Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01601587
First received: May 10, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Mental Health Disorders
Other: A psychoeducational group intervention.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Selected Treatment [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    one single question

  • Health Care utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Health care registration (adherence, attendance, consultations, dropout's rates and cost)

  • Health Care utilization [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Health care registration (adherence, attendance, consultations, dropout's rates and cost)


Secondary Outcome Measures:
  • Preferences for involvement in treatment decision making [ Time Frame: Baseline, 1, 4 and 12 months ] [ Designated as safety issue: No ]
    Control Preferences Scale

  • Treatment Satisfaction [ Time Frame: Baseline, 1, 4, and 12 months ] [ Designated as safety issue: No ]
    Client Satisfaction Questionnaire-8 (CSQ-8)

  • Quality of Life [ Time Frame: Baseline, 1, 4 and 12 months ] [ Designated as safety issue: No ]
    WHO-Five Well-being Index (WHO-5)

  • Motivation [ Time Frame: Baseline, 1, 4 and 12 months ] [ Designated as safety issue: No ]
    One single question about motivation for treatment.


Estimated Enrollment: 54
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual
Patients will receive treatment as usual
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:

  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?

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601587

Locations
Norway
Tiller DPS
Trondheim, Norway, 7055
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Principal Investigator: Olav Linaker, Dr.Med, Prof. NTNU
  More Information

Additional Information:
No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01601587     History of Changes
Other Study ID Numbers: 4.2009.77.2009/1980 ( part 2)
Study First Received: May 10, 2012
Last Updated: April 16, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian University of Science and Technology:
Introductory Seminar
Waiting list
Community Mental Health Centre

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014