SchizophreniaD-FORESTNCT05074732
Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.
An observational study of Schizophrenia and Forensic Psychiatry, run by Health Service Executive, Ireland at 1 site in Ireland.
Trial summary
The DUNDRUM Forensic Redevelopment Evaluation study (D-FOREST study) is a multi-site comprehensive evaluation of a complete National Forensic Mental Health Service. The study will have a prospective, observational, longitudinal design which will permit the evaluation of benefit over time for individual patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Forensic Psychiatry, Outcome Measure
- How many people
- 350 participants
- Where
- 1 siteIreland
- Study dates
- 1 Dec 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The NFMHS Ireland provides secure forensic mental health services for adult men and women, who require care and treatment in conditions of therapeutic security. All patients are over 18 years. The majority of patients will have a major mental illness, most commonly treatment resistant schizophrenia, with high rates of polysubstance misuse, personality co-morbidity and physical health issues such as obesity and type II diabetes. All patients are deemed to pose a serious risk of violence towards others. All patients are detained under mental health legislation, with over 40% having been found not guilty by reason of insanity (not criminally responsible due to illness) of a serious offence.
Who may be able to join
- Admitted to the National Forensic Mental Health Service (NFMHS) Ireland after 1st December 2019 until 7 years after the transfer of the National Service to the newly developed complete National Forensic Service at Portrane, North Dublin, Ireland.
Who cannot join
- This study comprises a complete cohort of admissions to the NFMHS. All adult patients admitted during the time period will be included in the study, regardless of their length of stay.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
National Forensic Mental Health Service, Central Mental Hospital
Dublin, D14 W0V6
Mary Davoren, M.D., 0035312157401, davorem@tcd.ie
About this study
The DUNDRUM Forensic Redevelopment Evaluation study (D-FOREST study) is a multi-site comprehensive evaluation of a complete National Forensic Mental Health Service. The study will have a prospective, observational, longitudinal design which will permit the evaluation of benefit over time for individual patients, groups of patients and the evaluation of the benefit in terms of service based outcomes of the redevelopment of a complete National Forensic Mental Health Service e.g. effects on waiting list times, length of stay. The study will systematically evaluate multiple domains of recovery in a complete National Forensic Service, including patients' physical health, mental health, offending behaviours and social and occupational functioning.
Read the detailed description
The DUNDRUM Forensic Redevelopment Evaluation Study (D-FOREST).
Forensic Mental Health Services have a dual role, to treat mental disorder and reduce violent recidivism. Forensic mental health services are low volume, high cost services and therefore it is vital to conduct robust outcome measure studies to demonstrate benefit and effectiveness. D-FOREST is a study comprising the evaluation of a complete national forensic mental health service at a time of significant change, that of the re-development of Ireland's National Forensic Mental Health Service from a 19th century building to a complete national service in North Dublin.
We hypothesise that the redevelopment of the campus from Dundrum Hospital to a new 170-bed hospital in Portrane will demonstrate improvements in two main areas, firstly service wide improvements and secondly patient benefit related improvements.
We hypothesise that the development of the new campus at Portrane will lead to reduced time on the waiting list for admission and reduced length of stay in the hospital as well as sustainable rates of admissions and discharges maintained over the five year period of this study.
We anticipate that the newly expanded hospital will be able to facilitate the admission of patients with higher security needs from the prison settings, and therefore there may be a rise in the security needs profile of the group, while urgency of need for admission on the waiting list will decrease.
We anticipate that patient engagement with group and individual therapy will improve with greater access to therapists as the staff number will expand and therefore measures of therapeutic programme completion and recovery and measures of risk in a broad sense should improve across the patient group. We also anticipate finding improved measures of patient ratings on environmental measures such as ward atmosphere on moving to the new campus.
