- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04862897
Patient-controlled Admissions to Inpatient Care
Patient-controlled Admissions to Inpatient Care for Patients With Severe Psychiatric Conditions in Region Stockholm
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
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
-
-
Stockholm County
-
Stockholm, Stockholm County, 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
Accepts Healthy Volunteers
Sampling Method
Study Population
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 (concerns only self-reported outcomes).
Matched control group:
- A matched control group consisting of seven times the number of of patients receiving patient-control admissions will be utilised for all primary outcome measures, other psychiatric or somatic healthcare consumption, sick-leave, and redeemed prescriptions (matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient-controlled admissions
Patients who have been granted access to 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)
|
|
Matched control group
Patients matched on account of age, gender, diagnosis, and history of psychiatric inpatient care, but who have not been granted access to patient-controlled admissions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Admissions to inpatient care
Time Frame: Change in number of admissions to inpatient care between baseline and at 12 months
|
Number of admissions to inpatient care
|
Change in number of admissions to inpatient care between baseline and at 12 months
|
|
Admissions to inpatient care
Time Frame: Change in number of admissions to inpatient care between baseline and at 24 months
|
Number of admissions to inpatient care
|
Change in number of admissions to inpatient care between baseline and at 24 months
|
|
Admissions to involuntary care
Time Frame: Change in number of admissions to involuntary care between baseline and at 12 months
|
Number of admissions to involuntary care
|
Change in number of admissions to involuntary care between baseline and at 12 months
|
|
Days in involuntary care
Time Frame: Change in number of days in involuntary care between baseline and at 12 months
|
Number of days in involuntary care
|
Change in number of days in involuntary care between baseline and at 12 months
|
|
Days in inpatient care
Time Frame: Change in number of days in inpatient care between baseline and 12 months
|
Number of days in inpatient care
|
Change in number of days in inpatient care between baseline and 12 months
|
|
Days in inpatient care
Time Frame: Change in number of days in inpatient care between baseline and 24 months
|
Number of days in inpatient care
|
Change in number of days in inpatient care between baseline and 24 months
|
|
Admissions to inpatient care
Time Frame: Change in number of admissions to inpatient care between baseline and at 36 months
|
Number of admissions to inpatient care
|
Change in number of admissions to inpatient care between baseline and at 36 months
|
|
Days in inpatient care
Time Frame: Change in number of days in inpatient care between baseline and 36 months
|
Number of days in inpatient care
|
Change in number of days in inpatient care between baseline and 36 months
|
|
Admissions to involuntary care
Time Frame: Change in number of admissions to involuntary care between baseline and at 24 months
|
Number of admissions to involuntary care
|
Change in number of admissions to involuntary care between baseline and at 24 months
|
|
Days in involuntary care
Time Frame: Change in number of days in involuntary care between baseline and at 24 months
|
Number of days in involuntary care
|
Change in number of days in involuntary care between baseline and at 24 months
|
|
Admissions to involuntary care
Time Frame: Change in number of admissions to involuntary care between baseline and at 36 months
|
Number of admissions to involuntary care
|
Change in number of admissions to involuntary care between baseline and at 36 months
|
|
Days in involuntary care
Time Frame: Change in number of days in involuntary care between baseline and at 36 months
|
Number of days in involuntary care
|
Change in number of days in involuntary care between baseline and at 36 months
|
|
Coercive measures
Time Frame: Change in number of coercive measures between baseline and at 12 months
|
Number of coercive measures (forced medication, seclusion, and restraint)
|
Change in number of coercive measures between baseline and at 12 months
|
|
Coercive measures
Time Frame: Change in number of coercive measures between baseline and at 24 months
|
Number of coercive measures (forced medication, seclusion, and restraint)
|
Change in number of coercive measures between baseline and at 24 months
|
|
Coercive measures
Time Frame: Change in number of coercive measures between baseline and at 36 months
|
Number of coercive measures (forced medication, seclusion, and restraint)
