CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 460 enrolled
Drug / intervention
Implementation support programother
Likely dose
Not stated in record
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Search/NCT03869177
NCT03869177N/ACompleted

Implementation of Guidelines on Family Involvement for Persons With Psychotic Disorders in Community Mental Health Centres. A Cluster Randomised Controlled Trial.

University of Oslo·interventional·Posted Mar 11, 2019·Updated Jan 4, 2023

In Brief

A clinical study evaluating Implementation support program for Psychotic Disorders. Completed, enrolled 460 participants across 15 sites.

Detailed Summary

This study will develop and evaluate a complex intervention to implement guidelines on family involvement for patients with psychotic disorders (F20-29 in International Classification of Diseases ICD-10) in community mental health centres, by using a cluster randomised design. Fifteen Norwegian outpatient units participate in the study, and each of them constitutes a single cluster, except for two collaborating clinics who are considered one cluster. Of the fourteen clusters, half will receive implementation support and training immediately, whereas the other half will receive it one and a half year later. The study will assess both service level outcomes, by measuring fidelity scores, and selected outcomes for patients and relatives, by collecting questionnaires and data from central health registers and patient records. In addition, qualitative interviews will be performed with patients, relatives and health care personnel. The study will also include a cost-effectiveness analysis and a political economy analysis.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 11, 2019
Enrollment StartMar 21, 2019
Primary CompletionNov 30, 2021
Study CompletionMay 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 7.3 years ago

Interventions

Implementation support programother

The IFIP intervention consists of the following elements: I. Clinical interventions 1.1 A basic level of family involvement and support 1.2 Family psychoeducation in single-family groups II. Implementation interventions 2.1 Training and guidance of health care personnel 2.2 A family coordinator 2.3 Other implementation measures