Repeated measures in the area of physical health, mental health and violence risk and forensic recovery will be taken, at baseline (time of admission to the service) as well as at six-monthly intervals throughout the patients admission journey. These main areas will include structured interview measures of psychopathology e.g. SCID, PANSS, clinician rated measures violence and self-harm risk assessment instruments e.g. HCR-20, SRAMM, and measures of therapeutic programme completion and recovery (DUNDRUM-3 and DUNDRUM-4 scales) as well as overall functioning MIRECC GAF. Physical health measures will include measures of BMI, frailty and sedentary behaviours.
Other measures including ward atmosphere scales ESSENCES and measures of quality of life (WHO-QUOL) will also be offered to the patient group to complete.
A combination of both self-rated and interview based measures to engage patients, and clinician rated measures will be used. This is due to the high rates of treatment resistant psychoses in forensic hospital settings, and therefore to rely on self-rated or interview rated measures along would mean that many of the most unwell patients may not be able or willing to engage. Thus utilising this combination approach ensures that any bias in the results and outcomes observed will be minimised.
Statistical analysis plan:
Statistical methods for primary and secondary outcomes. Time intervals (time in days to admission from waiting list, length of stay) will be measured by median and 95% confidence interval using Kaplan Meyer and Cox regression analyses. Survival analysis will be used to assess factors affecting length of stay.
Patient level measures will be expressed as changes from baseline (typically from the time of admission) using ANCOVA, MANOVA or logistic regression as appropriate with correction for the effects of static baseline variables such as demographic characteristics (e.g. age, sex and ethnicity) or diagnosis including multi-axial diagnoses, neurocognitive function, and legal status. Measures of effect size will be used alongside measures of statistical significance for primary and secondary outcomes. At the individual level measures of reliable and clinically meaningful change will be calculated and proportions achieving this will be expressed with 95% confidence intervals.
Analysis of repeated measures will be used to compare mean scores on measures of physical health, risk of violence, therapeutic programme completion, recovery and overall functioning, at time points in advance of the move of the NFMHS to the new Portrane Hospital Campus and for five years after the move.
Lagged causal model analysis will be used to assess the existence and significance of potential directed relationships between the baseline measures of symptomatology of schizophrenia and violence risk and final outcome namely length of stay.
The lagged causal model approach will be used also to examine the relationship between amount of 'treatment' received and change in outcome measures.
- Conditions
- Schizophrenia, Forensic Psychiatry, Outcome Measure, Violence, Personality Disorders, Recovery
- Medical subject headings
- Schizophrenia, Personality Disorders, Obesity, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Frailty, Psychotic Disorders, Schizophrenia, Treatment-Resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the secure forensic hospital setting.
Length of stay in the secure forensic hospital setting
Measured: 5 years
Recovery from psychosis
Reduction in psychotic symptoms and stabilisation of psychosis
Measured: 5 years
Reduction in violence
Reduction in violent behaviours, violent incidents and pro-violent attitudes
Measured: 5 years
Secondary outcomes (2)
Reducing BMI and sedentary behaviours
Improving physical health measures namely reduction in obesity and reduction in sedentary behaviours
Measured: 5 years
Improving overall functioning level
Improving scores on GAF MIRECC for measure of overall functioning
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Dec 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Service Executive, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mary Davoren, Health Service Executive, Ireland
- Investigators
- Mary Davoren, M.D., Principal investigator, Trinity College University of Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074732
- Sponsor's protocol ID
- HSEIreland
- Acronym
- D-FOREST
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the uniquely sensitive nature of data from secure forensic mental health services, aggregate anonymised data only will be presented and published. Any access to aggregated anonymised datasets will be considered by request on a case-by-case basis only.
Publications
Davoren M, Abidin Z, Naughton L, Gibbons O, Nulty A, Wright B, Kennedy HG. Prospective study of factors influencing conditional discharge from a forensic hospital: the DUNDRUM-3 programme completion and DUNDRUM-4 recovery structured professional judgement instruments and risk. BMC Psychiatry. 2013 Jul 9;13:185. doi: 10.1186/1471-244X-13-185.
