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Adverse medical incidents and outcomes - understanding the experience, contexts, motivation and decision-making journey of patients who do and who do not make legal claim - Call Specification

 

Contents

 Introduction

1. The National Institute for Health Research (NIHR) Policy Research Programme (PRP) invites applications for a single research project that will develop a detailed understanding of the experience of patients who feel that they have had an adverse medical incident or outcome. The focus of the study should be on developing a robust understanding of the motivation, contexts and decision-making journey of those who have and who have not taken legal action.

2. In this study, we are especially interested in the full decision-making journey of this group of patients. We want to understand the views and experiences of the options they think are available to them - including other actions that they may have considered and/or also taken (e.g. speaking to their local Patient Advice & Liaison Service [PALS], making a formal complaint etc).

3. This is a significant opportunity to help develop a robust evidence base that will inform policy and delivery in a vital area for the NHS, patients, staff and the public. 

Timetable and Budget

  • Deadline for stage 1 applications: 08 October 2019 1 PM
  • Notification of outcome of stage 1 applications: January 2020
  • Deadline for stage 2 application: 18 February 2020  1 PM
  • Notification of outcome of stage 2 applications: May 2020
  • Project start: June 2020 (subject to negotiations)
  • Budget: indicatively £400,000 

Background – Policy Requirement

4. The number and costs of NHS clinical negligence claims is high and has grown substantially over recent years. For example, the number of clinical negligence claims registered with NHS Resolution under its Clinical Negligence Scheme for Trusts doubled between 2006/07 and 2016/17 (from 5,300 to 10,600[1]) and costs of claims have quadrupled – now 1.8% of total health spend (from £0.4 billion to £2.3 billion in 2018/19[2])[3]. This constitutes a large pressure on an already stretched healthcare budget.

5. The National Audit Office, in their 2017 study[4] have attributed these increases to legal and market factors rather than any detectable decline in safety.

6. Developing an appropriate range of policy responses to these emerging trends is complex. We know that:

  • Only a small proportion of people who think they’ve been harmed proceed to make a claim[5] or complaint[6]
  • In some legal claims, the patient has also made a complaint[7]
  • There is no coalescence between the harm that patients perceive5, the number of serious incidents or near-misses reported by healthcare professionals (e.g. to the National Reporting and Learning Service [NRLS]) and those incidents found by case-finding research[8]
  • Other factors such as communication issues or poorer outcomes than expected may contribute to patients’ decisions to take legal action.[9]

7. This complexity is evident in available data – for example: 

  • The number of patient safety incidents estimated by research studies exceeds those recognised and reported as incidents by staff by as much as a hundred-fold factor[10]
  • The two million incidents reported to the NRLS annually exceeds formal complaints[11] by a ten-fold factor[12]
  • The number of formal complaints, most of which are not about clinical issues, exceeds clinical negligence cases by a twenty-fold factor[13]

8. Avoiding increased litigation costs is not just a matter of putting a range of measures in place to prevent harm. The relationship between having an adverse experience of healthcare, including being affected by a patient safety incident and deciding to pursue a complaint or litigation, is not so linear or straightforward. Although only a small proportion of patients make a complaint or claim, the recent doubling in the volume of legal claims suggests we need to better understand the factors affecting patients’ decisions about whether to claim and how best to act.

9. Multiple factors influence the experience, motivation, context and decision-making journey of a patient, from the point of an adverse event or outcome onwards. These factors can be personal, social, cultural, and service-related and will shape the patients’ response to the incident.

 10. Available evidence also suggests that there may be some systematic patterns in how patients respond - in terms of who the issue relates to, and what they are reporting, complaining about, or claiming for (e.g. the mortality review[14] identified that a greater proportion of claims relate to elective procedures and working age adults rather than       incidents or deaths due to problems in care). 

11. While there is significant literature exploring complaints and litigation[15], we have little understanding of the wider experience, motivation and decision-making journey of patients, and what factors may impact on their decisions.

12. This means that there is a lack of a comprehensive and rigorous evidence base to draw on in order to inform service interventions or policy development. Available evidence[16] shows that patients who complain or claim tend to cite a wide range of factors as reasons for the action they have taken - including a desire for an apology, for the incident not to happen to anyone else, for key individuals to be held accountable, and/or for financial compensation.

13. But, from a national policy perspective, there remain some especially critical gaps in the available research approach and intelligence. For example:

  • The evidence base is particularly weak on understanding what motivates those who suffer harm in healthcare to make a claim.
  • Research in the UK setting has explored the patient perspective and motivation for making a claim for compensation due to clinical negligence[17], but there has been less research exploring the reasons why people have not claimed or complained.
  • Less is known about a larger group of patients who were harmed but did not make a complaint and/or did not make a claim.
  • Where research has sought to understand the motivations of those who do and do not complain[10], it is difficult to assess whether the presence of a motivation amongst one group is matched by a corresponding absence of the same motivating factor in the other group. There is no existing research providing an in-depth comparison of groups who did and did not make a claim.
  • Furthermore, in terms of motivations to pursue (or not pursue) a legal claim, little is known about how multiple motivating factors interact with each other in determining the harmed patient’s decision.
  • There is also little evidence as to whether those individuals who have been through a complaint or claim procedure feel that their needs or objectives were met.  

