Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01601587|
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : September 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Disorders||Other: A psychoeducational group intervention.||Not Applicable|
Part I: An exploratory study of educational content of the seminar: a qualitative study (started october 2011)
Part II (RCT)
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:
- 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?.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List|
|Actual Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
No Intervention: Treatment as usual
Patients will receive treatment as usual
Other: A psychoeducational group intervention.
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:
- Selected Treatment [ Time Frame: 1 month ]one single question
- Health Care utilization [ Time Frame: 1 year ]Health care registration (adherence, attendance, consultations, dropout's rates and cost)
- Health Care utilization [ Time Frame: 2 years ]Health care registration (adherence, attendance, consultations, dropout's rates and cost)
- coping [ Time Frame: 4 months ]Patient Activation Measure (PAM-13)
- Preferences for involvement in treatment decision making [ Time Frame: Baseline, 1, 4 and 12 months ]Control Preferences Scale
- Treatment Satisfaction [ Time Frame: Baseline, 1, 4, and 12 months ]Client Satisfaction Questionnaire-8 (CSQ-8)
- Quality of Life [ Time Frame: Baseline, 1, 4 and 12 months ]WHO-Five Well-being Index (WHO-5)
- Motivation [ Time Frame: Baseline, 1, 4 and 12 months ]One single question about motivation for treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601587
|Trondheim, Norway, 7055|
|Principal Investigator:||Olav Linaker, md phd||NTNU|