NCT05074732

Brief 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, 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Dec 2019Dec 2027

Study Start

First participant enrolled

December 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

6.1 years

First QC Date

October 2, 2021

Last Update Submit

October 2, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Length of stay in the secure forensic hospital setting.

    Length of stay in the secure forensic hospital setting

    5 years

  • Recovery from psychosis

    Reduction in psychotic symptoms and stabilisation of psychosis

    5 years

  • Reduction in violence

    Reduction in violent behaviours, violent incidents and pro-violent attitudes

    5 years

Secondary Outcomes (2)

  • Reducing BMI and sedentary behaviours

    5 years

  • Improving overall functioning level

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Forensic Mental Health Service, Central Mental Hospital

Dublin, D14 W0V6, Ireland

RECRUITING

Related Publications (16)

  • 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.

    PMID: 23837697BACKGROUND
  • Davoren 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.

    PMID: 22794187BACKGROUND
  • Donnelly 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.

    PMID: 30199989BACKGROUND
  • Davoren 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.

    PMID: 25428523BACKGROUND
  • Donnelly 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.

    PMID: 22074788BACKGROUND
  • Ijaz 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.

    PMID: 30282262BACKGROUND
  • Flynn 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.

    PMID: 21410967BACKGROUND
  • Freestone 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.

    PMID: 26446536BACKGROUND
  • Kennedy H, O'Neill C, Flynn G, Gill P, Davoren M. The DUNDRUM toolkit draft V1. 0.30. Dublin: Trinity College Dublin; 2016.

    BACKGROUND
  • Kennedy, H. (2021). Models of care in forensic psychiatry. BJPsych Advances, 1-14. doi:10.1192/bja.2021.34

    BACKGROUND
  • 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.

  • Kennedy 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.

  • Basrak 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.

  • Davoren 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.

  • Abidin 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.

  • Davoren M, O'Reilly K, Mohan D, Kennedy HG. Prospective cohort study of the evaluation of patient benefit from the redevelopment of a complete national forensic mental health service: the Dundrum Forensic Redevelopment Evaluation Study (D-FOREST) protocol. BMJ Open. 2022 Jul 22;12(7):e058581. doi: 10.1136/bmjopen-2021-058581.

MeSH Terms

Conditions

SchizophreniaPersonality DisordersObesityDiabetes Mellitus, Type 2Cardiovascular DiseasesFrailtyPsychotic DisordersSchizophrenia, Treatment-Resistant

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPathologic Processes

Study Officials

  • Mary Davoren, M.D.

    Trinity College University of Dublin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Davoren, M.D.

CONTACT

Harry G Kennedy, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Forensic Psychiatrist and Clinical Senior Lecturer in Forensic Psychiatry

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 12, 2021

Study Start

December 1, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

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.

Locations