Genotype Specific Approaches to Therapy in Childhood (GATC); Canadian Pharmacogenomic Network for Drug Safety (CPNDS) – REB #06/14E
CHEO is an active member of an Adverse Drug Reaction surveillance network that is unique in the world. It began with one surveillance site at BC Children’s Hospital, and grew to include 13 major paediatric teaching hospitals across Canada. GATC developed its first pharmacogenomic panel of single nucleotide polymorphisms (SNPs) to study the genetics of ADRs in 2005. This panel allowed for the detection of genetic variation in over 220 key candidate genes that influence the way patients respond to a given medication. To date, this panel allowed for the detection of genetic variation in over 220 key candidate genes, and many more to be discovered in the future that influence the way patients respond to a given medication. CHEO has contributed drug safety data from over 670 patients since the start of the study in October of 2006. Patients with a wide range of medical conditions have participated in the study by allowing CHEO researchers to collect drug safety data from their medical records and by providing a DNA sample for candidate gene analysis. Participants have been recruited from various medical areas such as Rheumatology, Oncology, Hematology and Nephrology.
Study status: Patients who have experienced an adverse reaction to a medication are referred to the study investigator by any health professional involved in their care. Patients who have not had a reaction can also be enrolled as they can be part of the control group. In the future CHEO hopes to collaborate with the CPNDS panel to implement a Personalized Medicine Project whereby genetic analysis will be used to make drug safety decisions prior to the start of therapy to fulfill the ultimate goal of reducing drug adverse events in children.
Identifying and Reporting ADRs: An exploratory study of how Natural Language Processing can be used to extract data from EPIC using i2b2 data warehouse
The Protecting Canadians from Unsafe Drugs Act (Vanessa’s law – Bill C-17), amends the Food and Drugs Act regarding therapeutic products by introducing measures to strengthen safety oversight of therapeutic product throughout their life circle; by adding compulsory reporting by healthcare institutions of serious Adverse Drug Reactions (ADRs). However, there is currently no plan as to how such mandatory reporting will take effect. With CHEO transitioning to Electronic Health Records (EHR) our research team is exploring the promising possibilities of using EHR to detect possible ADRs to effectively complement SRS databases. An extensive review of the literature on the use of Electronic Health Records, especially EPIC and data warehouse i2b2 to easily extract ADRs, is currently underway at CHEO. This work will also pave the way for other researchers at CHEO and the CHEORI on how to use EHR to conduct research with the aim to improve the health of children.
Study Status: Actively reviewing the literature
Defining and Identifying Concepts of Medication Literacy: An International Survey and Delphi Consultation with Experts - CHEOREB# 15/115X
Nowadays, pharmaceuticals play a primary role in the management of most diseases around the world. At the same time, these same medicines are causing harm and are responsible for adverse health-related events. These adverse events are also “highly” preventable in 37% of cases, and are often caused by the inappropriate use of medicines which are linked to a poor understanding of medication instructions, and to low health literacy. The aim of this project is to develop a framework for the definition of ‘medication literacy’ based on international consensus using a modified Delphi process. A preliminary survey was sent to members of the International Pharmaceutical Federation to: (1) identify statements healthcare professionals would like to see integrated into a definition for medication literacy, and (2) identify experts from all the different region of the world in the area of health literacy in the context of medication use. Statements about ‘medication literacy’ found in the literature and identified in the preliminary survey were used to build a Delphi Questionnaire sent to experts. We conducted 3 rounds of Delphi and 24 experts agreed upon 30 statements about medication, which were divided into four clusters representing: (1) type of information necessary for optimal and safe use of medication; (2) skills necessary for optimal and safe use of medication; (3) format of information and pharmacy services; and (4) outcome and goals. We also asked experts to classify these statements as essentials (E) if there were absolutely necessary for patients or secondary (S) if the element was not necessary essential but would definitely benefit the patient. These statements were used to draft a definition that is currently under review at the International Pharmaceutical Federation.
Study status: Preliminary results were presented to the International Pharmaceutical Federation and the adoption of a definition of medication literacy is pending their approval.
Defining and Identifying Concepts of Medication Reconciliation: A Delphi Consultation with Experts - CHEOREB# 16/56X
Medication reconciliation has been acknowledged by several international patient safety organizations such as The Joint Commission (TJC), Institute for Health Care Improvement (IHI) and the World Health Organization (WHO) as important for achieving medication safety. Due to the many subtle variations in the definitions of medication reconciliation, and the inconsistency between the process elements of implementing medication reconciliation, it is time that consensus be sought on a universal definition, and the elements that make up the medication reconciliation process so as to optimize medication reconciliation and the health outcomes of patients. This study aims at developing a framework for the definition of ‘medication reconciliation’ based on international consensus using a modified Delphi process with experts identified based on their leadership in publication, education, professional interest and participation in the area of medication management. A threshold of 80% agreement will be used to establish consensus for each statement presented to the experts and a definition of medication reconciliation will be proposed.
