<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03271242</url>
  </required_header>
  <id_info>
    <org_study_id>2015106</org_study_id>
    <nct_id>NCT03271242</nct_id>
  </id_info>
  <brief_title>Implementation of National Guidelines for Treatment of Psychoses</brief_title>
  <official_title>A Pairwise Randomized Study on Implementation of Guidelines and Evidence Based Treatments of Psychoses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Akershus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Fonna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helse Stavanger HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sorlandet Hospital HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sykehuset Innlandet HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Westat</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mental helse</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a combined health services research study and a clinical patient outcomes&#xD;
      sub-study.&#xD;
&#xD;
      The aims of the study are to give new knowledge on (RQ1) current implementation in mental&#xD;
      health services of four evidence based practices for treatment of psychoses, (RQ2) how and to&#xD;
      what degree implementation support affects the implementation, and (RQ3) whether improved&#xD;
      implementation is associated with better clinical course and higher patient satisfaction.&#xD;
&#xD;
      Pairwise randomized study in six health trusts on implementation of the four evidence based&#xD;
      practices physical health care, antipsychotic medication, family psychoeducation, and illness&#xD;
      management and recovery. Data on model fidelity and patient course/experience are collected&#xD;
      at baseline and after 6, 12 and 18 months. 39 clinical units (CMHCs/departments) choose two&#xD;
      practices and receive implementation support on one for 18 months after randomization. RQ1 is&#xD;
      answered from baseline data, and RQ2 and RQ3 from data after 6-18 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      (Based on Protocol of 27 October 2015 approved by the Regional Committee for Medical and&#xD;
      Health Research Ethics 17 December 2015, with some adjustments of June and August 2016.)&#xD;
&#xD;
      BACKGROUND: During the last two decades, several evidence-based practices and clinical&#xD;
      guidelines have been developed to improve treatment for psychoses. But there is limited&#xD;
      knowledge on to what extent guidelines and evidence-based practices for psychoses are&#xD;
      implemented in everyday routine practice in Norway and elsewhere, and on how implementation&#xD;
      support and readiness for change influence the implementation process and degree of&#xD;
      implementation. There is even less knowledge whether implementation of clinical guidelines&#xD;
      and evidence-based practices actually improves clinical outcome and patient satisfaction in&#xD;
      routine practice. In efficacy studies that guidelines build upon, clinicians may be&#xD;
      especially skilled and motivated, and patients with additional problems are often excluded.&#xD;
      But in routine practice non-selected clinicians are expected to implement evidence-based&#xD;
      practices in treatment of unselected patients. FIDELITY SCALES: Fidelity measures for&#xD;
      implementation have been developed for several evidence-based practices in treatments for&#xD;
      psychoses, giving data on whether a clinical team or program have implemented key components&#xD;
      of the specific evidence-based model. IMPLEMENTATION SUPPORT: Research has shown that several&#xD;
      strategies need to be combined both on the system level and for clinicians to achieve a&#xD;
      successful implementation of a new practice. Strategies include engaging leaders and&#xD;
      clinicians, understanding of the needs to change practice, supervision frequently over some&#xD;
      time with small group discussions on feedback from fidelity assessments and other measures,&#xD;
      toolkits with a practice manual and other tools to help implement the practice, a &quot;kickoff&quot;&#xD;
      to build enthusiasm, and initial training for the practitioners. The implementation support&#xD;
      must be reasonably intensive during the first months, must be sensitive to site-specific&#xD;
      conditions, and helpful to implementers through three phases of implementation: building&#xD;
      momentum for change, making the changes, and reinforcing the changes. Clinicians' readiness&#xD;
      to change seems to be an important factor in the implementation process.&#xD;
&#xD;
      SETTING: The mental health clinics of six of the 19 Norwegian health trusts are partners in&#xD;
      the project, representing three of the four health regions in Norway and serving a population&#xD;
      of 1.9 million (38 % of Norway's population). Altogether they have 30 community mental health&#xD;
      centers (CMHCs), each serving a specific area and population in collaboration with other&#xD;
      departments. The target group for the project is persons with psychoses served by these&#xD;
      mental health services.&#xD;
&#xD;
      RESEARCH QUESTIONS&#xD;
&#xD;
      RQ1.What is the current level of implementation of evidence-based practices recommended in&#xD;
      the national clinical guidelines for treatment of persons with psychoses? RQ2.How and to what&#xD;
      degree Is the implementation of evidence-based practices influenced by an implementation&#xD;
      support program and by clinician readiness for change? RQ3.Does implementation of&#xD;
      evidence-based practices improve patient clinical course and patient satisfaction with the&#xD;
      services?&#xD;
&#xD;
      HYPOTHESES&#xD;
&#xD;
      (H1).Current implementation of evidence-based practices is low. (H2).Implementation support&#xD;
      for an evidence-based practice gives significant increase in implementation of the practice&#xD;
      compared to no such support. (H3).Higher implementation of evidence-based practices is&#xD;
