Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02442193
Status:
TERMINATED
Last Update Posted:
2018-02-12
First Post:
2015-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual Placement and Support for Patients With Offending Histories
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Terminated by the funder due to low recruitment rates.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-09', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Open Employment: Proportion of people in open employment', 'timeFrame': '12 Months', 'description': 'Proportion of people in open employment at 12 month follow-up'}], 'secondaryOutcomes': [{'measure': 'Number of hours worked', 'timeFrame': '12 Months', 'description': 'Number of hours worked at 12 month follow-up'}, {'measure': 'Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)', 'timeFrame': 'Baseline, 6 and 12 Months', 'description': 'Measured using the Brief Psychiatric Rating Scale (BPRS)'}, {'measure': 'Social Functioning as measured using the Social Functioning Questionnaire (SFQ)', 'timeFrame': 'Baseline, 6 and 12 Months', 'description': 'Measured using the Social Functioning Questionnaire (SFQ)'}, {'measure': "Self-Esteem as measured using the Rosenberg's Self Esteem Scale", 'timeFrame': 'Baseline, 6 and 12 Months', 'description': "Measured using the Rosenberg's Self Esteem Scale"}, {'measure': 'Work Limitations as measured using the Work Limitation Questionnaire', 'timeFrame': 'Baseline, 6 and 12 Months', 'description': 'Measured using the Work Limitation Questionnaire'}, {'measure': 'Quality of life as measured using SF-12v2', 'timeFrame': 'Baseline, 6 and 12 Months', 'description': 'Health-related quality of life as measured using SF-12v2'}, {'measure': 'Economic Costing as measured using the Client Service Receipt Inventory (CSRI)', 'timeFrame': 'Baseline, 6 and 12 Months', 'description': 'Measured using the Client Service Receipt Inventory (CSRI)'}, {'measure': 'Re-offending rates', 'timeFrame': 'Baseline and 18 Months', 'description': 'Re-offending rates'}, {'measure': 'Number of days in open employment', 'timeFrame': '12 months', 'description': 'Number of days in open employment at 12 months'}, {'measure': 'Quality of life as measured using the EQ5-D', 'timeFrame': 'Baseline, 6 and 12 months', 'description': 'Health-related quality of life as measured using the EQ5-D'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Employment, Supported', 'Treatment as Usual']}, 'referencesModule': {'references': [{'pmid': '27449894', 'type': 'RESULT', 'citation': 'Khalifa N, Talbot E, Schneider J, Walker DM, Bates P, Bird Y, Davies D, Brookes C, Hall J, Vollm B. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol. BMJ Open. 2016 Jul 22;6(7):e012710. doi: 10.1136/bmjopen-2016-012710.'}, {'pmid': '31998164', 'type': 'DERIVED', 'citation': 'Khalifa N, Talbot E, Barber S, Schneider J, Bird Y, Attfield J, Bates P, Walker DM, Vollm B. A Feasibility Cluster Randomized Controlled Trial of Individual Placement and Support (IPS) for Patients With Offending Histories. Front Psychiatry. 2020 Jan 13;10:952. doi: 10.3389/fpsyt.2019.00952. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'http://bmjopen.bmj.com/content/6/7/e012710', 'label': 'Study Protocol'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of the study is to assess the feasibility of conducting a Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.', 'detailedDescription': 'This is a feasibility trial which aims to assess the feasibility of conducting a full Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.\n\nGiven that IPS is a complex intervention, the design of this study has drawn from the principles set out in the UK Medical Research Council (MRC) Guidance on developing and evaluating complex interventions by defining three major research strands in order to achieve the specific objectives of the study as follows:\n\nA. Implementation of IPS in community forensic services: The specific objective of this strand is to embed the IPS model in the community forensic services in which the feasibility study will be carried out (aided by an IPS Expert), by bringing an employment specialist into clinical teams, raising awareness about IPS within the organization, forming links with IPS services in the area and developing links with employers, as well as conducting IPS fidelity reviews.\n\nB. Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including:\n\n1. Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.\n2. The feasibility of randomization, recruitment and retention rates to the IPS and controls;\n3. The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores.\n\nC. Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods:\n\n1. Qualitative interviews with staff to identify the structural, legal, organizational and individual-level to barriers and facilitators to implementation of IPS in community forensic services.\n2. Fidelity Reviews to assess the extent to which the services follow the principles of IPS and to assess how well the employment specialist functions within the community forensic services.\n3. Qualitative interviews with patients assigned to IPS in order to assess their general views of IPS, benefits from participating, disadvantages from or dislikes about participating and barriers and facilitators to implementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 18 years\n* Patients (females and males) on the caseload of the community forensic services\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent\n* Patients not eligible to work in the UK\n* Patients currently in open employment\n* Patients who do not wish to work'}, 'identificationModule': {'nctId': 'NCT02442193', 'acronym': 'IPSOH', 'briefTitle': 'Individual Placement and Support for Patients With Offending Histories', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Nottinghamshire Healthcare NHS Trust'}, 'officialTitle': 'Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings', 'orgStudyIdInfo': {'id': 'KHALIFA/020415'}, 'secondaryIdInfos': [{'id': 'PB-PG-1013-32093', 'type': 'OTHER_GRANT', 'domain': 'NIHR - Research for Patient Benefit (RfPB)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual Placement and Support', 'description': 'Individual Placement and Support', 'interventionNames': ['Other: Individual Placement and Support']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as Usual', 'description': 'Treatment as Usual is comprised of routine clinical care.'}], 'interventions': [{'name': 'Individual Placement and Support', 'type': 'OTHER', 'description': 'Individual Placement and Support is a form of supported employment.', 'armGroupLabels': ['Individual Placement and Support']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottinghamshire NHS Foundation Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Najat R Khalifa, DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottinghamshire Healthcare NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottinghamshire Healthcare NHS Trust', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Nottingham', 'class': 'OTHER'}, {'name': 'University of Southampton', 'class': 'OTHER'}, {'name': 'University of Leicester', 'class': 'OTHER'}, {'name': 'Institute of Mental Health Nottingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Najat Khalifa', 'investigatorAffiliation': 'Nottinghamshire Healthcare NHS Trust'}}}}