Table 1 Progression criteria to determine a larger trial
Proceed with a larger trial | Amend — proceed with a larger trial | Stop — do not proceed unless changes are possible | |
|---|---|---|---|
Patient recruitment Can 50 patients be recruited from the pilot site? | If 50 patients are recruited during a 5-month recruitment period | If 25 patients are recruited during a 5-month recruitment period | If less than 10 patients are recruited during the 5-month recruitment period |
Patient retention Do at least 80% of recruited patients return to the site within 3–6 months with at least one blood pressure reading recorded in the EHR? | If at least 40 (80%) of recruited patients return within 3–6 months and have a recorded blood pressure reading in the EHR | If at least 35 (70%) of recruited patients return within 3–6 months and have a recorded blood pressure reading in the EHR | If less than 35 (< 70%) of recruited patients return within 3–6 months and have a recorded blood pressure reading in the EHR |
Appropriateness of implementation strategies | Strong interest in using the ASPIRE toolkit by patients and providers based on qualitative interviews | Strong interest in using the ASPIRE toolkit by patients and providers based on qualitative interviews | Limited or no interest in using the ASPIRE toolkit by patients and providers based on qualitative interviews |