Advance Choice Document Implementation
Conditions: Detention Under the Mental Health Act
Sponsor: King's College London

King’s Clinical Trials Unit 
 
Confidential 
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1.  PROTOCOL FULL TITLE Advance Choice Document Implementation 
IRAS 346853 
Protocol Short Title/ Acronym: ACDI 
 
 
Trial Identifiers  
ISRCTN: 
 
REC Number: 
25/WM/0117  
UKCRN Number: 
 
Protocol Version 
Number: 
2.0 
Date: 
25.09.25  
 
(Co) Sponsor(s) 
Name: 
Professor Bashir Al-Hashimi 
Vice President & Vice Principal 
(Research) 
 
Dale Batham  
Address: 
King’s College London 
Room 8.11, 8th Floor Melbourne House 
44-46 Aldwych 
London WC2B 4LL 
 
South London and Maudsley NHS 
Foundation Trust 
R&D Department  
Room W1.08 
Institute of Psychiatry, 
Psychology & Neuroscience 
(IoPPN) 
De Crespigny Park 
London SE5 8AF 
 
Telephone: 
+44 (0)207 848 7306  
020 7848 0339 
Email: 
vpri@kcl.ac.uk  
slam-ioppn.research@kcl.ac.uk  
 
Co-Principal investigators 
Name: 
Prof Claire Henderson 
Address: 
Health Services and Population Research Department P029,  
David Goldberg Centre, King's College London Institute of Psychiatry, Psychology and 
Neuroscience  
De Crespigny Park 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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London SE5 8AF.  
 
Telephone: 
020 7848 5075             
Email: 
Claire.1.henderson@kcl.ac.uk 
Name: 
Dr Shubulade Smith 
Address: 
Maudsley Hospital 
Denmark Hill 
London SE5 8AZ 
Telephone: 
0203 228 5730 (Joyce Fevrier - Project Administrator, SLP) 
Email: 
Shubulade.smith@kcl.ac.uk 
 
 
 
Name and address of Co-Investigator(s), Statistician, Therapy Service, Laboratories etc 
Name: 
Mr Steve Gilbert 
Position/ Role: 
chair, Lived Experience Advisory Groups and advise on service user engagement. 
Address: 
 
Telephone: 
07736307573 
Email: 
steve@stevegilbertconsulting.co.uk 
 
Name: 
Professor Alan Simpson 
Position/ Role: 
Advise on qualitative data collection and staff engagement. 
Address: 
David Goldberg Centre, King's College London Institute of Psychiatry, Psychology and 
Neuroscience  
De Crespigny Park 
London SE5 8AF.  
Telephone: 
020 7848 2901 
Email: 
Alan.Simpson@kcl.ac.uk 
 
Name: 
Prof Gareth Owen 
Position/ Role: 
Advise on Advance Choice Document (ACD) implementation in services for older adults 
Address: 
Department of Psychological Medicine, King's College London Institute of Psychiatry, 
Psychology and Neuroscience  

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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De Crespigny Park 
London SE5 8AF. 
Telephone: 
 
Email: 
Gareth.owen@kcl.ac.uk 
 
Name: 
Dr Lucy Stephenson 
Position/ Role: 
advice based on previous crisis PaCK study  
Address: 
Department of Psychological Medicine, King's College London Institute of Psychiatry, 
Psychology and Neuroscience  
De Crespigny Park 
London SE5 8AF. 
Telephone: 
n/a 
Email: 
Lucy.Stephenson@slam.nhs.uk 
 
Name: 
Dr Kia-Chong Chua 
Position/ Role: 
Lecturer in applied statistics; advise on implementation science methods 
Address: 
Department of Biostatistics and Health Informatics, King's College London Institute of 
Psychiatry, Psychology and Neuroscience  
De Crespigny Park 
London SE5 8AF. 
Telephone: 
020 7848 0633 
Email: 
Kia-chong.chua@kcl.ac.uk 
 
Name: 
Mr Alex Ruck Keene 
Position/ Role: 
Legal consultant: provide a guidance note in the implementation resource and ensure 
study documentation is consistent with legislation. 
Address: 
81 Chancery Lane London WC2A 1DD 
Telephone: 
 
Email: 
alex.ruckkeene@39essex.com 
 
Name: 
Dr Amy Ronaldson 
Position/ Role: 
Research fellow/ lead on statistical analysis 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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Address: 
David Goldberg Centre, King's College London Institute of Psychiatry, Psychology and 
Neuroscience  
De Crespigny Park 
London SE5 8AF. 
Telephone: 
 
Email: 
Amy.ronaldson@kcl.ac.uk 
 
Name: 
Prof Barbara Barrett 
Position/ Role: 
Professor of Health Economics/ Lead on health economic analysis 
Address: 
David Goldberg Centre, King's College London Institute of Psychiatry, Psychology and 
Neuroscience  
De Crespigny Park 
London SE5 8AF. 
Telephone: 
 
Email: 
Barbara.Barrett@kcl.ac.uk 
 
Name: 
Dr Daniel Hayes 
Position/ Role: 
Consultant in Child and Adolescent Psychiatry/advise on ACD implementation in CAMHS 
Address: 
Maudsley Hospital 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
Daniel.Hayes@slam.nhs.uk 
 
Name: 
Carla Fourie 
Position/ Role: 
Project Senior Responsible Officer 
Address: 
Maudsley Hospital 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
carla.fourie@slam.nhs.uk 
 
 
 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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Name: 
Mandy Mudholkar 
Position/ Role: 
ACD Clinical Supervisor 
Address: 
Maudsley Hospital 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
mandy.mudholkar@slam.nhs.uk 
 
 
Name: 
Mohini Chauhan 
Position/ Role: 
Project Management Officer  
Address: 
Maudsley Hospital 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
mohini.chauhan@slam.nhs.uk 
 
 
 
 
Name: 
Pauline Edwards 
Position/ Role: 
Peer Recovery Trainer 
Address: 
SLaM Recovery College 
1st Floor Administration Building 
Maudsley Hospital 
Denmark Hill 
London 
SE5 8AZ 
Telephone: 
 
Email: 
pauline.edwards@slam.nhs.uk 
 
 
Name: 
Dr Jaya Chaturvedi 
Position/ Role: 
Research Associate/Health Informatics lead 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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Address: 
David Goldberg Centre, King's College London Institute of Psychiatry, Psychology and 
Neuroscience  
De Crespigny Park 
London SE5 8AF. 
King’s College London 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
jaya.3.chaturvedi@kcl.ac.uk 
 
 
Name: 
Mr Jonathan Simpson 
Position/ Role: 
Research Assistant 
Address: 
Kings College London 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
Jonathan.simpson@kcl.ac.uk 
Name: 
Ms Riddhi Daryanani 
Position/ Role: 
Research Assistant 
Address: 
Kings College London 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
Riddhi.1.daryanani@kcl.ac.uk 
 
 
Name: 
Dr Mariam Namasaba 
Position/ Role: 
Research Associate 
Address: 
Kings College London 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
Mariam.namasaba@kcl.ac.uk 
 
 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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Name: 
Margaret Thurer 
Position/Role: 
PhD Student 
Address: 
Kings College London 
Denmark Hill 
London SE5 8AZ 
Telephone: 
 
Email: 
Margaret.thurer@kcl.ac.uk 
 
 
Name 
Ana Hagström 
Position/Role 
Visiting Researcher 
Address 
Medical Management Centre (MMC). Learning, Informatics, Management and Ethics 
(LIME) 
Karolinska Institutet ,Tomtebodavägen 18A 
SE-171 77 Stockholm, Sweden 
Telephone 
+46704744945 
Email 
ana.hagstrom@ki.se 
 
 
2. STUDY SUMMARY / SYNOPSIS 
TITLE OF STUDY: 
Advance Choice Document Implementation 
Protocol Short Title/ Acronym: 
ACDI 
Sponsor Name: 
Professor Bashir Al-Hashimi  
Vice President & Vice Principal (Research) 
King’s College London 
Room 8.11, 8th Floor Melbourne House 
44-46 Aldwych 
London WC2B 4LL 
Tel: +44 (0)207 848 7306  
Email: vpri@kcl.ac.uk  
Co Principal Investigators: 
Prof Claire Henderson and Dr Shubulade Smith 
UKCRN Number: 
 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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REC Number: 
 
Medical Condition or Disease Under 
Investigation: 
Severe mental illness 
Purpose of study: 
To evaluate the effectiveness of Advance Choice Document 
implementation in an NHS Mental Health Trust 
Primary Objective: 
To evaluate the effect of Advance Choice Document implementation 
on rates of detention under the Mental Health Act  
Secondary Objective(s): 
To evaluate the effect of Advance Choice Document implementation 
on: 
(i) rates of restraint, seclusion, and involuntary medication  
(ii) safety events (violence, self-harm, consequences of self-neglect 
and other serious untoward incidents) 
(iii) acute mental health and emergency services use 
(iv) criminal justice service involvement  
(v) trust in mental health services 
 
