Implementation, Efficacy and Costs of Inpatient Equivalent Home-Treatment in German Mental Health… (NCT04745507) | Clinical Trial Compass
UnknownNot Applicable
Implementation, Efficacy and Costs of Inpatient Equivalent Home-Treatment in German Mental Health Care
Germany629 participantsStarted 2021-01-01
Plain-language summary
The "inpatient-equivalent home treatment"(IEHT) according to §115d SGB-V is a particular version of the internationally well-known and evidence-based Home Treatment. As a complex intervention, IEHT requires a multi-method evaluation on different levels in the German context. The AKtiV study that is financed by the Innovation Fund of the Federal Joint Committee (proposal ID: VSF2\_2019-108) meets this request. In this quasi-experimental study with a propensity score-matched control group, we assess and combine quantitative and qualitative data. Outcome parameters include classical clinical ones such as hospital readmission rates, mental state, and recovery outcomes. In addition, it evaluates issues concerning the right target population, treatment processes, implementation strategies, and factors associated with positive outcomes. The study takes into account the perspective of patients, relatives, staff as well as decision makers in politics and administration. Therefore, we expect the results to be relevant for a broad audience and to contribute to further refinement and adaption of the model.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For C1 and C2:
Inclusion criteria:
* IEHT inclusion criteria
* acute mental health crisis that requires inpatient treatment;
* social and living surrounding allowing for home visits and private conversations;
* informed consent of all adults living in the service user's place of residency;
* ability to provide informed consent
* sufficient German language skills
* permanent residence in the catchment area of the IEHT delivering Hospital
* main diagnosis within the ICD codes F0X, F1X, F2X, F3X, F4X, F5X, or F6X
Exclusion criteria:
* IEHT exclusion criteria
o in case of children living in the same household, presence of child welfare risk
* acute suicidality or aggressiveness towards others requiring hospital admission
* Being under order of commitment
* participation in an interventional study during the recruitment
* presence of substantial cognitive deficits as indicated by severe organic brain disease
* diagnosis of intellectual impairment
* admission longer ago than 7 days
For C3: Close relative or informal caregiver living in the same household of the participating patient
Inclusion criteria:
• informed consent regarding study participation
For C4: IEHT staff member of participating study cite OR local or political stakeholder engaged with IEHT
Inclusion criteria:
• informed consent regarding study participation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences and change in the hospital re-admission rate
Timeframe: (T0.1) within 7 days after admission, (T1) 6 months after T0.1, (T2) 12 months after T0.1