Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
Primary Purpose
Mental Health Disorders
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
A psychoeducational group intervention.
Sponsored by
About this trial
This is an interventional other trial for Mental Health Disorders focused on measuring Introductory Seminar, Waiting list, Community Mental Health Centre
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
Sites / Locations
- Tiller DPS
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
Treatment as usual
Introduction Seminar
Arm Description
Patients will receive treatment as usual
Psychoeducational group
Outcomes
Primary Outcome Measures
Selected Treatment
one single question
Health Care utilization
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Health Care utilization
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
coping
Patient Activation Measure (PAM-13)
Secondary Outcome Measures
Preferences for involvement in treatment decision making
Control Preferences Scale
Treatment Satisfaction
Client Satisfaction Questionnaire-8 (CSQ-8)
Quality of Life
WHO-Five Well-being Index (WHO-5)
Motivation
One single question about motivation for treatment.
Full Information
NCT ID
NCT01601587
First Posted
May 10, 2012
Last Updated
August 31, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01601587
Brief Title
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
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorders
Keywords
Introductory Seminar, Waiting list, Community Mental Health Centre
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Patients will receive treatment as usual
Arm Title
Introduction Seminar
Arm Type
Other
Arm Description
Psychoeducational group
Intervention Type
Other
Intervention Name(s)
A psychoeducational group intervention.
Intervention Description
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?
Primary Outcome Measure Information:
Title
Selected Treatment
Description
one single question
Time Frame
1 month
Title
Health Care utilization
Description
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Time Frame
1 year
Title
Health Care utilization
Description
Health care registration (adherence, attendance, consultations, dropout's rates and cost)
Time Frame
2 years
Title
coping
Description
Patient Activation Measure (PAM-13)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Preferences for involvement in treatment decision making
Description
Control Preferences Scale
Time Frame
Baseline, 1, 4 and 12 months
Title
Treatment Satisfaction
Description
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame
Baseline, 1, 4, and 12 months
Title
Quality of Life
Description
WHO-Five Well-being Index (WHO-5)
Time Frame
Baseline, 1, 4 and 12 months
Title
Motivation
Description
One single question about motivation for treatment.
Time Frame
Baseline, 1, 4 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olav Linaker, md phd
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tiller DPS
City
Trondheim
ZIP/Postal Code
7055
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
26682971
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.
Results Reference
result
Learn more about this trial
Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
We'll reach out to this number within 24 hrs