PubMed 23837697Davoren M, O'Dwyer S, Abidin Z, Naughton L, Gibbons O, Doyle E, McDonnell K, Monks S, Kennedy HG. Prospective in-patient cohort study of moves between levels of therapeutic security: the DUNDRUM-1 triage security, DUNDRUM-3 programme completion and DUNDRUM-4 recovery scales and the HCR-20. BMC Psychiatry. 2012 Jul 13;12:80. doi: 10.1186/1471-244X-12-80.
PubMed 22794187Donnelly V, Lynch A, Devlin C, Naughten L, Gibbons O, Mohan D, Kennedy HG. Therapeutic alliance in forensic mental health: coercion, consent and recovery. Ir J Psychol Med. 2011 Mar;28(1):21-28. doi: 10.1017/S0790966700011861.
PubMed 30199989Davoren M, Fitzpatrick M, Caddow F, Caddow M, O'Neill C, O'Neill H, Kennedy HG. Older men and older women remand prisoners: mental illness, physical illness, offending patterns and needs. Int Psychogeriatr. 2015 May;27(5):747-55. doi: 10.1017/S1041610214002348. Epub 2014 Nov 27.
PubMed 25428523Donnelly V, Lynch A, Mohan D, Kennedy HG. Working alliance, interpersonal trust and perceived coercion in mental health review hearings. Int J Ment Health Syst. 2011 Nov 10;5(1):29. doi: 10.1186/1752-4458-5-29.
PubMed 22074788Ijaz A, Papaconstantinou A, O'Neill H, Kennedy HG. The Suicide Risk Assessment and Management Manual (S-RAMM) Validation Study 1. Ir J Psychol Med. 2009 Jun;26(2):54-58. doi: 10.1017/S0790966700000215.
PubMed 30282262Flynn G, O'Neill C, McInerney C, Kennedy HG. The DUNDRUM-1 structured professional judgment for triage to appropriate levels of therapeutic security: retrospective-cohort validation study. BMC Psychiatry. 2011 Mar 16;11:43. doi: 10.1186/1471-244X-11-43.
PubMed 21410967Freestone M, Bull D, Brown R, Boast N, Blazey F, Gilluley P. Triage, decision-making and follow-up of patients referred to a UK forensic service: validation of the DUNDRUM toolkit. BMC Psychiatry. 2015 Oct 7;15:239. doi: 10.1186/s12888-015-0620-9.
PubMed 26446536Kennedy H, O'Neill C, Flynn G, Gill P, Davoren M. The DUNDRUM toolkit draft V1. 0.30. Dublin: Trinity College Dublin; 2016.
Kennedy, H. (2021). Models of care in forensic psychiatry. BJPsych Advances, 1-14. doi:10.1192/bja.2021.34
Williams HK, Senanayke M, Ross CC, Bates R, Davoren M. Security needs among patients referred for high secure care in Broadmoor Hospital England. BJPsych Open. 2020 Jun 2;6(4):e55. doi: 10.1192/bjo.2020.35.
PubMed 32482202Kennedy HG, Mullaney R, McKenna P, Thompson J, Timmons D, Gill P, O'Sullivan OP, Braham P, Duffy D, Kearns A, Linehan S, Mohan D, Monks S, McLoughlin L, O'Connell P, O'Neill C, Wright B, O'Reilly K, Davoren M. A tool to evaluate proportionality and necessity in the use of restrictive practices in forensic mental health settings: the DRILL tool (Dundrum restriction, intrusion and liberty ladders). BMC Psychiatry. 2020 Oct 23;20(1):515. doi: 10.1186/s12888-020-02912-6.
PubMed 33097036Basrak N, Mulcrone N, Sharifuddin S, Ghumman Z, Bechan N, Mohamed E, Murray M, Rajendran H, Gunnigle S, Nolan M, Quane T, Terao M, Hoare T, Kirrane K, Kennedy HG, Davoren M. Risk of adverse outcome of COVID-19 among patients in secure psychiatric services: observational cohort study. BJPsych Open. 2021 Jan 11;7(1):e31. doi: 10.1192/bjo.2020.169.
