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The feasibility and efficacy of intensive home treatment (IHT)


- candidate number25585
- NTR NumberNTR6151
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-nov-2016
- Secondary IDsNL 55432.029.16 
- Public TitleThe feasibility and efficacy of intensive home treatment (IHT)
- Scientific TitleThe feasibility and efficacy of intensive home treatment as an alternative to acute psychiatric admission
- ACRONYMIHT-trial
- hypothesisAs our primary outcome, we expect a 33% reduction in hospitalisation days at 52 weeks post-treatment allocation in IHT.
- Healt Condition(s) or Problem(s) studiedPsychiatric crisis
- Inclusion criteria- Admission to a clinical crisis care department is indicated (or compulsory).
- There is at least one axis I or II disorder diagnosed in the patient.
- The patient is a resident of Amsterdam area, the Netherlands.
- Age 18 years or older.
- Written informed consent has been provided by the patient.
- Exclusion criteria- Patient is homeless.
- Primary diagnosis of the patient is substance use disorder for which referral to a specialized unity for detoxification is indicated.
- Patient is currently receiving (F)ACT care.
- Patient has had previous IHT treatment.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-nov-2016
- planned closingdate1-mei-2018
- Target number of participants230
- InterventionsIntervention: Intensive home treatment is a treatment modality that addresses some of the imperfections of inpatient crisis care by providing intensive care in the patients' home setting, thus maximising the utilization of the patient's social system in providing crisis care and support and limiting the duration of hospitalisation following psychiatric crisis. It also allows for a more gradual transition between in-patient care and low intensity out-patient/out-reaching care. IHT starts immediately after reference by a specialised health care professional.

Control (Care As Usual): CAU commonly starts with inpatient care. During hospitalisation, mental health workers in the psychiatric hospital will stabilize and treat the patient and prepare his/her return to the home situation, in collaboration with outpatient mental health workers (excluding the IHT team). The outpatient care in the CAU condition is much less intensive then IHT.
- Primary outcomeThe number of admission days.
- Secondary outcome- Safety of the patient and his/her direct social environment
- Mental well-being
- General functioning
- Quality of life
- TimepointsPatient:
Baseline = T0
Post-treatment 6-10 weeks after baseline = T1
26 weeks follow-up = T2
52 weeks follow-up = T3 (primary endpoint)

Family/informal caregivers:
Baseline = T0
Post-treatment 6-10 weeks after baseline = T1
26 weeks follow-up = T2

Healthcare professionals:
Baseline = T0
Post-treatment 6-10 weeks after patient signed informed consent = T1
- Trial web sitewww.ibtonderzoek.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Matthijs Blankers
- CONTACT for SCIENTIFIC QUERIESMSc Matthijs Blankers
- Sponsor/Initiator Arkin Institute for Mental Health
- Funding
(Source(s) of Monetary or Material Support)
Stichting tot Steun (VCVGZ)
- PublicationsN/A
- Brief summaryRationale: The availability of intensive home treatment (IHT) is hypothesized to reduce the need for hospitalisation of patients in a psychiatric crisis situation. This is done without jeopardising the quality and clinical outcome of treatment by organising and managing IHT care in the home situation of patients. IHT care is delivered by professionals in co-operation with family, friends and informal care network of the patient during the first weeks following a psychiatric crisis. A psychiatric crisis is a situation in which there is an urgent need for professional intervention arising at least in part from mental health problems (Johnson et al., 2011). A psychiatric intervention at this stage will often be in the form of hospitalization. The duration of hospitalization needed is dependent on the duration of the acute crisis, but also on the outpatient intervention opportunities following hospitalization.

Objective: To test the (cost-) effectiveness, safety and feasibility of 6 week IHT compared to care-as-usual (CAU) for patients in or immediately following a psychiatric crisis.

Study design: We will perform a 2-centre, 2-arm Zelen double consent randomised controlled trial. In this trial we aim to include 230 patients. Assessments take place at baseline, 6-10, 26, and 52 weeks after baseline. Participants will be recruited from the crisis departments of 2 mental health treatment centres based in Amsterdam, the Netherlands.

Study population: Patients experiencing an acute psychiatric crisis for whom a psychiatric admission is indicated by a psychiatrist.

Interventions: IHT is a treatment modality that addresses some of the imperfections of inpatient care by providing intensive care in the patientsí home setting, thus maximising the utilization of the patientís social system in providing crisis care and support and limiting the duration of hospitalisation following psychiatric crisis. It also allows for a more gradual transition between in-patient care and low intensity out-patient/out-reaching care. IHT starts immediately after reference by a specialised health care professional. Care as Usual (CAU) commonly starts with inpatient care. During hospitalisation, mental health workers in the psychiatric hospital will stabilize and treat the patient and prepare his/her return to the home situation, in collaboration with outpatient mental health workers (excluding the IHT team). The outpatient care in the CAU condition is much less intensive than IHT.

Main study parameters/endpoints: Primary outcome measure is the number of admission days. Secondary outcomes include safety of the patient and his/her direct social environment, mental well-being, general functioning, and quality of life. In addition to reporting clinical outcomes and hospitalisation duration, an economic evaluation alongside the RCT is planned.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The literature does not indicate there is an elevated risk on adverse events in IHT in comparison to CAU (Murphy et al., 2012; Hubbeling & Bertram, 2012). According to Murphy et al. (2015) IHT improved the mental state of service users more than standard care, it was more acceptable and satisfactory to service users, their families and caregivers, placed less burden on families and carers, and it reduced the stigmatization of hospitalisation.
- Main changes (audit trail)25-juli-2017 -IK:

Inclusiecriteria:
"Age 18 years or older."
replaced by
"Age ≥ 18 and < 65 years."
- RECORD23-nov-2016 - 25-jul-2017


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