To evaluate key aspects of ACD implementation: Completion; access; 
honouring; and review. See detail in section 8.2.  
Design: 
Mixed methods evaluation: 
Consultation on adaptation for forensic, older adults and child and 
adolescent mental health (CAMHS) services 
Retrospective matched cohort study  
Pre-post evaluation  
Sample Size: 
Work package 1:  
Older Adults: 10- 20 service users 
                        10-20 carers  
                        10-20 professionals 
 
CAMHS users: 10- 20 service users 
                          10 -20 carers  
                          10 - 20 professionals 
  
Total = 60 - 120 
 
Work package 2: ACD creation & follow up  
General adult mental health service users: n=40 
Forensics service users: n=20 
Older adults service users: n=10 
CAMHS users: n=20 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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Service users to be interviewed only post expected ACD application: 
n=15 (from any of general adult, older adult, forensic or child and 
adolescent services).  
Parents/people with parental responsibility for CAMHS service users: 
n=20 
Carers of adults completing ACDs; Staff of the South London and 
Maudsley Trust and of the acute NHS Trusts, local authorities, 
advocacy services, relevant voluntary sector services and primary care 
practices serving the Trust catchment area n=60 
Total: 170  
Summary Of Eligibility Criteria: 
Service users  
- 
Currently under the care of South London and Maudsley NHS 
Foundation Trust 
- 
Previously detained under the Mental Health Act (MHA) 
- 
Aged ≥ 16 years 
Carers / Informal supporters  
- 
Aged ≥ 16 years 
- 
A relative or friend of a service user who is eligible for the 
study, although the service user does not have to be a study 
participant 
Professionals   
- 
Professional involved in supporting the completion of ACDs 
(i.e., ACD facilitators, community mental health team (CMHT) 
staff, advocates, peer support workers) 
- 
SLaM NHS professional potentially involved in referring to 
ACDs (i.e., inpatient and emergency department, home 
treatment, place of safety and street triage staff); Approved 
mental health professionals (AMHPs) and Section 12 (MHA) 
approved doctors; General Practitioners; advocates 
Intervention (Description, frequency, 
details of delivery) 
Advance Choice Document 
Comparator Intervention: 
No ACD 
Maximum Duration Of Treatment Of A 
Subject: 
As the Trust has committed to the rollout of ACDs, there is no 
maximum duration of treatment. Instead, service users completing an 
ACD may have one for as long as they wish. 
Maximum duration of participation in the pre-post evaluation= 21 
months 
Version And Date Of Final Protocol: 
v.1.1 16.07.25 
Version And Date Of Protocol 
Amendments: 
v2.0 25.09.25; SA01 
 
 
 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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3. Revision History 
Document ID - (Document 
Title) revision X.Y 
Description of changes from previous revision 
Effective Date 
 
 
 
 
 
 
 
4. PROTOCOL CONTENTS  
 
1. 
PROTOCOL FULL TITLE ADVANCE CHOICE DOCUMENT IMPLEMENTATION IRAS 346853 .......1 
2. 
STUDY SUMMARY / SYNOPSIS ....................................................................................................................7 
3. 
REVISION HISTORY ...................................................................................................................................10 
4. 
PROTOCOL CONTENTS..............................................................................................................................10 
5. 
STUDY MANAGEMENT .............................................................................................................................11 
5.1 ROLE OF STUDY SPONSOR AND FUNDER .................................................................................................................11 
5.2 STUDY MANAGEMENT COMMITTEES ....................................................................................................................11 
6. 
STUDY BACKGROUND & RATIONALE .........................................................................................................12 
7. 
STUDY AIM AND OBJECTIVE .....................................................................................................................15 
8. 
OUTCOME MEASURES / ENDPOINTS .........................................................................................................15 
8.1 PRIMARY OUTCOME MEASURE / ENDPOINT .................................................................................................15 
8.2 
SECONDARY OUTCOME MEASURE(S) / ENDPOINT(S) (I – IV MEASURED BY CASE NOTE REVIEW) .............................15 
9. 
STUDY DESIGN .........................................................................................................................................17 
9.1 STUDY SETTING ..........................................................................................................................................19 
9.2 DATA ANALYSIS ..........................................................................................................................................20 
10. 
SELECTION OF PARTICIPANTS ...................................................................................................................20 
10.1 ELIGIBILITY CRITERIA ................................................................................................................................20 
10.1.1 
INCLUSION CRITERIA ......................................................................................................................20 
10.1.2 
EXCLUSION CRITERIA .....................................................................................................................22 
10.2 SIZE OF SAMPLE ........................................................................................................................................22 
10.5 RECRUITMENT ..........................................................................................................................................23 
10.5.1 Participant payment / compensation ...................................................................................................25 
10.6 CONSENT .................................................................................................................................................25 
11. 
STUDY PROCEDURES ................................................................................................................................27 
11.1 STUDY FLOWCHART ..................................................................................................................................27 
11.2 METHODS ................................................................................................................................................28 
11.3 SCHEDULE OF PROCEDURES .......................................................................................................................30 
11.4 WITHDRAWAL ..........................................................................................................................................30 
12. 
ETHICAL AND REGULATORY CONSIDERATIONS ..........................................................................................30 
12.1 ASSESSMENT AND MANAGEMENT OF RISK ...................................................................................................30 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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12.2 ADVERSE EVENTS ......................................................................................................................................32 
RECORDING AND REPORTING ADVERSE EVENTS .............................................................................................32 
RECORDING ADVERSE EVENTS ..................................................................................................................................32 
DEFINITIONS .......................................................................................................................................................33 
SEVERITY ...........................................................................................................................................................33 
CAUSALITY .........................................................................................................................................................34 
EXPECTEDNESS ....................................................................................................................................................34 
PROCEDURES FOR RECORDING AND REPORTING SERIOUS ADVERSE EVENTS .........................................................35 
REPORTING LINES FOR SAES ....................................................................................................................................35 
SERIOUS ADVERSE EVENTS THAT DO NOT REQUIRE REPORTING ...........................................................................................35 
REPORTING URGENT SAFETY MEASURES .............................................................................................................35 
NOTIFICATION OF REPORTABLE PROTOCOL VIOLATIONS .................................................................................35 
12.3 ETHICS REVIEW AND COMPLIANCE .............................................................................................................35 
12.4 FUNDING .................................................................................................................................................36 
12.5 PUBLIC & PATIENT INVOLVEMENT ..............................................................................................................36 
12.6 PROTOCOL COMPLIANCE ..........................................................................................................................36 
13. 
DATA PROTECTION AND SERVICE USER CONFIDENTIALITY .........................................................................36 
14. 
INDEMNITY .............................................................................................................................................37 
14.1 ACCESS TO THE FINAL DATASET ..................................................................................................................37 
15. 
DISSEMINATION POLICY ...........................................................................................................................37 
16. 
SIGNATURES ............................................................................................................................................37 
17. 
REFERENCES ............................................................................................................................................39 
 
5. STUDY MANAGEMENT  
5.1 Role of Study Sponsor and Funder 
South London and Maudsley NHS Foundation Trust and King’s College London are joint sponsors. 
This study is funded by the Maudsley Charity. 
 
The Co-Principal Investigators have overall responsibility for the study and shall oversee the study 
management. Both Co-Principal Investigators and the Research associate will have weekly meetings for the 
entire duration of the study.  
5.2 Study Management Committees 
1. Study Steering Committee: The steering committee will consist of policy stakeholders 
nationally. They will meet every 6 months once the study has begun, and will advise on 
implementation, dissemination, and the overall process of the study.  
2. Co-Applicants: The co-applicants will meet at least every two months to receive feedback from 
the co-principal investigators and research associate on the progress of the study and provide 
input. 
3. Patient and Public Involvement (PPI) / Lived Experience Advisory Groups: Five groups will be 
convened and will be chaired by experienced facilitators 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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• 
Black people with a previous experience of detention under the MHA while aged over 18 to 
South London and Maudsley (SLaM) general adult inpatient unit, and relatives and carers of 
such service users:  
• 
Any service user with previous experience of detention as above, and relatives and carers 
of such service users:  
• 
Adults who have previously been detained under the MHA in SLaM forensic services, and 
relatives and carers of such people.  
• 
Adults who are current or former users of SLaM Older Adults services and were detained 
under the MHA in an inpatient unit for Older Adults, and relatives and carers of such 
people.  
• 
People aged 16 or over who are current or former users of SLaM CAMHS and were 
detained under the MHA while aged under 18, and relatives and carers of such people.  
The lived experience advisory groups will meet every 2-3 months and will advise on engagement at all 
stages of the study to optimise both the recruitment and participation of service users. 
  
6. STUDY BACKGROUND & RATIONALE 
 
The evidence base and policy position regarding Advance Choice Documents 
 
The UK government committed to legislating for Advance Choice Documents1 following their 
recommendation by the Independent Review of the MHA (2018) 2. This recommendation is based on 
ethical and legal arguments as well as evidence from systematic reviews and meta-analyses of randomised 
controlled trials (RCTs)3–5 of interventions variously termed Joint Crisis Plans or Psychiatric Advance 
Directives. These trials show such interventions are associated with a reduction (25%, RR 0.75, CI 0.61-0.93) 
in compulsory psychiatric admission3,4. They are yet to be implemented in routine practice despite this 
evidence and indications of high demand in England and elsewhere6,7. The joint parliamentary scrutiny 
committee of the Mental Health Bill recommended a statutory offer of an ACD be made to anyone who has 
previously been detained under the MHA and, in line with the research interventions, that support to 
create one be provided by someone independent of the treating team. The 2024 King’s Speech, made as 
the new government came to power, highlighted an intention to amend the MHA with a view to 
“strengthening the voice of patients by adding statutory weight to patients’ rights to be involved with 
planning for their care, and to make choices and refusals regarding the treatment they receive”53.  
 