      associated with better patient clinical course and higher patient satisfaction with the&#xD;
      services.&#xD;
&#xD;
      DESIGN&#xD;
&#xD;
      Pairwise randomized study in six health trusts on implementation of the four evidence-based&#xD;
      practices physical health care, antipsychotic medication, family psychoeducation, and illness&#xD;
      management and recovery. Data on model fidelity and patient course/experience are collected&#xD;
      at baseline and after 6, 12 and 18 months. 39 clinical units (CMHCs/departments) choose two&#xD;
      practices and receive implementation support on one for 18 months after randomization. RQ1 is&#xD;
      answered from baseline data, and RQ2 and RQ3 from data after 6-18 months compared with&#xD;
      baseline.&#xD;
&#xD;
      THE IMPLEMENTATION STUDY (Study of health services)&#xD;
&#xD;
      The unit of analysis for the implementation study is the CMHC/department. CMHCs are the&#xD;
      primary type of clinical units because they give a whole range of outpatient and inpatient&#xD;
      services over time for the population in a local area, including for persons with psychosis.&#xD;
      But other departments serving patients with psychosis may also participate in the study.&#xD;
&#xD;
      Primary outcome measure is fidelity to models for the four evidence-based practices. Each&#xD;
      practice covering a set of core recommendations in the Norwegian guidelines, has been chosen&#xD;
      based on a set of specific criteria (see below) and on a survey among the units&#xD;
      (CMHCs/departments) in May 2015 on their interest for five evidence-based practices. Each&#xD;
      unit chooses two practices that they will implement. For each unit one practice is randomized&#xD;
      to implementation support and the other to be control with no implementation support.&#xD;
&#xD;
      Power calculation with 5% two-tailed significance and 90% power based on data from the US&#xD;
      National Evidence Based Project (US NEBP) shows that 8 units are needed in each arm to show&#xD;
      that implementation support for a practice gives a significant increase in fidelity compared&#xD;
      to baseline with low fidelity. Average fidelity scores in the US NEBP project for five&#xD;
      practices and 51 sites with implementation support were 2.28 at baseline and 3.76 after 12&#xD;
      months, with effect size 1.70.&#xD;
&#xD;
      The four practices for randomization were selected based on specific criteria like covering&#xD;
      guidelines recommendation with high evidence and/or importance, considered to be among core&#xD;
      elements in services for persons with psychosis, fidelity scales were available or could be&#xD;
      developed, relevance for most patients with psychosis, and the required competence is&#xD;
      available or within reach by training. The four selected practices are described below.&#xD;
&#xD;
      Antipsychotic medication: The model for this practice includes limiting polypharmacy,&#xD;
      avoiding high doses and fast dose increase, adjusting medication to phases and situations,&#xD;
      monitoring effect and side effects, and assessing and supporting adherence. As no established&#xD;
      fidelity scale were found to cover the specified practice, a fidelity scale had to be&#xD;
      developed.&#xD;
&#xD;
      Family psychoeducation: Family and the patient is offered psychoeducation with frequent&#xD;
      sessions over some time alone or together with other families. A model and fidelity scales&#xD;
      existed for this evidence-based practice.&#xD;
&#xD;
      Physical health care: The need for physical health care is great due to the documented higher&#xD;
      morbidity and mortality of persons with schizophrenia and related psychoses. As no&#xD;
      established fidelity scale were found to cover the specified practice, a fidelity scale had&#xD;
      to be developed.&#xD;
&#xD;
      Illness management and recovery (IMR): IMR is a training program with several modules with&#xD;
      emphasis on illness management, independent living and personal recovery. The IMR manual and&#xD;
      fidelity scales were translated to Norwegian and made available by another project.&#xD;
&#xD;
      Emphasis on personal recovery and shared decision making are recommended in the guidelines.&#xD;
      These will also be measured and included in data analyses as additional outcome measures of&#xD;
      patient experiences with the services.&#xD;
&#xD;
      Data collection in Implementation study: Fidelity assessment of the two practices in each&#xD;
      clinical unit (CMHC/department) is done every 6 months independently by two fidelity&#xD;
      assessors to calculate inter-rater reliability. Consensus score will be used in data&#xD;
      analyses. The assessments are done at site visits where the researchers gather information&#xD;
      from the sources specified in the fidelity measure (written material, interviews,&#xD;
      observations and reading randomly selected patient records).&#xD;
&#xD;
      PATIENT OUTCOMES SUBSTUDY (Clinical study of patients)&#xD;
&#xD;
      A sub-study of patient clinical course and patient satisfaction with key elements of each&#xD;
      evidence-based practice aims to measure whether the patients experience differences in&#xD;
      implementation of the practices (RQ3). The unit of analysis for this sub-study is the&#xD;
      patient.&#xD;
&#xD;
      Inclusion criteria: Patients 16+ years old with psychoses (diagnosis F20-29 in the ICD-10).&#xD;
      Based on national statistics the aim is to include 20% of the persons with psychoses seen by&#xD;
      the mental health services during a year, which would be a total of 1074 patients (96-280 per&#xD;
      health trust based on population in the area). Only patients giving written informed consent&#xD;
      will be included. There are no exclusion criteria.&#xD;
&#xD;
      The inclusion period of 6 months will start when the implementation support starts and will&#xD;
      be coordinated by the local coordinator. Eligible patients already in contact with the clinic&#xD;