Study status: Experts were recently recruited and the first Delphi questionnaire was sent to them. We expect to conduct a minimum of three rounds of Delphi.
An International Survey on Pictogram Preferences for Safer Medication Handling by Healthcare Workers - 16/90X
This project aims to determine international preference of medication safety pictograms to better medication handling by healthcare workers. Using a mass communication strategy, a survey invitation will invite healthcare workers, including pharmacists, pharmacy technicians, nurses and physicians to complete a survey with aims of determining the preferred pictographic representation of medication safety issues. A total of 18 pictograms depicting 9 medication safety issues and high risk drugs classes that have been previously identified, in a nation-wide study, as benefiting from safety pictogram, will be presented to participants. For each category the preferred pictogram will be retained for future comprehension testing.
Study status: The survey is currently being distributed internationally to healthcare providers involved in medication management.
Usability Testing and Satisfaction of iDoseCheck: a Mobile Health Application for Families - CHEOREB# 15/69X
Mobile phone apps are becoming increasingly important in the delivery of healthcare, and have the potential to be an effective and accessible means of improving the safety and quality of healthcare. Also popular is the use of over-the-counter medication for the relief of common cold symptoms, or for the treatment of minor conditions in children. Unfortunately, children are particularly susceptible to risks caused by medication error, as child drug dosing is usually calculated based on the patient’s age, weight, and clinical condition; a child’s weight can change quickly, thus predisposing them to potential medication errors.1 This study aims to validate the design of iDoseCheck, a mobile health (mHealth) application developed to assist parents and caregivers in calculating the proper dose of common over-the-counter medications for children. The evaluation of the design and usability will be conducted using an iterative process to refine the design, features and functions of iDoseCheck. Parents and caregivers will be recruited from the Children’s Hospital of Eastern Ontario. These results will provide useful information to ensure the iDoseCheck application is easy to use for parents and caregivers.
Study status: We are currently recruiting parents and caregivers of children weighing less than approximately 45 kg at KidCare Pharmacy at CHEO and from an Early Year’s Program at the South East Ottawa Community Health Centre.
In collaboration with the Emergency Department:
Provider and User-Centered Design and Usability Testing of a Mobile Asthma Action Plan Application - CHEOREB#15/57X
When designing mobile applications, it is recommended that patients be involved in the design and testing of health applications. There are 209 distinct asthma applications available to patients. Unfortunately, only a few mobile healthcare applications address and report usability. This study aims to design a mobile asthma action plan application through a user-centered iterative design process. The mobile asthma action plan application is based around a validated pictogram-based Asthma Action Plan and Prescription developed at the Children’s Hospital of Eastern Ontario. An initial prototype of the application will be created with the consultation of physicians. Parents and caregivers of children will then be asked to complete a series of tasks designed to demonstrate the functionalities of the application. As participants are completing the tasks, the participants will be asked to talk out loud and describe their likes, dislikes, and missing function of the application. Physicians will also be involved in the application design and usability testing process. Physicians will first be consulted prior to the start of the study to gain feedback on the information, features, and functions that should be included in the applications. The information gained from the first two cycles of usability testing by parents and caregivers will be used to improve the prototype application. Physicians will then participate in a cycle of usability testing and the application will be updated. After this, cycles of usability testing with parents and caregivers will continue until a mean SUS score of 77 is reached. Between each cycle of usability testing the application will be updated. These results will provide useful information to ensure the application is easy to use for parents and caregivers and contains the necessary features and functions. It will also ensure that the needs of physicians, recommending the application are met.
Study status: The first round of testing was completed with parents/caregivers of children presenting in the ED for asthma and physicians. The mobile application was upgraded based on the feedback received and we are now recruiting families in the ED for round 2 of usability testing.