The current NHS England position is: 
1. NHSE Patient and Carer Race Equality Framework reporting requirements include: (i) ACD completion by 
race/ethnicity and (ii) experience of completion on the part of people from minoritized groups. 
 
2. The guidance: Acute inpatient mental health care for adults and older adults states: 
 
“From the point of presentation to within 72 hours of admission: 
Holistic assessment conducted to understand the person’s needs. This assessment should build on 
information contained within the person’s EPR, including any recorded advance choices and reasonable 
adjustments.” 
 
“Decision reached, considering as fully as possible the person’s preferences (including any ACDs), those of 
their chosen carer/s, and the views of relevant partner services, that the person’s needs can only be met in 
an inpatient setting and cannot be supported in the community.” 
 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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“Formulation review completed to gain an in-depth understanding of the person, the circumstances leading 
up to their admission and what will help them to recover. This, together with recorded ACDs should be 
used as the basis to co-develop a personalised care plan with the person and their chosen carer/s, which 
should then be uploaded to the person’s EPR.” 
 
“At and following discharge: 
Prompt access provided to all planned post-discharge support included in the person’s discharge plan. The 
person should also be supported to develop ACDs and a crisis plan, if they were not developed ahead of 
discharge.” 
 
This guidance suggests that ACDs should be created while someone is an inpatient or post discharge. 
However, the two trials of advance statements developed during inpatient stays showed negative results in 
terms of compulsory hospitalisation1,2 and service users have expressed a clear preference to create them 
when in the community 3. This may differ in forensic settings however, where patients may have 
significantly longer stays due to sentencing. In such cases, the better option may be to create an ACD while 
the person is still receiving inpatient treatment and is well, for example in a low secure or rehabilitation 
setting.  
 
As the trials took place in countries without specific legislation for ACDs for mental healthcare, it might be 
expected that legislation would lead to widespread implementation. However, in countries with such 
legislation (USA and Scotland), uptake has been slow and remains low11. In England and Wales there is little 
evidence that service users have the opportunity to use the advance planning provisions under the Mental 
Capacity Act (MCA)7.  Research in the USA, Scotland, and England suggests barriers at service user, clinician, 
and service levels 7,11. 
 
Completing an ACD involves asserting advance wishes and preferences as requests and/or refusals for 
treatment and other aspects of care when one has the capacity to do so. US research shows that the 
majority of service users need support to do this7,8. This is also demonstrated by a survey7 of people with 
bipolar disorder in England. Among the third who were aware of the MCA, unrealistic expectations about 
advance planning and misunderstanding about the different forms (advance treatment refusals, advance 
statements, and power of attorney) were common. Among the 10% who had made an advance refusal, 
only half were written down (of these, many were not given to anyone else and almost all were described 
as being ignored during MHA detention). Scottish evidence suggests some service users are sceptical about 
whether ACDs will be followed by staff, while others do not acknowledge their relevance9. 
 
At the clinician and service levels, mental health professionals express reservations about being able to 
access ACDs and honour the person’s wishes10–12. In the CRIMSON trial of JCPs, co-lead Henderson et al. 
identified three barriers: (1) lack of recognition of the benefits of advance statements; (2) not recognising 
the need for a change in the clinician-patient relationship including discussing treatment options and 
supporting patient choice; and (3) difficulties in implementation arising from working across the system13. 
Moreover, while some clinicians believed the external JCP facilitator was necessary for empowering service 
users to participate in shared decision making, senior clinicians – namely psychiatrists – feared losing 
control of their role in patients’ care 14. 
 
Service users, clinicians and carers view ACDs as potentially offering positive outcomes including: reduced 
coercion or trauma associated with compulsory treatment; building therapeutic alliance8,13; earlier 
presentation; avoiding harms; enhancing communication; empowering service users; and improving 
clinician confidence15,16. The above guidance on ACDs creates an implementation gap, and there remains a 
need for an evidence-based approach to ensure effective implementation. In the protocol we will 
henceforth use the term ACD. 
 
The Importance of ACDs to Black people 

IRAS NUMBER:  346853                                                                                                            PROTOCOL VERSION: 2.0 
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Detention rates of Black people (defined as people of Black African and Caribbean heritage, including those 
of mixed Black ethnicity) are disproportionately (>3 times) higher than those of White British people and 
they have poorer care experiences and outcomes18,21. They are more likely to access mental healthcare via 
the criminal justice system than through primary care22 or have police involved in their detention23. Their 
treatment involves increased use of compulsion, longer admissions and more detention in secure settings24. 
Black people of Caribbean heritage are more likely to be re-admitted or repeatedly detained than White 
people18, and less likely to be referred for specialist mental healthcare25. This pattern incurs increased 
service costs26 – the current unit cost/day for caring for someone with a psychotic relapse in the 
community is £146, compared with £455 in hospital. The current rate of detention of Black people has been 
conservatively estimated to cost ~£158 million/year2. 
 
Black people with severe mental illness (SMI) therefore benefit more than other groups from ACDs: the 
CRIMSON trial showed greater cost-effectiveness of JCPs for Black people compared with White and Asian 
participants13, arising from reduced inpatient service use. In a US study6, completing an ACD was a more 
empowering experience for African Americans compared with other ethnic groups17 and demand for these 
was higher among non-White people6. Lack of trust in mental health services may create a high demand for 
ACDs among Black people in England18–20. 
 
Almost half (47%) of the explanations for these variations in care have no or limited supporting evidence. 
Interventions based on these explanations are likely to fail27, and current methods of supporting Black 
people previously detained under the MHA are insufficient2. In contrast, ACDs are the only evidence-based 
intervention to reduce compulsory psychiatric admission overall, with particular benefit for Black people 
due to their higher likelihood of being detained under the MHA because of racial stereotyping and 
discrimination 3,28. ACDs thus represent a way to reduce unwarranted variation by intervening in a negative 
cycle of dissatisfaction with services29, impaired therapeutic alliance and trust, disengagement from 
services, reduced help seeking25,30 and repeated compulsory admissions, associated with reduced quality of 
life.  
 
In our previous study, Advance Statements for Black African and African Caribbean People (AdStAC) we 
developed an implementation resource for ACDs developed with and for Black people. Our rationale was: 
1) Strategies that support successful implementation of ACDs will enable better access and delivery of 
mental health services for Black people; and 2) if the most marginalised groups, who are least engaged, can 
be supported with these strategies, then these strategies are likely to work for other people with SMI.  
 
The resource developed and tested includes an ACD template, a manual for the independent facilitator 
professional leading the process of creating the ACD (ACD facilitator), and trainings provided by the SLaM 
Recovery College and Maudsley Learning simulation team respectively. The resources will be used in the 
present project and adapted as necessary for specific services.  
 
This project will also benefit from the following work undertaken by the applicants and their associated 
NHS trusts:  
 
• 
A study led by Henderson32 suggests that services need to be flexible, allowing service users to 
choose not just the content of an ACD but also when and where to complete one and whom to 
involve.  
• 
The process and documents for producing ACDs in the form of JCPs (Henderson) were developed 
with input from service users14 and a manual was developed for the trials13,33.  
• 
Qualitative work during CRIMSON (Henderson) identified the processes to ensure shared decision 
making about the content of JCPs and the positive impact of these processes on therapeutic 
relationships15, as well as difficulties ensuring consistency14.  