PubMed 33427191Davoren M, Byrne O, O'Connell P, O'Neill H, O'Reilly K, Kennedy HG. Factors affecting length of stay in forensic hospital setting: need for therapeutic security and course of admission. BMC Psychiatry. 2015 Nov 23;15:301. doi: 10.1186/s12888-015-0686-4.
PubMed 26597630Abidin Z, Davoren M, Naughton L, Gibbons O, Nulty A, Kennedy HG. Susceptibility (risk and protective) factors for in-patient violence and self-harm: prospective study of structured professional judgement instruments START and SAPROF, DUNDRUM-3 and DUNDRUM-4 in forensic mental health services. BMC Psychiatry. 2013 Jul 27;13:197. doi: 10.1186/1471-244X-13-197.
PubMed 23890106
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.
- ClinicalTrials.gov ID
- NCT05074732
- Acronym / sponsor ID
- D-FOREST / HSEIreland
- Conditions
- Schizophrenia, Forensic Psychiatry, Outcome Measure, Violence, Personality Disorders, Recovery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Health Service Executive, IrelandUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DUNDRUM Forensic Redevelopment Evaluation study (D-FOREST study) is a multi-site comprehensive evaluation of a complete National Forensic Mental Health Service. The study will have a prospective, observational, longitudinal design which will permit the evaluation of benefit over time for individual patients, groups of patients and the evaluation of the benefit in terms of service based outcomes of the redevelopment of a complete National Forensic Mental Health Service e.g. effects on waiting list times, length of stay. The study will systematically evaluate multiple domains of recovery in a complete National Forensic Service, including patients' physical health, mental health, offending behaviours and social and occupational functioning.
Detailed description
The DUNDRUM Forensic Redevelopment Evaluation Study (D-FOREST).
Forensic Mental Health Services have a dual role, to treat mental disorder and reduce violent recidivism. Forensic mental health services are low volume, high cost services and therefore it is vital to conduct robust outcome measure studies to demonstrate benefit and effectiveness. D-FOREST is a study comprising the evaluation of a complete national forensic mental health service at a time of significant change, that of the re-development of Ireland's National Forensic Mental Health Service from a 19th century building to a complete national service in North Dublin.
We hypothesise that the redevelopment of the campus from Dundrum Hospital to a new 170-bed hospital in Portrane will demonstrate improvements in two main areas, firstly service wide improvements and secondly patient benefit related improvements.
We hypothesise that the development of the new campus at Portrane will lead to reduced time on the waiting list for admission and reduced length of stay in the hospital as well as sustainable rates of admissions and discharges maintained over the five year period of this study.
We anticipate that the newly expanded hospital will be able to facilitate the admission of patients with higher security needs from the prison settings, and therefore there may be a rise in the security needs profile of the group, while urgency of need for admission on the waiting list will decrease.
We anticipate that patient engagement with group and individual therapy will improve with greater access to therapists as the staff number will expand and therefore measures of therapeutic programme completion and recovery and measures of risk in a broad sense should improve across the patient group. We also anticipate finding improved measures of patient ratings on environmental measures such as ward atmosphere on moving to the new campus.
Repeated measures in the area of physical health, mental health and violence risk and forensic recovery will be taken, at baseline (time of admission to the service) as well as at six-monthly intervals throughout the patients admission journey. These main areas will include structured interview measures of psychopathology e.g. SCID, PANSS, clinician rated measures violence and self-harm risk assessment instruments e.g. HCR-20, SRAMM, and measures of therapeutic programme completion and recovery (DUNDRUM-3 and DUNDRUM-4 scales) as well as overall functioning MIRECC GAF. Physical health measures will include measures of BMI, frailty and sedentary behaviours.
