Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.

Obesity Clinical Trial

— D-FOREST  

Official title:

Dundrum Forensic Redevelopment Evaluation Study: D-FOREST Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05074732
• Other study ID #: HSEIreland
• Status: Recruiting
• Start date: December 1, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2021
• Source: Health Service Executive, Ireland
• Contact: Mary Davoren, M.D.
• Phone: 0035312157401
• Email: davorem[@]tcd.ie
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Frailty
• Obesity
• Outcome Measure
• Personality Disorders
• Psychosis
• Recovery
• Schizophrenia
• Treatment-resistant Schizophrenia
• Type II Diabetes
• Violence

Locations

Country	Name	City	State
Ireland	National Forensic Mental Health Service, Central Mental Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Health Service Executive, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (15)

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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 necess — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in the secure forensic hospital setting.	Length of stay in the secure forensic hospital setting	5 years
Primary	Recovery from psychosis	Reduction in psychotic symptoms and stabilisation of psychosis	5 years
Primary	Reduction in violence	Reduction in violent behaviours, violent incidents and pro-violent attitudes	5 years
Secondary	Reducing BMI and sedentary behaviours	Improving physical health measures namely reduction in obesity and reduction in sedentary behaviours	5 years
Secondary	Improving overall functioning level	Improving scores on GAF MIRECC for measure of overall functioning	5 years