Psychosis Clinical Trial
— DEALOfficial title:
Shared Decision Making in Psychiatric Inpatient Care to Enhance Patient Participation
Introduction
National guidelines and The Patient Act from 2014 call for an active role for the patient in
the decision making process. The role of the doctor is not only to give advice and to
prescribe treatments, but also to present different alternatives with pros and cons. The
method of Shared Decision Making (SDM) is meant to improve patient participation in line with
ethical guidelines and legal demands. In summary, SDM consists of three steps:
1. To introduce a choice.
2. To discuss the options.
3. To make a shared decision. Systematic studies on SDM show patients becoming better
informed and less uncertain regarding decisions made, and decisions closer to clinical
guidelines compared to treatment as usual (TAU). It is still unresolved if SDM leads to
improved clinical outcomes.
Aim
The aim of the study is to investigate outcomes of SDM carried out in psychiatric inpatient
care: the patients' perceived participation (primary outcome) and health related outcomes
(secondary).
Method
The decision situation in focus for this project is the planning of hospital discharge and
future outpatient care. The participants are randomized to either SDM or TAU. Patient
participation will be measured by questionnaires, interviews with patients and recorded
decision talks. Clinical outcomes will be measured 12 months after discharge.
Preliminary results
A pilot study conducted in 2017-2018 clarified the feasibility of instruments and the
intervention, and gave data for power estimation.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | December 2022 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Admission to psychiatric inpatient care. - Informed consent to study participation. Exclusion Criteria: - Lack of basic language skills in Swedish. - Earlier enrollment in the study. |
Country | Name | City | State |
---|---|---|---|
Sweden | Ward 5, Stockholms Norra Psykiatri | Stockholm | Sverige |
Sweden | Ward 1 and 2, Umeå Psykiatri | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University |
Sweden,
Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. Epub 2012 May 23. Review. — View Citation
Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Shared decision making and long-term outcome in schizophrenia treatment. J Clin Psychiatry. 2007 Jul;68(7):992-7. — View Citation
Joosten EA, DeFuentes-Merillas L, de Weert GH, Sensky T, van der Staak CP, de Jong CA. Systematic review of the effects of shared decision-making on patient satisfaction, treatment adherence and health status. Psychother Psychosom. 2008;77(4):219-26. doi: 10.1159/000126073. Epub 2008 Apr 16. Review. — View Citation
Slade M. Implementing shared decision making in routine mental health care. World Psychiatry. 2017 Jun;16(2):146-153. doi: 10.1002/wps.20412. — View Citation
Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017 Apr 12;4:CD001431. doi: 10.1002/14651858.CD001431.pub5. Review. — View Citation
Stovell D, Morrison AP, Panayiotou M, Hutton P. Shared treatment decision-making and empowerment-related outcomes in psychosis: systematic review and meta-analysis. Br J Psychiatry. 2016 Jul;209(1):23-8. doi: 10.1192/bjp.bp.114.158931. Epub 2016 May 19. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of patient perceived participation | Measurement with the questionnaire Dyadic OPTION, with a sum score of 1-44 where 44 is the highest perceived participation. | Measurement 6 weeks after inclusion or at discharge if earlier. | |
Primary | Level of patient perceived participation | Measurement with the questionnaire SDM-Q-9 with a sum score of 0-45 where 45 is the highest perceived participation. | Measurement 6 weeks after inclusion or at discharge if earlier. | |
Primary | Level of patient perceived participation | Measurement with the questionnaire Collaborate with a sum score of 0-12 where 12 is the highest perceived participation. | Measurement 6 weeks after inclusion or at discharge if earlier. | |
Primary | Level of patient perceived participation | Measurement with the questionnaire SURE, (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) screening test for decisional conflict in patients, with a sum score of 0-4 where 4 is the highest perceived participation. | Measurement 6 weeks after inclusion or at discharge if earlier. | |
Secondary | Percentage of carried out planned outpatient visits | 1 year | ||
Secondary | Number of rehospitalisations | 1 year | ||
Secondary | Days of compulsory care | 1 year | ||
Secondary | Number of episodes of compulsory care | 1 year | ||
Secondary | Number of inpatient days | 1 year | ||
Secondary | Number of emergency visits | 1 year | ||
Secondary | Days until rehospitalisation | 1 year | ||
Secondary | Percentage of decisions on social support carried out | 1 year | ||
Secondary | Level of quality of Life: EuroQol EQ-5D | Measurement with the questionnaire EuroQol EQ-5D with a score of 0-1 where 1 is the highest quality of life. | Measurement 6 weeks after inclusion or at discharge if earlier. | |
Secondary | Level of quality of Life: EuroQol EQ-VAS | Measurement with the questionnaire EuroQol EQ-VAS with a score of 0-100 where 100 is the highest quality of life. | Measurement 6 weeks after inclusion or at discharge if earlier. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04929938 -
Application of UP for Transdiagnostic Treatment of Emotional Disorders for UHR for Psychosis Patients
|
N/A | |
Recruiting |
NCT05863572 -
Strengthening Care in Collaboration With People With Lived Experience of Psychosis in Uganda
|
N/A | |
Completed |
NCT04277585 -
Improving Access to Early Psychosis Coordinated Specialty Care
|
N/A | |
Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
Not yet recruiting |
NCT05558332 -
Youth Nominated Support Team
|
N/A | |
Not yet recruiting |
NCT05358457 -
Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)
|
N/A | |
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Completed |
NCT02895269 -
COllaborative Shared Care to IMprove Psychosis Outcome
|
N/A | |
Recruiting |
NCT02622048 -
Understanding and Helping Families: Parents With Psychosis
|
N/A | |
Completed |
NCT02653729 -
Cbt for Psychosis and Affect on Psychosis Symptoms
|
Phase 2 | |
Completed |
NCT02531243 -
Computer-Aided Learning for Managing Stress
|
N/A | |
Completed |
NCT02733575 -
Compassion Focused Therapy for Distressing Experiences
|
N/A | |
Not yet recruiting |
NCT02244970 -
Mindfulness RCT for Early Psychosis
|
N/A | |
Enrolling by invitation |
NCT01364818 -
Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment
|
N/A | |
Withdrawn |
NCT00786318 -
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
|
Phase 4 | |
Recruiting |
NCT00722163 -
A Randomized Controlled Trial of Individual Therapy for First Episode Psychosis
|
Phase 0 |