In collaboration with the Complex Care Team:
Exploring Parents/Caregivers’ Experiences and Perceptions of Medication Errors in the Care of a Child with Medical Complexity - CHEOREB# 15/41X
When medication errors happen, the health of a patient may be threatened, and each error can increase the cost of health care for the patient. Therefore, the identification and classification of the types of errors that occur within children with medical complexity while in hospital or the community, is essential to construct and/or enforce procedures to promote medication safety in this demographic. Additionally, patients and/or caregivers may alter their behaviour after experiencing a medication error. In particular, parents/caregivers of children who have experienced medication errors are more likely to engage in safety behaviour to protect their children from future errors.14 Medication errors are often underreported, and data already exists regarding the management of medication errors from a hospital point of view. However, there is a scarcity of data regarding medication error experiences from a patient/caregiver perspective. This study aims to develop an understanding of the beliefs and experiences of patients and their caregivers about medication errors in the Champlain Complex Care Program at The Children’s Hospital of Eastern Ontario.
Study status: We are currently recruiting primary caregivers of patients from the Champlain Complex Care Program at The Children’s Hospital of Eastern Ontario in Ottawa, Ontario, who were hospitalized at least once in the last two years.
In collaboration with the Dermatology Outpatient Clinic:
Evaluation, Modification and Validation of an Illustrated Eczema Action Plan for Children - CHEOREB# 15/40X
This study aims to evaluate and validate an evidence-based eczema (atopic dermatitis) action plan using pictograms as an adjunct to verbal and written material. The use of infographics can improve patient comprehension, treatment compliance, and retention of counselling points, which are key components to improving the management of eczema. The validated Eczema Action Plan will then be used as a supplementary aid in the treatment and management of paediatric eczema. This multi-phase project aims at 1) validating a set of eczema images depicting counselling points used during consultation, 2) assessing the comprehension, satisfaction and usability of the eczema action plan and 3) evaluating the clinical impact of using the eczema action plan. A total of 265 patients were recruited in the dermatology clinic to evaluate the images.
Study status: We are now recruiting patients from the CHEO Dermatology Clinic aged 10 through 17 years of age and the parents of children (0 through 9 years of age) are eligible for the study to assess usability, satisfaction and overall comprehension of eczema management at the CHEO Outpatient Dermatology Clinic. The validated eczema action plan will be subsequently implemented into the Dermatology Clinic to assist health professionals in communicating instructions to children and their parents.
In collaboration with Roger Nelson’s House:
Using a Failure Mode Effect & Analysis and a review of Safety Reports to Reduce the Risk of Medication Errors in Paediatric Palliative Care - CHEOREB# 16/54X
Hospice populations are especially at risk for medication errors due to advanced illness and the use of high-risk medications. However, there is a lack of data on error rates and factors influencing medication errors in palliative care. The recommended approach to dealing with ADE events that have occurred is to focus on a systems approach rather than on the individual. Using a proactive approach of detection and reduction of the medication errors occurrence risk, such as Failure Mode and Effect Analysis (FMEA) is relevant due to its anticipative character which allows us to identify needed improvements that will reduce the chance of unintended adverse events. Since the opening in 2006 of Roger Neilson’s House, a pediatric hospice, medication errors have been identified, reported and reviewed quarterly, but no systematic review of medication errors has been undertaken. At the hospice patients come in with their own medications, ordered by their own health care providers, and dispensed by their own pharmacy. Exceptionally if there is a special need or an emergency, medications are delivered by a particular pharmacy affiliated with the hospice, or the nearby hospital pharmacy. This study will determine the incidence of medication errors reported at the hospice, and to review the processes and policies surrounding medication administration using a FMEA and a review of the medication error reports.
Study status: Medication incidents are currently being reviewed and analyzed by a group of experts to identify factors that contribute to medication errors and identify strategies to reduce/prevent medication error occurrence at the hospice.
Review of the Pain & Symptom management Referrals at the CHEO Palliative Care Team
In 2006, with the expansion of the Children’s Hospital of Eastern Ontario’s (CHEO) Palliative Care team and the opening of Roger Nelson’s House, a pediatric hospice located in Ottawa, symptom-based support became a priority of the interdisciplinary team that includes physicians, nurses, pharmacists, social workers and child life specialists. To ensure success in providing pain and symptom management, a collaborative approach between the most responsible physician/team and the Palliative Care/Pain and Symptom Management Team was put in place in order to enhance patient outcomes and allows provision of better care. The Palliative Care physicians began providing time limited symptom-based support to a variety of patients during hospitalization, in addition to patients with life-threatening conditions followed by the team.7 From January 2006-August 2015, a total of 906 referrals were made to the Palliative Care team. Of these, 257 (28.5%) were solely for pain and symptom management. This study will explore the characteristics of children admitted to the hospital and referred specifically for pain and symptom management, providing a descriptive analysis of processes and outcomes from referral to the team to discharge.
Study status: We currently are reviewing the charts of patients that were referred to the PSMT.