NCT04175366

Brief Summary

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. 1.To introduce a choice.
  2. 2.To discuss the options.
  3. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1.5 years

First QC Date

November 14, 2019

Last Update Submit

December 17, 2019

Conditions

Participation, PatientPsychiatric HospitalizationPsychosis

Keywords

Shared Decision MakingCompulsory CarePsychiatric Care

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (10)

  • Percentage of carried out planned outpatient visits

    1 year

  • Number of rehospitalisations

    1 year

  • Days of compulsory care

    1 year

  • Number of episodes of compulsory care

    1 year

  • Number of inpatient days

    1 year

  • +5 more secondary outcomes

Study Arms (2)

Shared Decision Making

EXPERIMENTAL

Intervention with Shared Decision Making procedure regarding decision on planning of care and treatment before discharge.

Other: Shared Decision Making

Care as usual

NO INTERVENTION

Discharge planning as usual.

Interventions

Shared Decision MakingOTHER

Shared Decision Making including adapted decision aid.

Shared Decision Making

Eligibility Criteria

Age18 Years - 100 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsPatient record.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to psychiatric inpatient care.
  • Informed consent to study participation.

You may not qualify if:

  • Lack of basic language skills in Swedish.
  • Earlier enrollment in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ward 5, Stockholms Norra Psykiatri

Stockholm, Sverige, Sweden

RECRUITING

Ward 1 and 2, Umeå Psykiatri

Umeå, Sweden

RECRUITING

Related Publications (6)

  • 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.

    PMID: 18418028BACKGROUND

  • Stacey D, Legare 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(4):CD001431. doi: 10.1002/14651858.CD001431.pub5.

    PMID: 28402085BACKGROUND

  • 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. doi: 10.4088/jcp.v68n0703.

    PMID: 17685733BACKGROUND

  • 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.

    PMID: 27198483BACKGROUND

  • 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. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.

    PMID: 22618581BACKGROUND

  • Slade M. Implementing shared decision making in routine mental health care. World Psychiatry. 2017 Jun;16(2):146-153. doi: 10.1002/wps.20412.

    PMID: 28498575BACKGROUND

MeSH Terms

Conditions

Patient ParticipationPsychotic Disorders

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Mikael Sandlund, Professor

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Sandlund, Professor

CONTACT

+46907856495mikael.sandlund@umu.se

Tove Janarv, MD

CONTACT

tove.janarv@umu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 25, 2019

Study Start

December 10, 2019

Primary Completion

June 1, 2021

Study Completion

December 1, 2022

Last Updated

December 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)