Policy Research Programme - Evaluation of reforms to the Mental Health Act

Timetable and Budget

Description	Deadline/Limit
Deadline for Stage 1 Applications	04 October 2022, 1 PM
Notification of outcome of Stage 1 Application	December 2022
Deadline for Stage 2 application	24 January 2023, 1 PM
Notification of Stage 2 Application	July 2023
Project Start	September 2023
Budget	£1.3m. Indicative budget for A - £350k, B - £600k, C - £350k

Introduction

The National Institute for Health and Care Research (NIHR) Policy Research Programme (PRP) invites applications for three research studies to contribute to evaluation of reforms to the Mental Health Act (MHA).

The MHA reforms are a large government programme, which will be implemented over a long timescale both through legislation and operational changes from NHS England, other healthcare providers, the police, local authorities and the Care Quality Commission. Evaluation will be necessary so that all partners in this programme can adapt policy implementation, guidance and supporting measures.

This research is needed to assess implementation of initial measures and form the groundwork for later evaluation of the reforms.

Up to £1.3m in total is available for three studies judged to be of sufficiently high scientific quality.

Background

The MHA provides a legal framework to authorise the detention and compulsory treatment of people who have a mental health disorder and are considered at risk of harm to themselves or others. The MHA was most recently reformed in 2007 and was subject to a 2018 Independent Review[1] by Professor Sir Simon Wessely, which concluded that the Act does not always work as well as it should for patients, or for their families and carers. In response to the Independent Review, the government published a White Paper[2], which accepted the vast majority of the review’s recommendations and sought views on the impact of these recommendations and how best to implement them in practice. A summary of findings from this consultation[3] was published in August 2021 and a Draft Bill to enact legislative aspects of the reforms was published for pre-legislative scrutiny in July 2022[4].

The reforms are wide ranging, but broadly they seek to:

• Reduce restriction both by avoiding detentions where possible and increasing the opportunities to challenge detentions and treatment decisions. For example, through legislative changes to tighten detention criteria, an increased frequency of tribunals and greater scrutiny from second opinion appointed doctors (SOADs).
• Increase patient empowerment and autonomy for those who are detained. For example, patients will have more access to Independent Mental Health Advocates (IMHAs), which will become opt-out rather than opt-in. They will also have stronger rights to have previously expressed preferences over treatment heeded in decisions, via Advance Choice Documents (ACDs), and more treatment decisions will require consultation with SOADs.
• Promote equality by reducing disparities, including those related to race and other protected characteristics, both through tightening of criteria for the act and additional measures such as the provision of culturally appropriate advocacy and the NHS’s Advancing Mental Health Equalities Strategy [5].

The MHA reforms are a large government programme, which will be implemented over a long timescale both through legislation and operational changes from NHS England, other healthcare providers, police, local authorities, and the Care Quality Commission. As well as informing policy implementation, guidance and supporting measures, evaluation will also allow us to assess the overall policy’s effects, providing an evidence base for future mental health policies.

Research needed

Three studies are proposed to help inform implementation of the reforms and lay the groundwork for further evaluation in the future:

1. A baseline and feasibility study on collecting patient experience data for those assessed and/or detained under the MHA and using it to assess the impact of reforms.
2. A process and qualitative outcome evaluation of early reform measures expected to be implemented in 2024-25, which include (a) changes to detention criteria, (b) allowing patients to choose a nominated person, and (c) automatic referral to Independent Mental Health Advocacy services.
3. Process and outcome evaluation of culturally appropriate advocacy pilots.

Although bids for individual studies will be considered in this call, we welcome bids that combine these studies especially where they can be coordinated for better outcomes. We will also consider collaborative bids with multiple coordinated providers on each project.

We expect a clear commitment to involvement of people with lived experience of mental health problems and/or detention, both in the development and implementation of the proposed research. Applicants should ensure PPIE representatives reflect the objectives of this call, and the project they are bidding for, with thought being given to ethnicity and the promotion of equality in particular.

We also encourage applications that demonstrate inclusivity and relevance to geographically diverse areas and areas with a high mental health burden.

A: Baseline and Feasibility Study on Patient Experience

Evaluation of the reforms will require assessing patient and carer experience and perspectives on the therapeutic benefit of treatment and support. It will be important to establish ways of reliably obtaining perspectives on patient and carer experiences and start to establish baselines for this in advance of full implementation of reforms, in order to later evaluate their impact.

The Care Quality Commission collects some qualitative information on patient experience as part of MHA monitoring[6] and the Independent Review also collected wide ranging and valuable feedback. This study would go beyond this to provide a robust baseline on patient and carer experience, which we can measure future progress against in a quantitative way.

The NIHR has previously funded research [7] on the use of patient experience for improvements in mental health inpatient services. Bids should demonstrate how they build on the findings of this study where relevant and additionally seek to build a nationwide picture of patient experience that is quantitatively analysable along with bringing in non-inpatient experiences such as MHA assessment and CTOs.

Along with establishing a baseline for patient experience, the study would establish the feasibility of collecting such information over the course of or following full implementation to assess the effects of reforms. This work would be in preparation for evaluation of the full reforms, which are expected to be implemented in phases until 2030-2031.

This study should collect both qualitative and quantitative information on patient and carer experiences, where individuals are assessed, detained or subject to community treatment orders (CTOs) under the Act. This would address aspects including patient dignity, understanding of rights, involvement in decision-making, and perception of priority being given to therapeutic benefit and patient preferences.

We expect the research team to work with clinicians/practitioners to understand and develop practical approaches to engaging with patients and carers/families, along with approaches to measuring patient experience.

The research should also collect data on access to and engagement with advocacy processes and how patient experiences change through these processes. This would include Advance Choice Documents, Care and Treatment Plans and Independent Mental Health Advocates.

This research should consider previous approaches for patient experience data capture and use this to develop a proposed method which would then be tested and used to generate a baseline. The research should also develop an evidence base on effective approaches to this type of data capture.

We would expect the research to cover a diverse mix of trusts with varied geographical locations, detention rates, sizes and population composition.

In terms of assessing feasibility and informing development of future evaluation work, the lead question is ‘How can we best assess patient and carer experience for the purpose of evaluating reforms to the Mental Health Act?’. These are some indicative questions that this research could consider:

• How can the existing methods and practices used by services to collect patient and carer experience, including those identified in previous research, be utilised to inform this research?
• What are the best metrics for measuring patient experience reliably over time?
• What model or models might be recommended for how we should measure patient experience in the future?
• How much would the chosen approach(es) cost?
• What approaches might be taken to best ensure patient engagement with any future data collection on their experience?
• Previous research has identified that patient experience data should be collected at several points along a patient pathway. What are the optimal timepoints in a Mental Health Act pathway to ask for feedback?
• How can the experience of patients who are assessed but not ultimately detained, or patients post-discharge best be captured?
• How can data on access to and engagement with advocacy processes best be captured?

B: Process and Qualitative Outcome Evaluation of Early Reforms

The first reforms are currently planned to be implemented in mid 2024-25, but there is some uncertainty in this timeline and they could be implemented in 2025-. These three reforms are summarised below:

1. Changes to detention criteria, to require a stronger level of risk and therapeutic benefit for patients. This includes changes to criteria for patients with learning disabilities and autism.
2. Allowing patients detained under the act to select a nominated person to make decisions on their behalf, who no longer needs to be their nearest relative.
3. Automatic referral of patients to Independent Mental Health Advocacy, making this form of support ‘opt-out’ rather than ‘opt-in’ for patients detained under the act.

Process evaluation will be necessary to understand whether these reforms are being implemented as intended and whether they are achieving their aims. This will help us to understand if we need to adjust further implementation steps and whether there should be any changes to our approach after initial implementation.

We would expect the process evaluation to use a range of quantitative and qualitative approaches. This may include quantitative analysis of data, such as the Mental Health Services Dataset and other sources as necessary, to evaluate whether the reforms are being implemented as planned and early signs of any impacts. We would also expect some mixed methods to evaluate implementation and early impacts, e.g. surveys and interviews/focus groups with patients, carers, clinicians, representatives and non-NHS professionals involved in detention processes (e.g. Approved Mental Health Professionals, employed by local authorities).

The research should also, where possible, measure or detail how the cost and benefits of the delivery models for each policy can be measured.

The research team should consider both the national picture and individual areas and delivery models.

Along with the below research questions, we would also want the study to consider workforce awareness of the changes and what training is carried out along with how far processes and organisational/workforce culture may have changed following the reforms. This should include both staff with direct responsibilities under the MHA and other staff who work with people affected by the act.

This research should also consider the views of key workforce/clinicians and how they have been affected by the reforms.

The research questions for (a) Detention Criteria are summarised as:

1. Are the changes to detention criteria reducing the likelihood that a patient is detained and the period that patients are detained?
2. What happens to patients subject to different detention decisions as a result of changes to detention criteria (e.g. health service use and interactions with the criminal justice system for those not detained)?
3. Are the changes to detention criteria increasing the level of therapeutic benefit for patients detained under the MHA?
4. Are clinicians/AMHPs changing their approach to decisions to detain people, to require a greater level of risk and therapeutic benefit?
5. Are clinicians/AMHPs taking a different approach to patients with learning disabilities and autism when making decisions about detention under the act?
6. Have changes to criteria changed how the act is applied to people with protected characteristics, especially considering ethnic minorities?
7. How are clinicians/AMHPs interpreting the new guidelines when reviewing decisions to detain patients? What impact is this having on whether an individual gets detained?
8. What tools, approaches and resources are being used by practitioners to guide them and can examples of good practice be identified?
9. Are tribunals more likely to discharge patients because of the new guidelines?

The research questions for (b) Nominated Persons are summarised as:

1. Are patients making different decisions about who can represent them with this new power?
2. Are nominated persons able to effectively advocate for their patients' wishes?
3. Is there any disproportionate uptake or effectiveness of nominated persons across protected characteristics?
4. What barriers or supporting factors are relevant for patients seeking better representation following the changes?
5. What tools, approaches and resources are being used by practitioners to guide them and can examples of good practice be identified?

The research questions for (c) Auto Referral for IMHAs are summarised as:

1. Has the move to an ‘opt-out’ model resulted in higher uptake of advocacy?
2. What are the barriers and enablers relevant to this reform achieving stronger access to advocacy in practice?
3. Is the IMHA workforce sufficient to allow all patients to access advocacy?
4. Are patients engaging with their advocate?
5. Are IMHAs able to effectively advocate for their patients' wishes?
6. What tools, approaches and resources are being used by practitioners to guide them and can examples of good practice be identified?

C: Process and Outcome Evaluation of Culturally Appropriate Advocacy Pilots

We are also seeking a process and early outcome evaluation of culturally appropriate advocacy pilots.

Evaluation of the pre-pilots which ran to June 2022 has already been completed. We are planning to commence full pilots in January 2023, with a three month development phase until April 2023 and then running for 12 months after that date, with a possible further 12 month extension.

We would expect this evaluation to use quantitative and qualitative approaches, both to consider how effectively the pilots are implemented and provide early evidence on their impact. We would expect the evaluation to capture management data and qualitative data from patients, carers, clinicians, and advocates.

The research should also seek to measure the different costs of delivery models.

Indicative research questions are summarised below:

1. Which models of culturally appropriate advocacy are most effective at achieving the aims and why?
2. Do culturally appropriate advocates/advocacy services have improved uptake across minority groups?
3. Do these schemes result in a greater use of rights and advocacy either within/across minority groups?
4. Are these schemes improving patient experience and decreasing the level of restriction across minority groups?
5. How are the pilots influenced by contextual differences, such as demographics in each area?
6. Do the benefits of culturally appropriate advocacy programmes outweigh the cost?

New Guidance on Health Inequalities data collection within NIHR PRP Research:

Health Inequalities is a high priority area within the Department of Health and Social Care and the NIHR and is often present in a majority of funded projects. We are now assessing all NIHR research proposals in relation to health inequalities. We are asking applicants to identify in their application whether or not there is a health inequalities component or theme and how this research hopes to impact health inequalities. We are also asking researchers to collect relevant data, if appropriate for the research. Our goal is to collect information on health inequalities in research and data relating to the main outcome(s) of the proposed research. Please clearly identify in this section whether or not your application has a health inequalities component or relevance to health inequalities and detail the core set of health inequalities breakdowns that will be reported; if none please explain why. We understand that research projects have different methodologies and focus on different populations, so please explain what data will be collected and reported for the methodology you plan to use. If a health inequalities component is not included, please explain why this does not fit within your proposed research. This should only be a few sentences.

