Table 1

Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT)

Study period
Hospital stayHospital dischargeFollow-upClose-out
TIME POINT1 to −7 days 0 M3 M6 M9 M12
ENROLMENT
Eligibility screenX
Informed consentX
INTERVENTIONS
Medication reconciliationX*
Medication reviewX
Interview before dischargeX*
Providing educational brochures, discharge plan, medication planX*
Providing follow-up diaryX
Information sharing with healthcare professionalsX*X*X*X*X*
Telephone interviewsX*X*X*
Final interviewX
ASSESSMENTS
History, demographicsX
PRIMARY OUTCOME
Medication possession ratioX*X*X*X
Adherence scaleXX
SECONDARY OUTCOMES
Blood glucose controlXX
Lipid controlXX
Abdominal girthXX
Blood pressureXX
Quality of life (SF-36)XX
Belief/representation about the disease (Brief IPQR)XX
Knowledge about the disease and the treatmentsXX
LifestyleXX
Number, type and severity of iatrogenic eventsX
Proportion of patients having recurrent stroke or other major adverse cardiovascular eventX
Proportion of patients readmitted to hospitalX
Adherence to each secondary preventive drugX
Patient satisfaction regarding treatments (SATMED-Q)X
Patient satisfaction regarding the intervention programme X*
Community pharmacist’s satisfaction regarding the intervention programmeX*
General practitioner’s satisfaction regarding the intervention programmeX*
  • *Intervention group.

  • Brief IPQR, Brief Illness Perception Questionnaire; SATMED-Q, Treatment Satisfaction with Medicines Questionnaire; SF-36, Short Form 36 Health Survey questionnaire.