Other measures including ward atmosphere scales ESSENCES and measures of quality of life (WHO-QUOL) will also be offered to the patient group to complete.
A combination of both self-rated and interview based measures to engage patients, and clinician rated measures will be used. This is due to the high rates of treatment resistant psychoses in forensic hospital settings, and therefore to rely on self-rated or interview rated measures along would mean that many of the most unwell patients may not be able or willing to engage. Thus utilising this combination approach ensures that any bias in the results and outcomes observed will be minimised.
Statistical analysis plan:
Statistical methods for primary and secondary outcomes. Time intervals (time in days to admission from waiting list, length of stay) will be measured by median and 95% confidence interval using Kaplan Meyer and Cox regression analyses. Survival analysis will be used to assess factors affecting length of stay.
Patient level measures will be expressed as changes from baseline (typically from the time of admission) using ANCOVA, MANOVA or logistic regression as appropriate with correction for the effects of static baseline variables such as demographic characteristics (e.g. age, sex and ethnicity) or diagnosis including multi-axial diagnoses, neurocognitive function, and legal status. Measures of effect size will be used alongside measures of statistical significance for primary and secondary outcomes. At the individual level measures of reliable and clinically meaningful change will be calculated and proportions achieving this will be expressed with 95% confidence intervals.
Analysis of repeated measures will be used to compare mean scores on measures of physical health, risk of violence, therapeutic programme completion, recovery and overall functioning, at time points in advance of the move of the NFMHS to the new Portrane Hospital Campus and for five years after the move.
Lagged causal model analysis will be used to assess the existence and significance of potential directed relationships between the baseline measures of symptomatology of schizophrenia and violence risk and final outcome namely length of stay.
The lagged causal model approach will be used also to examine the relationship between amount of 'treatment' received and change in outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The NFMHS Ireland provides secure forensic mental health services for adult men and women, who require care and treatment in conditions of therapeutic security. All patients are over 18 years. The majority of patients will have a major mental illness, most commonly treatment resistant schizophrenia, with high rates of polysubstance misuse, personality co-morbidity and physical health issues such as obesity and type II diabetes. All patients are deemed to pose a serious risk of violence towards others. All patients are detained under mental health legislation, with over 40% having been found not guilty by reason of insanity (not criminally responsible due to illness) of a serious offence.
Key inclusion criteria (1 listed)
- Admitted to the National Forensic Mental Health Service (NFMHS) Ireland after 1st December 2019 until 7 years after the transfer of the National Service to the newly developed complete National Forensic Service at Portrane, North Dublin, Ireland.
Key exclusion criteria (1 listed)
- This study comprises a complete cohort of admissions to the NFMHS. All adult patients admitted during the time period will be included in the study, regardless of their length of stay.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay in the secure forensic hospital setting.
Time frame: 5 years
Length of stay in the secure forensic hospital setting
Recovery from psychosis
Time frame: 5 years
Reduction in psychotic symptoms and stabilisation of psychosis
Reduction in violence
Time frame: 5 years
Reduction in violent behaviours, violent incidents and pro-violent attitudes
2 secondary outcomes
Reducing BMI and sedentary behaviours
Time frame: 5 years
Improving overall functioning level
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 23837697Davoren M, Abidin Z, Naughton L, Gibbons O, Nulty A, Wright B, Kennedy HG. Prospective study of factors influencing conditional discharge from a forensic hospital: the DUNDRUM-3 programme completion and DUNDRUM-4 recovery structured professional judgement instruments and risk. BMC Psychiatry. 2013 Jul 9;13:185. doi: 10.1186/1471-244X-13-185.
- Background: PubMed 22794187Davoren M, O'Dwyer S, Abidin Z, Naughton L, Gibbons O, Doyle E, McDonnell K, Monks S, Kennedy HG. Prospective in-patient cohort study of moves between levels of therapeutic security: the DUNDRUM-1 triage security, DUNDRUM-3 programme completion and DUNDRUM-4 recovery scales and the HCR-20. BMC Psychiatry. 2012 Jul 13;12:80. doi: 10.1186/1471-244X-12-80.