For quantitative research we would ideally like researchers to provide one-way breakdowns of their main outcome(s) by the following equity-relevant variables: age, sex, gender, disability, region, 5 ONS Ethnic groups, and the 5 IMD quintile groups. If more detailed cross tabulations are appropriate, please include these. This table should be submitted to NIHR PRP at the end of the project. Due to data limitations, judgement calls may be necessary about which breakdowns to report and whether to merge categories to increase counts in particular cells; we ask you to make these judgement calls yourself, bearing in mind our data curation aim of enabling future evidence synthesis work in pooling results from different studies. More details and an example table can be found in Appendix A.

For qualitative research projects, this can be purely descriptive statistics giving the number of observations against the various variables.

Further details about this new request can be found in Appendix A.

We will also be holding a Health Inequalities in NIHR PRP Research Q&A Event on 19 September 2022, more details in APPENDIX B.

Technical requirements

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.

Applicants are expected to have:

• previous experience evaluating national policy programmes;
• previous experience of qualitative research in order to gather and analyse views from various stakeholders (e.g. service users, families, clinicians);
• previous experience of quantitative research to analyse data where available.
• health economic expertise;
• experience of working with vulnerable populations (e.g. people with serious mental illnesses).

Outputs

A meeting to discuss policy needs with DHSC officials will be convened as a matter of priority following contracting for each of these studies. Expected outputs for each study includes:

1. Policy-tailored briefings to explain key findings to policy officials.
2. Briefings/study summary findings tailored for clinicians, patients/service users and their families/carers
3. Interim reporting as required by the funder and meetings with officials to present initial findings and progress with the research.
4. A presentation of findings to DHSC colleagues and key stakeholders.
5. Draft publishable report and final publishable report, with executive and lay summary in a form suitable for policy colleagues.

The successful applicant(s) will produce a final report, fully accessible to policymakers and members of the public and circulate to DHSC. When the study is complete, the successful applicants will place a final report summary on the NIHR PRP website, where outputs resulting from public expenditure are available for public scrutiny. It is important the final report summaries are easily accessible to lay readers.

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 and resources should be flexible to meet this need.

Budget and duration

A total budget of £1.3m is available for these studies.

The indicative budget for each study is £350k, £600k, and £350k respectively. A full justification of costing is required whether an application is being made for a single study or for a combination of more than one of the specified studies.

The patient experience study (A) should start no later than September 2023. This study will be funded for 15 months which includes set up, data collection and reporting, and therefore needs to be completed by the end of December 2024 ahead of implementation of the MHA reforms.

The process and outcome evaluation study (B) would be expected to cover a 30-month period, with 12 months before and 18 months after implementation. Under current plans, this would mean the study would operate from March 2024 to September 2026 but this is subject to parliamentary and implementation timescales.

The independent evaluation of culturally appropriate advocacy study (C) should commence no later than September 2023 and would run alongside the pilot study for 18 months, after the pilot has completed its development phase.

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

In order to maximise the benefit from the findings, the research will need to commence as soon as possible following selection of the successful proposals and placing of contracts. Capability to start promptly will be an advantage and for this commissioning round, applicants should demonstrate that studies can start by the relevant date.

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.

Areas out of scope for this programme of work

This research should be focused on the Mental Health Act in England only.

Management arrangements

A research advisory group including, but not limited to, representatives of DHSC, 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:

1. Provide regular feedback on progress
2. Produce timely reports to the advisory group
3. Produce a final report for sign off

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.

References and key documents

1. Department of Health and Social Care (2018). Modernising the Mental Health Act – final report from the independent review. [Accessed August 2022]
2. Department of Health and Social Care (2021). Reforming the Mental Health Act. [Accessed August 2022]
3. Department of Health and Social Care (2021). Reforming the Mental Health Act - government response. [Accessed August 2022]
4. NHS England (2020). Advancing mental health equalities strategy. [Accessed August 2022]
5. Department of Health and Social Care, Ministry of Justice (2022). Draft Mental Health Bill. [Accessed August 2022]
6. Care Quality Commission (2022). Monitoring the Mental Health Act. [Accessed August 2022]
7. Weich S, Fenton S-J, Staniszewska S, Canaway A, Crepaz-Keay D, Larkin M, et al. (2020). Using patient experience data to support improvements in inpatient mental health care: the EURIPIDES multimethod study. Health Serv Deliv Res [online]. 2020;8(21). [Accessed August 2022]

Appendix A: Further Detail on the New Guidance on Health Inequalities data collection within NIHR PRP Research

Health Inequalities is a high priority area within the Department of Health and Social Care and the NIHR and is often present in a majority of funded projects. We are now assessing all NIHR research proposals in relation to health inequalities. We are asking applicants to identify in their application whether or not there is a health inequalities component or theme and how this research hopes to impact health inequalities. We are also asking researchers to collect relevant data related to health inequalities, if appropriate for the research. Collecting specific information about health inequalities in research submitted to the programme will allow for categorisation of health inequalities research, curation of data to aid future health inequalities research and enable policymakers to better understand the implications of health inequalities within their policy areas. This is a new request from the NIHR PRP and we will be continuing to monitor queries and adapt the process as needed. If you have any feedback on this new request, please contact us at prp@nihr.ac.uk.

