Feasibility and acceptability of implementing a Pelvic Floor Muscle Exercise (PFME) programme in antenatal care: process evaluation of a feasibility and pilot randomised controlled trial

Hay-Smith J1, Salmon V2, Smith C2, Jones E3, Edwards E4, Terry R2, May R2, De Giorgio L2, Frawley H5, Bick D6, MacArthur C3, Dean S2

Research Type

Clinical

Abstract Category

Health Services Delivery

Abstract 558
Open Discussion ePosters
Scientific Open Discussion Session 21
Thursday 28th September 2023
15:05 - 15:10 (ePoster Station 4)
Exhibit Hall
Pelvic Floor Incontinence Prevention Conservative Treatment Female
1. University of Otago, 2. University of Exeter, 3. University of Birmingham, 4. Birmingham Women’s and Children’s NHS FoundationTrust, 5. University of Melbourne, 6. University of Warwick
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Pregnancy and childbirth are major risk factors for developing urinary incontinence (UI). UI affects approximately 30% of women after childbirth and evidence suggests that Pelvic Floor Muscle Exercises (PFME), begun in pregnancy, can prevent UI antenatally and postnatally (1). Midwives in the UK are well placed to provide advice and education during the antenatal period, yet they lack confidence to teach PFME. The research programme developed a comprehensive training package for midwives and resources for pregnant women to support teaching of PFME within antenatal care (2). The training was evaluated in a feasibility and pilot cluster randomised controlled trial (RCT). This process evaluation, conducted in parallel with the pilot trial, aimed to understand if the intervention training, implementation and trial processes were feasible and acceptable to those delivering (midwives) and receiving (women) the intervention and resources.
Study design, materials and methods
In the feasibility and pilot cluster RCT, community midwifery teams from two UK hospitals were allocated to either intervention (n=8) or control (n=9) teams. Midwives in intervention teams received the training package and were then asked to implement PFME education and support as they had been trained. This involved raising the topic of PFME at the first booking appointment or early in pregnancy, then progressing PFME and asking about UI at each subsequent antenatal appointment. Midwives in control teams continued to deliver standard antenatal care.

In the process evaluation, multiple methods and data sources were used: qualitative online or telephone interviews with intervention team midwives (during implementation and post-trial), with control team midwives (post-trial), and with women who received care from either intervention or control team midwives (post-trial only); an implementation evaluation questionnaire for intervention community midwifery teams indicating which steps of the intervention were delivered to women (end of implementation period); and intervention champions monitoring data submitted via email to research midwives throughout the trial. Research questions, methods and data sources were mapped to a framework for designing process evaluations to inform overall analyses. Processes involving trial clusters (community midwifery teams), the target population delivering PFME in antenatal care (community midwives) and the target recipients of the PFME teaching (women), such as fidelity, uptake, challenges and opportunities for implementation, were analysed to understand the feasibility and acceptability of implementing the intervention.
Results
Evaluation of the training content and delivery was presented previously (3).

Response of trial clusters (midwifery teams)
95 community midwives were trained. Seven midwives on long-term sick leave during the implementation period were not. A further 11 maternity support workers (MSWs) in some teams received the training as they provided translation services for women who did not speak English. All intervention teams recruited an intervention midwife champion to support implementation. Interviews with intervention midwives indicated that the champion role was helpful for support and advice. Champions provided a monthly summary of intervention related activity. The nature of the activity was predominately reminding team midwives to implement the intervention or addressing referral queries.

Delivery to and response of midwives
Interviews with a sample of intervention midwives (n=13) during trial implementation suggested  the intervention was well received and acceptable: they expressed a positive attitude towards it: “I’m enthusiastic about it”; “it’s a very good fit” with personal and professional values and felt to be important for women; it was perceived to be effective “I think it should help get that message across”; it improved personal self-efficacy “I do feel confident” about the intervention; and it made sense “I’ve never thought about the impact of pregnancy on the pelvic floor” before the training.  Ambivalence towards the intervention related to the burden of delivery “it just feels a bit impossible” mainly due to volume of work, time pressures for appointments and wider system challenges. Some midwives reported difficulty remembering everything with “so many other priorities”; and felt hopeful rather than certain that they would be able to implement their learning in practice, or that women would perform PFME. 

