Implementation of National Guidelines for Treatment of Psychoses

NCT ID: NCT03271242

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-22

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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(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.

Conditions

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Psychotic Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Systematic implementation support

Intervention Type OTHER

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.

No implementation support

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of North Norway

OTHER

Sponsor Role collaborator

Helse Fonna

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Westat

OTHER

Sponsor Role collaborator

Mental helse

UNKNOWN

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Torleif Ruud

Senior Researcher, Professor emeritus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Torleif Ruud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

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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.

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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.

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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.

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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.

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Skar-Froding R, Clausen HK, Saltyte Benth J, Ruud T, Slade M, Sverdvik Heiervang K. Relationship between satisfaction with mental health services, personal recovery and quality of life among service users with psychosis: a cross-sectional study. BMC Health Serv Res. 2021 May 8;21(1):439. doi: 10.1186/s12913-021-06409-0.

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Skar-Froding R, Clausen H, Saltyte Benth J, Ruud T, Slade M, S Heiervang K. Associations between personal recovery and service user-rated versus clinician-rated clinical recovery, a cross-sectional study. BMC Psychiatry. 2022 Jan 18;22(1):42. doi: 10.1186/s12888-022-03691-y.

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Nordin H, Rortveit K, Mathisen GE, Joa I, Johannessen JO, Ruud T, Hartveit M. Frontline leadership for implementing clinical guidelines in Norwegian mental health services: a qualitative study. J Health Organ Manag. 2022 Mar 8;ahead-of-print(ahead-of-print). doi: 10.1108/JHOM-08-2021-0286.

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Haugom EW, Stensrud B, Beston G, Ruud T, Landheim AS. Experiences of shared decision making among patients with psychotic disorders in Norway: a qualitative study. BMC Psychiatry. 2022 Mar 17;22(1):192. doi: 10.1186/s12888-022-03849-8.

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Hartveit M, Hovlid E, Ovretveit J, Assmus J, Bond G, Joa I, Heiervang K, Stensrud B, Hoifodt TS, Biringer E, Ruud T. Can systematic implementation support improve programme fidelity by improving care providers' perceptions of implementation factors? A cluster randomized trial. BMC Health Serv Res. 2022 Jun 22;22(1):808. doi: 10.1186/s12913-022-08168-y.

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Linde J, Schmid MT, Ruud T, Skar-Froding R, Biringer E. Social Factors and Recovery: A Longitudinal Study of Patients with Psychosis in Mental Health Services. Community Ment Health J. 2023 Feb;59(2):294-305. doi: 10.1007/s10597-022-01007-8. Epub 2022 Aug 17.

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Haugom EW, Benth JS, Stensrud B, Ruud T, Clausen T, Landheim AS. Shared decision making and associated factors among patients with psychotic disorders: a cross-sectional study. BMC Psychiatry. 2023 Oct 13;23(1):747. doi: 10.1186/s12888-023-05257-y.

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Nordin HMA, Mathisen GE, Rortveit K, Joa I, Johannessen JO, Ruud T, Hartveit M. Implementing Clinical Guidelines for the Treatment of Psychosis: The Frontline Leaders' Point of View. A Qualitative Study. J Healthc Leadersh. 2024 Feb 29;16:93-104. doi: 10.2147/JHL.S430285. eCollection 2024.

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Skar-Froding R, Clausen H, Ruud T, Saltyte Benth J, Veland M, Heiervang KS. The relationship between personal recovery, clinical symptoms, and psychosocial functioning over time among service users with psychosis. Psychiatr Rehabil J. 2025 Mar;48(1):23-31. doi: 10.1037/prj0000635. Epub 2025 Feb 10.

Reference Type DERIVED
PMID: 39928442 (View on PubMed)

Clausen H, Ruud T. The Practical and Social Functioning (PSF) scale: development and measurement properties of an instrument for assessing activity and social participation among people with serious mental illness. BMC Psychiatry. 2024 Oct 16;24(1):693. doi: 10.1186/s12888-024-06135-x.

Reference Type DERIVED
PMID: 39415117 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2015106

Identifier Type: -

Identifier Source: org_study_id

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