Patient-controlled Admissions to Inpatient Care

Patient-controlled Admissions to Inpatient Care for Patients With Severe Psychiatric Conditions in Region Stockholm

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.

Study Overview

• Status: Recruiting
• Conditions: Patient-controlled Admissions
• Intervention / Treatment: Other: Patient-controlled admissions

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.

• Study Type: Observational
• Enrollment (Estimated): 564

Contacts and Locations

• Study Contact: Name: Alexander Rozental, PhD; Phone Number: +46(0)736937948; Email: alexander.rozental@ki.se
• Study Contact Backup: Name: Sigrid Salomonsson, PhD; Phone Number: +46(0)722025947; Email: sigrid.salomonsson@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 113 64
    • Recruiting
    • Centre for psychiatry research
    • Contact: Alexander Rozental, PhD; Phone Number: +46(0)736937948; Email: alexander.rozental@ki.se
    • Contact: Sigrid Salomonsson, PhD; Phone Number: +46(0)722025947; Email: sigrid.salomonsson@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient-controlled admissions; Patients who have been granted access to patient-controlled admissions and agreed to its use with inpatient care and outpatient care	Other: Patient-controlled admissions; Patients are allowed to admit themselves to inpatient care when needed (standard procedure, four days of inpatient care at a time, up to three times a month)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admissions to inpatient care	Number of admissions to inpatient care	Change in number of admissions to inpatient care between baseline and at 12 months
Admissions to inpatient care	Number of admissions to inpatient care	Change in number of admissions to inpatient care between baseline and at 24 months
Admissions to involuntary care	Number of admissions to involuntary care	Change in number of admissions to involuntary care between baseline and at 12 months
Days in involuntary care	Number of days in involuntary care	Change in number of days in involuntary care between baseline and at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ5D-5L	Self-rated quality of life (somatic) on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has five levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The scores for the five dimensions can be combined into a five-digit number that describes the patient's health state, with 11,111 indicating perfect health and 55,555 the worst health state. The outcome ranges from 5 (no health limitations at all, 11,111) to 25 (for state 55,555).	Change in self-rated quality of life (somatic) between baseline and at 12 months
World Health Organization Disability Assessment Schedule	Self-rated quality of life (somatic) on six dimensions: cognition, mobility, self-care, getting along with people, life activities and participation - including work-related disability. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5) - are then summed. A higher sum score indicates worse quality of life (100 = full disability; 0 = no disability).	Change in self-rated quality of life (somatic) between baseline and at 12 months
Clinical Global Impression	Clinician-rated functional level, measuring symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. It has two domains, severity scale and Improvement scale. Both are scored on a 7 point scale; 1 = Normal, not at all ill to 7 = Among the most extremely ill patients, as well as 1 = Very much improved, and 7 = Very much worse. A higher score indicates worse functional level and a worsening of functioning, respectively.	Change in clinician-rated functional level between baseline and at 12 months
Brunnsviken Brief Quality of life scale	Self-rated quality of life (psychological), including 12 items covering six life areas: Leisure, View on life, Creativity, Learning, Friends and Friendship, and View on self. All items are scored using the same response format, con- sisting of a five-step Likert rating scale, visually scored 0-4 with written anchor points at 0 (Strongly disagree) and 4 (Strongly agree). The BBQ total score is computed by summing the weighted satisfaction ratings, i.e. by multiplying the Satisfaction and Importance items for each life area and summing the six products for a total score (possible score range 0-96). A higher sum score indicates a better quality of life.	Change in self-rated quality of life (psychological) between baseline and at 12 months
General Self-Efficacy scale	Self-rated self-efficacy, assessing a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. The response to 10 items are made on a 4-point scale ( 1 = Not at all true, 2 = Hardly true, 3 = Moderately true. 4 = Exactly true). The sum of all 10 items yield the final composite score with a range from 10 to 40. A higher sum score indicates a higher self-efficacy.	Change in self-rated self-efficacy between baseline and at 12 months
