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PRP Research Call to Evaluate the Use of the ICON Programme in its Purpose to Prevent Instances of Abusive Head Trauma (AHT) in Infants Research Specification

 

Contents

Timetable and Budget

Please be aware this is a Single Stage (full) Application Process

Deadline for applications: 08 September 2020, 1pm
Notification of outcome of applications: November 2020
Award of contract: within 2 months of funding being agreed (subject to pre-contract negotiations)
Budget : £300,000

Introduction

1. Abusive Head Trauma (AHT) can result when a baby is shaken, thrown, hit or slammed against a surface. This is also referred to as ‘Shaken Baby Syndrome’. It occurs when a parent or carer loses control, often when a baby’s crying becomes too much for them to cope with. This can result in death or severe injury. Typical injuries include broken bones which usually heal, but also AHT which often has long-term consequences and a significant risk of death. The peak incidence of AHT occurs in babies aged about 3.5 months, which is similar to the age of peak crying in babies (see Additional Information). There are multiple publicly available sources with further information on the issue. [Source 1 Source 2]

2. In addition to the catastrophic impact of AHT to the baby, the impact on NHS staff should also not be underestimated. Experienced A&E paediatricians report that dealing with victims of AHT can be the most difficult patients for NHS paediatric staff to deal with emotionally. This stress occurs not only during the treatment of the baby but through the child safeguarding and criminal justice follow-up.

3. The financial costs are significant both in terms of A&E and intensive care time, and require rapid action by Social Care teams, often having to work cross-boundary as these babies are often admitted to the regional Major Trauma Centre hospital. The greatest financial cost is incurred by the lifelong social and healthcare needed for many of these children, who are brain damaged. The costs soar with the provision of physiotherapy, occupational therapy, speech and language therapy and significant equipment costs.

4. A number of programmes have been developed and tested primarily in the US and Canada aimed at preventing cases of AHT. They are based on providing parents and carers with a simple message during maternity provision that explains about the normal pattern of a baby crying, the stress that a crying baby can cause to parents and caregivers and how parents/caregivers can cope. It can help them understand that infant crying is normal and that the pattern of baby crying changes over time; provide advice on methods to comfort crying babies; provide advice on coping strategies for parents under stress; and to reinforce clear, simple messages such as ‘never shake a baby’.

5. Research on the US programmes indicate that the programmes can reduce the incidence of AHT by up to 75%. [Source 3: 470 – 477] Analysis from North America on the return on investment has shown that a programme that reduces long term disabilities caused by AHT by as little as 2% can be cost saving overall. [Source 4: 695-704]

6. The ICON programme has been developed in England to prevent infant head trauma, based on evidence gathered from North America. The ICON programme has been adopted in a number of areas in England.

7. The Department of Health and Social Care invites full proposals for a single research project to design and deliver an evaluation of the ICON programme in England.

8. This is a significant opportunity to support the prevention of AHT with the ambition to reduce infant mortality in the Maternity Transformation ambitions; to prevent avoidable long-term disabilities and support needs; and to reduce burden on non-health areas; such as children’s social care, and the Criminal Justice service.

Background

9. As of December 2019, implementation of the ICON programme had been commissioned in 12 areas (Isle of Wight, Portsmouth, Pan Lancashire, Manchester, Rochdale, North Yorkshire and York, Oldham, Plymouth, Gloucestershire, Southampton, Hampshire, Pan Sussex – see Annex for details on ICON implementation by area and date). CCGs are required to fund the programme for their organisation which includes a one-off payment of between £1500-4000 depending on birth rate, plus approximately £800 for printing per year depending on choice of materials and size of CCG. The programme is deliberately designed to be flexible to meet the needs of the local communities, with the core programme remaining the same throughout.

10. The primary message is given in the hospital setting before the mother has been discharged from hospital with her baby following the birth. This is seen as the key ‘teachable moment’ and is one where the father is more likely to be present which is vital as over 70% of AHT cases are caused by men.

11. Also, as part of the COVID-19 emergency response by NHSE, all maternity units were asked to roll out the first of the five ICON touchpoints, given in hospital.

Research Priorities and Objectives

12. The evaluation will provide robust evidence of the impact of the ICON programme. We are interested in impact evaluation and process evaluation, with the aim that a robust evaluation of the programme will provide valuable information for commissioners.

