Implementation of National Guidelines for Treatment of Psychoses

NCT03271242 | Completed

• 1 other identifier: 2015106
• Study Type: observational
• Target: 325
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (2)

• Implementation Study: Fidelity to the model for each evidence-based practice

  Fidelity scales for each practice, with 10-17 items rated from 1 (low) to 5 (high).

  Baseline to 18 months (0, 6, 12 and 18 months)

• Patient Sub-Study: Patient satisfaction with each evidence-based practice

  Set of 5-7 questions developed for each practice, rated 1-5 on a likert scale by patients

  Baseline to 18 months (0, 6, 12 and 18 months)

Secondary Outcomes (8)

• Patient Sub-Study: Patient general satisfaction with the mental health services

  Baseline (0 months) and 18 months

• Patient Sub-Study: Patient experiences of their own mental health and functioning

  Baseline to 18 months (0, 6, 12 and 18 months)

• Patient Sub-Study: Patient experiences of their own personal recovery

  Baseline (0 months) and 18 months

• Patient Sub-Study: Clinician assessment of patient mental health and functioning

  Baseline to 18 months (0, 6, 12 and 18 months)

• Patient Sub-Study: Clinician assessment of patient mental health

  Baseline to 18 months (0, 6, 12 and 18 months)

Other Outcomes (3)

• Patient experiences of the extent of emphasis on personal recovery by the services

  Baseline (0 months) and 18 months

• Patient experience of the extent of shared decision-making

  Baseline to 18 months (0, 6, 12 and 18 months)

• Implementation study: Clinician readiness for change

  Baseline to 18 months (0, 6, 12 and 18 months)

Study Arms (2)

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

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

Interventions

Systematic implementation support 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.

Implementation support

No implementation support 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.

No implementation support

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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+.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University Hospital of North Norway: collaborator
• Helse Fonna: collaborator
• Helse Stavanger HF: collaborator
• Sorlandet Hospital HF: collaborator
• Sykehuset Innlandet HF: collaborator
• Westat: collaborator
• Mental helse: collaborator

Related Publications (42)

• Weinmann S, Koesters M, Becker T. Effects of implementation of psychiatric guidelines on provider performance and patient outcome: systematic review. Acta Psychiatr Scand. 2007 Jun;115(6):420-33. doi: 10.1111/j.1600-0447.2007.01016.x.

  PMID: 17498153 BACKGROUND

• Tansella M, Thornicroft G. Implementation science: understanding the translation of evidence into practice. Br J Psychiatry. 2009 Oct;195(4):283-5. doi: 10.1192/bjp.bp.109.065565.

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• Torrey WC, Drake RE, Dixon L, Burns BJ, Flynn L, Rush AJ, Clark RE, Klatzker D. Implementing evidence-based practices for persons with severe mental illnesses. Psychiatr Serv. 2001 Jan;52(1):45-50. doi: 10.1176/appi.ps.52.1.45.

  PMID: 11141527 BACKGROUND

• 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 BACKGROUND

• Torrey WC, Bond GR, McHugo GJ, Swain K. Evidence-based practice implementation in community mental health settings: the relative importance of key domains of implementation activity. Adm Policy Ment Health. 2012 Sep;39(5):353-64. doi: 10.1007/s10488-011-0357-9.

  PMID: 21574016 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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  PMID: 23159157 BACKGROUND

• 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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  PMID: 15550803 BACKGROUND

• Law H, Neil ST, Dunn G, Morrison AP. Psychometric properties of the questionnaire about the process of recovery (QPR). Schizophr Res. 2014 Jul;156(2-3):184-9. doi: 10.1016/j.schres.2014.04.011. Epub 2014 May 9.

  PMID: 24816049 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

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• 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

  BACKGROUND

• Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.

  PMID: 10443245 BACKGROUND

• Wing JK, Beevor AS, Curtis RH, Park SB, Hadden S, Burns A. Health of the Nation Outcome Scales (HoNOS). Research and development. Br J Psychiatry. 1998 Jan;172:11-8. doi: 10.1192/bjp.172.1.11.

  PMID: 9534825 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Hoifodt TS, Lund-Stenvold E, Hoye A. Don't forget the teeth. Tidsskr Nor Laegeforen. 2018 Nov 27;138(20). doi: 10.4045/tidsskr.18.0581. Print 2018 Dec 11. No abstract available. English, Norwegian.

  PMID: 30539603 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 33964917 RESULT

• Hoifodt TS. [Good dental health for all]. Tidsskr Nor Laegeforen. 2021 Sep 10;141. doi: 10.4045/tidsskr.21.0597. Print 2021 Sep 28. No abstract available. Norwegian.

  PMID: 34597002 RESULT

• 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.

  PMID: 35042494 RESULT

• 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.

  PMID: 35253414 RESULT

• 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.

  PMID: 35300633 RESULT

• 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.

  PMID: 35733211 RESULT

• 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.

  PMID: 35976477 RESULT

• 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.

  PMID: 37833737 RESULT

• 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.

  PMID: 38440078 RESULT

• Ruud T, Benth JS, Biringer E, Hartveit M, Drivenes K, Heiervang K, Hoifodt TS, Haaland VO, Joa I, Johannessen JO, Johansen KJ, Stensrud B, Haugom EW, Clausen H, Bond GR. A secondary exploratory study of associations between patient- and clinician-reported clinical outcomes and fidelity for four evidence-based psychosis treatments. BMC Psychiatry. 2025 Nov 28;25(1):1134. doi: 10.1186/s12888-025-07566-w.

  PMID: 41316110 DERIVED

• 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.

  PMID: 39928442 DERIVED

• 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.

  PMID: 39415117 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Torleif Ruud, MD, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher, Professor emeritus

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 5, 2017
• Study Start: June 22, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share