Clinical trial NCT04862897: Patient-controlled Admissions to Inpatient Care
Official title: Patient-controlled Admissions to Inpatient Care for Patients with Severe Psychiatric Conditions in Region Stockholm
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Patient-controlled Admissions
Keywords: Patient-controlled admissions
Self-referrals
Patient participation
Inpatient care
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm Health Care Services
First posted: 2021-04-28
Enrollment: 564
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with severe psychiatric conditions in Region Stockholm who fulfil the inclusion criteria will access patient-controlled admissions. This includes child and adolescent psychiatry, but excludes forensic psychiatry. Only those patients who consent to participate in the research project will be evaluated.

Brief summary: Patient-controlled admissions refer to the possibility for patients with severe psychiatric conditions to admit themselves to inpatient care. Compared to having a healthcare provider make this decision, patient-controlled admissions are believed to decrease the need for involuntary care, decrease symptom levels, and increase quality of life and autonomy for the patient. The current research project aims to evaluate the implementation of patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry.

Detailed description: Patients with severe psychiatric conditions represent a group who have extensive care needs and for whom few effective interventions exist. Diagnoses such as schizophrenia and borderline personality disorder usually have a poor prognostic outlook in terms of recovery, and patients often suffer from life-long disabilities. Meanwhile, their healthcare expenditures are typically high. In case of increased symptoms and novel sickness spells, healthcare providers make an assessment if admission to inpatient care is needed. This gatekeeper-model is typical of most western countries and infers that the decision to be admitted is always made by a third party. Since about a decade, attempts at transferring the responsibility of admissions to patients themselves is being implemented and tested in several countries and contexts, referred to as patient-controlled admissions. The idea is to increase patient involvement, enhance self-determination, and improve their ability to manage signs of illness. Patient-controlled admissions involve signing an agreement between inpatient care, outpatient care, and those patients that are deemed to have the highest care needs, whereby the patients can contact an inpatient ward and be admitted when required. Previous research have revealed that patient-controlled admissions decrease involuntary admissions and that both healthcare providers and patients are positive towards its use. These studies have however been small and used limited outcome measures. The current research project aims to study the results of implementing patient-controlled admissions to all patients with severe psychiatric conditions within Region Stockholm, Sweden, including child and adolescent psychiatry. Apart from determining the possible impact on both number of admissions and days in admission (voluntary and involuntary), self-report measures will be used to assess the effects on symptom levels, quality of life, and autonomy.

Eligibility criteria: Inclusion Criteria:

* Have an on-going contact with outpatient care.
* Have an individual care plan and crisis plan.
* Have had at least one inpatient care period the previous year.
* Are expected to have the greatest need of inpatient care.
* Are interested in, and understand the concept of, patient-controlled admissions.

Exclusion Criteria:

* No informed consent to participate in the research project.

Primary outcomes:
measure: Admissions to inpatient care
timeFrame: Change in number of admissions to inpatient care between baseline and at 12 months
measure: Admissions to inpatient care
timeFrame: Change in number of admissions to inpatient care between baseline and at 24 months
measure: Admissions to involuntary care
timeFrame: Change in number of admissions to involuntary care between baseline and at 12 months
measure: Days in involuntary care
timeFrame: Change in number of days in involuntary care between baseline and at 12 months
Secondary outcomes:
measure: EQ5D-5L
timeFrame: Change in self-rated quality of life (somatic) between baseline and at 12 months
measure: World Health Organization Disability Assessment Schedule
timeFrame: Change in self-rated quality of life (somatic) between baseline and at 12 months
measure: Clinical Global Impression
timeFrame: Change in clinician-rated functional level between baseline and at 12 months
measure: Brunnsviken Brief Quality of life scale
timeFrame: Change in self-rated quality of life (psychological) between baseline and at 12 months
measure: General Self-Efficacy scale
timeFrame: Change in self-rated self-efficacy between baseline and at 12 months
measure: Generalized Anxiety Disorder - 7 items
timeFrame: Change in self-rated anxiety between baseline and at 12 months
measure: The Patient Health Questionnaire - 9 items
timeFrame: Change in self-rated depression between baseline and at 12 months
measure: Visual Analogue Scales
timeFrame: Change in self-rated care needs and current health status between baseline and at 12 months
Other outcomes:
measure: KIDSCREEN
timeFrame: Change in self-rated quality of life (health-related) between baseline and at 12 months
measure: Alcohol, Smoking and Substance Involvement Screening Test
timeFrame: Change in self-rated alcohol and substance use between baseline and at 12 months
measure: Childrens Global Assessment Scale
timeFrame: Change in clinician-rated functional level between baseline and at 12 months
measure: The Strengths and Difficulties Questionnaire
timeFrame: Change in self-rated functional level between baseline and at 12 months
measure: Revised Children's Anxiety and Depression Scale
timeFrame: Change in self-rated anxiety and depression between baseline and at 12 months
Locations:
city: Stockholm
country: Sweden
facility: Centre for Psychiatry Research
Study officials:
affiliation: Karolinska Institutet
name: Alexander Rozental, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smitmanis Lyle M, Allenius E, Salomonsson S, Bjorkdahl A, Strand M, Flyckt L, Hellner C, Lundgren T, Jayaram-Lindstrom N, Rozental A. What are the effects of implementing patient-controlled admissions in inpatient care? A study protocol of a large-scale implementation and naturalistic evaluation for adult and adolescent patients with severe psychiatric conditions throughout Region Stockholm. BMJ Open. 2022 Aug 16;12(8):e065770. doi: 10.1136/bmjopen-2022-065770.