Blinding status and measures to assure blinding
| Blinding status | How to achieve blinding | |
| Recruitment team (study nurse/research physician) | Blinded | Randomisation status will be kept concealed from the recruiting team, no access is given to unblinded study information in the database or locally to the source data. |
| Intervention team (physician, pharmacist) | Unblinded | In order to perform a safe intervention, including a shared decision-making with the patient, blinding is impossible. |
| Follow-up team (study nurse) | Blinded | Randomisation status will be kept concealed from the team conducting follow-up calls, no access is given to unblinded study information in the database or locally to the source data. In case an event or serious adverse event has occurred, the unblinded study team will be informed. |
| Unblinded | This team is informed about the treatment allocation. They collect the necessary information about events and anonymise revealing information about allocation on the documents for the adjudications. Make safety assessments. | |
| Adjudication (pharmacist/physician) | Blinded, work independently from study team | Receives only blinded information on hospital admission and deaths after study inclusion. |
| Patients | Partially blinded | Will be seen by the study team in case of intervention or control allocation. Control patients undergo a sham intervention using the ©MMAS-8.30–32 |
| Prescribing physician | Partially blinded | Will receive only high-level information about the trial. Every prescribing physician who defines a cluster will sign a disclosure form in order not to share information about the approach of the study team with their colleagues. |
| General practitioner | Partially blinded | Will receive only high-level information about the trial using an information flyer that does not inform about the two different study arms. The GP will receive a form about study inclusion for each patient (regardless of study allocation), and in the case of the intervention group, the GP will also receive the STRIPA report. |
©MMAS, Medication Adherence Measure Questionnaire; GP, general practitioner; STRIPA, STRIP Assistant.