13. The design of the programme to be flexible to meet the needs of local areas does present challenges to the evaluation of the programme. It is vital that an evaluation is designed to robustly reflect these challenges, and where possible isolates and assesses the independent impact of the ICON programme.

14. In light of this, we are requesting a two-phase project, with a breakpoint after Phase 1. The first Phase is to design a robust plan for the evaluation of the ICON programme in England, including highlighting any limitations. Applicants are encouraged to develop a “Theory of Change” or logic model to articulate the links through which attribution could be considered plausible. The strengths and weaknesses of the Plan need to be clearly articulated.

15. The Plan will be independently assessed and, if considered robust and that the evaluation detailed in the Plan will add significantly to the evidence base, then the second Phase of the work – the evaluation – will commence.

16. The evaluation should seek to show whether and how the policy has contributed to a reduction in abusive head trauma in babies.

17. Outcome measures may include:

  • Feedback from healthcare professionals delivering the advice to parents (such as confidence in content, implementation, and retention).
  • Feedback from health professionals not directly involved with the implementation of the programme (other maternal and paediatric service providers) on their own awareness of the programme and observations of patient knowledge.
  • Parental awareness, satisfaction, recall of the message, and confidence in implementing the ICON advice after exposure to the programme, by gender.
  • The costs of delivery of the programme and, if possible, a cost benefit analysis.
  • If possible, comparison of the impact of the ICON programme with similar programmes, particularly those in other countries.
  • Attendance of infants at primary care and emergency department with presentations related to perceived excessive crying.
  • The incidence/rate of severe trauma and the resultant severe brain injury and death of infants using existing national databases, such as TARN, PICAnet, NCMD.

18. We would welcome inclusion of an economic evaluation once sufficient data has been captured; including comparison to those carried out in North America. However, this is not an essential component of the research as this may be too ambitious within the duration of the project.

19. This is a complex problem and therefore not counted within the existing national hospital data systems, such as HES and ECDS, as Abusive Head Trauma requires complex diagnosis and reasons for attending A&E tend to be medicalised, for example, it is unlikely to report ‘persistent crying’ as a reason for attendance. Therefore, we ask applicants to comment on what existing data sources can and cannot tell us in their proposal.

Budget and Duration

20. We would like the results of the evaluation design and the theory of change within 3 months from the start of the project. If these demonstrate that an evaluation will be beneficial, then we would like results of the evaluation within a further 18 months, with the total of 21 months for duration of the project. We are open to hearing applicants’ suggestions on whether further Phases giving results over a longer time period would be useful, including justification on why the duration should be extended.

21. The total available budget is £300K. Applicants are requested to submit the budget for each Phase with the cost for Phase 2 being indicative for their proposal.

22. In assessing proposals, the Department will be seeking value for money as well as scientific excellence and, in particular, the potential for policy impact which is key.

23. Applicants are asked to address the timing and nature of deliverables, maximising staff resources and other options for interim reporting in their proposals.

24. Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Applicants are advised that value for money is one of the key criteria that peer reviewers and commissioning panel members will assess applications against.

25. All applications are expected to start within 2 months of funding being agreed, subject to pre-contract negotiations and specific requirements.

Governance

26. A research advisory group including representatives of the National Health Service (NHS) England and Improvement, DHSC, PHE and stakeholder bodies will provide guidance for the research, meeting regularly over the lifetime of the research. The successful bidders for this research should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. You will be expected to:

  • provide regular feedback on progress
  • produce timely reports to the advisory group
  • produce a final report for sign off

27. Research contractors will be expected to work with nominated officials in DHSC, NHS England etc., once the research project is due to start. Key documents including, for example, research protocols, research instruments and reports must be provided to DHSC in draft form allowing sufficient time for review.

 

Image 2* - Regions and date of commission 

Standard Information for Applicants

The sections below provide standard information on different aspects of NIHR PRP funding and will contain details relevant to your application.

General Comments About Applications

The National Institute for Health Research Policy Research Programme (NIHR PRP) is a national programme of research dedicated to providing an evidence base for policy-making through the Department of Health and Social Care. It provides information to the Secretary of State for Health and his Ministers directly and through policy directorates in the Department of Health and Social Care and covers all aspects of the Department’s policy-making activity.

Applications will be considered from other UK countries (Scotland, Wales and Northern Ireland) provided they address the priority areas in a way that is relevant to the needs of the Department of Health and Social Care (England) and meet all other selection criteria.