- Background: PubMed 30199989Donnelly V, Lynch A, Devlin C, Naughten L, Gibbons O, Mohan D, Kennedy HG. Therapeutic alliance in forensic mental health: coercion, consent and recovery. Ir J Psychol Med. 2011 Mar;28(1):21-28. doi: 10.1017/S0790966700011861.
- Background: PubMed 25428523Davoren M, Fitzpatrick M, Caddow F, Caddow M, O'Neill C, O'Neill H, Kennedy HG. Older men and older women remand prisoners: mental illness, physical illness, offending patterns and needs. Int Psychogeriatr. 2015 May;27(5):747-55. doi: 10.1017/S1041610214002348. Epub 2014 Nov 27.
- Background: PubMed 22074788Donnelly V, Lynch A, Mohan D, Kennedy HG. Working alliance, interpersonal trust and perceived coercion in mental health review hearings. Int J Ment Health Syst. 2011 Nov 10;5(1):29. doi: 10.1186/1752-4458-5-29.
- Background: PubMed 30282262Ijaz A, Papaconstantinou A, O'Neill H, Kennedy HG. The Suicide Risk Assessment and Management Manual (S-RAMM) Validation Study 1. Ir J Psychol Med. 2009 Jun;26(2):54-58. doi: 10.1017/S0790966700000215.
- Background: PubMed 21410967Flynn G, O'Neill C, McInerney C, Kennedy HG. The DUNDRUM-1 structured professional judgment for triage to appropriate levels of therapeutic security: retrospective-cohort validation study. BMC Psychiatry. 2011 Mar 16;11:43. doi: 10.1186/1471-244X-11-43.
- Background: PubMed 26446536Freestone M, Bull D, Brown R, Boast N, Blazey F, Gilluley P. Triage, decision-making and follow-up of patients referred to a UK forensic service: validation of the DUNDRUM toolkit. BMC Psychiatry. 2015 Oct 7;15:239. doi: 10.1186/s12888-015-0620-9.
- BackgroundKennedy H, O'Neill C, Flynn G, Gill P, Davoren M. The DUNDRUM toolkit draft V1. 0.30. Dublin: Trinity College Dublin; 2016.
- BackgroundKennedy, H. (2021). Models of care in forensic psychiatry. BJPsych Advances, 1-14. doi:10.1192/bja.2021.34
- Results publication: PubMed 32482202Williams HK, Senanayke M, Ross CC, Bates R, Davoren M. Security needs among patients referred for high secure care in Broadmoor Hospital England. BJPsych Open. 2020 Jun 2;6(4):e55. doi: 10.1192/bjo.2020.35.
- Results publication: PubMed 33097036Kennedy HG, Mullaney R, McKenna P, Thompson J, Timmons D, Gill P, O'Sullivan OP, Braham P, Duffy D, Kearns A, Linehan S, Mohan D, Monks S, McLoughlin L, O'Connell P, O'Neill C, Wright B, O'Reilly K, Davoren M. A tool to evaluate proportionality and necessity in the use of restrictive practices in forensic mental health settings: the DRILL tool (Dundrum restriction, intrusion and liberty ladders). BMC Psychiatry. 2020 Oct 23;20(1):515. doi: 10.1186/s12888-020-02912-6.
- Individual participant dataSharing planned: No. Due to the uniquely sensitive nature of data from secure forensic mental health services, aggregate anonymised data only will be presented and published. Any access to aggregated anonymised datasets will be considered by request on a case-by-case basis only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Davoren, M.D. principal investigator
Trinity College University of Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Forensic Psychiatry, run by Health Service Executive, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Davoren, M.D. (0035312157401, davorem@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in the secure forensic hospital setting. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074732, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.