Short title
Tommy's Graded Model pilot
Aim
The aim of this study is to evaluate the graded model of care for miscarriage with regards to feasibility, acceptability (to service users and providers), clinical and service use outcomes, implications on other services, and cost.
Trial Design
Pilot study
Setting
The implementation work would be piloted at the Birmingham Women’s Hospital (BWH) over a three-month period. Following the pilot, to ensure generalisability across geographically distinct regions of the UK, this miscarriage care package will also be implemented and evaluated in up to eight other NHS trusts.
Number of Participants
367 participants
Eligibility Critera
Inclusion Criteria
All women who have miscarried pregnancies up to 14 weeks are eligible for care according to the graded model.
Exclusion Criteria
Molar pregnancy, ectopic pregnancy or a miscarriage at later gestations (> 14 weeks) will be excluded from the model as the aetiology and therefore management is different to first trimester miscarriage.
Study Interventions
Pilot of the graded model of care for miscarriage.
Duration of Study
3 month pilot
Outcome Measures
Service evaluation outcomes and data capture methods are detailed as follows:
Feasibility measures
- Demand - measured by the number of women receiving care as per the graded model and semi-structured interviews (SSI) – recruitment and retention (percentage of women receiving care (the denominator is women diagnosed with miscarriage in the EPAU, proportion of women lost to follow-up or declining referral to services) and thematic analysis
- Delivery - adherence and adaptations assessed by direct observation of practice (DOP), random case note review, completion of an implementation checklist and SSI – analysis of proportion and thematic analysis
- Adoption - setting level (proportion of patients approached that participate) and staff level (SSI to understand staff participation) – percentage of patients approached that participate and thematic analysis
- Fidelity - completed referrals to services or for further tests (e.g. full blood counts and thyroid function tests or scans) – n is the total number of indicated referrals, tests, or scans
- Practicality - time taken to complete consultation – comparison with time taken for consultations prior to implementation; thematic analysis and SSI
- Experience - barriers, facilitators, feasibility assessment on Likert scale assessed by SSI with key stakeholders and focus group discussions with EPAU staff – thematic analysis and analysis of Likert scale
- Sustainability - continuation of service following implementation assessed by direct observation of practice, random case note review –analysis of the proportion of women receiving care as per the graded model compared with the total number of women diagnosed with miscarriage in EPAU
Acceptability to service user
- Confidence in service - ‘How confident are you that if you required treatment this model of care would be able to support you?’, ranging from ‘not at all confident’ to ‘completely confident’ – analysis of Visual analogue scores
- Experience - experience and burden assessed using SSI, friends and family survey– thematic analysis, analysis of results of friends and family survey
- Negative consequences - burden and knock on effects assessed during SSI and any complaints through Patient advice and liaison service (PALS) – thematic analysis
- Appropriateness - perceived appropriateness assessed using SSI – thematic analysis
- Satisfaction - retrospective client satisfaction questionnaire (CSQ-8) – Mixed methods (scores of overall experiences and CSQ-8 and themes through SSI)
Acceptability to providers
- Experience - experience assessed using SSI with key stakeholders and focus group discussions – thematic analysis
- Negative consequences - burden and knock on effects assessed during SSI – thematic analysis
- Appropriateness - perceived appropriateness assessed using SSI – thematic analysis
Clinical outcomes: modifiable risk factors
- Proportion of women who are smokers
- Proportion of women who are underweight, overweight and obese
- Proportion of women with underlying medical conditions
- Proportion of women with abnormal thyroid function tests
Clinical outcomes
- Miscarriages averted
- Additional live births
- Women identified to be at risk of obstetric adverse events (preterm birth, intra-uterine growth restriction, Stillbirth)
- Women identified to be at risk of perinatal mental health consequences
Service use outcomes
- Number of referrals to specialist services (e.g. smoking cessation)
- Number of declined referrals
- Number of women who had previously been referred to services
- Number of appointments
- Type of appointment (face-to-face or telephone)
- Time taken for each appointment
- Number of full blood counts performed and proportion of abnormal tests requiring further intervention
- Number of thyroid function tests performed and proportion of abnormal tests requiring further intervention
- Number of declined full blood counts
- Number of declined thyroid function tests
- Number of reassurance scans
- Number of declined reassurance scans
- Number of cases where care did not follow the graded model of care package
- Time taken (days) until first appointment with the graded model care service
Implications on other services
- Service use - data collection on rates of referrals to services in the baseline and after implementation
- Negative consequences - burden and knock on effects assessed during SSI with other providers – thematic analysis
Implications of access to services
- Reach - data collection of sociodemographic characteristics of women accepting referrals to those women who declined – comparison of data and subgroup analysis
- Acceptability across different ethnicities - SSI with an ethnically diverse sample – thematic analysis
- Patient ease of participating - facilitators and barriers identified during SSI – thematic analysis
Health Economic Analysis
The primary objective of the economic evaluation within the pilot is to ascertain the cost-effectiveness of the graded model. Associated costs and health outcomes will be assessed for 367 patients. The core health outcome for this economic assessment is the quality-adjusted life year, which blends the duration and health-related quality of life achieved post-treatment. This will be measured using EQ-5D-5L utility scores, ensuring a robust evaluation of the graded model's effectiveness. The valuation of these outcomes will rely on the EQ-5D-5L health questionnaire, with utility values being drawn in line with NICE's recommended methods. Downstream resource use associated with the graded model will be obtained through SF-12, iMTA productivity cost questionnaire and bespoke questionnaires given to patients.
The ultimate of this pilot is to compare the clinical and cost implications of the graded model against the existing standard of care, utilising a vast dataset of UK healthcare records.
Project Team
- CI: Arri Coomarasamy, University of Birmingham
- Senior Investigators: Adam Devall, University of Birmingham and Mr Justin Chu, Birmingham Women’s and Children’s NHS Foundation Trust
- National Coordinator: Dr Rosinder Kaur, Birmingham Women’s and Children’s NHS Foundation Trust
- Team Leader: Lee Priest, University of Birmingham
- Lead Statistician: Christina Easter University of Birmingham
UoB (REC) Number
ERN_1158-Sep2023
Contact Details
Bwc.tommysclinics@nhs.net
Rxk193@student.bham.ac.uk