Applicants are encouraged to submit multidisciplinary applications.

Applicants should consider the full range of potential audiences and describe how the research findings could be disseminated most effectively to ensure that the lessons from this research impact on policy and practice.

Research Management

Day-to-day management of this research will be provided by the principal investigator. They and their employers should ensure that they identify, and are able to discharge effectively, their respective responsibilities under the Health Research Authority (HRA) UK Policy Framework for Health and Social Care Research (Health Research Authority, 2018), which sets out the broad principles of good research governance.

All successful research involving National Health Service (NHS) and social care users, carers, staff, data and/or premises must be approved by the appropriate research ethics committee (REC) or social care research ethics committee (SCREC). For further information on RECs, please visit the Health Research Authority website

The successful research team must adhere to the General Data Protection Regulation and the new Data Protection Act (2018) and the Freedom of Information Act (2000). Effective security management, and ensuring personal information and assessment data are kept secure, will be essential. In particular:

The research team shall, at all times, be responsible for ensuring that data (including data in any electronic format) are stored securely. The research team shall take appropriate measures to ensure the security of such data, and guard against unauthorised access thereto, disclosure thereof, or loss or destruction while in its custody.

Personal data shall not be made available to anyone other than those employed directly on the project by the research team, to the extent that they need access to such information for the performance of their duties.

For any research involving clinical trials, the successful team will be expected to be familiar with the Medical Research Council (MRC) Framework for Evaluating Complex Interventions, and to follow the principles of the MRC Guidelines for Good Clinical Practice in Clinical Trials in proposing structures for oversight of such trials and comply with the Medicines for Human Use (Clinical Trials) Regulations 2004.

The Institution leading the proposal should confirm that it has the capacity and is prepared to take on sponsorship responsibilities for clinical trials undertaken as part of the programme. Where the proposal includes a proposal for multi-site clinical trial activities, the research unit should demonstrate that they have the experience of governance and management of clinical trials across multiple clinical trial sites.

Risk Management

Applicants should submit, as part of their proposal, a summary explaining what they believe will be the key risks to delivering their research, and what contingencies they will put in place to deal with them. Please ensure this is detailed in the Management and Governance section of the online application form.

A risk is defined as any factor which may delay, disrupt or prevent the full achievement of a project objective. All risks should be identified. The summary should include an assessment of each risk, together with a rating of the risks likelihood and its impact on a project objective (using a high, medium or low classification for both). The risk assessment should also identify appropriate actions that would reduce or eliminate each risk, or its impact.

Typical areas of risk for an evaluation study might include ethical approval, site variation in data gathering, staffing, resource constraints, technical constraints, data access and quality, timing, management and operational issues; however, please note this is not an exhaustive list.

Patient and Public Involvement (PPI)

The NIHR Policy Research Programme expects the active involvement of patients and the public (e.g. service users and carers) in the research that it supports, where appropriate. However, the nature and extent of patient and public involvement (PPI) is likely to vary depending on the context of the study. Applicants should describe how the issue of PPI will be addressed throughout the research process. For example, this could include patient and public involvement in refining research questions, designing research instruments, advising on approaches to recruitment, assisting in the collection and analysis of data, participation or chairing advisory and steering groups, and in the dissemination of research findings.

Applicants are required to detail what active involvement is planned, how it will benefit the research and the rationale for their approach. PPI needs to be undertaken in a manner that acknowledges that some people may need additional support, or to acquire new knowledge or skills to enable them to become involved effectively (see INVOLVE publications for guides for researchers). Applicants should therefore provide information on arrangements for training and support. In addition, applicants should note that a budget line for the costs of PPI is included in the finance form. Where no PPI is proposed, a rationale for this decision must be given.

For further information and guidance about PPI, please visit the INVOLVE website: http://www.invo.org.uk/

Outputs and Reporting Arrangements

The research team will be expected to provide regular progress reports over the lifetime of the research and will be provided with a progress report template to complete at regular intervals. In addition to describing progress, these reports will allow researchers to indicate any significant changes to the agreed protocol, as well as setting down milestones for the next reporting period, giving an update on PPI and any publications or other outputs. Information on emergent findings that can feed more immediately into policy development will be encouraged and should be made available as appropriate.