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• 
Recent focus group and consultation work in England indicates that successful implementation 
requires: user-friendly templates and supporting materials; attention to the legal framework; NHS 
Trust support, health professional training and time; third sector engagement; and service user 
‘readiness’16. A template and guidance for advance statements was developed for people with 
bipolar disorder (Owen)5,16.  
• 
The Crisis Plus service at South London and Maudsley (SLaM) NHS Foundation Trust comprises a 
team of psychologists helping people frequently admitted to hospital to develop crisis plans. This 
service addresses some of the barriers to accessing and honouring plans identified during 
CRIMSON14.  
• 
A minimally viable product (MVP) for digitising ACDs for deployment in clinical settings 
(https://kclpure.kcl.ac.uk/ws/portalfiles/portal/239348291/Thalamos_KCL_Digital_ACD_Discovery_
Document.pdf p48) 
 
 
7. STUDY AIM AND OBJECTIVE 
7.1 AIM 
To evaluate the effectiveness of Advance Choice Document implementation in an NHS Mental Health Trust 
 
7.2 PRIMARY OBJECTIVE 
To evaluate the effect of Advance Choice Document implementation on rates of detention under the 
Mental Health Act  
 
7.3 SECONDARY OBJECTIVE(S) 
A) To evaluate the effect of Advance Choice Document implementation on: 
(i) rates of restraint, seclusion, and involuntary medication  
(ii) safety events (violence, self-harm, consequences of self-neglect and other serious untoward incidents) 
(iii) acute mental health and emergency services use 
(iv) criminal justice service involvement  
(v) trust in mental health services 
 
B) To evaluate key aspects of ACD implementation: Completion; access; honouring; and review 
 
8. OUTCOME MEASURES / ENDPOINTS  
8.1 PRIMARY OUTCOME MEASURE / ENDPOINT 
Admission to hospital under a section of the MHA 
 
8.2 SECONDARY OUTCOME MEASURE(S) / ENDPOINT(S) (i – iv measured by case note review)  
 
Case Note Review:  

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(i) episodes of restraint, seclusion, and involuntary medication 
(ii) safety events: episodes of violence, self-harm, consequences of self-neglect and other serious untoward 
incidents 
(iii) compulsory transport to hospital/place of safety using Section 135 or 136 of the MHA; length of stay for 
informal and formal psychiatric admissions; presentation at Emergency Departments  
(iv) contact with police related to use of acute mental health services; imprisonment; length of time in 
prison 
 
Single Item:  
(v) Trust in mental health services, measured by a single item 'Generally you can trust mental health staff 
and services' with response options ranging from strongly agree to strongly disagree. This item is adapted 
from a measure previously employed in research on social capital46 
 
 
Implementation outcomes: 
These will be assessed via case note review and recordings of meetings given consent, for all those who 
express an interest in creating an ACD across the services where implementation is taking place (i.e. not 
only research participants).  
 
Completion: 
• 
Fidelity of the process: attendance, participation, efforts to complete all ACD sections, 
completion of capacity statement 
• 
Completion procedures to allow costing: setting/location, duration and number of sessions, 
time preparing for meetings and finalising the ACD 
• 
Reasons for non-completion following initial expression of interest 
• 
ACD content (types of requests and refusals35)  
• 
Distribution of hard and electronic copies 
 
Accessing: 
• 
Rates of access to ACD by service users during follow-up for: Approved Mental Health 
Professional team; emergency department, home treatment team; recovery house staff; 
inpatient staff. 
• 
Participant use of the ACD during use of an acute service  
 
Honouring: 
• 
Proportions of ACDs in which one or more choices were honoured/not honoured 
• 
Rate of documentation of reasons for choices clearly not honoured 
• 
Content of choices not honoured and reasons given  
 
Reviewing: 
• 
Proportion of ACDs reviewed and reason for review  
• 
Proportion revised after review 
• 
Types of revisions made 
 
On ACD completion and after use of an acute service, service users who have consented to take part in the 
study, and staff who have been involved in their care, will be interviewed about their views on: 

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a. Acceptability: the aspects which participants found acceptable about the processes of completion, 
access and use of ACDs acceptable,  
b. Appropriateness: the aspects about the processes of completing an ACD which participants found to 
be suitable for their needs, using the Intervention 
c. Feasibility: the aspects of the processes of completing an ACD that are possible. Additionally, we will 
assess the barriers and facilitators of implementing Advance Choice Documents across the different 
services in SLaM by analysing audio recordings of ACD implementation group meetings, the minutes 
and the action tracker. 
 
 
Evaluation of ACD creation and use:  
The primary outcome and secondary outcomes (i-iv) will be ascertained using a retrospective cohort study 
supported by the SLaM Clinical Records Interactive Search (CRIS) database following approval by the BRC 
CRIS oversight committee (Work package 3). Secondary outcome (v) and all implementation outcomes will 
be ascertained using interviews and record reviews of samples of those referred to ACD facilitators who in 
addition provide informed consent to take part in the research: service users under the care of general 
adult, forensic, older adults services and CAMHS (Workpackage 2). 
 
 
9. STUDY DESIGN 
Summary 
Work package 1: Focus groups and stakeholder consultation for Older Adults and CAMHS implementation 
Work package 2: Prospective study of ACD completion and use 
Work package 3: Retrospective controlled study of ACD creation and its relationship to service use and 
routinely collected outcomes 
Work package 4: Pilot retrospective study of ACD use and its relationship to: ACD content, service user and 
service characteristics, and to service use and routinely collected outcomes 
 
Study Design  
 
WP1: Focus groups and stakeholder consultation for Older Adults and CAMHS implementation  
Adaptation for older adults’ services and CAMHS: The research team will run focus groups with service 
users and carers from those groups using services for which adaptation is needed. We will also run focus 
groups with staff who work with people from each of these groups, from SLaM and other organisations 
(e.g. social care and advocacy). All focus groups will be audio recorded.  
 
The purpose of these focus groups will be:  
a) To inform service users, carers, and staff about ACDs 
b) To understand aspects of ACD creation that may be unclear, especially in relation to the specific needs of 
different groups 
c) To understand any concerns or barriers that stakeholders may have in relation to ACD creation  

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d) To ensure that the ACD resources (i.e. ACD creation template) have been suitably adapted (where 
necessary) for use in older adults’ services and CAMHS.  
e) To understand the barriers and facilitators for ACD implementation for staff across different mental 
health services (e.g. CMHT, inpatient wards, staff working with service users on Community Treatment 
Orders etc).  
 
WP 2: Prospective study of ACD completion and use 
Trained ACD facilitators will be in post across SLaM to facilitate the implementation of ACDs. When service 
users are referred to facilitators to create an ACD, they will be asked if they would like to participate in a 
research study. If they wish to participate, they will speak with a member of the research team who will go 
through the consent process (see 10.6).  ACD facilitators will also refer service users who expressed interest 
in participating in the study but have already created their ACDs. Once the participant has provided written 
consent, they will complete a baseline single item regarding their level of trust in mental health care 
services and socio-demographic information. Participants will also be asked for information about their 
treating team.  
Where ACDs are created, we will seek optional consent to record the ACD creation meeting (from service 
users, carers, and all staff present at the meeting). This recording will be used for fidelity purposes. 
Participants who complete ACDs will also be asked to complete a single item regarding their level of trust in 
mental health care services and questions on their satisfaction with and perceived value of their ACD. We 
will also seek optional consent from participants to contact them about future research on ACDs and send a 
letter to their GPs, to notify them that the service user is taking part in the study. 
 
The research team will follow up participants based on their clinical notes. In the event that their ACD is, or 
should have been, used the research team will seek to interview the service user about this experience.  
Situations in which an ACD should be used or reviewed will include:  
• 
Zoning (where a service user’s care team increase contact due to concern about their mental 
health) 
• 
Referral for an MHA assessment 
• 
An MHA assessment  
• 
Home Treatment Team (HTT) referral  
• 
A&E presentation, where they are seen by the mental health liaison team  
• 
Admission to inpatient ward, crisis house, or place of safety  
• 
Any transfer of care to another team  
• 
Discharge from their care team  
 As the project progresses, these criteria will be reviewed and changed as necessary. Additionally, 
facilitators will identify service users whose ACDs are expected to have been applied in the above events, 
either through their care teams or other appropriate channels, and will invite them to participate in the 
study to explore their experiences of the expected use event. 
The research team will invite participants to take part in an interview based on advice from the 
participant’s care team, to ensure that they are well enough to be contacted and to give informed consent. 
When participants are interviewed, they will also be asked to again complete the questionnaire measure of 
trust.  
 
We will also seek to interview SLaM Trust clinical staff involved with the event that led to the use of the 
ACD, as well as the facilitator who led its creation and review. SLaM clinical staff will have the option to 
answer interview questions via email correspondence in cases when an interview is not possible. 

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Facilitators will also be interviewed about their perspectives on integration of their role within SLaM mental 
health services. With participants’ consent, research staff will be given access to participants’ clinical 
records for ongoing observation regarding use / non-use of their ACD. 
 
We will conduct up to eight focus groups covering inpatient, CMHT, liaison and home treatment team and 
all of CAMHS, OA, general adult and forensics about their experience of ACD completion and use. Staff who 
cannot join a focus group will be invited to do an interview instead.  
 
 
WP3: Retrospective controlled study of ACD creation and its relationship to service use and routinely 
collected outcomes 
The CRIS (Clinical Record Interactive Search) database is a de-identified case register extracted from the 
SLaM electronic health record54. Using the CRIS database, following approval from the SLaM BRC oversight 
committee, we will aim to use anonymised routinely collected data to create a retrospective cohort study 
where we will aim to compare service users who hold an ACD to those who are eligible for one but have not 
created one.  
 
Data from the Clinical Record Interactive Search (CRIS) database at SLaM will be used, with the intention of 
creating a retrospective cohort to evaluate the impact of ACDs on primary and secondary outcomes. 
Permission to perform the evaluation will be sought from the SLaM CRIS Oversight Committee and all data 
will be accessed within the SLaM trusted research environment. Data will be extracted six months before 
the end of the study (date of completion of data analyses: 31/09/26) to ensure there is an adequate follow-
up period to assess the impact of ACDs on outcomes. We aim to use the CRIS database to create an 
anonymised cohort of ACD holders and potential control participants. These potential control participants 
will comprise SLaM service users who have been detained under the MHA more than once and last 
discharged from SLaM within 24 months. We aim to match ACD holders with service user controls based on 
sociodemographic (age, gender) and clinical variables (e.g. primary diagnosis) using propensity score 
matching. For ACD holders, the study follow-up period will begin when the ACD is recorded on their 
electronic health record. Each matched control will have the same follow-up period as their corresponding 
ACD holder. This study design has been applied previously to evaluate an intervention, namely recovery 
colleges, as part of the RECOLLECT programme52. 
Work package 4: Pilot retrospective study of ACD use and its relationship to: ACD content, service user and 
service characteristics, and to service use and routinely collected outcomes 
ACDs as identified through Work package 3 will have content extracted in preparation for coding and 
further analysis as described under 9.2. 
 