      will be invited to take part, and new referred patients assessed to have psychosis will be&#xD;
      invited consecutively until the requisite number is met. Each included patient will be&#xD;
      followed for 18 months from inclusion.&#xD;
&#xD;
      Data collection will be coordinated by the local coordinator, and done by the clinical units&#xD;
      at baseline (inclusion) and after 6, 12 and 18 months, as long as the patient is in contact&#xD;
      with the mental health services. Clinicians will administer questionnaires to patients and do&#xD;
      clinical ratings of outcome measures.&#xD;
&#xD;
      The project will order data extraction from official registers on use of health services,&#xD;
      primary care, social benefits, prescriptions, and causes of death. This will be done for the&#xD;
      whole period (18 months before inclusion and 18 months during the study) when such data will&#xD;
      be available after the data collection of the study has been finished in 2018.&#xD;
&#xD;
      ANALYSES&#xD;
&#xD;
      Data analyses for the first available data (baseline data) will start in September 2017.&#xD;
&#xD;
      Analyses of RQ1: The percentage of sites achieving high fidelity (4.0) will be calculated for&#xD;
      each practice at baseline. The distribution of fidelity scores and exploration of&#xD;
      contributing factors will also be analyzed based on data collected on implementation support&#xD;
      and readiness to change.&#xD;
&#xD;
      Analyses of RQ2: First, the experimental and control conditions on fidelity will be compared&#xD;
      across time, controlling for baseline and ignoring the content of practice. This analysis&#xD;
      will consist of 39 pairs of sites, measured 4 points in time. Baseline scores will be used as&#xD;
      covariates. Various ANOVA analyses is considered. Second, for each practice all experimental&#xD;
      sites will be compared to all control sites. The number of observation in this analysis will&#xD;
      depend on how many units choose each practice. Baseline scores will be used as covariates.&#xD;
      Third, within-group changes over time will be examined for each practice receiving&#xD;
      implementation support, calculating effect size and determining percentage of sites achieving&#xD;
      various levels of fidelity at each point in time. Readiness for change may be included as a&#xD;
      moderator in these analyses.&#xD;
&#xD;
      Analyses of RQ3: Data analysis on primary and secondary patient outcomes will include&#xD;
      multi-level analysis with patient as individual level and CMHC/department (clinical unit) as&#xD;
      system level. Correlations between fidelity and various patient outcomes may be done as&#xD;
      secondary analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation Study: Fidelity to the model for each evidence-based practice</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Fidelity scales for each practice, with 10-17 items rated from 1 (low) to 5 (high).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Sub-Study: Patient satisfaction with each evidence-based practice</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Set of 5-7 questions developed for each practice, rated 1-5 on a likert scale by patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Patient general satisfaction with the mental health services</measure>
    <time_frame>Baseline (0 months) and 18 months</time_frame>
    <description>The Client Satisfaction Questionnaire (CSQ8) with 8 questions rated 1-4 by patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Patient experiences of their own mental health and functioning</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Patient experiences of their own personal recovery</measure>
    <time_frame>Baseline (0 months) and 18 months</time_frame>
    <description>Process of recovery Questionnaire version 2 (QPR V2) with 15 questions completed by patients on a scale 1-5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Clinician assessment of patient mental health and functioning</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Health of the Nation Outcome Scale (HoNOS) scale rated by clinicians on 12 items rated 0-4 (no problem - very serious problem)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Clinician assessment of patient mental health</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Clinical Global Impression scale (CGI) rated 1-7 by clinicians.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Clinician assessment of patient practical and social functioning</measure>
    <time_frame>Baseline (0 months) and 18 months</time_frame>
    <description>Practical and Social Functioning version 2 (PSF2) scale rated by clinicians on 32 items rated 1-5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Clinician assessment of patient global functioning</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Global Assessment of Functioning Scale, spilt version for symptoms and functioning</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Sub-Study: Clinician assessment of patient substance use last 6 months</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Scales for use of alcohol and drugs last 6 months</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient experiences of the extent of emphasis on personal recovery by the services</measure>
    <time_frame>Baseline (0 months) and 18 months</time_frame>
    <description>The INSPIRE questionnaire (20 items rated 1-5) completed by the patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient experience of the extent of shared decision-making</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>The CollaboRATE questionnaire (3 items rated 0-9) completed by patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Implementation study: Clinician readiness for change</measure>
    <time_frame>Baseline to 18 months (0, 6, 12 and 18 months)</time_frame>
    <description>Implementation Process Assessment Tool (IPAT), a questionnaire (27 items rated 1-6) to clinicians regarding experience of implementation of a specified practice</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">325</enrollment>
