Testing a new digital platform (ReMedi) to help people report and manage side effects from medicines

INTERVENTION: The intervention involves consumers using a digital tool (ReMedi) to report any new symptoms or suspected adverse drug events (ADEs) they may experience after commencing on a medicine that is new to them. Consumers can access the platform using a web browser on their smart phone/device or computer. Interaction with the platform will involve completion of an ADE questionnaire, which takes approximately 10 minutes to complete and may be used by consumers on an ad hoc basis during a 30‐day follow‐up period when they experience an ADE and wish to make a report. The questionnaire will collect information on participant demographics (age, sex), details of symptoms (type, severity, current status, and duration), the suspected medicine (brand or generic name, prescribed or non‐prescribed, dose, frequency, duration of use, and indication, if known), comorbidities, and other concomitant medicines. Responses will be provided using pre‐specified options, with free‐text entry available for selected items. With the consumer’s consent, their report will be sent to their GP and/or pharmacist who consent to receive the report to support targeted assessment and management of the reported ADE. After reviewing a copy of the reports, the GP or pharmacist may contact the consumer to discuss and/or manage the reported ADE. For consumers who have provided additional consent, a copy of their reports will also be shared with the TGA. Participants may choose whether or not they wish to be contacted by the TGA for further information about their report, if needed. If they agree, the research team will share the participants’ report along with their contact details to the TGA. If they do not, only a de‐identified copy of their report will be shared, unless they choose not to have th CONDITION: Adverse Drug Events; ; Adverse Drug Events Public Health ‐ Health service research PRIMARY OUTCOME: Process evaluation: the implementation process (what works, where, and why), the acceptability of, and satisfaction with the platform[Two focus group discussions will be conducted with the two stakeholder groups (consumers and healthcare professionals). Each focus group will be facilitated by members of the research team and will include 4–6 participants, with a maximum of six participants invited to each group. Participants will be selected using purposive sampling to ensure representation of diverse demographic characteristics, including age and sex. At the end of the study] Usability of ReMedi by consumers[An online consumer survey using the mHealth App Usability Questionnaire (MAUQ), an 18‐item commonly used scale As soon as possible after a consumer submits an ADE report (Anytime between day 2 to day 30 post‐baseline)] INCLUSION CRITERIA: Adult consumers (greater than or equal to 18 years) or parents of children (<18 years) residing in South Australia Prescribed or dispensed a prescription‐only or pharmacist‐only medicine that is new to them. Own or have access to a smartphone/tablet/personal computer with internet connectivity. SECONDARY OUTCOME: The number and proportion of ADE reports shared with HCPs[Consumer and HCP follow up by the research team, a structured interview From day 2 to day 30 post‐baseline, as events occur] The number and proportion of reports reviewed by HCPs[Consumer and HCP follow up by the research team, a structured interview From day 2 to day 30 post‐baseline, as events occur] The number and type of treatment changes prompted by the detected ADE (e.g., dose adjustments, medication discontinuation, pharmacologic and non‐pharmacologic management) along with the timing of these changes. [Consumer and HCP follow up by the research team, a structured interview From day 2 to day 30 post‐baseline, as events occur] The number of ADEs consumers consented to be shared with the TGA[ReMedi platform data, supplemented by consumer and/or medical and pharmacy dispensing records From day 2 to day 30 post‐baseline, as events occur] The number of consumer self‐initiated vs. HCP‐recommended treatment changes.[Consumer and HCP follow up by the research team, a structured interview From day 2 to day 30 post‐baseline, as events occur] The proportion of ADE per newly prescribed medication[ReMedi platform data, supplemented by consumer and/or medical and pharmacy dispensing records From day 2 to day 30 post‐baseline, as events occur] The proportion of ADE reports per consumer[ReMedi platform data From day 2 to day 30 post‐baseline, as events occur] The total number of ADE reports[ReMedi platform data From day 2 to day 30 post‐baseline, as events occur]