End of study 
The study will end on the date when all data analyses are completed (predicted end date is 31/03/27). The 
Research Ethics Committee (REC) will be notified of the study’s conclusion within 90 days of the end date, 
and a final study report will be submitted within 12 months of the study’s end date. We will also inform the 
host sites of the study’s completion and request them to communicate this information to participants 
recruited at their respective sites. Lastly, the study’s findings will be published in peer-reviewed journals 
using open-access mechanisms. 
 
9.1 STUDY SETTING  
South London and Maudsley NHS Foundation Trust   
 

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9.2 DATA ANALYSIS  
All data analyses will be undertaken by the research team at the Institute of Psychiatry, Psychology and 
Neuroscience, King’s College London and within SLaM.  
 
Qualitative data (Workpackages 1 and 2):  
Following transcription, framework analysis36 will be used to code the transcripts and identify key themes 
from: 
Workpackage 1 focus groups to adapt the ACD resources and processes. 
Workpackage 2 interviews with service users, people in parental roles, and carers, and staff on expected 
ACD use events. 
Workpackage 2 staff focus groups on ACD implementation.  
 
Quantitative data (Workpackages 2 and 3): 
Primary outcome and secondary outcomes (i-iv) 
 
• 
Primary and secondary outcomes (i-iv) will be analysed using inferential statistics (e.g. regression 
models) to assess differences between participants and controls using the CRIS data (Workpackage 3 
data)  
• 
Pre and Post comparisons of the question asked to research participants about trust in services will be 
undertaken. The statistical test used will depend on the scoring distribution.  
• 
Baseline comparison comparisons on trust in mental health services will be conducted to compare 
differences between service users who complete ACDs and those who do not. 
 
Workpackage 4: Analysis of ACD Content: Coding frameworks developed through previous research will be 
applied to the content of the full ACD sample available within the Trust via both manual records review, 
and automated methods to include topic modelling, measures of textual similarity, and information 
extraction. Output of these reviews will be analysed using descriptive statistics. Differences in content by 
service user race/ethnicity (Black African and African Caribbean heritage or mixed heritage vs all other) will 
be tested for. We will also look at differences in content between different service user groups (i.e. young 
people/older adult/forensic).  
 
 
10. SELECTION OF PARTICIPANTS  
10.1 ELIGIBILITY CRITERIA 
Gender: Participants of any gender.   
Lower age limit: 16 years 
Upper age limit: No upper age limit 
Location: Lambeth, Lewisham, Croydon or Southwark 
Language: Participants who do not speak English, or who feel more comfortable expressing themselves in 
their first language, will be able to participate in the study with the assistance of an NHS interpreter.  
 
10.1.1 INCLUSION CRITERIA 
 

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WP1: Focus Groups  
Service users 
Young people  
a) Aged ≥ 16 
b) Experienced detention under the MHA while in the care of CAMHS  
c) Currently under the care of community mental health services (CAMHS / EI / CMHT)  
Older adults  
a) Experienced detention under the MHA while under services for Older Adults 
b) Currently under the care of older adult community mental health services  
 
Carers / Informal supporters 
a) Aged ≥ 16 years 
b) A relative or friend of a service user who is eligible for the study 
 
Professionals  
a) Professional potentially involved in supporting the completion of ACDs (i.e., community 
mental health team (CMHT) staff, advocates, peer workers) 
b) SLaM professionals potentially involved in referring to ACDs (i.e., inpatient and emergency 
department liaison mental health staff, home treatment, place of safety and street triage 
staff) 
c) Approved mental health professionals (AMHPs) and Section 12 (MHA) approved doctors 
involved in detention.  
d) Ambulance, prison mental health and Emergency Department staff 
e) General Practitioners, including mental health leads, or other primary care professionals 
who care for people with SMI discharged from secondary services 
 
WP 2: Prospective study of ACD completion and use 
 
Service users 
All service users: accepted referral to an ACD facilitator for ACD creation 
 
Young people  
a) Aged ≥ 16  
b) Experienced detention under the MHA while in the care of CAMHS  
c) Currently under the care of community mental health services (CAMHS / EI / CMHT/)  
d) Accepted referral to an ACD facilitator for ACD creation; including participants who decline to complete 
and ACD after referral to an ACD facilitator. 
 
Older adults  
a) Experienced detention under the MHA while under services for Older Adults 
b) Currently under the care of older adult community mental health services 
c) accepted referral to an ACD facilitator for ACD creation 

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General Adult:  
a) Aged ≥ 18 years 
b) Previously detained under the MHA 
c) Under the care of community mental health services (CMHT or EI) 
 
Forensic  
a) Aged ≥ 18 years 
b) Experience detention under the MHA into forensic services 
c) Currently under the care of forensic mental health services  
 
Carers: relative or friend of someone referred to an ACD facilitator 
 
Professionals: SLaM staff involved in the care of a participant with an ACD whose ACD is expected to have 
been consulted because they were: involved in a transfer of care, placed in zoning, referred for a MHA 
assessment or to a home treatment team, attended an Emergency Department or Place of Safety, admitted 
to a psychiatric inpatient unit or imprisoned. 
The interviews conducted with service users and staff after the expected use event will also include 
questions about satisfaction with and perceived value of the process of completing, distributing, accessing, 
honouring, and reviewing an ACD.  
 
10.1.2 EXCLUSION CRITERIA 
Service users 
a) Aged under 16 years 
b) Lacking capacity to provide consent and/or is unwilling to do so 
c) Currently detained under the MHA in psychiatric hospital 
d) Currently under the care of eating disorder services 
 
Carers/informal supporters  
a) Aged under 16 years 
b) Is not a relative or friend of a service user who is eligible for the study 
Professionals 
a) Is not a mental health professional or Section 12 (MHA) approved doctor 
b) Is not a professional involved in supporting the completion of ACDs 
c) Is not a General Practitioner or mental health lead caring for people with SMI discharged 
from secondary services. 
 
10.2 SIZE OF SAMPLE 
WP 1: Focus groups  
This sample size will enable us to capture diverse perspectives that will allow us to adapt ACD resources 
and processes for CAMHS and older adults’ services. We will hold 3-6 focus groups for both CAMHS and 
older adults. These will be specifically focused on the barriers and facilitators for ACDI implementation in 
SLaM.  
 

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1-2 Older Adults service users’ focus groups = 15-20 participants (max 10 per group) 
1-2 CAMHS service users’ focus groups = 15-20 participants (max 10 per group) 
1-2 Older Adults carers / informal supporters’ focus groups = 15-20 participants (max 10 per group) 
1-2 CAMHS carers / informal supporters’ focus groups = 15-20 participants (max 10 per group) 
1-2 CAMHS professionals’ focus groups = 15-20 participants (max 10 per group) 
1-2 older adults professionals' focus groups = 15-20 participants (max 10 per group) 
 
Total = up to 90-120 
 
Work package 2: Prospective study of ACD completion  
The sample size for the numbers of participants allows for estimation of implementation outcomes and the 
potential effectiveness with respect to the outcome of trust in mental health services.  
General adult mental health service users: n=40 
Forensics service users: n=20 
Older adults service users: n=10 
CAMHS users: n=20 
Service users to be interviewed only post expected ACD application: n=15 (from any of general adult, older adult, 
forensic or child and adolescent services.  
Parents/people with parental responsibility for CAMHS service users: n=20 
Carers of adults completing ACDs n=10 
Staff interviews: This will be determined by the eligibility criterion above, i.e. all staff involved in the care of 
a participant with an ACD whose ACD is expected to have been consulted, max n=58 
 
Staff focus groups: up to eight focus groups each with maximum 12 participants max n=96 
 
Total:  289 
 
10.4 SAMPLING TECHNIQUE 
WP1: Purposive sampling will be used with the aim of recruiting all staff types, and service users of Black 
African and Caribbean vs other heritage, of at least cis-male and cis-female genders, of varying ages 
(between 16-25 for CAMHS group). For CAMHS we will aim to include young people looked after by the 
local authority, as well as those who are not. For Older Adults, we will aim to include service users who 
have experience creating other planning documents such as LPAs, and ACPs.  
 
WP 2: we will recruit in order of referrals made, with purposive sampling used if required to achieve our 
sample size for each group of interest. 
 
10.5 RECRUITMENT  
WP 1: Focus Groups  
Professionals:  
Recruitment will take place through presentations to clinical teams, service directors and other services 
within SLaM and consent for contact (c4c) list.  
 