  <condition>Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>Implementation support</arm_group_label>
    <description>Units and their patients where the unit according to pairwise randomization is offered systematic implementation support for 18 months for the specific practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No implementation support</arm_group_label>
    <description>Units and their patients where the unit according to pairwise randomization is not offered systematic implementation support for 18 months for the specific practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Systematic implementation support</intervention_name>
    <description>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.</description>
    <arm_group_label>Implementation support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No implementation support</intervention_name>
    <description>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.</description>
    <arm_group_label>No implementation support</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in participating clinical units (community mental health centers or other&#xD;
        departments in mental health services in six health trusts in Norway) assessed by&#xD;
        clinicians to have a psychotic disorder (ICD-11 diagnosis F20-29) and age 16+.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients assessed to have a psychotic disorder (ICD 11: F20-F29)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Torleif Ruud, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <link>
    <url>http://www.bedrepsykosebehandling.no</url>
    <description>Website for the study with information and resources (in Norwegian)</description>
  </link>
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    <PMID>9534825</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <results_reference>
    <citation>Hartveit M, Hovlid E, Nordin MHA, Ovretveit J, Bond GR, Biringer E, Assmus J, Mariniusson GH, Ruud T. Measuring implementation: development of the implementation process assessment tool (IPAT). BMC Health Serv Res. 2019 Oct 21;19(1):721. doi: 10.1186/s12913-019-4496-0.</citation>
    <PMID>31638967</PMID>
  </results_reference>
  <results_reference>
    <citation>Egeland KM, Heiervang KS, Landers M, Ruud T, Drake RE, Bond GR. Psychometric Properties of a Fidelity Scale for Illness Management and Recovery. Adm Policy Ment Health. 2020 Nov;47(6):885-893. doi: 10.1007/s10488-019-00992-5.</citation>
    <PMID>31701294</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruud T, Drivenes K, Drake RE, Haaland VO, Landers M, Stensrud B, Heiervang KS, Tanum L, Bond GR. The Antipsychotic Medication Management Fidelity Scale: Psychometric properties. Adm Policy Ment Health. 2020 Nov;47(6):911-919. doi: 10.1007/s10488-020-01018-1.</citation>
    <PMID>32030595</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruud T, Hoifodt TS, Hendrick DC, Drake RE, Hoye A, Landers M, Heiervang KS, Bond GR. The Physical Health Care Fidelity Scale: Psychometric Properties. Adm Policy Ment Health. 2020 Nov;47(6):901-910. doi: 10.1007/s10488-020-01019-0.</citation>
    <PMID>32036479</PMID>
  </results_reference>
  <results_reference>
    <citation>Heiervang KS, Egeland KM, Landers M, Ruud T, Joa I, Drake RE, Bond GR. Psychometric Properties of the General Organizational Index (GOI): A Measure of Individualization and Quality Improvement to Complement Program Fidelity. Adm Policy Ment Health. 2020 Nov;47(6):920-926. doi: 10.1007/s10488-020-01025-2.</citation>
    <PMID>32107674</PMID>
  </results_reference>
  <results_reference>
    <citation>Joa I, Johannessen JO, Heiervang KS, Sviland AA, Nordin HA, Landers M, Ruud T, Drake RE, Bond GR. The Family Psychoeducation Fidelity Scale: Psychometric Properties. Adm Policy Ment Health. 2020 Nov;47(6):894-900. doi: 10.1007/s10488-020-01040-3.</citation>
    <PMID>32323217</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruud T, Drake RE, Bond GR. Measuring Fidelity to Evidence-Based Practices: Psychometrics. Adm Policy Ment Health. 2020 Nov;47(6):871-873. doi: 10.1007/s10488-020-01074-7.</citation>
    <PMID>32737716</PMID>
  </results_reference>
  <results_reference>
    <citation>Ruud T, Drake RE, Saltyte Benth J, Drivenes K, Hartveit M, Heiervang K, Hoifodt TS, Haaland VO, Joa I, Johannessen JO, Johansen KJ, Stensrud B, Woldsengen Haugom E, Clausen H, Biringer E, Bond GR. The Effect of Intensive Implementation Support on Fidelity for Four Evidence-Based Psychosis Treatments: A Cluster Randomized Trial. Adm Policy Ment Health. 2021 Sep;48(5):909-920. doi: 10.1007/s10488-021-01136-4. Epub 2021 Apr 19.</citation>
    <PMID>33871742</PMID>
  </results_reference>
  <results_reference>
    <citation>Skar-Froding R, Clausen HK, Saltyte Benth J, Ruud T, Slade M, Sverdvik Heiervang K. The Importance of Personal Recovery and Perceived Recovery Support Among Service Users With Psychosis. Psychiatr Serv. 2021 Jun;72(6):661-668. doi: 10.1176/appi.ps.202000223. Epub 2021 Apr 22.</citation>
    <PMID>33882681</PMID>
  </results_reference>
  <results_reference>
    <citation>Haugom EW, Stensrud B, Beston G, Ruud T, Landheim AS. Mental health professionals' experiences with shared decision-making for patients with psychotic disorders: a qualitative study. BMC Health Serv Res. 2020 Nov 27;20(1):1093. doi: 10.1186/s12913-020-05949-1.</citation>
    <PMID>33246451</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Torleif Ruud</investigator_full_name>
    <investigator_title>Senior Researcher, Professor emeritus</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 27, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03271242/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03271242
org study id: 2015106
nct id: NCT03271242
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
(Based on Protocol of 27 October 2015 approved by the Regional Committee for Medical and
      Health Research Ethics 17 December 2015, with some adjustments of June and August 2016.)

      BACKGROUND: During the last two decades, several evidence-based practices and clinical
      guidelines have been developed to improve treatment for psychoses. But there is limited
      knowledge on to what extent guidelines and evidence-based practices for psychoses are
      implemented in everyday routine practice in Norway and elsewhere, and on how implementation
      support and readiness for change influence the implementation process and degree of
      implementation. There is even less knowledge whether implementation of clinical guidelines
      and evidence-based practices actually improves clinical outcome and patient satisfaction in
      routine practice. In efficacy studies that guidelines build upon, clinicians may be
      especially skilled and motivated, and patients with additional problems are often excluded.
      But in routine practice non-selected clinicians are expected to implement evidence-based
      practices in treatment of unselected patients. FIDELITY SCALES: Fidelity measures for
      implementation have been developed for several evidence-based practices in treatments for
      psychoses, giving data on whether a clinical team or program have implemented key components
      of the specific evidence-based model. IMPLEMENTATION SUPPORT: Research has shown that several
      strategies need to be combined both on the system level and for clinicians to achieve a
      successful implementation of a new practice. Strategies include engaging leaders and
      clinicians, understanding of the needs to change practice, supervision frequently over some
      time with small group discussions on feedback from fidelity assessments and other measures,
      toolkits with a practice manual and other tools to help implement the practice, a "kickoff"
      to build enthusiasm, and initial training for the practitioners. The implementation support
      must be reasonably intensive during the first months, must be sensitive to site-specific
      conditions, and helpful to implementers through three phases of implementation: building
      momentum for change, making the changes, and reinforcing the changes. Clinicians' readiness
      to change seems to be an important factor in the implementation process.

