Condition category
Mental and Behavioural Disorders
Date applied
12/07/2013
Date assigned
08/08/2013
Last edited
08/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Since 2007, Routine Outcome Monitoring (ROM) assessments have been a regular element in care for people with psychotic disorders in the northern provinces of the Netherlands. The ROM protocol which is specifically developed for people with psychotic disorders - this protocol is called Phamous - consists of a physical investigation (e.g., weight, height, waist measurement and glucose levels), multiple interviews and questionnaires concerning psychiatric and psychosocial issues, and service user satisfaction (www.phamous.eu). All service users with schizophrenia who receive care from any mental health care organization involved take part in ROM assessment at least once a year. After completion of the assessment, the parameters of the ROM assessment are uploaded into a central database by clinicians and research nurses via a link in the patient’s electronic file. Currently, the ROM-results are only reported to clinicians. Clinicians are supposed to discuss the results with their patients so that they can mutually decide whether the course of treatment needs readjustment. However, a large percentage of service users do not receive adequate feedback concerning their ROM-results, as clinicians are not yet accustomed to discussing ROM results with service users.
In an attempt to improve ROM practice and to increase potential for service user empowerment, we developed a prototype of a web-based support system that provides service users diagnosed with accessible information about their ROM results, which may enable them to participate in shared decision making.

Who can participate?
Male and female patients aged >18 years diagnosed with a psychotic disorder, fluent in Dutch and participating in Phamous assessments.

What does the study involve?
In this study, participants will be randomly allocated to an intervention group or a control group. In the intervention group, patients are invited to use the web-based support system. This web system provides patients with information about ROM, access to their ROM results, and access to individualized advice based on these ROM results. Patients in the control group receive care as usual.

What are the possible benefits and risks of participating?
Patients in the intervention group can benefit from participating in the study as they can access their ROM results and get personalized advice based on these results. As a consequence, they have the opportunity to better prepare themselves for the ROM evaluation meeting with their clinician. We do not expect any risks.

Where is the study run from?
The study takes place at the University Center for Psychiatry at the University Medical Center Groningen, the Netherlands.

When is the study starting and how long is it expected to run for?
The study started in March 2013 and will run until November 2013.

Who is funding the study?
1. Netherlands Organisation for Health Research and Development (ZonMw)
2. Foundation for Mental Health (Fonds Psychische Gezondheid), Netherlands)
3. ICT regie, Netherlands
3. Ministry of Health, Welfare and Sport under the name WEGWEIS, Netherlands

Who is the main contact?
Dr Sjoerd Sytema
s.sytema@umcg.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sjoerd Sytema

ORCID ID

Contact details

Hanzeplein 1
Groningen
9700 RB
Netherlands
+31 (0)50 3614678
s.sytema@umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A web-based tool to support shared decision making between clinicians and patients in routine outcome monitoring (ROM): a pilot randomised controlled trial

Acronym

Study hypothesis

We hypothesize that a web-based tool can support processes of shared decision making between patients with a psychotic disorder and their clinicians, in the evaluation of routine outcome monitoring results.

Ethics approval

The medical ethical committee of the University Medical Center Groningen approved our study. Number: METc 2012/367

Study design

Pilot randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Psychotic disorders

Intervention

The intervention is behavioural in nature. It should lead to more patient involvement in medical decision making. In the intervention condition, patients are invited to use the web-based support system that provides patients with information about ROM, access to their ROM results, and access to individualized advice based on these ROM results.
Patients in the control condition receive care as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The degree of shared decision making between patients and clinicians, measured with conversation analysis of audio-taped conversation (using the Mappin' SDM rating instrument, and items of the RIAS).

Secondary outcome measures

Satisfaction with the web-based support tool, knowledge of one's treatment goals, patient's perceived benefit of ROM

Overall trial start date

08/03/2013

Overall trial end date

30/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Patients with psychotic disorders
3. Participating in Phamous assessments (ROM assessments for people with psychotic disorder)
4. Fluent in Dutch

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

08/03/2013

Recruitment end date

30/11/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Hanzeplein 1
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Postbox 93 245
The Hague
2509 AE
Netherlands
+31 (0)70 349 51 11
info@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl/en/contact/

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Foundation for Mental Health (Fonds Psychische Gezondheid) (Netherlands)

Alternative name(s)

Foundation for Mental Health

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

ICT regie (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ministry of Health, Welfare and Sport under the name WEGWEIS (grant number 300020011) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes