A web-based tool to support shared decision making between clinicians and patients in routine outcome monitoring
| ISRCTN | ISRCTN51103766 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51103766 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/07/2013
- Registration date
- 08/08/2013
- Last edited
- 08/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 patients 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
Contact information
Scientific
Hanzeplein 1
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3614678 |
|---|---|
| s.sytema@umcg.nl |
Study information
| Study design | Pilot randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | The medical ethical committee of the University Medical Center Groningen approved our study. Number: METc 2012/367 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 08/03/2013 |
| Completion date | 30/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 08/03/2013 |
| Date of final enrolment | 30/11/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
9700 RB
Netherlands
Sponsor information
Research organisation
Postbox 93 245
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 349 51 11 |
|---|---|
| info@zonmw.nl | |
| Website | http://www.zonmw.nl/en/contact/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Foundation for Mental Health
- Location
- Netherlands
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
