Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): Study protocol for a cluster randomised controlled trial

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Johanna Breilmann - , Ulm University (Author)
  • Reinhold Kilian - , Ulm University (Author)
  • Steffi G. Riedel-Heller - , Leipzig University (Author)
  • Uta Gühne - , Leipzig University (Author)
  • Alkomiet Hasan - , Ludwig Maximilian University of Munich, Augsburg University (Author)
  • Peter Falkai - , Ludwig Maximilian University of Munich (Author)
  • Andreas Allgöwer - , Ulm University (Author)
  • Rainer Muche - , Ulm University (Author)
  • Thomas Becker - , Ulm University (Author)
  • Klemens Ajayi - , kbo-Isar-Amper-Clinics Munich (Author)
  • Peter Brieger - , kbo-Isar-Amper-Clinics Munich (Author)
  • Karel Frasch - , Ulm University, District hospital Donauwörth (Author)
  • Stephan Heres - , kbo-Isar-Amper-Clinics Munich (Author)
  • Markus Jäger - , Ulm University, Kempten District Hospital (Author)
  • Andreas Küthmann - , Memmingen Hospital (Author)
  • Albert Putzhammer - , District Hospital Kaufbeuren (Author)
  • Max Schmauß - , Augsburg University (Author)
  • Bertram Schneeweiß - , kbo-Isar-Amper-Clinics Munich (Author)
  • Michael Schwarz - , kbo-Isar-Amper-Clinics Munich (Author)
  • Markus Kösters - , Ulm University (Author)

Abstract

Background: The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. Methods: The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18-65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the 'empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders' (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. Discussion: The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. Trial registration: The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

Details

Original languageEnglish
Article number275
JournalTrials
Volume21
Issue number1
Publication statusPublished - 18 Mar 2020
Peer-reviewedYes
Externally publishedYes

External IDs

PubMed 32183897
ORCID /0000-0001-7018-6021/work/168207887

Keywords

Sustainable Development Goals

Keywords

  • Cluster randomised controlled trial, Guideline, Implementation, Patient version