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Implementation of National Guidelines for Treatment of Psychoses

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ClinicalTrials.gov Identifier: NCT03271242
Recruitment Status : Active, not recruiting
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
University Hospital of North Norway
Helse Fonna
Helse Stavanger HF
Sorlandet Hospital HF
Sykehuset Innlandet HF
Westat
Mental helse
Information provided by (Responsible Party):
Torleif Ruud, University Hospital, Akershus

Brief Summary:

The study is a combined health services research study and a clinical patient outcomes sub-study.

The aims of the study are to give new knowledge on (RQ1) current implementation in mental health services of four evidence based practices for treatment of psychoses, (RQ2) how and to what degree implementation support affects the implementation, and (RQ3) whether improved implementation is associated with better clinical course and higher patient satisfaction.

Pairwise randomized study in six health trusts on implementation of the four evidence based practices physical health care, antipsychotic medication, family psychoeducation, and illness management and recovery. Data on model fidelity and patient course/experience are collected at baseline and after 6, 12 and 18 months. 39 clinical units (CMHCs/departments) choose two practices and receive implementation support on one for 18 months after randomization. RQ1 is answered from baseline data, and RQ2 and RQ3 from data after 6-18 months.


Condition or disease Intervention/treatment
Psychotic Disorders Other: Systematic implementation support Other: No implementation support

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1074 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pairwise Randomized Study on Implementation of Guidelines and Evidence Based Treatments of Psychoses
Actual Study Start Date : June 22, 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Implementation support
Units and their patients where the unit according to pairwise randomization is offered systematic implementation support for 18 months for the specific practice.
Other: Systematic implementation support
Implementation support is offered by implementation trainers visiting each clinical unit every two weeks for 6 months and then monthly for 12 months. Support is given only for the practice randomly assigned to support. The aim is to engage leaders and clinicians in identifying and overcoming implementation barriers, and in building systems to support and sustain implementation. Implementation trainers from all sites are trained together and meet every 2-3 month with leaders of the implementation training for supervision, mutual discussion, and exchange of experiences. At the start of the implementation, leaders and clinicians were also invited to a workshop on the practice they have been randomly assigned to receive support for. Toolkits are made available on a website.

No implementation support
Units and their patients where the unit according to pairwise randomization is not offered systematic implementation support for 18 months for the specific practice.
Other: No implementation support
No implementation support is offered to clinical units for the practice randomly assigned to no implementation support, of the two practices (of the four practices in the project) that unit has chosen to implement.




Primary Outcome Measures :
  1. Implementation Study: Fidelity to the model for each evidence-based practice [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Fidelity scales for each practice, with 10-17 items rated from 1 (low) to 5 (high).

  2. Patient Sub-Study: Patient satisfaction with each evidence-based practice [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Set of 5-7 questions developed for each practice, rated 1-5 on a likert scale by patients


Secondary Outcome Measures :
  1. Patient Sub-Study: Patient general satisfaction with the mental health services [ Time Frame: Baseline (0 months) and 18 months ]
    The Client Satisfaction Questionnaire (CSQ8) with 8 questions rated 1-4 by patients.

  2. Patient Sub-Study: Patient experiences of their own mental health and functioning [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    The BASIS-24 questionnaire with 24 questions on mental health, functioning and substance use. Each question is answered by patients on a scale 1-5.

  3. Patient Sub-Study: Patient experiences of their own personal recovery [ Time Frame: Baseline (0 months) and 18 months ]
    Process of recovery Questionnaire version 2 (QPR V2) with 15 questions completed by patients on a scale 1-5.

  4. Patient Sub-Study: Clinician assessment of patient mental health and functioning [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Health of the Nation Outcome Scale (HoNOS) scale rated by clinicians on 12 items rated 0-4 (no problem - very serious problem)

  5. Patient Sub-Study: Clinician assessment of patient mental health [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Clinical Global Impression scale (CGI) rated 1-7 by clinicians.

  6. Patient Sub-Study: Clinician assessment of patient practical and social functioning [ Time Frame: Baseline (0 months) and 18 months ]
    Practical and Social Functioning version 2 (PSF2) scale rated by clinicians on 32 items rated 1-5

  7. Patient Sub-Study: Clinician assessment of patient global functioning [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Global Assessment of Functioning Scale, spilt version for symptoms and functioning

  8. Patient Sub-Study: Clinician assessment of patient substance use last 6 months [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Scales for use of alcohol and drugs last 6 months


Other Outcome Measures:
  1. Patient experiences of the extent of emphasis on personal recovery by the services [ Time Frame: Baseline (0 months) and 18 months ]
    The INSPIRE questionnaire (20 items rated 1-5) completed by the patients

  2. Patient experience of the extent of shared decision-making [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    The CollaboRATE questionnaire (3 items rated 0-9) completed by patients

  3. Implementation study: Clinician readiness for change [ Time Frame: Baseline to 18 months (0, 6, 12 and 18 months) ]
    Implementation Process Assessment Tool (IPAT), a questionnaire (27 items rated 1-6) to clinicians regarding experience of implementation of a specified practice



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in participating clinical units (community mental health centers or other departments in mental health services in six health trusts in Norway) assessed by clinicians to have a psychotic disorder (ICD-11 diagnosis F20-29) and age 16+.
Criteria

Inclusion Criteria:

  • All patients assessed to have a psychotic disorder (ICD 11: F20-F29)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271242


Sponsors and Collaborators
University Hospital, Akershus
University Hospital of North Norway
Helse Fonna
Helse Stavanger HF
Sorlandet Hospital HF
Sykehuset Innlandet HF
Westat
Mental helse
Investigators
Principal Investigator: Torleif Ruud, MD, PhD University Hospital, Akershus
  Study Documents (Full-Text)

Documents provided by Torleif Ruud, University Hospital, Akershus:
Study Protocol  [PDF] October 27, 2015


Additional Information:
Publications of Results:
Horne R, Weinman J, Hankins M. The Beliefs about Medicines Questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and Health 14: 1-24, 1999
Rishovd Rund B, Ruud T. Måling av funksjonsnivå og funksjonsendring i psykiatrisk behandling [Measuring functioning and change in functioning during psychiatric treatment. Norwegian Board of Health. Report.] Statens helsetilsyn. IK 2422, Oslo. 1994.
Karterud S, Pedersen G, Løvdal H, Friis S. S-GAF: Global Funsjonsskåring - Splittet Versjon [Global Assessment of Functioning - Split version]. Bakgrunn og skåringsveiledning. Klinikk for psykiatri, Ullevål sykehus, Oslo, 1998.
Mueser KT, Drake RE, Clark RE, McHugo GJ, Mercer-McFadden C, Ackerson TH. Toolkit for Evaluating Substance Abuse in Person with Severe Mental Illness. 1995.

Responsible Party: Torleif Ruud, Senior Researcher, Professor emeritus, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03271242     History of Changes
Other Study ID Numbers: 2015106
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders