Condition category
Mental and Behavioural Disorders
Date applied
27/05/2016
Date assigned
06/07/2016
Last edited
06/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Schizophrenia is a serious mental health problems that affects how a person thinks, feels and behaves. Schizoaffective disorder is a serious mental illness that has features of both schizophrenia, and an affective (mood) disorder, such as depression (low mood). Traditionally, deciding upon the most appropriate treatment for patients is done by doctors. This study is looking at a shared decision making (SDM) approach, in which patients work with nurse to present a summary of the patient's preferences regarding treatment. The aim of this study is to find out whether this participative way of making decisions of which treatment to take at discharge from acute (sudden) hospitalization is better than a more doctor-driven decision making in treatment compliance and readmissions at 12 months.

Who can participate?
Adults diagnosed of schizophrenia or schizoaffective disorder who have been admitted to Jerez Adult Psychiatric Hospitalization Unit and will be prescribed antipsychotic medication at discharge.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the shared decision making (SDM) program, which is made up of two stages, the informative stage and the deliberative stage. The informative stage is made up of three sessions, lasting for 30-90 minutes in which the patients are given the information they need about different treatments and put together a summary of their treatment preferences with a nurse. The deliberative stage involves the treatment proposal being reviewed by the psychiatrist and patient together in a further 90 minute session in which the decision of treatment is finalized. Those in the second group take part in usual care, which involves the patient's treatment being decided by the medical team. Participants in both groups complete a number of questionnaires at the start of the study, and again after 3, 6 and 12 months in order to find out if their symptoms has improved, as well as the patients' confidence about the treatment decisions made.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part but there should be benefits in the future, as the results of the study are likely to influence the implementation of shared decision making and empowerment policies and in our care system. There are no notable risks to participants is the study as both groups will receive the best available treatment options.

Where is the study run from?
Jerez General Hospital (Spain)

When is the study starting and how long is it expected to run for?
January 2014 to June 2017

Who is funding the study?
Andalusian Regional Government (Spain)

Who is the main contact?
1. Dr José Ildefonso Pérez-Revuelta (public)
2. Dr José M. Villagrán-Moreno (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr José Ildefonso Pérez-Revuelta

ORCID ID

Contact details

Unidad de Hospitalización de Salud Mental
Hospital Jerez de la Frontera
Carretera de Circunvalación s/n
Jerez de la Frontera
Cádiz
11407
Spain

Type

Scientific

Additional contact

Dr José M. Villagrán-Moreno

ORCID ID

Contact details

Unidad de Hospitalización de Salud Mental
Hospital Jerez de la Frontera
Carretera de Circunvalación s/n
Jerez de la Frontera
Cádiz
11407
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI-0309-2013

Study information

Scientific title

DECIDE Study: Effectiveness of shared decision making in the choice of antipsychotic treatment at discharge from a hospitalization after an acude episode in schizophrenic patients

Acronym

DECIDE Study

Study hypothesis

A two-stage shared decision making program on antipsychotic drug choice is better than treatment as usual with respect to long term compliance and rehospitalisations among schizophrenic inpatients to be discharged from an acute hospitalization.

Ethics approval

Comité de Ética de la Investigación (CEI) del Área Sanitaria Jerez-Costa Noroeste y Sierra de Cádiz (Research Ethics Board Jerez-Costa Noroeste-Sierra de Cádiz Health Area), 21/11/2013, ref: PI-0309-2013

Study design

Prospective single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (available in Spanish)

Condition

Schizophrenia and schizoaffective disorders

Intervention

Following provision of informed consent, participants are randomly allocated to one of two groups.

Shared decision making (SDM) group: Participants receive the SDM program which is delivered by trained psychiatrists and nurses and consists of two stages: informative and deliberative. The informative stage (IS) includes three sessions:
1. An introduction to the program by the nurse (30 minutes) in which information sheets adapted at patient’s educational level are used
2. An exploratory session (Es) run by psychiatrist and nurse (90 minutes) in which they convey information on the disorder, appropriate management and different treatment options by using treatment decision aids, whereas the patient expresses his/her preferences and values
3. A confirmatory session (Cs) (30 minutes) in which patient and nurse jointly elaborate a personal decision guide which summarizes patient’s preferences.
The IS will be implemented in 48-72 hours. Once the IS has been completed, psychiatrist and patient engage in the deliberative stage (DS), a 90 minute-session that includes deliberation upon the personal decision guide of the patient and adopting a consensual decision on the antipsychotic treatment at discharge. The DS will be implemented in the 48 hours before the discharge.

Treatment as usual (TAU) group: Participants receive treatment as usual for the duration of the intervention. The treatment used for each participant is decided upon by each participants usual care team.

Participants in both groups will be evaluated at 3, 6 at 12 months after discharge. Those in the SDM group will receive SDM booster sessions (45 minutes) at 3 and 6 months whereas those in TAU will receive routine care.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Antipsychotic treatment adherence is measured using the Brief Adherence Rating Scale (BARS) and the Drug Attitude Inventory (DAI) at baseline, 3, 6 and 12 months

Secondary outcome measures

1. Readmission rate is measured through medical record review at 3, 6 and 12 months
2. Quality of doctor-patient relationship measured using the Working Alliance Inventory Short Version (WAI-S) at baseline, 3, 6 and 12 months
3. Patient satisfaction with intervention and confidence on decision taken is measured using the Combined Outcome Measure Communication and Treatment Decision making Effectiveness Scale (COMRADE Scale) at baseline, 3, 6 and 12 months
4. Patient perception of hospitalization is measured using the Picker Patient Experience Questionnaire (PPE-15) at discharge

Overall trial start date

01/01/2014

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18 years and over
2. Diagnosed of schizophrenia (ICD-10: F20) or schizoaffective disorder (ICD-10: F.25)
3. Admitted to Jerez Adult Psychiatric Hospitalization Unit
4. Prescribed antipsychotic medication at discharge

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Patients who refuse to sign informed consent
2. Patients who lack capacity in the moment of entering the study,as measured by the Aid to Capacity Evaluation (ACE)
3. Patients with a comorbid diagnosis of severe or moderate mental retardation
4. Patients with poor knowledge or communication skills in Spanish

Recruitment start date

01/03/2014

Recruitment end date

30/06/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital de Jerez de la Frontera
Unidad Hospitalaria de Salud Mental Servicio Andaluz de Salud Carretera de Circunvalación S/N Jerez de la Frontera
Cádiz
11407
Spain

Sponsor information

Organisation

Foundation for Biomedical Research Management Cadiz (Fundación para la Gestión de la Investigación Biomedica de Cádiz)

Sponsor details

Avda. María Auxiliadora
2
Cádiz
11009
Spain

Sponsor type

Research council

Website

http://www.fundacioncadiz.es/

Funders

Funder type

Government

Funder name

Andalusian Regional Government

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

30/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes