NCT03271242

Implementation of National Guidelines for Treatment of Psychoses

Completed Last updated 2 April 2025

What this trial tests

trial testing Systematic implementation support in Psychotic Disorders in 325 participants. Completed in 31 December 2018.

Timeline

22 June 2016

Primary endpoint
31 December 2018

31 December 2018

Quick facts

Lead sponsor	University Hospital, Akershus
Status	Completed
Study type	OBSERVATIONAL
Enrollment	325
Start date	22 June 2016
Primary completion	31 December 2018
Estimated completion	31 December 2018

Drugs / interventions tested

• Systematic implementation support
• No implementation support

Conditions studied

• Psychotic Disorders — all drugs for Psychotic Disorders →

Sponsor

University Hospital, Akershus

Who can join

16 and older, any sex, with Psychotic Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Relationship between satisfaction with mental health services, personal recovery and quality of life among service users with psychosis: a cross-sectional study.
   Skar-Fröding R, Clausen HK, Šaltytė Benth J, Ruud T, et al · · 2021 · cited 18× · PMID 33964917 · DOI 10.1186/s12913-021-06409-0
2. Measuring implementation: development of the implementation process assessment tool (IPAT).
   Hartveit M, Hovlid E, Nordin MHA, Øvretveit J, et al · · 2019 · cited 15× · PMID 31638967 · DOI 10.1186/s12913-019-4496-0
3. The Family Psychoeducation Fidelity Scale: Psychometric Properties.
   Joa I, Johannessen JO, Heiervang KS, Sviland AA, et al · · 2020 · cited 12× · PMID 32323217 · DOI 10.1007/s10488-020-01040-3
4. Psychometric Properties of a Fidelity Scale for Illness Management and Recovery.
   Egeland KM, Heiervang KS, Landers M, Ruud T, et al · · 2020 · cited 12× · PMID 31701294 · DOI 10.1007/s10488-019-00992-5
5. The Effect of Intensive Implementation Support on Fidelity for Four Evidence-Based Psychosis Treatments: A Cluster Randomized Trial.
   Ruud T, Drake RE, Šaltytė Benth J, Drivenes K, et al · · 2021 · cited 11× · PMID 33871742 · DOI 10.1007/s10488-021-01136-4
6. The Physical Health Care Fidelity Scale: Psychometric Properties.
   Ruud T, Høifødt TS, Hendrick DC, Drake RE, et al · · 2020 · cited 10× · PMID 32036479 · DOI 10.1007/s10488-020-01019-0
7. Associations between personal recovery and service user-rated versus clinician-rated clinical recovery, a cross-sectional study.
   Skar-Fröding R, Clausen H, Šaltytė Benth J, Ruud T, et al · · 2022 · cited 9× · PMID 35042494 · DOI 10.1186/s12888-022-03691-y
8. Psychometric Properties of the General Organizational Index (GOI): A Measure of Individualization and Quality Improvement to Complement Program Fidelity.
   Heiervang KS, Egeland KM, Landers M, Ruud T, et al · · 2020 · cited 9× · PMID 32107674 · DOI 10.1007/s10488-020-01025-2