Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Patient Guided Psychiatric Admissions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01133587
First received: May 19, 2010
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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".


Condition Intervention
Schizophrenia
Bipolar Disorder
Other: wait list control
Behavioral: admissions contract

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Patient Guided Psychiatric Admissions (Self-referral to Inpatient Beds)

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Patient activation/coping [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Patient Activation Measure (PAM 13)

  • Patient activation/coping [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient Activation Measure (PAM 13)


Secondary Outcome Measures:
  • Number of admissions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of admissions in CMHC, psychiatric hospital of community rehabilitation centre

  • Total number of inpatient days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total number of inpatient days in CMHC, psychiatric hospital or community rehabilitation centre

  • Number of outpatient consultations [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of outpatient consultations in primary care, in CMHC and psychiatric hospital

  • Number of involuntary admissions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of involuntary admissions either as inpatient or outpatient

  • Symptoms/functioning and recovery [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)

  • Symptoms/functioning and recovery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Behavior and symptom identification scale (BASIS 32) and Recovery Assessment Scale (RAS 24)


Enrollment: 53
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: admissions contract
contract regarding "patient-guided admissions"
Behavioral: admissions contract
contract regarding "patient-guided admissions" starting immediately
Active Comparator: wait list control
1 year on waiting list
Other: wait list control
Patient-guided admissions contract regarding "patient-guided admissions" starting a year after.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133587

Locations
Norway
St.Olavs hospital, Psykisk helsevern, Nidaros DPS
Trondheim, Norway, 7440
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Principal Investigator: Lasse Eriksen, PhD St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01133587     History of Changes
Other Study ID Numbers: 2009/1704, 2009/1704
Study First Received: May 19, 2010
Last Updated: November 4, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
Schizophrenia
bipolar disorder
Long term care
patient admission

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 20, 2014