A final report on the research, with an accessible executive summary, will be required within one month following completion of the research. The report will be peer reviewed and may be circulated among relevant stakeholders within the Department of Health and Social Care and its partners. Once the study is completed, a summary of the final report will be placed in the public domain, on the Policy Research Programme web pages found at: http://www.nihr.ac.uk/prp. This is where the outputs resulting from expenditure of public funds are made available for public scrutiny so it is important that the summary of your final report is easily accessible to the lay reader.

Research contractors are obliged to give at least 28 days notice before submission of any publication arising from research funded by the NIHR Policy Research Programme. In this instance, ‘publication’ concerns any presentation, paper, press release, report or other output for public dissemination arising from a research project funded by the PRP. Research contractors remain under an obligation to provide notice even after the contract has ended. Publication of PRP-commissioned research is subject to prior consent of the Secretary of State, which will not be withheld unreasonably and cannot be withheld for more than three months from the time the publication is submitted.

Dissemination

Applicants should describe how the research findings could be disseminated most effectively, ensuring that results of this research impact on policy and practice in the NHS, DHSC, and/or in social care.

Publication of scientifically robust research results is encouraged. This could include plans to submit papers to peer reviewed journals, national and regional conferences aimed at service providers, professional bodies and professional leaders. It might also include distribution of executive summaries and newsletters. Less traditional dissemination routes are also welcomed for consideration.

Transparency

In line with the government’s transparency agenda, any contract resulting from this tender may be published in its entirety to the general public. Further information on the transparency agenda is at: https://www.gov.uk/government/publications/procurement-and-contracting-transparency-requirements-guidance.

If you wish to view the standard terms and conditions of the NIHR Policy Research Programme contract, please go to: https://www.nihr.ac.uk/funding-and-support/funding-for-research-studies/manage-my-study/contracts-and-intellectual-property.htm

Application Process

To access the research specification and application form, please visit the NIHR Policy Research Programme Central Commissioning Facility (NIHR PRP CCF) website at or visit http://www.nihr.ac.uk/prp

The NIHR CCF runs an online application process and all applications must be submitted electronically. No applications will be accepted that are submitted by any means other than the online process. Deadlines for the submission of research applications occur at 1.00 pm on the day indicated and no applications can be accepted after this deadline.

We strongly recommend that you submit your application on the day before. Once the 1.00 pm deadline passes, the system shuts down automatically and CCF Programme Managers are unable to re-open it. If you are experiencing any technical difficulties submitting your application, please contact the CCF on 0208 843 8027 in good time, before 1.00 pm on a closing date.

Applicants are expected, before submitting applications, to have discussed their applications with their own and any other body whose cooperation will be required in conducting the research.

In order for your full application to be validated and submitted you are required to gain electronic approval from the relevant authorities before the application deadline. The Declarations page must be approved:

a) by the Lead Applicant to confirm that the content of the application is complete and correct.
b) by an administrative or finance officer for the contracting (host) institution to confirm that the financial details of the application are correct and that the host institution agrees to administer the award if made.
c) by a Head of Department or Senior Manager to confirm that they have read the application and that, if funded, the work will be accommodated and administered in the named institution and that the applicants may undertake the work.

Until this is completed the lead applicant is unable to validate and submit the application.

Commissioning Process

All full applications submitted to NIHR PRP will be peer-reviewed by both stakeholder and independent academic referees. Wherever time permits, applicants will be given one week to respond to the peer reviewers’ comments.

Full applications, peer reviewers’ comments and any responses to those comments will then be considered by the Commissioning Panel, which is comprised of independent experts (possibly with observers from other government departments and executive agencies), who will advise the NIHR on which applications are most suited to receive funding. The Panel will be informed by the reviewers’ comments and any responses made to these comments by the researchers. However, it is ultimately the responsibility of the Panel to make any funding recommendations to the Department of Health and Social Care.

Selection Criteria

The Commissioning Panel members are directed to consider applications against the criteria stated in this research specification as well as selection criteria detailed below:

RELEVANCE of the proposed research to the research specification
QUALITY of the research design
QUALITY of the work plan and proposed management arrangements
STRENGTH of the research team
IMPACT of the proposed work
VALUE for money (justification of the proposed costs)
INVOLVEMENT of patients and the public

Contacts

General enquiries regarding the application and commissioning process can be directed to the PRP CCF Help Desk by telephone at 020 8843 8027 or by email to prp@nihr.ac.uk

Please be advised that the team are working from home at the moment and the best way to get a timely and accurate response to your query is through our email address.