Research processes

Module 6 of the pharmacist e-learning outlines the 3 separate components of the PROMPPT trial (MOPP questionnaire study, the pain reviews and the MOPP-2 process evaluation), and the associated research processes and study documents. Although it is the responsibility of the pharmacist and the participating GP practice to ensure the processes and relevant study documents are completed, it is important that you as a clinical champion are aware of these so you can support and signpost the pharmacist.

This module will highlight how you can help and support the pharmacist in completing each of the research processes. For more information, please refer to Module 6 ‘Taking part in the PROMPPT trial’ of the pharmacist e-learning.

Pain Reviews

Scheduling pain reviews

  • Explore with the pharmacists how they plan to schedule pain reviews
  • Our suggestion is to book pain reviews over a number of weeks, which will likely be of less burden to the pharmacist and will facilitate reflective practice
  • Pain reviews should be booked 2 weeks in advance to allow time for the audio-recording process to be arranged by the research team (informing the patients, taking consent from the patient, confirming with the practice which pain reviews are to be audio-recorded)
  • Be aware that reminder phone calls will be made by the GP practice at 2 and 4 weeks after the invitation letter is sent to schedule a pain review if the patient is happy to go ahead.
  • Signpost to e-learning ‘Module 6 – Pain reviews’

Keeping in contact with Keele CTU

  • Remind the pharmacists to keep in contact with Keele CTU to ensure the success of the trial:
    • When pain reviews are booked
    • When reminder phone calls are made
    • When a pain review has taken place and to
    • When follow-up pain reviews are arranged

Electronic Case Report Forms (e-CRFs)

  • Discuss with the pharmacist about the procedure for completing the case report forms after each review (first pain review and each follow-up), and highlight any gaps where they may need to find out more
  • Signpost to e-learning ‘Module 6 – Pain reviews’ if necessary
  • Highlight timeliness – e-CRFs should be completed within or shortly after the pain review (on the same day as the pain review)

MOPP-2 Process Evaluation

Practice profile forms

  • Be aware that the GP practice is required to complete a practice profile form at the beginning and at the end of the trial
  • Encourage the pharmacist to ask other practice staff, including the lead GP to help complete the forms
  • Signpost to e-learning ‘Module 6 – MOPP-2 Process Evaluation’ if necessary

Audio-recorded pain reviews

  • Discuss with the pharmacist about the procedure for audio-recording pain reviews and highlight any gaps where they may need to find out more
  • Check that the pharmacist can access ‘The PROMPPT Trial’ Microsoft team in readiness for transferring audio-files
  • Be aware of pain reviews that are to be audio-recorded
  • Access audio-files on ‘The PROMPPT Trial’ Microsoft team to use during your meetings with the pharmacist to support reflective practice
  • Signpost to e-learning ‘Module 6 – MOPP-2 Process Evaluation’ if necessary

Safety Reporting

  • Discuss with the pharmacist about the procedure for any serious adverse events (SAE’s) and highlight any gaps where they may need to find out more
  • Highlight the process for reporting SAE’s
  • Signpost to e-learning ‘Module 6 -Safety Reporting’ if necessary

Clinical Champion Interviews

As part of the evaluation of the PROMPPT trial, we would like to speak to Clinical Champions, to find out about your experiences as a PROMPPT Clinical Champion supporting practice pharmacists to train and deliver PROMPPT pain reviews.

Once the practice pharmacists have delivered the PROMPPT pain management reviews, a researcher will contact you to arrange a telephone interview at a convenient time to suit you. The interview will take approximately 45-60 minutes. With your permission, the interview will be audio-recorded and the recording transcribed.

Before the interview commences, the researcher will read through and complete a consent form over the phone. Once the interview is complete, you will be sent a link via email to complete an online consent form to provide us with a written record of consent.