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Table 6 Final decisions for each of the progression criteria (‘Stop’, ‘Amend’, ‘Go’) for the S-MAP pilot study

From: A non-randomised pilot study of the Solutions for Medication Adherence Problems (S-MAP) intervention in community pharmacies to support older adults adhere to multiple medications

Concept

Data source(s)

Progression criteria

Final decision

Stop (unless there are clear and modifiable contextual or design issues that account for thisa)

Amend

Go

Pharmacy recruitment

Recruitment records held by 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

Go: 12 pharmacies were recruited within 3 months.

Pharmacy retention

Retention records held by 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

Go: 92% of pharmacies (i.e. 11) were retained until the end of the study 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 2 patients per month for any 3 consecutive months

If 60-95 patients are recruited within 6 monthsb or alternativelyc if 50-79% of pharmacies achieve a monthly recruitment rate of 2 patients per month for any 3 consecutive months

If ≥ 96 patients are recruited within 6 monthsb or alternativelyc if ≥ 80% of pharmacies achieve a monthly recruitment rate of 2 patients per month for any 3 consecutive months

Amend: 60 patients were recruited within 12 monthsb (extension to 12 months was made following amendments to screening/recruitment procedures).

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

Amend: 78.3% of patients were retained in the study (i.e. had either dispensing or self-reported adherence data available for primary outcome analysis). 73.3% of patients had data available for dispensing data analysis and 61.7% of patients had self-reported adherence data available for analysis.

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

Amend: 30.1% of primary and secondary outcome data were missing (see additional file 4).

Fidelity of pharmacist training package: delivery

Audio-recordings of pharmacist workshopsd

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

Go: 87% (13/15) of the planned training components (i.e. BCTs) included in the training practice were delivered by the researchersd

Fidelity of pharmacist training package: receipt

Post-workshop feedback surveyd

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

Go: 93% (n = 13) of pharmacists reported feeling ‘very prepared’ (n = 8) or ‘somewhat prepared’ (n = 5) in the post-workshop feedback surveyd

Audio-recordings of pharmacist workshopsd

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

This data source did not contribute to the decision-making process for this concept (see reasons for this in the results section).

Acceptability of pharmacist training day

Post-workshop feedback surveyd

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

Go: 100% of pharmacists (n = 14) rated the training day as completely acceptable (n = 12) or acceptable (n = 2) in the post-workshop feedback surveyd

Acceptability of intervention to pharmacists

Post-intervention delivery qualitative interviewsd

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

This concept was not assessed (see reasons for this in the ‘Results’ section).

Acceptability of intervention to patients

Post-intervention delivery feedback surveyd

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

Go: 88.6% (n = 39) of patients who completed the feedback survey (n = 44) reported the S-MAP intervention was completely acceptable (n = 22) or acceptable (n = 17). Three patients had no opinion and data were missing for two patients who completed the surveyd

Fidelity of intervention delivery

Audio-recordings of a sample of patient sessionsd

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

Go: 90.5% of BCTs were appropriately delivered to patients in the sample of audio-recorded sessions (data were available for six patients from six pharmacies)d

Fidelity of intervention receipt

Audio-recordings of a sample of patient sessionsd

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

Go: 83.2% of BCTs were received by patients as intended in the sample of audio-recorded sessions (data were available for six patients from six pharmacies)d

Enactment of treatment principlesd

Audio-recordings of a sample of patient sessionsd

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

Go: 100% of patients engaged with or used the recommended BCTs in the sample of audio-recorded sessions (data were suitable for analysis for four patients from four pharmacies)d

  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
  4. dThe supporting data for this concept has not been reported in this paper—instead it will be reported as part of the process evaluation study paper