Table 1 Study outcomes and data sources
Item | Domain definition | Measure and metrics | Data sourcesa |
|---|---|---|---|
Primary outcome | |||
Rate of complicationsb of the baseline disease | A secondary disease, an accident, or a negative reaction (including adverse reactions to treatment) occurring during the course of the baseline disease and usually aggravating the illness. | Measure: events, as recorded in the eCRF. Metrics and aggregation: event rate (i.e., proportion of patients experiencing an event within each arm and the follow-up period). | Investigator-reported in the eCRF Local EHR. |
Secondary outcomes | |||
Rate of severe complications of the baseline illness | A complication with significant impact on patient’s life and/or that require intervention by a healthcare professional | Measure: events, as recorded in the eCRF. Metrics and aggregation: event rate (i.e., proportion of patients experiencing an event within each arm and the follow-up period). | Investigator-reported in the eCRF Local EHR. |
Rate of severe adverse reactions related to the treatment of the baseline condition | An undesired health event related to a drug administered to treat the baseline health condition | Measure: events, as recorded in the eCRF. Metrics and aggregation: event rate (i.e., proportion of patients experiencing an event within each arm and the follow-up period). | Investigator-reported in the eCRF |
Rate of preventable hospitalizations | Hospitalizations due to illnesses secondary to the chronic diseases that can be managed in the outpatient settingc | Measure: events, as recorded in the eCRF. Metrics and aggregation: event rate (i.e., proportion of patients experiencing an event within each arm and the follow-up period). | Local EHR |
Non-scheduled medical encounters related to poor control of the baseline disease | The following events will be considered: • Non-scheduled appointments (phone, videoconference, or face-to-face). • Visits to primary care services. • Visits to the emergency room. • Hospital admissions. | Measure: events, as recorded in the eCRF. Metrics and aggregation: event rate (i.e., proportion of patients experiencing an event within each arm and the follow-up period). | Investigator-reported in the eCRF Local EHR |
Pharmaceutical prescriptions | The number of new prescriptions and renewals will be collected, along with the type of pharmaceutical prescription: long-term, acute process, or pro re nata. | Measure: ATC groups prescribed Metrics and aggregation: difference in number of ATC groups between baseline and last visit; the outcome will be measured as the mean and standard deviation, and median and interquartile range (i.e., 25th and 75th percentiles). | Administrative records. |
Usability | Usability parameters will be collected using two approaches: • Computer System Usability Questionnaire. • Technical incidents reported by the investigators. | Measure: Questionnaire score and number of technical incidents. Metrics and aggregation: score, expressed as the mean and standard deviation, and median and interquartile range (i.e., 25th and 75th percentiles). Cumulative number of incidents. | Phone call administration by trained interviewers to 10% of the study sample. Investigator report to the eCRF. |
Satisfaction | Satisfaction survey CSAPG included in the satisfaction survey plan of the Catalan Health System. | Measure: Questionnaire score. Metrics and aggregation: score, expressed as the mean and standard deviation, and median and interquartile range (i.e., 25th and 75th percentiles). | Phone call administration by trained interviewers to 10% of the study sample. |
Care provision expenditure | Expenses related to each of the interventions. | Measure: cost in euros of the year. Metrics and aggregation: mean and standard deviation per patient. | Administrative records. |