Clinical trial NCT01601587: Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
Official title: Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorders
Keywords: Introductory Seminar
Waiting list
Community Mental Health Centre
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2012-05-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* older than 18 years
* referred for out-patient treatment
* guarantee of starting treatment between 2 and 4 months

Exclusion Criteria:

* guarantee of starting treatment in less than 2 months
* Patients who do not understand the consequences of taking part of the study

Primary outcomes:
measure: Selected Treatment
timeFrame: 1 month
measure: Health Care utilization
timeFrame: 1 year
measure: Health Care utilization
timeFrame: 2 years
measure: coping
timeFrame: 4 months
Secondary outcomes:
measure: Preferences for involvement in treatment decision making
timeFrame: Baseline, 1, 4 and 12 months
measure: Treatment Satisfaction
timeFrame: Baseline, 1, 4, and 12 months
measure: Quality of Life
timeFrame: Baseline, 1, 4 and 12 months
measure: Motivation
timeFrame: Baseline, 1, 4 and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Tiller DPS
Study officials:
affiliation: National Taiwan Normal University
name: Olav Linaker, md phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lara-Cabrera ML, Salvesen O, Nesset MB, De las Cuevas C, Iversen VC, Grawe RW. The effect of a brief educational programme added to mental health treatment to improve patient activation: A randomized controlled trial in community mental health centres. Patient Educ Couns. 2016 May;99(5):760-8. doi: 10.1016/j.pec.2015.11.028. Epub 2015 Dec 2.