- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01133587
Patient Guided Psychiatric Admissions
Patient Guided Psychiatric Admissions (Self-referral to Inpatient Beds)
To meet the requirement for increased patient involvement, several Community Mental Health Centres (CMHC) have initiated a service called "patient-guided admissions". The investigators will compare a group with "patient guided admission/self-referral to inpatient beds" with a group having treatment as usual.
It is expected that patients in the intervention group will experience more increased feeling of coping (patient activation) after 4 months and 12 months as a result of participating in "patient-guided admissions" than patients getting treatment as usual. In addition the total number of inpatient days either in the CMHC, psychiatric hospital or community rehabilitation centre is expected to be clearly lower in the intervention group than in the 'treatment-as-usual' group during one year after intake. Also the number of involuntary admissions either as inpatient or outpatient will be significant lower in the intervention group than the 'treatment-as-usual' group.The number of admissions in CMHC and psychiatric hospital, as well as the number of outpatient consultations in primary care, CMHC and psychiatric hospitals, will be lower in the intervention group than in the 'treatment-as-usual' group. Patients in the intervention group will experience improved mental health, increased feeling of coping (patient activation) and increased experience of recovery after 4 months and 12 months as a result of participating in "patient-guided admissions".
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Participants will be patients with psychosis or bipolar disorders. Patients in the intervention group will have a contract on "self-referral to inpatient beds" for one year. They can call the CMHC directly and ask for a bed for until 5 nights.
The patients in the 'treatment-as-usual' group will follow common procedures by either contacting their general practitioner, emergency department or duty doctor, and they will be offered a "self-referral to inpatient bed" contract after a year if they satisfy the inclusion criteria.
Regardless of the participation in the intervention group, the patients can also be ordinary admitted during the project period by a doctor via regular procedures in both hospital and CMHC if there is a need for this. All admissions will appear in the register data.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Trondheim, Norwegen, 7440
- St.Olavs hospital, Psykisk helsevern, Nidaros DPS
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- schizophrenia or bipolar disorder
- long term care
- established relationship with the ward
Exclusion Criteria:
- extensive substance use problems
- self-destructive behavior
- not able to consent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: admissions contract
contract regarding "patient-guided admissions"
|
contract regarding "patient-guided admissions" starting immediately
|
|
Aktiver Komparator: wait list control
1 year on waiting list
|
Patient-guided admissions contract regarding "patient-guided admissions" starting a year after.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient activation/coping
Zeitfenster: 4 months
|
Patient Activation Measure (PAM 13)
|
4 months
|
|
Patient activation/coping
Zeitfenster: 12 months
|
Patient Activation Measure (PAM 13)
|
12 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of admissions
Zeitfenster: 12 months
|
Number of admissions in CMHC, psychiatric hospital of community rehabilitation centre
|
12 months
|
|
Total number of inpatient days
Zeitfenster: 12 months
|
Total number of inpatient days in CMHC, psychiatric hospital or community rehabilitation centre
|
12 months
|
|
Number of outpatient consultations
Zeitfenster: 12 months
|
Number of outpatient consultations in primary care, in CMHC and psychiatric hospital
|
12 months
|
|
Number of involuntary admissions
Zeitfenster: 12 months
|
Number of involuntary admissions either as inpatient or outpatient
|
12 months
|
|
Symptoms/functioning and recovery
Zeitfenster: 4 months
|
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
|
4 months
|
|
Symptoms/functioning and recovery
Zeitfenster: 12 months
|
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
|
12 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Lasse Eriksen, PhD, St. Olavs Hospital
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Moljord IE, Helland-Hansen KA, Salvesen O, Olso TM, Gudde CB, Rise MB, Steinsbekk A, Eriksen L. Short time effect of a self-referral to inpatient treatment for patients with severe mental disorders: a randomized controlled trial. BMC Health Serv Res. 2016 Sep 22;16(1):513. doi: 10.1186/s12913-016-1712-z.
- Moljord IEO, Lara-Cabrera ML, Salvesen O, Rise MB, Bjorgen D, Antonsen DO, Olso TM, Evensen GH, Gudde CB, Linaker OM, Steinsbekk A, Eriksen L. Twelve months effect of self-referral to inpatient treatment on patient activation, recovery, symptoms and functioning: A randomized controlled study. Patient Educ Couns. 2017 Jun;100(6):1144-1152. doi: 10.1016/j.pec.2017.01.008. Epub 2017 Jan 11.
- Sigrunarson V, Moljord IE, Steinsbekk A, Eriksen L, Morken G. A randomized controlled trial comparing self-referral to inpatient treatment and treatment as usual in patients with severe mental disorders. Nord J Psychiatry. 2017 Feb;71(2):120-125. doi: 10.1080/08039488.2016.1240231. Epub 2016 Oct 14.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2009/1704 (Andere Zuschuss-/Finanzierungsnummer: St Olavs Hospital)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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