Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01601587
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2012-05-10
Brief Title:
Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Introduction Seminar About Patient Participation Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participantsexperience and the seminars effect
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 participantsexperience and the seminars 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 patients 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 138 and 97 Pilot RCT data The numbers needed in each group becomes 25 calculated using SamplePower v20 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
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 patients 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 138 and 97 Pilot RCT data The numbers needed in each group becomes 25 calculated using SamplePower v20 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None