跳至主要内容
临床试验/NCT03271242
NCT03271242已完成不适用

A Pairwise Randomized Study on Implementation of Guidelines and Evidence Based Treatments of Psychoses

University Hospital, Akershus0 个研究点目标入组 325 人开始时间: 2016年6月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
325
主要终点
Implementation Study: Fidelity to the model for each evidence-based practice

研究概览

简要总结

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.

详细描述

(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?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: Baseline to 18 months (0, 6, 12 and 18 months)

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

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

时间窗: Baseline to 18 months (0, 6, 12 and 18 months)

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

次要结局

  • 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))
  • 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 practical and social functioning(Baseline (0 months) and 18 months)
  • Patient Sub-Study: Clinician assessment of patient global functioning(Baseline to 18 months (0, 6, 12 and 18 months))
  • Patient Sub-Study: Clinician assessment of patient substance use last 6 months(Baseline to 18 months (0, 6, 12 and 18 months))

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Torleif Ruud

Senior Researcher, Professor emeritus

University Hospital, Akershus

相似试验

Implementation of National Guidelines for Treatment... | 临床试验