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Service users and carers/informal supporters: 
• 
Presentations to clinical teams, other groups within SLaM including the Patient and Carer Race 
Equity Framework groups for each directorate, recovery colleges and peer support services, service 
user groups, carer groups, relevant voluntary sector organisations. 
• 
Informal coffee mornings/events for service users  
• 
Identification of interested mental health service staff to discuss involvement with service users, 
carers and their clinical colleagues, including service PPI leads, existing research champions or 
professionals with particular interest in the project. 
• 
Flyers, to be distributed throughout participating Trust sites and to groups and organisations listed 
above. 
• 
A webpage (hosted by SLaM) providing study information for service users, informal supporters and 
Trust staff. 
• 
Through the Recovery College 
• 
Social media – X/Twitter, TikTok, Instagram, and a brief YouTube video, to signpost people to the 
webpage. 
• 
Contact with local media including radio, newspapers, and podcasts. 
• 
Presentations at research clubs, including the one hosted by the SLaM Recovery College  
 
A search for eligible participants using the Clinical Records Interactive Search system (CRIS) in collaboration 
with the Maudsley Biomedical Research Centre (BRC), thus study information can be sent to those who 
have provided Consent for Contact (c4c). The Maudsley BRC will provide the research associate and 
research assistants with the details of potentially eligible patients who have provided Consent for Contact 
within the BRC's trusted environment.  
 
The potential participants will be contacted by a member of the research team who has a Letter of Access. 
In cases where the participant is yellow lit, the researcher will contact the patients’ care team to make sure 
it would be an appropriate time to contact the potential participant. If it is not (e.g., due to patient 
hospitalisation, relapse, in crisis, or the individual is not contactable), it will be arranged with the care team 
whether or when to contact them again. If the care team says that the potential participant can be 
contacted, the researcher staff or facilitator clinical research staff member, will contact the potential 
participant via email or post, or the person will be contacted by phone to arrange the provision of the 
Participant Information Sheet depending on the patient’s stated preferences on the consent to contact 
system. Service users currently not living in the community due to hospital admission, incarceration, or 
being out of the country will not be contacted until they are living at the usual address again. Those waiting 
for a Mental Health Act Assessment will also not be contacted. 
 
WP 2: ACD Referral  
Service users referred for ACD creation and their carers/informal supporters: 
Facilitators and the administrator working with facilitators will ask service users referred to them and carers 
attending ACD creation meetings for permission to pass their contact details to the research team. 
 
Professionals involved in the care of a participant with an ACD whose ACD is expected to have been 
consulted: 
Professionals will be identified via review of the records of participating service users who have given their 
consent for their records to be accessed as part of the study. They will be contacted for recruitment via 
their professional email account or workplace telephone or address. 
 

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10.5.1 Participant payment / compensation  
Service users and their carers/informal supporters will be compensated for their time with vouchers or cash 
provided either in person, electronically, or posted, dependent on preference. They will also be reimbursed 
for any travel expenses.  
Voucher prices per service user/carer participant: 
• 
WP1 Focus Groups: £20  
• 
WP2 Interviews: £15 per interview  
10.6 CONSENT  
All participants will provide written consent. For WP1 Focus groups, the research associate or research 
assistants will obtain written consent from all participants. The consent form will be signed and dated by the 
participant before they participate in the study.  
 
For WP2, Consent will be sought to a) Interview participants following ACD referral b) access service users’ 
clinical records and c) contact participants in the event that ACD is or should have been used. The Consent 
Form (CF) will be signed and dated by the participant before they participate in the study. There will be an 
opportunity for potential participants to ask questions. Mental capacity will be confirmed by the facilitator. 
However, it will again be evaluated by researchers during interactions with service users, to ensure capacity 
to consent and understanding of the research process. If researchers are unsure if participants have the 
capacity to consent, they will not progress with the consent process. Instead, they will suggest meeting 
another day and speak to the facilitator who referred the participant, in addition to a member of the care 
team if appropriate. Electronic consent may be taken in some instances e.g. if service users prefer to 
communicate over the phone or remotely using MS Teams. If any phase of the study must take place 
online, consent will be taken through over the phone and/or MS Teams. 
 
 
 
A Participant Information Sheet (PIS) will be provided before consent is taken, ensuring that the participant 
has sufficient time to consider participating or not. The participant will be given the opportunity to ask any 
questions they may have has concerning study participation.  
 
The Research Associate and Research Assistants will confirm participant consent verbally at follow-up if the 
interview is done in person at settings, including outpatient care locations, low secure forensic facilities, 
forensic rehabilitation settings, and participants' homes. Additionally, consent will be confirmed 
electronically via email or audio recording on the phone when setting up a remote follow-up interview. 
 
The process for obtaining participant informed consent will be in accordance with the REC guidance, and 
Good Clinical Practice (GCP), and any other regulatory requirements that might be introduced. The co-
principal investigators, the research associate or research assistants and the participant or other legally 
authorised representative shall both sign and date the CF before the person can participate in the study. 
 
Informed consent will be collected from each participant before they participate in each part of the study. 
One copy of the CF will be kept by the participant, one will be kept by the research team. Should there be 
any subsequent amendment to the final protocol, which might affect a participant’s participation in the 
study, continuing consent will be obtained using an amended CF which will be signed by the participant. 
 
 
 

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11. STUDY PROCEDURES 
11.1 STUDY FLOWCHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
WP1 Stakeholders focus groups for 
older adults’ services and CAMHS 
WP1: Adaptions to facilitator manual/ACD template for use 
in forensics and older adults’ services and CAMHS 
WP1: Resources incorporated into 
SLaM Standard Operating Procedure 
for ACDs 
WP1: Consultation with 
forensics PPI group and staff 
WP 2: Facilitators 
start taking referrals  
WP2: Service users referred to ACD facilitator 
WP2 Recruited: Baseline data collection 
Not recruited 
WP2: Completes ACD: Post ACD 
completion data collection or 
recruitment and data collection if 
not recruited at baseline, total n=90 
WP2 Does not complete 
ACD: Noncompletion data 
collection 
WP2 Event when ACD 
use expected: Post 
event data collection 
No event when 
ACD use expected 
Completes ACD 
Does not complete 
ACD 
WP3 and 4 BRC CRIS oversight committee 
reviewed studies: Medical Record review 
for primary outcomes and secondary 
outcomes i-iv with controls (WP3) and 
ACD content (WP4) 
ACD facilitator informed of event and 
arranges ACD review: Recruited (n=15) 

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11.2 METHODS 
Work package 1: Focus Groups 
Focus groups with staff, carers, and service users will be led by the research team, where a brief 
presentation will explain: 
• 
What is an ACD 
• 
Process of completing ACDs, and which stakeholders (professionals, staff and carers/informal 
supporters) are involved 
• 
The Trust project to roll out the use of ACDs, why it is doing this and why this way 
 
A facilitated discussion will follow, where participants will view and discuss the current ACD template 
developed through AdStAC. Questions will cover completing, accessing, honouring and reviewing advance 
statements.  
 
Data collection: The focus groups will be recorded and transcribed.  
Analysis: Data will be analysed using framework analysis.36  
Output: Results of the focus groups will be discussed with the respective advisory groups and the SLaM 
ACD implementation project working group and used to inform the SLaM SOP for the respective service.  
 
Work package 2: Prospective study of ACD completion.  
 
The measures and other data to be collected at each time point, plus the sources of data, are summarised 
in Table 1. 
 
 
 
 
 

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Table 1. ACD creation and use data collection: measures, time points and sources:  
 
Baseline 
Post ACD 
completion 
Post event when 
ACD use expected 
End of study 
Demographic 
& clinical data;  
Service users 
 
 
 
Trust in 
services  
Service users 
Service 
users 
Service users 
 
ACD 
completion log 
 
 
EPJS notes 
 
 
Satisfaction 
with and 
perceived 
value of ACD 
 
Service 
users’ 
interviews 
 
 
 
Interviews with: 
Service users 
 
Carers/informal 
supporters involved 
in completion 
 
SLaM Staff involved 
in completion and/or 
event 
 
Reasons for 
completion 
and non-
completion*  
 
Interviews 
with service 
users and 
facilitators 
 
 
 
Distribution of 
hard & 
electronic 
copies  
 
ACD 
facilitator 
Clinical 
notes 
 
 
Service user 
interview 
 
ACD access 
and honouring 
 
 
Service users 
  
SLaM Staff involved 
in the event 
Carers/informal 
supporters involved 
in completion 
(interview) 
 
 
ACD review 
frequency, and 
revisions   
 
 
Facilitator notes on 
ePJS/interviews with 
service users 
 
Staff feedback  
 
 
 
SLaM staff involved in 
completion and/or use 
including facilitators 
Primary 
outcome and 
secondary 
outcomes i-iv 
 
 
 
Electronic record review 
ACD content 
 
 
 
Electronic record review 
 

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*Non-completion will be determined as having occurred at 3 months post baseline or if the participating service user decides against 
completion before this. 
WP3 Retrospective controlled study of ACD creation and its relationship to service use and routinely 
collected outcomes 
To maximise data collection on access to, honouring and review of ACDs a variable follow-up period will be 
used. Follow-up duration will depend on when the participant is recruited. We will collect all follow-up data 
leaving 6 months for analysis and dissemination at the end of the study period. 
 