      SETTING: The mental health clinics of six of the 19 Norwegian health trusts are partners in
      the project, representing three of the four health regions in Norway and serving a population
      of 1.9 million (38 % of Norway's population). Altogether they have 30 community mental health
      centers (CMHCs), each serving a specific area and population in collaboration with other
      departments. The target group for the project is persons with psychoses served by these
      mental health services.

      RESEARCH QUESTIONS

      RQ1.What is the current level of implementation of evidence-based practices recommended in
      the national clinical guidelines for treatment of persons with psychoses? RQ2.How and to what
      degree Is the implementation of evidence-based practices influenced by an implementation
      support program and by clinician readiness for change? RQ3.Does implementation of
      evidence-based practices improve patient clinical course and patient satisfaction with the
      services?

      HYPOTHESES

      (H1).Current implementation of evidence-based practices is low. (H2).Implementation support
      for an evidence-based practice gives significant increase in implementation of the practice
      compared to no such support. (H3).Higher implementation of evidence-based practices is
      associated with better patient clinical course and higher patient satisfaction with the
      services.

      DESIGN

      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 compared with
      baseline.

      THE IMPLEMENTATION STUDY (Study of health services)

      The unit of analysis for the implementation study is the CMHC/department. CMHCs are the
      primary type of clinical units because they give a whole range of outpatient and inpatient
      services over time for the population in a local area, including for persons with psychosis.
      But other departments serving patients with psychosis may also participate in the study.

      Primary outcome measure is fidelity to models for the four evidence-based practices. Each
      practice covering a set of core recommendations in the Norwegian guidelines, has been chosen
      based on a set of specific criteria (see below) and on a survey among the units
      (CMHCs/departments) in May 2015 on their interest for five evidence-based practices. Each
      unit chooses two practices that they will implement. For each unit one practice is randomized
      to implementation support and the other to be control with no implementation support.

      Power calculation with 5% two-tailed significance and 90% power based on data from the US
      National Evidence Based Project (US NEBP) shows that 8 units are needed in each arm to show
      that implementation support for a practice gives a significant increase in fidelity compared
      to baseline with low fidelity. Average fidelity scores in the US NEBP project for five
      practices and 51 sites with implementation support were 2.28 at baseline and 3.76 after 12
      months, with effect size 1.70.

      The four practices for randomization were selected based on specific criteria like covering
      guidelines recommendation with high evidence and/or importance, considered to be among core
      elements in services for persons with psychosis, fidelity scales were available or could be
      developed, relevance for most patients with psychosis, and the required competence is
      available or within reach by training. The four selected practices are described below.

      Antipsychotic medication: The model for this practice includes limiting polypharmacy,
      avoiding high doses and fast dose increase, adjusting medication to phases and situations,
      monitoring effect and side effects, and assessing and supporting adherence. As no established
      fidelity scale were found to cover the specified practice, a fidelity scale had to be
      developed.

      Family psychoeducation: Family and the patient is offered psychoeducation with frequent
      sessions over some time alone or together with other families. A model and fidelity scales
      existed for this evidence-based practice.

      Physical health care: The need for physical health care is great due to the documented higher
      morbidity and mortality of persons with schizophrenia and related psychoses. As no
      established fidelity scale were found to cover the specified practice, a fidelity scale had
      to be developed.

      Illness management and recovery (IMR): IMR is a training program with several modules with
      emphasis on illness management, independent living and personal recovery. The IMR manual and
      fidelity scales were translated to Norwegian and made available by another project.

      Emphasis on personal recovery and shared decision making are recommended in the guidelines.
      These will also be measured and included in data analyses as additional outcome measures of
      patient experiences with the services.

      Data collection in Implementation study: Fidelity assessment of the two practices in each
      clinical unit (CMHC/department) is done every 6 months independently by two fidelity
      assessors to calculate inter-rater reliability. Consensus score will be used in data
      analyses. The assessments are done at site visits where the researchers gather information
      from the sources specified in the fidelity measure (written material, interviews,
      observations and reading randomly selected patient records).

      PATIENT OUTCOMES SUBSTUDY (Clinical study of patients)

      A sub-study of patient clinical course and patient satisfaction with key elements of each
      evidence-based practice aims to measure whether the patients experience differences in
      implementation of the practices (RQ3). The unit of analysis for this sub-study is the
      patient.

      Inclusion criteria: Patients 16+ years old with psychoses (diagnosis F20-29 in the ICD-10).
      Based on national statistics the aim is to include 20% of the persons with psychoses seen by
      the mental health services during a year, which would be a total of 1074 patients (96-280 per
      health trust based on population in the area). Only patients giving written informed consent
      will be included. There are no exclusion criteria.

      The inclusion period of 6 months will start when the implementation support starts and will
      be coordinated by the local coordinator. Eligible patients already in contact with the clinic
      will be invited to take part, and new referred patients assessed to have psychosis will be
      invited consecutively until the requisite number is met. Each included patient will be
      followed for 18 months from inclusion.

      Data collection will be coordinated by the local coordinator, and done by the clinical units
      at baseline (inclusion) and after 6, 12 and 18 months, as long as the patient is in contact
      with the mental health services. Clinicians will administer questionnaires to patients and do
      clinical ratings of outcome measures.

      The project will order data extraction from official registers on use of health services,
      primary care, social benefits, prescriptions, and causes of death. This will be done for the
      whole period (18 months before inclusion and 18 months during the study) when such data will
      be available after the data collection of the study has been finished in 2018.

      ANALYSES

      Data analyses for the first available data (baseline data) will start in September 2017.

