Patient Guided Psychiatric Admissions | NCT01133587

Studies
Patient Guided Psychiatric Admissions

NCT01133587

Sponsor

St. Olavs Hospital

Status

Completed

Last Update Posted

Apr 4, 2017Actual

Enrollment

53Actual

Phase

Not Applicable

Conditions

Schizophrenia
Bipolar Disorder

Interventions

wait list control
admissions contract

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009/1704	Other Grant/Funding Number	St Olavs Hospital

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 19, 2010

First Submission Date that Met QC Criteria

May 28, 2010

First Posted Date

May 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2017

Last Update Posted Date

Apr 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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".

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
admissions contract	Experimental	contract regarding "patient-guided admissions"	Behavioral: admissions contract
wait list control	Active Comparator	1 year on waiting list	Other: wait list control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
wait list control	Other	Patient-guided admissions contract regarding "patient-guided admissions" starting a year after.	wait list control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient activation/coping	Patient Activation Measure (PAM 13)	4 months
Patient activation/coping	Patient Activation Measure (PAM 13)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Number of admissions	Number of admissions in CMHC, psychiatric hospital of community rehabilitation centre	12 months
Total number of inpatient days	Total number of inpatient days in CMHC, psychiatric hospital or community rehabilitation centre

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lasse Eriksen, PhD	St. Olavs Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St.Olavs hospital, Psykisk helsevern, Nidaros DPS		Trondheim		7440	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27659102	Result	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.
28096034	Result

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

ID	Term
D012559	Schizophrenia
D001714	Bipolar Disorder