
| Alexander G Logan, MD, FRCP(C) | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33737321 | Derived | Ong SW, Jassal SV, Porter EC, Min KK, Uddin A, Cafazzo JA, Rac VE, Tomlinson G, Logan AG. Digital Applications Targeting Medication Safety in Ambulatory High-Risk CKD Patients: Randomized Controlled Clinical Trial. Clin J Am Soc Nephrol. 2021 Apr 7;16(4):532-542. doi: 10.2215/CJN.15020920. Epub 2021 Mar 18. |
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| Integrated mobile medication app | Device | Use of mobile app to maintain, manage medication list on a smartphone device that allows for bidirectional transfer of medication information |
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| Commercially available mobile medication app | Device | Use of mobile app to manually record and maintain medication records with no integration to databases. |
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| 12 months |
| CKD specific laboratory values (hemoglobin) | Proportion of patients in target hemoglobin, defined as hemoglobin of 100 to 120 g/L | 12 months |
| CKD specific laboratory values (potassium) | Proportion of patients in target potassium ; defined as potassium of 3.2 to 5.0 mmol/L | 12 months |
| CKD specific laboratory values (phosphate) | Proportion of patients in target phosphate; defined as phosphate range of less than 1.5 mmol/L. | 12 months |
| Medication Discrepancy Proportion of Patients | Proportion of patients more than 1 unintentional discrepancy | 12 months |
| Satisfaction | Key feedback on usability, experience and perceived strengths and weakness of mobile app | 12 months |
| Quality of Life | Change in health utility scores as captured in the EQ-5D questionnaire | 12 months |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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