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.

Study Overview

• Status: Completed
• Conditions: Mental Health Disorders
• Intervention / Treatment: Other: A psychoeducational group intervention.

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7055
    • Tiller DPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual; Patients will receive treatment as usual
Other: Introduction Seminar; Psychoeducational group	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: 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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Selected Treatment	one single question	1 month
Health Care utilization	Health care registration (adherence, attendance, consultations, dropout's rates and cost)	1 year
Health Care utilization	Health care registration (adherence, attendance, consultations, dropout's rates and cost)	2 years
coping	Patient Activation Measure (PAM-13)	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preferences for involvement in treatment decision making	Control Preferences Scale	Baseline, 1, 4 and 12 months
Treatment Satisfaction	Client Satisfaction Questionnaire-8 (CSQ-8)	Baseline, 1, 4, and 12 months
Quality of Life	WHO-Five Well-being Index (WHO-5)	Baseline, 1, 4 and 12 months
Motivation	One single question about motivation for treatment.	Baseline, 1, 4 and 12 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: St. Olavs Hospital
• Investigators: Principal Investigator: Olav Linaker, md phd, National Taiwan Normal University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 18, 2012

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: August 31, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Waiting list; Introductory Seminar; Community Mental Health Centre
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 4.2009.77.2009/1980 ( part 2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No