      Analyses of RQ1: The percentage of sites achieving high fidelity (4.0) will be calculated for
      each practice at baseline. The distribution of fidelity scores and exploration of
      contributing factors will also be analyzed based on data collected on implementation support
      and readiness to change.

      Analyses of RQ2: First, the experimental and control conditions on fidelity will be compared
      across time, controlling for baseline and ignoring the content of practice. This analysis
      will consist of 39 pairs of sites, measured 4 points in time. Baseline scores will be used as
      covariates. Various ANOVA analyses is considered. Second, for each practice all experimental
      sites will be compared to all control sites. The number of observation in this analysis will
      depend on how many units choose each practice. Baseline scores will be used as covariates.
      Third, within-group changes over time will be examined for each practice receiving
      implementation support, calculating effect size and determining percentage of sites achieving
      various levels of fidelity at each point in time. Readiness for change may be included as a
      moderator in these analyses.

      Analyses of RQ3: Data analysis on primary and secondary patient outcomes will include
      multi-level analysis with patient as individual level and CMHC/department (clinical unit) as
      system level. Correlations between fidelity and various patient outcomes may be done as
      secondary analyses.
observational model: Cohort
time perspective: Prospective
measure: Implementation Study: Fidelity to the model for each evidence-based practice
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Fidelity scales for each practice, with 10-17 items rated from 1 (low) to 5 (high).
measure: Patient Sub-Study: Patient satisfaction with each evidence-based practice
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Set of 5-7 questions developed for each practice, rated 1-5 on a likert scale by patients
measure: Patient Sub-Study: Patient general satisfaction with the mental health services
time frame: Baseline (0 months) and 18 months
description: The Client Satisfaction Questionnaire (CSQ8) with 8 questions rated 1-4 by patients.
measure: Patient Sub-Study: Patient experiences of their own mental health and functioning
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: 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.
measure: Patient Sub-Study: Patient experiences of their own personal recovery
time frame: Baseline (0 months) and 18 months
description: Process of recovery Questionnaire version 2 (QPR V2) with 15 questions completed by patients on a scale 1-5.
measure: Patient Sub-Study: Clinician assessment of patient mental health and functioning
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Health of the Nation Outcome Scale (HoNOS) scale rated by clinicians on 12 items rated 0-4 (no problem - very serious problem)
measure: Patient Sub-Study: Clinician assessment of patient mental health
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Clinical Global Impression scale (CGI) rated 1-7 by clinicians.
measure: Patient Sub-Study: Clinician assessment of patient practical and social functioning
time frame: Baseline (0 months) and 18 months
description: Practical and Social Functioning version 2 (PSF2) scale rated by clinicians on 32 items rated 1-5
measure: Patient Sub-Study: Clinician assessment of patient global functioning
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Global Assessment of Functioning Scale, spilt version for symptoms and functioning
measure: Patient Sub-Study: Clinician assessment of patient substance use last 6 months
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Scales for use of alcohol and drugs last 6 months
measure: Patient experiences of the extent of emphasis on personal recovery by the services
time frame: Baseline (0 months) and 18 months
description: The INSPIRE questionnaire (20 items rated 1-5) completed by the patients
measure: Patient experience of the extent of shared decision-making
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: The CollaboRATE questionnaire (3 items rated 0-9) completed by patients
measure: Implementation study: Clinician readiness for change
time frame: Baseline to 18 months (0, 6, 12 and 18 months)
description: Implementation Process Assessment Tool (IPAT), a questionnaire (27 items rated 1-6) to clinicians regarding experience of implementation of a specified practice
arm group label: Implementation support
description: Units and their patients where the unit according to pairwise randomization is offered systematic implementation support for 18 months for the specific practice.
arm group label: No implementation support
description: Units and their patients where the unit according to pairwise randomization is not offered systematic implementation support for 18 months for the specific practice.
intervention type: Other
intervention name: Systematic implementation support
description: 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.
arm group label: Implementation support