11.3 SCHEDULE OF PROCEDURES  
Gantt Chart of schedule of procedures and see Table 2.  
 
11.4 WITHDRAWAL  
Participants may be withdrawn from the study either at their own request or at the discretion of the Co-
Principal investigators. The participants will be made aware that this will not affect their future care. 
 
Participants will be made aware (via the PIS and CF) that should they wish to withdraw the data collected 
once it has been analysed, their anonymised data may not be erased in accordance with King College 
London’s  Research Privacy Notice and information given in the PIS and may still be used in the final analysis. 
 
12. ETHICAL AND REGULATORY CONSIDERATIONS  
12.1 ASSESSMENT AND MANAGEMENT OF RISK  
Sensitive nature of this research 
This project includes people from vulnerable groups who have a SMI diagnosis and have also been detained 
under the MHA. Due to this, the research will need to be accomplished with skill and sensitivity. At all 
times, we will use listening and non-judgemental techniques to create an open yet confidential safe space 
for people to freely discuss their views and recommendations.  
 
Experience of research leads and research team 
The study will be carried out by an experienced research team who have the appropriate clinical research 
expertise and experience with working with vulnerable groups. The Co-Principal Investigators (Prof Claire 
Henderson and Dr Shubulade Smith) are the co-leads for this study. Both are experienced clinicians, 
academics and have successfully run and completed projects that have involved co-production, evaluation 
and working with marginalised and vulnerable groups.  Prof Henderson also has topic expertise having led 
the first randomised controlled trial of joint crisis plans, a type of ACD33. She also collaborated on the 
multisite RCT of Joint Crisis Plans13 and led a consensus study on the implementation of Mental Health 
Advance Directives in the US Veterans Health Administration32.. Prof Henderson and Dr Smith co-led the 
AdStAC project. 
 
WP1 
The focus groups are not expected to raise any significant ethical issues; however, they may cause distress 
or make participants upset. This is due to the focus groups being centred around opinions on ACDs.  
Participants who are service users or carers/informal supporters may find discussing their experiences of 
mental healthcare or mental illness distressing or upsetting. During the focus groups, should participants 
become upset, distressed or wish to leave, their needs will be accommodated. Should they wish to leave 

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the focus group/discussion. they can do this for as long as needed. They will have the option to withdraw or 
re-join the discussion depending on their preference. The Co-Principal investigators are both experienced 
clinicians who have experience working with marginalised and vulnerable groups. The research team are 
trained in, and have experience of, working with vulnerable people and facilitating sensitive mental health 
discussions.   
 
During discussions participants may disclose past criminal or other activity on the part of staff that indicates 
risk to participants or others including thoughts or actions related to self-harm. If this happens, the 
research team member will inform the participant that they will have to inform the co-principal 
investigators of the disclosure. From here, the co-principal investigators will take action based on Trust 
safeguarding policy. 
 
It is not anticipated that participants will feel marginalised during the focus groups, as recommendations 
from our Staff and Lived Experience Advisory groups will be obtained to inform and guide the research 
team on using an appreciative and open approach where all participants’ views are valued. Participants will 
be made aware that the focus groups will be recorded, and their consent for this will be obtained both 
before and during the focus group.  
 
Consent will be obtained in written format before the focus groups, and again in verbal format on the day 
of the focus groups. 
 
 
WP2 
As ACD creation and use is to be led by SLaM clinicians employed by the Trust to implement ACD use per a 
Trust SOP, the ACD facilitators and their supervisor will be responsible for the wellbeing of service users 
during the process of ACD creation. This section will therefore cover the research data collection processes 
only. 
 
Service users and staff will both be informed that participation is entirely voluntary, and that there is an 
option to withdraw at any stage of the study, although the research team may contact participants to 
explore reasons for non-completion.  
 
Follow-up 
Risks and burdens for participating service users 
There are two potential follow up points: in addition to post ACD completion, we propose to ask service 
users whether their ACD was used and honoured as soon as practicable and appropriate after an event 
during which the ACD should be used i.e. contact with acute services. 
 
We are aware that after admission/detention under the MHA it may take time for service users to discuss 
this especially if they had a negative experience, or their wishes in the ACD were not honoured. We will not 
interview service users who have lost capacity to participate in the research and will wait until this has been 
regained following discussion with treating staff. We aim to discuss with the Lived Experience Advisory 
Groups and ways in which this process can be approached, in order to gather sufficient and useful data 
from service users regarding feasibility of the process of completing ACDs, if their ACD was not honoured. 
We aim to do this without over-burdening service users at a difficult time. If service users do not wish to 
meet following an event during which the ACD should be used, we will instead wait until the ACD review to 
invite them to an interview about the event. 
 

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Service users will also have the option of having a carer/supporter or a mental health professional support 
them by sitting in on any interview they take part in.  
 
Potential burden on mental health professionals and carers/informal supporters 
To minimise burden on carers/informal supporters and staff we will conduct one follow up interview to 
gain their perspectives on the feasibility, acceptability and appropriateness of the process of completion, 
and on any experience they have had of accessing and using the ACD. Other follow up data to be collected 
will only occur when record review indicates an event which should entail access to the ACD. 
 
Personal information / data confidentiality 
Participants’ identifiable details will be pseudonymised during the study, and then anonymised once the 
study has completed, and will be stored securely on the King’s College London SharePoint study site on 
computers at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London, and on 
laptops administered by the institution. All audio files gained from each part of the study will use either an 
encrypted recording device (face-to-face) or Microsoft Teams (online) and will be saved to the study folder 
on the King’s College SharePoint study site , to which only the research team has access. Transcriptions of 
recordings will be done by a transcription service that has an existing data sharing agreement with King’s 
College London. Once the research team have approved the transcription, the audio files will be deleted. 
We will abide by the Data Protection Act and the NHS Code of Confidentiality.    
 
Only the research team will have access to the study documentation and final data set, which will be 
retained for 10 years after the study has completed.  
 
Inclusivity 
This study will aim to be as inclusive as possible. We will be guided by our Lived Experience Advisory Groups 
(Public and Patient Involvement) and who will advise on appropriate approaches to every part of the study, 
where all participants views will be valued and acknowledged throughout. The LEAG chairs will meet 
between group meetings to support each other and confer about advice to be given to the research team. 
 
 Individual participant medical information obtained as a result of this study are considered confidential and 
disclosure to third parties is prohibited with the exceptions noted. Medical information may be given to the 
participant’s medical team and all appropriate medical personnel responsible for the participant’s welfare 
 
If information is disclosed during the study that could pose a risk of harm to the participant or others, the 
researcher will discuss this with the Co-Principal Investigators and where appropriate report according to 
Trust safeguarding procedures. 
12.2 ADVERSE EVENTS 
We will actively collect information at each assessment of the study about adverse events and serious 
adverse events. These will be recorded in the standard way. There are standard operating procedures for 
reporting serious adverse events to the Project Steering Committee (PSC), sponsor, funder, and NHS 
Research Ethics Committee (REC). 
 
RECORDING AND REPORTING ADVERSE EVENTS 
Recording adverse events 
All adverse events will be recorded in the medical records in the first instance. 

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Procedures for recording adverse events will be reviewed by the research team, and ethics committee 
approval sought for any proposed changes before the beginning of the pre-pilot study.  
Definitions 
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence in a patient or participant, which does 
not necessarily have a causal relationship with the intervention involved.  
Serious Adverse Event 
(SAE). 
Any adverse event that: 
• 
results in death, 
• 
is life-threatening*, 
• 
requires 
hospitalisation 
or 
prolongation 
of 
existing 
hospitalisation**  
• 
results in persistent or significant disability or incapacity 
*     A life- threatening event, this refers to an event in which the participant was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have caused death if 
it were more severe. 
** Hospitalisation is defined as an acute in-patient admission, regardless of length of stay. 
Hospitalisation for pre-existing, non-mental health conditions, including elective procedures, do not 
constitute an SAE. 
 
Assessments of Adverse Events 
Each adverse event will be assessed for severity, causality, seriousness and expectedness as described 
below: 
Severity  
Category 
Definition 
Mild 
The adverse event does not interfere with the participant’s daily routine, and 
does not require further intervention; it causes slight discomfort 
Moderate 
The adverse event interferes with some aspects of the participant’s routine, or 
requires further intervention, but is not damaging to health; it causes 
moderate discomfort 
Severe 
The adverse event results in alteration, discomfort or disability which is clearly 
damaging to health 
 

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Causality 
The assessment of relationship of adverse events to the intervention is a clinical decision based on all 
available information at the time of the completion of the case report form.   
The differentiated causality assessments will be captured in the study specific AE database and the SAE 
form.  
The following categories will be used to define the causality of the adverse event: 
Category 
Definition 
Definitely: 
There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. 
Probably: 
There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely 
Possibly 
There is some evidence to suggest a causal relationship (e.g. the event 
occurred within a reasonable time after administration of the study 
intervention). However, the influence of other factors may have contributed 
to the event (e.g. the participant’s clinical condition, other concomitant 
events). 
Unlikely 
There is little evidence to suggest there is a causal relationship (e.g. the event 
did not occur within a reasonable time after administration of the study 
intervention). There is another reasonable explanation for the event (e.g. the 
participant’s clinical condition, other concomitant treatments). 
Not related 
There is no evidence of any causal relationship. 
Not Assessable 
Unable to assess on information available. 
 