Generalized Anxiety Disorder - 7 items	Self-rated anxiety, a seven-item instrument that is used to measure or assess the severity of generalised anxiety disorder and symptoms of anxiety and worry. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively.	Change in self-rated anxiety between baseline and at 12 months
The Patient Health Questionnaire - 9 items	Self-rated depression, measures depression using nine items on 4-point scales and a 4-point scale for impact on daily life. As a severity measure, the PHQ-9 score can range from 0 to 27, since each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day); 0-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, 20-27 = severe depression.	Change in self-rated depression between baseline and at 12 months
Visual Analogue Scales	Four items assessing different aspects of the patients' care needs and current health status are administered monthly. These include the following; 1) "I feel confident about receiving care when I need it" 2) "I am able to actively participate in my care", and 3) "I believe care is available when needed". These are scored on a continuum ranging from "I do not agree at all" (0) to "Totally agree" (10). Also, a fourth item concerns "How would you rate your current health status?", which is rated between "Worst possible health" (0) and "Best possible health" (10).	Change in self-rated care needs and current health status between baseline and at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
KIDSCREEN	For child and adolescent psychiatry only: Self-rated quality of life (health-related), using 11 items. It is scored on a five-point Likert-scale, "Not at all" or "Never" (0) to "Extreme" or "Always" (4). One item is supposed to reflect the participant's overall health status, i.e., "In general, how would you say your health is?". KIDSCREEN is administered to both the patients and their caregivers.	Change in self-rated quality of life (health-related) between baseline and at 12 months
Alcohol, Smoking and Substance Involvement Screening Test	For child and adolescent psychiatry only: Self-rated alcohol and substance use, using 7 items. Item 1 has a no/yes-response, items 2-5 has a 0, 5, 6, 7, 8 scale, ranging from "Never" to "Daily or almost daily", item 6 has a 0, 6, 3 scale, ranging from "No, never" to "Yes, but not in the past 3 months", and item 7 has a categorical respons "No, never", "Yes, the past 3 months", and "Yes, but not in the past 3 months". Scores from items 2-6 are summed, with a higher score indicating greater severity of alcohol, smoking, and substance use.	Change in self-rated alcohol and substance use between baseline and at 12 months
Childrens Global Assessment Scale	For child and adolescent psychiatry only: Clinician-rated functional level. The child or young person is given a single score between 1 and 100, based on a clinician's assessment of a range of aspects related to a child's psychological and social functioning. The score will put them in one of ten categories that range from 'extremely impaired' (1-10) to 'doing very well' (91-100): 0-10: Extremely impaired (24 hour care), 11-20: Very severely impaired, 21-30: Severe problems, 31-40: Serious problems, 41-50: Obvious problems, 51-60: Some noticeable problems, 61-70: Some problems, 71-80: Doing all right, 81-90: Doing well, 91-100: Doing very well.	Change in clinician-rated functional level between baseline and at 12 months
The Strengths and Difficulties Questionnaire	For child and adolescent psychiatry only: Self-rated functional level that ask about 25 attributes, some positive and others negative. These 25 items are divided between 5 scales: emotional symptoms (5 items), conduct problems (5 items), hyperactivity/inattention (5 items), peer relationship problems (5 items), prosocial behaviour (5 items). The four first scales generate a totalt difficulties score, with a higher score indicating greater difficulties (0-40). The Strengths and Difficulties Questionnaire is administered to both the patients and their caregivers.	Change in self-rated functional level between baseline and at 12 months
Revised Children's Anxiety and Depression Scale	For child and adolescent psychiatry only: Self-rated anxiety and depression, a 47-item, youth self-report questionnaire with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). A higher score indicates greater symptom severity. The Revised Children's Anxiety and Depression Scale is administered to both the patients and their caregivers.	Change in self-rated anxiety and depression between baseline and at 12 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Stockholm Health Care Services
• Investigators: Principal Investigator: Alexander Rozental, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Patient participation; Inpatient care; Patient-controlled admissions; Self-referrals
• Other Study ID Numbers: 2020-06498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data include patient records and need a permit from Stockholm Health Care Services in order to become available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No