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Table 8 Performance against pre-specified progression criteria

From: Proactive clinical review of patients taking opioid medicines long term for persistent pain led by clinical pharmacists in primary care teams (PROMPPT): a non-randomised mixed methods feasibility study

Objective

Pre-specified progressions criteriaa

Performance

Implications for the main trial

Recruitment to the MOPP questionnaire study and retention at 3-month follow-up

• ≥ 20% of eligible patients consent to participate

• ≥ 70% of consenting patients complete a 3-month follow-up questionnaire

• 14.5% (148/1020) of eligible patients consented to participate

• 83.1% of MOPP participants completed a 3-month follow-up questionnaire

The recruitment findings informed the sample size estimate for the main trial. As the main loss of potential participants was at the ‘consent to contact’ stage, the recruitment process for the definitive cluster RCT will be changed, removing the ‘consent to contact’ stage and introducing text (SMS) invitations from GP practices for potentially eligible patients

Uptake of the PROMPPT intervention

 > 50% of participants invited attend at least one PROMPPT consultation

90.9% of participants invited attended the initial PROMPPT review consultation

The process of GP practices inviting patients to schedule a PROMPPT review remained the same

Acceptability and credibility of the PROMPPT intervention

• Mean acceptability/credibility score ≥ 5

• Evidence from interviews about intervention acceptability

• Mean acceptability/credibility score 6.7 (SD 2.2)

• Overall, participants interviewed perceived the PROMPPT review as acceptable, easy to organise and participate in, and not burdensome. There was a preference for face-to-face consultations. There were varied emotional responses to the PROMPPT review and varied perceptions of its purpose. Some participants reported feeling worried before the review (about what would happen), and some did not feel it was relevant to them. Following the review, participants seemed more reassured and more satisfied with the plan when clear arrangements for a follow-up appointment had been made

In light of these findings, for the main trial, the option of face-to-face reviews was offered. Patient invitation letters and information leaflets were revised, and the pharmacist training was updated to include new case studies and to emphasise the importance of clear follow-up plans (see Fig. 4)

  1. aProceed to main trial with no more than minor modifications