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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