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Table 3 Progression criteria (‘Stop’, ‘Amend’, ‘Go’) for the S-MAP pilot study

From: A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol

Concept Data source(s) Progression criteria
Stop (unless there are clear and modifiable contextual or design issues that account for thisa) Amend Go
Pharmacy recruitment Recruitment records held by the research team If ≤ 5 pharmacies are recruited within 8 months If 6–9 pharmacies are recruited and/or it takes longer than predicted (> 4–6 months) If ≥ 10 pharmacies are recruited to take part in ≤ 4 months
Pharmacy retention Retention records held by the research team If ≤ 49% of pharmacies are retained for the required period If 50–79% of pharmacies are retained for the required period If ≥ 80% of pharmacies are retained for the required period
Patient recruitment Study documentation completed by pharmacy staff If ≤ 59 patients are recruited within 6 monthsb or alternativelyc if ≤ 49% of pharmacies achieve a monthly recruitment rate of two patients per month for any three consecutive months If 60–95 patients are recruited within 6 monthsb or alternativelyc if 50–79% of pharmacies achieve a monthly recruitment rate of two patients per month for any three consecutive months If ≥ 96 patients are recruited within 6 monthsb or alternativelyc if ≥ 80% of pharmacies achieve a monthly recruitment rate of two patients per month for any three consecutive months
Patient retention Study documentation completed by pharmacy staff If ≤ 49% of patients are retained for the required period If 50–79% of patients are retained for the required period If ≥ 80% of patients are retained for the required period
Fidelity of pharmacist training package: delivery Audio-recordings of pharmacist workshops If ≤ 49% of planned training components are delivered by the researchers If 50–79% of planned training components are delivered by the researchers If ≥ 80% of planned training components are delivered by the researchers
Fidelity of pharmacist training package: receipt Audio-recordings of pharmacist workshops If ≤ 49% of delivered training components are received by pharmacists as intended If 50–79% of delivered training components are received by pharmacists as intended If ≥ 80% of delivered training components are received by pharmacists as intended
Post-workshop feedback survey If ≤ 49% of pharmacists report that they feel prepared to take part in the study If 50–79% of pharmacists report that they feel prepared to take part in the study If ≥ 80% of pharmacists report that they feel prepared to take part in the study
Acceptability of pharmacist training day Post-workshop feedback survey If ≤ 49% of pharmacists report that the training day was acceptable If 50–79% of pharmacists report that the training day was acceptable If ≥ 80% pharmacists report that the training day was acceptable
Fidelity of intervention delivery Audio-recordings of a sample of patient sessions If ≤ 49% of BCTs are delivered to patients when appropriate If 50–79% of BCTs are delivered to patients when appropriate If ≥ 80% of BCTs are delivered to patients when appropriate
Fidelity of intervention receipt Audio-recordings of a sample of patient sessions If ≤ 49% of delivered BCTs are received by patients as intended If 50–79% of delivered BCTs are received by patients as intended If ≥ 80% of delivered BCTs are received by patients as intended
Acceptability of intervention to pharmacists Post-intervention delivery qualitative interviews If ≤ 49% of pharmacists report that the intervention was acceptable If 50–79% of pharmacists report that the intervention was acceptable If ≥ 80% pharmacists report that the intervention was acceptable
Acceptability of intervention to patients Post-intervention delivery feedback survey If ≤ 49% of patients report that the intervention is acceptable If 50–79% of patients report that the intervention is acceptable If ≥ 80% of patients report that the intervention is acceptable
Enactment of treatment principles Audio-recordings of a sample of patient sessions If ≤ 49% of patients engaged with (or used) the delivered (or recommended) BCTs If 50–79% of patients engaged with (or used) the delivered (or recommended) BCTs If ≥ 80% of patients engaged with (or used) the delivered (or recommended) BCTs
Missing data Data collected during the study (questionnaires, dispensing data) If ≥ 50% of the main outcome data are missing If 21–49% of the main outcome data are missing If ≤ 20% of the main outcome data are missing
  1. aThis includes aspects of the study/intervention that may be modified in advance of a larger definitive trial
  2. bTo enable sufficient time to assess patient recruitment procedures, the patient recruitment period may be extended up to a maximum of 12 months (post-training) if major ethics amendments are made during the pilot study
  3. cThe alternative ‘rate-related’ criterion recognises that successful patient recruitment procedures may take some time to establish