|
Change in number of coercive measures between baseline and at 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EQ5D-5L
Time Frame: Change in self-rated quality of life (somatic) between baseline and at 12 months
|
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
Time Frame: Change in self-rated quality of life (somatic) between baseline and at 12 months
|
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
Time Frame: Change in clinician-rated functional level between baseline and at 12 months
|
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
Time Frame: Change in self-rated quality of life (psychological) between baseline and at 12 months
|
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
Time Frame: Change in self-rated self-efficacy between baseline and at 12 months
|
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
Time Frame: Change in self-rated anxiety between baseline and at 12 months
|
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
Time Frame: Change in self-rated depression between baseline and at 12 months
|
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
Time Frame: Change in self-rated care needs and current health status between baseline and at 12 months
|
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 psychiatric or somatic healthcare consumption
Time Frame: Change in number of other psychiatric or somatic healthcare consumption between baseline and 12 months
|
Number of other psychiatric or somatic healthcare consumption
|
Change in number of other psychiatric or somatic healthcare consumption between baseline and 12 months
|
|
Sick-leave
Time Frame: Change in number of days in sick-leave between baseline and 12 months
|
Number of days in sick-leave
|
Change in number of days in sick-leave between baseline and 12 months
|
|
Redeemed medical prescriptions
Time Frame: Change in number of redeemed medical prescriptions between baseline and 12 months
|
Number of redeemed medical prescriptions
|
Change in number of redeemed medical prescriptions between baseline and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KIDSCREEN
Time Frame: Change in self-rated quality of life (health-related) between baseline and at 12 months
|
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
Time Frame: Change in self-rated alcohol and substance use between baseline and at 12 months
|
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
Time Frame: Change in clinician-rated functional level between baseline and at 12 months
|
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
Time Frame: Change in self-rated functional level between baseline and at 12 months
|
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
Time Frame: Change in self-rated anxiety and depression between baseline and at 12 months
|
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
Collaborators
Investigators
- Principal Investigator: Alexander Rozental, PhD, Karolinska Institutet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-06498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patient-controlled Admissions
-
Universiti Kebangsaan Malaysia Medical CentreCompletedPatient-controlled SedationMalaysia
-
Korea University Guro HospitalRecruitingDexmedetomidine | Analgesia, Patient-ControlledKorea, Republic of
-
Jun wangCompletedAnalgesia, Patient-ControlledChina
-
University of MontanaProvidence St. Patrick Hospital, Missoula MontanaCompletedAll Causes Hospital Admissions
-
Charite University, Berlin, GermanyWithdrawnWaiting-time in the Anaesthesia Admissions Ambulance
-
Seoul National University HospitalCompletedAnalgesia, Patient-ControlledKorea, Republic of
-
University Hospital, Basel, SwitzerlandCompletedSpinal Stenosis | Analgesia, Patient-controlledSwitzerland
-
Seoul National University Bundang HospitalNot yet recruitingBrachial Plexus Block | Analgesia, Patient-Controlled | Arthroscopic Rotator Cuff Repair
-
Pether JildenstalGöteborg UniversityCompletedPostoperative Pain | Surgery | Nurse-Patient Relations | Patient Controlled AnalgesiaSweden
-
Ain Shams UniversityCompletedQuadratus Lumborum Block | Quality of Recovery | Elective Cesarean Section | Patient Controlled AnalgesiaEgypt
Clinical Trials on Patient-controlled admissions
-
Heart Care FoundationCompletedManagement and Epidemiology of Patients Admitted in ICUItaly
-
Hamad Medical CorporationUniversity of Hull; Australian Catholic University; Weill Cornell Medical College... and other collaboratorsUnknownno Spedific Condition, All-cause In-patient Mortality
-
University Hospital, AkershusCompletedAffective Disorder | Psychoses
-
Gulhane Training and Research HospitalCompleted
-
University of Auckland, New ZealandCompleted
-
National Taiwan University HospitalCompleted
-
St. Olavs HospitalCompleted
-
University of Wisconsin, MadisonNational Institute of Nursing Research (NINR)CompletedPain | Cancer | Fatigue | Sleep DisturbanceUnited States