Intervention midwives and MSWs (n=59) completed the implementation evaluation questionnaire, indicating that the intervention resource bag for women was the most frequently implemented component (89% most/all of the time). Asking women to practice PFME during an appointment was least frequently implemented (45% most/all of the time). Respondents reported that the resource bag (n=31), prompt cards (n=17) and team champions (n=16) as the most important resources to support implementation. ‘Lack of time’ (n=39); ‘forgetting’ (n=29); and ‘language barriers’ (n=26) were the top challenges. Midwives (n=18) reported making 44 referrals to physiotherapy services in the nine months of the trial. Monitoring data recorded 20 referrals discussed with champions.

Interviews with intervention team midwives (n=6) post-trial indicated continued positive attitude to the intervention but suggested increasing implementation inconsistency with increased time since training, and ongoing challenges with the time? burden of delivery.

Interviews with control team midwives (n=12) post-trial confirmed lack of consistency for implementing PFME into standard care and re-iterated challenges of teaching PFME in antenatal care, such as volume of workload and time constraints.

Response of women
Interviews with women post-trial (intervention n=13, control n=16) did not indicate noteworthy differences in antenatal PFME advice received between trial arms. Some intervention arm women did recall being given the intervention resources but would have liked to be reminded how to do PFME more often during their pregnancy. However, it was evident from all interviews with women and midwives that understanding why and how to do PFME is important and that an intervention like this was wanted.
Interpretation of results
Findings from the process evaluation of this feasibility and pilot RCT indicate that the training package was delivered as planned to intervention midwifery teams, with minimal evidence of cross-contamination. The intervention was acceptable and feasible to implement, and midwives felt enthusiastic about embedding this in antenatal care. Midwives’ main concerns with implementation related to wider system pressures, difficulty remembering and lack of time in appointments to cover the high volume of competing priorities that community midwives are expected to address. Despite the challenges, midwives and women reiterated a desire for better PFME advice and education in the form of an intervention like the one developed for this trial.
Concluding message
The training package is acceptable to community midwives and is feasible to implement in antenatal care. However, service-level constraints will need to be addressed if post-programme implementation is to be successful.
References
  1. Woodley SJ, Lawrenson P, Boyle R, Cody JD, Mørkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database of Systematic Reviews 2020, Issue 5. Art. No.: CD007471. DOI: 10.1002/14651858.CD007471.pub4.
  2. Dean, S, Salmon V, Terry R, Hay-Smith J, Frawley H, Chapman S, Pearson M, Boddy, K, Cockcroft E, Webb S, Bick D, MacArthur C and on behalf of the research programme team. (2022). Teaching effective pelvic floor muscle exercises in antenatal care: design and development of a training package for community midwives in the United Kingdom. International Continence Society conference Vienna 7-10 Sept 2022 Short oral podium presentation. Category prize winner
  3. Smith C, Salmon V, Jones, E, Edwards L, Hay-Smith J, Frawley H, Webb S, Bick D, MacArthur C, Dean S and on behalf of the research programme team. (2022). Training for midwives to support women to do their exercises during pregnancy. A mixed method evaluation of the midwife training during a feasibility and pilot randomised controlled trial. International Continence Society conference Vienna 7-10 Sept 2022 Short oral podium presentation
Disclosures
Funding APPEAL is funded by the NIHR Programme Grant for Applied Research programme (project number RP-PG-0514-20002). Clinical Trial Yes Registration Number https://doi.org/10.1186/ISRCTN10833250 RCT Yes Subjects Human Ethics Committee West Midlands – Edgbaston Research Ethics Committee (19/WM/0368) Helsinki Yes Informed Consent Yes
20/12/2024 18:02:55