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Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601587
First Posted: May 18, 2012
Last Update Posted: June 14, 2017
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.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
May 10, 2012
May 18, 2012
June 14, 2017
May 2012
June 2015   (Final data collection date for primary outcome measure)
  • 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)
  • Selected Treatment [ Time Frame: From Baseline to 1 month ]
    one single question
  • Coping [ Time Frame: From Baseline to 4 month ]
    Patient Activation Measure (PAM-13) will be the intermediate main outcome and will be measured at 4 month.
  • Health Care utilization [ Time Frame: From Baseline to 2 years ]
    Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Complete list of historical versions of study NCT01601587 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Mental Health Disorders
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:

  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?
  • No Intervention: Treatment as usual
    Patients will receive treatment as usual
  • Introduction Seminar
    Psychoeducational group
    Intervention: Other: A psychoeducational group intervention.
Lara-Cabrera ML, Salvesen Ø, Nesset MB, De las Cuevas C, Iversen VC, Gråwe 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
June 2015
June 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01601587
4.2009.77.2009/1980 ( part 2)
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
St. Olavs Hospital
Principal Investigator: Olav Linaker, md phd NTNU
Norwegian University of Science and Technology
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP