Outcome/data | Timing of data capture | Process |
---|---|---|
Midwifery team characteristics (clusters); midwife experience of trial processes | Various times throughout the cluster trial process | Number of births per team, number and grades of midwives per team and team location, number of women/births per team from NHS trust managers/community-team leads. Interviews with individual midwives in both study arms. |
Health outcomes & PFME performance | Questionnaire follow up of all women in participating clusters at 10-12 weeks postpartum. | Overseen by local NHS trust Research Midwives. If no response to initial follow up, questionnaire resent. If no response after a further two weeks, other options will include sending a text message reminder |
Data from women’s maternity records | On return of consent in women’s questionnaire. | Extracted by local trust Research Midwives from maternity records. |
Data from telephone/online interviews with women from both trial arms | Interviews with 10-15 women from each trial arm | A sample of up to 30 women who agreed to be approached. Interviews to qualitatively explore their experiences of receiving (or not) information and advice about doing PFME during pregnancy; and to explore any possible contamination between arms. |
Intervention cluster midwives’ views of training | Questionnaire to all midwives attending training, at start & end of the training session. On completing training roll-out in intervention clusters. Up to 15 midwives (including champions). | To evaluate the acceptability and effect on confidence of the training. Purposive sampling to represent cluster site/size. Telephone/online interviews during the practice month to assess acceptability, fidelity to intervention. |
APPEAL midwives’ views of implementation of the intervention | Prior to completion of roll-out. All midwives in intervention clusters | Questionnaire to explore how midwives administered the intervention in practice, how often PFME were discussed with women at routine AN contacts, barriers and facilitators to implementation |
APPEAL midwife champions views of role supporting roll-out and implementation of training intervention | On completion of intervention roll-out. | The APPEAL champions included in the aforementioned intervention cluster interviews. Telephone/online interviews to assess acceptability, fidelity to intervention pertaining to the champion role. |
Midwives’ views on acceptability of the intervention/standard PFME advice (intervention and control clusters) and study processes (intervention and control midwives) | Interviews with up to 15 midwives from each trial arm. | Purposive sampling to represent cluster site/size. Telephone/online interviews to assess acceptability, fidelity to intervention (intervention) and potential contamination (control). |