intervention type: Other
intervention name: No implementation support
description: 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.
arm group label: No implementation support
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Torleif Ruud, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Akershus
url: http://www.bedrepsykosebehandling.no
description: Website for the study with information and resources (in Norwegian)
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PMID: 17498153
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PMID: 19794192
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PMID: 11141527
citation: McHugo GJ, Drake RE, Whitley R, Bond GR, Campbell K, Rapp CA, Goldman HH, Lutz WJ, Finnerty MT. Fidelity outcomes in the National Implementing Evidence-Based Practices Project. Psychiatr Serv. 2007 Oct;58(10):1279-84. doi: 10.1176/ps.2007.58.10.1279.
PMID: 17914003
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PMID: 21574016
citation: Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009 Jan;36(1):24-34. doi: 10.1007/s10488-008-0197-4. Epub 2008 Dec 23.
PMID: 19104929
citation: Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PMID: 20957426
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013 May;50(5):587-92. doi: 10.1016/j.ijnurstu.2012.09.010. Epub 2012 Nov 15. No abstract available.
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citation: Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
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citation: Williams J, Leamy M, Bird V, Le Boutillier C, Norton S, Pesola F, Slade M. Development and evaluation of the INSPIRE measure of staff support for personal recovery. Soc Psychiatry Psychiatr Epidemiol. 2015 May;50(5):777-86. doi: 10.1007/s00127-014-0983-0. Epub 2014 Nov 20.
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citation: 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.
citation: 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.
citation: 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.
citation: Hartveit M, Hovlid E, Nordin MHA, Ovretveit J, Bond GR, Biringer E, Assmus J, Mariniusson GH, Ruud T. Measuring implementation: development of the implementation process assessment tool (IPAT). BMC Health Serv Res. 2019 Oct 21;19(1):721. doi: 10.1186/s12913-019-4496-0.
PMID: 31638967
citation: Egeland KM, Heiervang KS, Landers M, Ruud T, Drake RE, Bond GR. Psychometric Properties of a Fidelity Scale for Illness Management and Recovery. Adm Policy Ment Health. 2020 Nov;47(6):885-893. doi: 10.1007/s10488-019-00992-5.
PMID: 31701294
citation: Ruud T, Drivenes K, Drake RE, Haaland VO, Landers M, Stensrud B, Heiervang KS, Tanum L, Bond GR. The Antipsychotic Medication Management Fidelity Scale: Psychometric properties. Adm Policy Ment Health. 2020 Nov;47(6):911-919. doi: 10.1007/s10488-020-01018-1.
PMID: 32030595
citation: Ruud T, Hoifodt TS, Hendrick DC, Drake RE, Hoye A, Landers M, Heiervang KS, Bond GR. The Physical Health Care Fidelity Scale: Psychometric Properties. Adm Policy Ment Health. 2020 Nov;47(6):901-910. doi: 10.1007/s10488-020-01019-0.
PMID: 32036479
citation: Heiervang KS, Egeland KM, Landers M, Ruud T, Joa I, Drake RE, Bond GR. Psychometric Properties of the General Organizational Index (GOI): A Measure of Individualization and Quality Improvement to Complement Program Fidelity. Adm Policy Ment Health. 2020 Nov;47(6):920-926. doi: 10.1007/s10488-020-01025-2.
PMID: 32107674
citation: Joa I, Johannessen JO, Heiervang KS, Sviland AA, Nordin HA, Landers M, Ruud T, Drake RE, Bond GR. The Family Psychoeducation Fidelity Scale: Psychometric Properties. Adm Policy Ment Health. 2020 Nov;47(6):894-900. doi: 10.1007/s10488-020-01040-3.
PMID: 32323217
citation: Ruud T, Drake RE, Bond GR. Measuring Fidelity to Evidence-Based Practices: Psychometrics. Adm Policy Ment Health. 2020 Nov;47(6):871-873. doi: 10.1007/s10488-020-01074-7.
PMID: 32737716
citation: Ruud T, Drake RE, Saltyte Benth J, Drivenes K, Hartveit M, Heiervang K, Hoifodt TS, Haaland VO, Joa I, Johannessen JO, Johansen KJ, Stensrud B, Woldsengen Haugom E, Clausen H, Biringer E, Bond GR. The Effect of Intensive Implementation Support on Fidelity for Four Evidence-Based Psychosis Treatments: A Cluster Randomized Trial. Adm Policy Ment Health. 2021 Sep;48(5):909-920. doi: 10.1007/s10488-021-01136-4. Epub 2021 Apr 19.
PMID: 33871742
citation: Skar-Froding R, Clausen HK, Saltyte Benth J, Ruud T, Slade M, Sverdvik Heiervang K. The Importance of Personal Recovery and Perceived Recovery Support Among Service Users With Psychosis. Psychiatr Serv. 2021 Jun;72(6):661-668. doi: 10.1176/appi.ps.202000223. Epub 2021 Apr 22.
PMID: 33882681
citation: Haugom EW, Stensrud B, Beston G, Ruud T, Landheim AS. Mental health professionals' experiences with shared decision-making for patients with psychotic disorders: a qualitative study. BMC Health Serv Res. 2020 Nov 27;20(1):1093. doi: 10.1186/s12913-020-05949-1.
PMID: 33246451
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Torleif Ruud
investigator title: Senior Researcher, Professor emeritus
mesh term: Psychotic Disorders
sharing ipd: No
provided document: 