Research Requirement

14. It is expected that this research will make a valuable contribution to the research evidence base on NHS litigation. Specifically, it will help address the evidence gap on why some people who feel they have been harmed in healthcare choose not to make a claim. A better understanding around these issues will not only increase insights into what drives people to make a claim (but will also help with developing interventions and policies around how services are delivered and systems are redressed.

15. We are not advocating what specific methods must be employed in this study. The applicants will need to propose how they plan to meet the research requirements set out in this specification. However, the complexity of the policy topic, and the low proportion of the population who do decide to seek redress, suggests that a mixed methods approach is likely to be required. The applicants may wish to set out several different work packages to address the policy and research questions from a variety of angles and demonstrate how they will synthesise findings from these different initiatives.

16. In designing their methodology, the applicants should ensure the key focus and eventual findings relate to the decision of whether to make or not to make a legal claim; whilst recognising that earlier stages of interaction with healthcare services, including complaints, may affect that decision.

17. Some examples of the approaches that might be considered are set-out below. Please note: this is an illustrative list only; please propose the specific methods and work packages that you feel are appropriate for this study.

  • A representative national population-level survey to identify the proportion of the public who have been in contact with the NHS, who feel they have experienced an adverse event or outcome, and what they did about it. Such a survey should explore a full range of factors and reasons why people have decided to report the issue, complain, pursue a claim, or take no action at all.
  • A programme of qualitative research to accompany any quantitative / survey work, to establish a detailed understanding of the factors, experiences, contexts, motivations and decision-making journey of patients (e.g. depth interviews, focus groups, workshops).
  • Targeted initiatives that try to ensure adequate inclusion in the study of particular sections of the population (e.g. those who are acting on behalf of someone else, or for whom treatment harm has led to life-changing injury etc), especially in any detailed qualitative work.
  • Over-sampling to ensure a sufficient sample of patients who have made a legal claim, in order to facilitate comparisons with those who believed they had suffered equivalent harm but did not make a claim.

18. The priority areas where we feel that the evidence base needs to be developed or strengthened are listed below. Please note that this list is not exhaustive – feel free to suggest additional topics in your application.

  • Establishing the proportion of the population that feel that they have experienced harm, or an adverse outcome following medical treatment, and what action (if any) they took.
  • Capturing their experience, motivations, contexts and decision-making journey – e.g. what specifically happened to them, what action did they take (or not), in what order, for what reason, what did they want to achieve in terms of redress, how was their issue handled by different organisations in the system, what was the outcome, and were they satisfied
  • Exploring the differential impact of various personal, social, cultural, contextual, staff and service factors – e.g. are there any factors that are systematically related to someone being more or less likely to launch a legal claim or taking no action at all. What factors in their experience could have been handled differently, and what impact might this have made on their experience and decisions.
  • Synthesising insights from across these different strands to map and describe the patient experience and journey, highlighting key personal, contextual, staff and service drivers and barriers that shape decisions and outcomes.    
  • Using insights from this study, and the available evidence base, to set out a range of policy implications. 

Outputs

19. Applicants are asked to consider the timing and nature of deliverables in their proposals. Policymakers will need research evidence to meet key policy decisions and timescales, so resource needs to be flexible to meet these needs. A meeting to discuss policy needs with DHSC officials will be convened as a matter of priority following contracting. 

Budget and duration

20. The NIHR PRP has secured an indicative budget of £400,000 for this study. There is some flexibility within this budget envelope, but should this amount not be sufficient to address all the requirements set out in this document, applicants are invited to prioritise key research questions that will start building the evidence base in this area, and to outline a pathway and plans (with indicative costing) for additional research that may help address the requirements in full. These may be considered at a later stage should additional funding become available. Applicants are advised that value for money is one of the key assessment criteria that peer reviewers and commissioning committee panel members will use to assess applications against.

21. Please set out the proposed costings in your application / research plan. Costings can include up to 100% full economic costing (FEC) but should exclude output VAT. Please set out an itemised costing for each separate work package you want to propose in your application.

22. We are not specifying the duration of the project. Please set out what you see as a suitable milestone timetable in your application. 

Management arrangements

23. A research advisory group including, but not limited to,representatives of DHSC, other stakeholders (such as NHS Improvement, NHS England, NHS Resolution), and the successful applicants for the research should be established. The advisory group will provide guidance, meeting regularly over the lifetime of the research. The successful applicants should be prepared to review research objectives with the advisory group, and to share emerging findings on an ongoing basis. They will be expected to:

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

24. Research contractors will be expected to work with nominated officials in DHSC, its partners and the NIHR Central Commissioning Facility. Key documents including, for example, research protocols, research instruments, reports and publications must be provided to DHSC in draft form allowing sufficient time for review. 

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

25. 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.

26. 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.

27. Applicants are encouraged to submit multidisciplinary applications.

28. 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 governance

29. 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)[18], which sets out the broad principles of good research governance.

30. 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: http://www.hra.nhs.uk/[19]

31. The successful research team must adhere to the General Data Protection Regulation and the new Data Protection Act (2018)[20] 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.

32. 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.

33. 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. 

[1] https://www.nao.org.uk/report/managing-the-costs-of-clinical-negligence-in-trusts/

[2] NHSR annual report and accounts 2018-19

[3] Written complaints https://digital.nhs.uk/data-and-information/publications/statistical/data-on-written-complaints-in-the-nhs/2017-18

[4] https://www.nao.org.uk/report/managing-the-costs-of-clinical-negligence-in-trusts/

[5] Gray, A. M., Fenn, P., Rickman, N., & Vencappa, D. (2017). Changing experience of adverse medical events in the National Health Service: Comparison of two population surveys in 2001 and 2013. Social Science & Medicine195, 83-89.

[6] National data on written NHS complaints has been recently published: https://digital.nhs.uk/data-and-information/publications/statistical/data-on-written-complaints-in-the-nhs/2017-18

[7] https://resolution.nhs.uk/resources/behavioural-insights-into-patient-motivation-to-make-a-claim-for-clinical-negligence

[8] https://www.researchgate.net/publication/51396222_What_can_we_learn_about_patient_safety_from_information_sources_within_an_acute_hospital_A_step_on_the_ladder_of_integrated_risk_management

[9] https://resolution.nhs.uk/resources/behavioural-insights-into-patient-motivation-to-make-a-claim-for-clinical-negligence

[10] Calculated from the DHSC commissioned study http://www.eepru.org.uk/prevalence-and-economic-burden-of-medication-errors-in-the-nhs-in-england-2/ estimated over 200 million medication errors occur annually; NRLS reporting is slightly over 200,000 medication incidents annually https://improvement.nhs.uk/resources/national-patient-safety-incident-reports-27-march-2019/ i.e. circa 1%

[12] NRLS reports from https://improvement.nhs.uk/resources/national-patient-safety-incident-reports-27-march-2019/ compared to written complaints from https://digital.nhs.uk/data-and-information/publications/statistical/data-on-written-complaints-in-the-nhs/2017-18

[13] https://www.nao.org.uk/report/managing-the-costs-of-clinical-negligence-in-trusts/ compared to written complaints from https://digital.nhs.uk/data-and-information/publications/statistical/data-on-written-complaints-in-the-nhs/2017-18

[14] Comparison of NRLS and litigation data within https://www.nao.org.uk/report/managing-the-costs-of-clinical-negligence-in-trusts/

[15] Birks, Y., Aspinal, F and Bloor K. (2108): Understanding the drivers of litigation in health service. A Report for Partnership for Responsive Policy Analysis and Research (PREPARE). Available at: https://www.york.ac.uk/media/healthsciences/images/research/prepare/UnderstandingDriversOfLitigationInHealthServices.pdf

[16] https://www.sciencedirect.com/science/article/abs/pii/S0277953617306809?via%3Dihub

[17] https://resolution.nhs.uk/resources/behavioural-insights-into-patient-motivation-to-make-a-claim-for-clinical-negligence/

[18] Available from URL: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

[19] https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

[20] https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/


Risk management

34. 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.

35. 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.

36. 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)

37. 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.

38. 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.

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

Outputs and reporting arrangements

40. 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.

41. Where applicable, 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. 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.

42. 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

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

44. 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

45. 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.

46. 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

47. 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

48. 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 outline and full research applications occur at 1.00 pm on the day indicated and no applications can be accepted after this deadline.

49. 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 the closing date.

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

51. 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:

  • by the Lead Applicant to confirm that the content of the application is complete and correct.
  • 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.
  • 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.

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

Commissioning process

53. The standard NIHR PRP commissioning cycle includes the following steps:

 

54. In standard 2 stage commissioning, outline applications or, in the case of Expression of Interest (EOI), short EOI applications will be shortlisted by a Commissioning Committee. Incomplete applications, applications too remote from the issues set out in the research specification, or applications that have clearly inadequate presentation or methods may be rejected at this stage.

55. Applications that are successfully shortlisted by the Commissioning Committee will proceed to Stage 2 of the application process and will be invited to submit a full Stage 2 application for consideration.

56. 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.

57. 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 Committee will be informed by the reviewers’ comments and any responses made to these comments by the researchers. It is ultimately the responsibility of the Committee to make any funding recommendations to the Department of Health and Social Care. 

Selection criteria

58. The Commissioning Committee 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

59. 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.