- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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".
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Trondheim, Norge, 7440
- St.Olavs hospital, Psykisk helsevern, Nidaros DPS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: admissions contract
contract regarding "patient-guided admissions"
|
contract regarding "patient-guided admissions" starting immediately
|
|
Aktiv komparator: wait list control
1 year on waiting list
|
Patient-guided admissions contract regarding "patient-guided admissions" starting a year after.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient activation/coping
Tidsramme: 4 months
|
Patient Activation Measure (PAM 13)
|
4 months
|
|
Patient activation/coping
Tidsramme: 12 months
|
Patient Activation Measure (PAM 13)
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of admissions
Tidsramme: 12 months
|
Number of admissions in CMHC, psychiatric hospital of community rehabilitation centre
|
12 months
|
|
Total number of inpatient days
Tidsramme: 12 months
|
Total number of inpatient days in CMHC, psychiatric hospital or community rehabilitation centre
|
12 months
|
|
Number of outpatient consultations
Tidsramme: 12 months
|
Number of outpatient consultations in primary care, in CMHC and psychiatric hospital
|
12 months
|
|
Number of involuntary admissions
Tidsramme: 12 months
|
Number of involuntary admissions either as inpatient or outpatient
|
12 months
|
|
Symptoms/functioning and recovery
Tidsramme: 4 months
|
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
|
4 months
|
|
Symptoms/functioning and recovery
Tidsramme: 12 months
|
Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Lasse Eriksen, PhD, St. Olavs Hospital
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009/1704 (Andet bevillings-/finansieringsnummer: St Olavs Hospital)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med admissions contract
-
Cardenal Herrera UniversityAfsluttetHamstringsfleksibilitetSpanien
-
Riphah International UniversityAfsluttetMuskelstramhedPakistan
-
Yonsei UniversityUkendt
-
University of FloridaAfsluttet