Smart About Meds (SAM) RCT

This is a composite, binary outcome of having experienced an ED visit, hospital readmission, or death in the 90 days post-discharge. In Quebec, physicians must record the location of the services they provide to be remunerated on a fee-for-service basis. These medical services claims data are timely and accurate in measuring hospitalization occurrence and length of stay. The hospitalization database, which records admission and discharge diagnoses and procedures for all acute care hospitalizations in Quebec, will be used to collect additional descriptive information on the reasons for hospitalization and to re-validate the medical services data. Patients will be classified as having an ED visit or hospital readmission if they received a service whose location is recorded as an ED or inpatient hospital unit, respectively. Post-discharge deaths will be retrieved from the RAMQ beneficiary database.

ED visits, hospital readmissions and deaths occurring in the 90 days post-discharge, each of which will be measured separately as a binary secondary outcome.

This is a binary outcome of a patient having adhered or not to medication changes in the discharge prescription. Nonadherence to medication changes is defined as a failure to fill a new prescription within 90 days of discharge, filling a modified prescription at the incorrect dose, or filling any discontinued medication in 90 days.

Disease-modifying medications are defined as those that prevent health deterioration and typically need to be taken on a daily basis to be effective. A list of these medications will be compiled based on the World Health Organization's list of essential medicines. Secondary adherence will be measured for each disease-modifying medication that is filled using the medication possession ratio, which is calculated as the days of supply (based on the duration of dispensed prescription during follow-up) divided by the number of days of follow-up. Left-over supply prior to admission, when relevant, will be included in the calculation and only supply within the 90-day period for post-discharge dispensations will be included. In Quebec, over 94% of prescriptions are dispensed for 30 days or less, which should provide an accurate measure of persistence.

Patient and caregiver empowerment will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) Self-Efficacy Measure for Managing Medication and Treatments (PROMIS-SE Meds). This 8-item measure assesses patient confidence in managing medication schedules of varying complexity and in challenging situations, such as when running out of supply or when adverse effects occur. Five-point ratings scales assess confidence levels. Scores are calibrated as T-scores (mean 50, SD 10), where higher scores indicate greater self efficacy.

Patient health-related quality of life (HRQoL) will be measured using the Patient Reported Outcome Measurement Information System-29 (PROMIS-29), which measures quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). Five-point ratings scales assess HRQoL. Scores are calibrated as T-scores (mean 50, SD 10), where higher scores indicate greater self HRQoL.