 
Expectedness 
There are no anticipated expected adverse events from the study processes. However, due to the nature of 
the participant group – people with severe mental illness, the following serious adverse events are not 
considered to be unexpected per se: admission to mental health acute care; attempted suicide or suicide. 
Harm to others perpetrated by the participant does constitute an unexpected adverse event.  

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Procedures for recording and reporting Serious Adverse Events 
All serious adverse events will be recorded in the medical records and the CRF. SAEs will also be recorded in 
an SAE database throughout the study, allowing a line-listing of SAEs to be easily extracted for review. 
All SAEs (except those specified below as not requiring reporting to the Sponsor) must be recorded on a 
serious adverse event (SAE) form. The Chief or Principal Investigator will respond to any SAE queries raised 
by the sponsor as soon as possible.  
Where the event is unexpected and thought to be related to the intervention, this must be reported by the 
Investigator to the Sponsor and Health Research Authority within 15 days. 
 
Reporting lines for SAEs 
The study researcher will screen records for AEs for participants during follow up. A report of the 
circumstances of the AE, and the informant’s view on causation and severity will be sought by the study 
researcher, who will then contact the study team without delay. The study Co-PI Henderson (a clinician) will 
complete an SAE form and make final assessments of severity, causality and expectedness. She will then 
disseminate any necessary safety information to the rest of the research team. 
SAEs will be reported to the sponsor until the end of the study. 
  
Serious Adverse Events that do not require reporting  
SAEs involving a psychiatric hospital admission for a participant which occur in the context of a relapse of an 
existing mental health condition and are assessed as unlikely to be causally related to the study will not be 
reported to the Sponsor, unless unusual in frequency or severity. Readmissions to hospital are likely to occur 
for a number of participants, given the study participant group – people with severe mental illness. These 
events will however be recorded in the medical records, CRF and the study AE database.  
Additionally, only SAEs which require reporting to the REC and HRA need be reported to the sponsor. 
No other notifiable events for immediate reporting to the sponsor have been identified for this study. 
Reporting Urgent Safety Measures  
If any urgent safety measures are taken the PI shall immediately and, in any event, no later than 3 days from 
the date the measures are taken, give written notice to the relevant REC and Sponsor of the measures taken 
and the circumstances giving rise to those measures. 
NOTIFICATION OF REPORTABLE PROTOCOL VIOLATIONS  
A reportable protocol violation is a breach which is likely to effect to a significant degree:  
(a) the safety or physical or mental integrity of the participants of the study; or 
(b) the scientific value of the study. 
The sponsor will be notified immediately of any case where the above definition applies during the study.  
12.3 ETHICS REVIEW AND COMPLIANCE 

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The study shall not commence until the study protocol, information sheets and consent forms have been reviewed 
and approved from a Research Ethics Committee. 
12.4 FUNDING  
The project has received funding from the Maudsley Charity. 
12.5 PUBLIC & PATIENT INVOLVEMENT  
The study will involve extensive patient and public involvement (PPI) through the Lived Experience Advisory 
Groups. In addition to this, Mr Steve Gilbert who will chair the Lived Experience advisory group is a co-
applicant of this project, as well as being a member of the Staff advisory group.   
 
Initial involvement: 
The consent forms and participant information sheets given to participants at different stages of the study, 
to ensure that both forms/sheets are participant friendly will be reviewed by the Lived Experience Advisory 
Group chairs.  
 
Planned on-going involvement: 
The Lived Experience Advisory Groups will consist of people who are both service users with experience of 
detention under the MHA in the respective service (general adult, forensics, older adults and CAMHS) and 
carers/informal supporters of such service users. They will meet every 2-3 months to ensure the study is 
conducted sensitively and has a people-centred and culturally sensitive approach, in addition to: 
• 
Reviewing and inputting advice on initial results from interviews of ACD holders 
• 
Advising on dissemination of results within and beyond the Trust. 
The chairs of each Lived Experience Advisory Group will confer between meetings to share learnings and 
support each other. We will hold a thank you and feedback session for all LEAG members and chairs at the 
study midpoint and at the end.  
12.6 PROTOCOL COMPLIANCE  
This study will be conducted in accordance with this protocol. Accidental protocol deviations may occur at 
any time. Accidental protocol deviations will be adequately documented on the relevant forms and 
reported to the Co-Principal Investigators, and the Sponsor immediately. Any amendments or accidental 
protocol deviations will also be reported to the Research and Ethics committee.  
 
13. DATA PROTECTION AND SERVICE USER CONFIDENTIALITY 
 
All study staff and investigators will comply with the principles of the Data Protection Act (2018) in protecting 
the rights of study participants with regards to the collection, storage, processing, and disclosure of personal 
information and will uphold the Act’s/Regulations core principles. 
A Data Protection Agreement between the Institute of Psychiatry, Psychology and Neuroscience, King’s 
College London and South London and Maudsley NHS Foundation Trust has been signed by the Co-Principal 
Investigators. 
 
Each participant will be assigned a study identity number, for use in obtaining contact details and linking 
the datasets, i.e., personal information (dataset 1) and research data (dataset 2). 
 

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Personal data, research data and the linking identity number will be stored in the same physical location – a 
secure locker in the IoPPN, King’s College London building, which the research team only have access to. 
When stored electronically, this will include encrypted digital files within the KCL study SharePoint site 
which the research team only have access to. Personal information will be stored separately to research 
data and will be kept secure and maintained.  
 
Personal data will be stored for 6 months after the project end date, so that the Co-Principal Investigators 
may provide participants with a summary of the research and follow up.  
 
Data generated as a result of this study will be available for inspection on request by the participating 
clinicians, King’s College London representatives, SLaM representatives, the REC, local R&D Departments 
and the regulatory authorities. 
14. INDEMNITY  
 
Mandatory text: Insurance and indemnity for trial participants and trial staff is covered within the NHS 
Indemnity Arrangements for clinical negligence claims in the NHS, issued under cover of HSG (96)48. There 
are no special compensation arrangements, but trial participants may have recourse through the NHS 
complaints procedures. 
14.1 ACCESS TO THE FINAL DATASET  
The Co-Principal Investigators (Dr Claire Henderson and Dr Shubulade Smith, Research Associate (Mariam 
Namasaba) and research assistants (Jonathan Simpson and Riddhi Daryanani) will have access to the final 
dataset. The dataset will be pseudonymised. At the end of the study all data will be anonymised by 
destroying the dataset containing participant contact details.  
15. DISSEMINATION POLICY 
The data custodian will be the Co-Principal Investigators on behalf of the Institute of Psychiatry, Psychology 
and Neuroscience, King’s College London and SLaM. The findings will be disseminated within SLaM, in peer 
reviewed scientific journals, internal report, conference presentations, publication on the SLaM website 
and other publications. We will invite participants and other SLaM staff, service users and carers to a 
knowledge mobilisation event to feed back the findings and present the implementation resource. 
 
15.1 Authorship eligibility guidelines and any intended use of professional writers 
We will follow the ICMJE authorship guidelines. We do not intend to use professional writers. 
 
 
 
16. SIGNATURES 
 
__
__________Claire Henderson_______________ 25/09/2025___________________ 
Chief Investigator 
Date 
Print name 

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______________________________________ 
_________________________ 
Statistician (if applicable) 
Date 
Print name 
 
 
 
 

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17. REFERENCES  
1 
Department of Health & Social Care. Government commits to reform the Mental Health Act. GovUK 
2018. 
2 
Department of Health & Social Care. Modernising the Mental Health Act: Increasing Choice, 
Reducing Compulsion. England: Department of Health & Social Care; 2018. 
3 
de Jong MH, Kamperman AM, Oorschot M, Priebe S, Bramer W, van de Sande R, et al. Interventions 
to reduce compulsory psychiatric admissions: A systematic review and meta-analysis. JAMA Psychiatry 
2016;73:657–64. 
4 
Molyneaux E, Turner A, Candy B, Landau S, Johnson S, Lloyd-Evans B. Crisis-planning interventions 
for people with psychotic illness or bipolar disorder: systematic review and meta-analyses. BJPsych Open 
2019;5:e53. https://doi.org/10.1192/bjo.2019.28. 
5 
Owen GS, Gergel T, Stephenson LA, Hussain O, Rifkin L, Keene AR. Advance decision-making in 
mental health – Suggestions for legal reform in England and Wales. Int J Law Psychiatry 2019;64:162–77. 
6 
Swanson J, Swartz M, Ferron J, Elbogen E, Van Dorn R. Psychiatric advance directives among public 
mental health consumers in five U.S. cities: prevalence, demand, and correlates. J Am Acad Psychiatry Law 
2006;34:43–57. 
7 
Morriss R, Mudigonda M, Bartlett P, Chopra A, Jones S. National survey and analysis of barriers to 
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