Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
Condition: Mental Health Disorders
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Patient participation (PP) in Hospital is a goal defined by the Norwegian Health Authorities
      and it is a mandatory activity for District Psychiatric out-patient Centres (DPC) in Norway:
      patients are entitled to have influence on their treatment and should receive sufficient
      information directed at empowerment. Nevertheless, studies from Norway have found that
      patients who seek help are dissatisfied with the information they receive and doubt their
      possibility for real influence on their treatment. One way to improve individual PP might be
      to give patients sufficient information and education before they start their treatment in
      the form of an educational group intervention, an introduction seminar (IS); this group
      intervention is less time and resource consuming than individual interventions.

      Aims: The main purpose of this project is to develop and evaluate an IS for patients on a
      waiting list of DPC. The seminar will educate patients, so they can actively participate in
      their own treatment and, thereby, choosing treatment, reducing the risk of dropping out of
      treatment. Another aim is to enable patients to participate in their own treatment, to cope
      with their problems while they are waiting for treatment by providing them contact with
      primary health care and user organizations during their waiting time, and to increase
      adherence.

      Methods: The project involves three components: an exploratory study of educational content
      of the seminar; RCT of that 4-hours program (to examine its effect on treatment preferences
      and choices, activation, satisfaction, mental health and cost-benefit) and then a
      post-seminar qualitative evaluation, which will be used to create a broad yet deep
      understanding of the practical side of the participants'experience and the seminar's effect.
    

Detailed description: 
      Part I: An exploratory study of educational content of the seminar: a qualitative study
      (started october 2011)

      Part II (RCT)

      The intervention:

      The introduction seminar will be held over one half day, 4 hours. Up to 15 patients can
      participate in each seminar. The content was developed based on study 1. The presentation
      about available treatment options and patient's rights are made by multi professional health
      personnel and user representatives. More specifically, this will be done under the following
      topics:

        1. What is mental health?

        2. Treatment options: orientation about individual and group based treatment modalities.

        3. Former patients experience with their own treatment, self-help and participation.

        4. How to influence and participate actively in the treatment and patient rights.

        5. What can I do while I wait for treatment and where can I otherwise do to avoid
           aggravation?.

      At the end of the day, the patients will be divided into small groups mentored by health
      personnel where they can discuss the presentations and ask questions. In the breaks,
      literature and other kinds of information for patients will be on display. All participants
      will get a folder with details of the program and leaflets from patient organisations and
      governmental agencies.

      Sample size Selected Treatment: The number of patients is calculated based on a significance
      level of 5% and a power of 93%. The numbers needed in each group becomes 25 (calculated using
      IR), and the aim is to include a total of 52 patients in the RCT. It is controlled that it is
      feasible to recruit this number of patients.

      PAM: Number of patients is calculated based on a significance level of 5% and a power of 87%.
      The standard deviation is estimated to be 13.8 and 9.7 (Pilot RCT data). The numbers needed
      in each group becomes 25 (calculated using SamplePower v2.0, SPSS Inc), and the aim is to
      include a total of 52 patients. It is controlled that it is feasible to recruit this number
      of patients.

      Part III Qualitative and quantitative analysis:

      To obtain information about the patients experience after the intervention, a post-seminar
      qualitative evaluation will be conducted:

      15 randomly selected patients will additionally participate in the seminar, and they will be
      take part in Part III and in the quantitative part of the study.
    

Intervention name(s): A psychoeducational group intervention.
Intervention type(s): Other
Intervention description(s): The intervention is an introduction seminar. It will be held over FOUR hours. Up to 15 patients can participate in each seminar. The content of the was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics:
What is mental health?
Treatment options: orientation about individual and group based treatment modalities.
Former patients experience with their own treatment, self-help and participation.
How to influence and participate actively in the treatment and patient rights.
What can I do while I wait for treatment and where can I otherwise do to avoid aggravation?
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Introductory Seminar; Waiting list; Community Mental Health Centre