Our goal is to facilitate more widespread and consistent reporting of health inequality breakdown data relating to the primary outcomes of NIHR funded research. We would ideally like researchers to focus on the following equity-relevant variables: age, sex, gender, disability, region*, 5 ONS Ethnic groups**, and the 5 IMD quintile groups. These variables are considered an ideal, but we understand that these are subject to change depending on the sample population and specific research question.

For qualitative research projects, this can be purely baseline characteristics of the participants, for example, the number of participants in each ethnic group.

For quantitative research projects, if there are multiple outcomes/effects with your stakeholders, select a small number of main outcomes as appropriate to report equity breakdowns. We will not be prescriptive about the number of the outcomes, as it will depend on the number of study design types and the nature of the project aims. We are asking for one way cross tabulations of each primary outcome by these equity-relevant variables, if appropriate for your research, together with the number of observations in each cell. If more detailed cross tabulations are appropriate for your proposed research, please include these as well. This request applies to both primary data collection studies and secondary analysis of routine data, and to causal inference studies as well as descriptive studies; however, if this is not possible due to data limitations then please explain. Due to sample size and other data limitations there may be difficult scientific and/or data security*** judgement calls to make about which breakdowns to report and whether to merge categories to increase counts in particular cells; we ask you to make these judgments yourself, bearing in mind our data curation aim of enabling future evidence synthesis work in pooling results from different studies. We also ask that researchers report breakdowns for the unadjusted as well as adjusted outcomes/effects, as appropriate.

We understand that research projects may employ different methodologies, and focus on different populations. Please explain how the variables and data collection methods chosen are appropriate to the methodologies used.

We ask that you please clearly identify in the research plan section of the application whether your application has a health inequalities component or not and detail the core set of health inequality breakdown data that will be collected, if applicable. Submission of the data collection will be a condition of the final report for all research with relevant methodologies regardless of whether the research has a health inequalities component that will need to be submitted to NIHR PRP when the grant has finished. This should only take a few sentences within the research plan section.

* Table below uses the nine regions in England, further regions can be used if using the UK as the study population. Please report region breakdown for large samples in nationally representative descriptive studies. There is no need to report this for small sample studies, for sub-national studies, or for quasi-experimental studies where it would require time-consuming re-estimation.
** White, Mixed/ Multiple ethnic groups, Asian/ Asian British, Black/ African/ Caribbean/ Black British, Other ethnic group. If the sample size is small then it is fine to report only some of the requested equity breakdowns and to merge some of the sub-groups as appropriate.
*** For guidance on how to handle data security concerns in reporting of sensitive data please see ONS guidance.

Example data table for submission at the end of the funded research project

(N.B. If there is more than one main outcome then you will require more tables and if you adjust your outcome then you will need two tables for the adjusted outcome and unadjusted outcome. For other methodologies, variable vs number of observations may be more appropriate to record participant data). This table is for an example only. It does not contain sub variables and does not illustrate any preference for certain variables, as these will be dependent on the proposed research.

Variable		Outcome (an appropriate average for this subgroup, usually the mean)	Number of observations	Additional information about variation if appropriate, e.g. range, standard deviation
Age		-	-	-
Sex		-	-	-
Gender		-	-	-
Disability		-	-	-
Ethnic Group		-	-	-
IMD Group		-	-	-
Region		-	-	-

Appendix B: Health Inequalities in NIHR PRP Research Q&A Event

This event will take place on Monday, 19 September 2022 from 2:00 - 3:00pm. There will be a discussion from the NIHR PRP, the Department of Health and Social Care and other panellists followed by the opportunity for a Q&A session to help applicants navigate this new request. Please register for the event using the google registration form for the event. Any questions that are not answered during the session will be anonymously answered and published in a FAQ document on the health inequalities webpage.