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NCT Number: NCT01601587

Introduction Seminar About Patient Participation and Treatment Options Decisional Preferences

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.

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Key information

Conditions

Mental Health Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tiller DPS

Trondheim, 7055, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A psychoeducational group intervention.

Other

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 outcomes

  1. Selected Treatment

    Time frame: 1 month

    one single question

  2. Health Care utilization

    Time frame: 1 year

    Health care registration (adherence, attendance, consultations, dropout's rates and cost)

  3. Health Care utilization

    Time frame: 2 years

    Health care registration (adherence, attendance, consultations, dropout's rates and cost)

  4. coping

    Time frame: 4 months

    Patient Activation Measure (PAM-13)

Secondary outcomes

  1. Preferences for involvement in treatment decision making

    Time frame: Baseline, 1, 4 and 12 months

    Control Preferences Scale

  2. Treatment Satisfaction

    Time frame: Baseline, 1, 4, and 12 months

    Client Satisfaction Questionnaire-8 (CSQ-8)

  3. Quality of Life

    Time frame: Baseline, 1, 4 and 12 months

    WHO-Five Well-being Index (WHO-5)

  4. Motivation

    Time frame: Baseline, 1, 4 and 12 months

    One single question about motivation for treatment.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study title

Introduction Seminar About Patient Participation, Treatment Options and Decisional Preferences for Psychiatric Outpatients on Waiting List

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 18, 2012
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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