NCT03182283

Brief Summary

Schizophrenia is a major mental illness that presents in young adulthood and affects \~1% of the population. Impact on affected persons life is often major and life expectancy is reduced by \~20 years. Better and more effective care models are needed to increase health in these persons. Person-centered care have been suggested to be one way to increase efficiency in care delivery for patients with chronical and complex conditions. The impact of person-centered care on a inpatient psychosis care setting is now being tested. The purpose of this study is to test whether inpatient Person-centered psychosis care (PCPC) can

  1. 1.increase patient empowerment
  2. 2.improve patient satisfaction
  3. 3.reduce the frequency of involuntary treatments
  4. 4.reduce the duration of inpatient care and
  5. 5.reduce overall ward burden

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 25, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

4.3 years

First QC Date

May 17, 2017

Last Update Submit

November 7, 2018

Conditions

Keywords

Person-centered carePsychosis careIntegrated care

Outcome Measures

Primary Outcomes (1)

  • Change in patient empowerment (between before and after cohorts)

    Patient reported empowerment measured by The Empowerment Scale (Rogers et al 2010).

    Baseline (for before-intervention cohort), 2 years (for after-intervention cohort)

Secondary Outcomes (4)

  • Change in consumer satisfaction (between before and after cohorts)

    Baseline (for before-intervention cohort), 2 years (for after-intervention cohort)

  • Change in staff care burden (before and after intervention and implementation)

    Baseline, 2 years

  • Change in inpatient days with/out involuntary care (between before and after cohorts)

    Baseline (for before-intervention cohort), 2 years (for after-intervention cohort)

  • Change in involuntary treatment (between before and after cohorts)

    Baseline (for before-intervention cohort), 2 years (for after-intervention cohort)

Study Arms (2)

Pre-intervention

NO INTERVENTION

All patients at the psychosis wards receive care as usual before staff goes through educational intervention.

Post-intervention

OTHER

After staff attended educational intervention and implemented Person-centered psychosis care in the wards all patients admitted will receive person-centered care.

Behavioral: Person-centered psychosis care

Interventions

Person-centered care educational intervention for staff with following implementation of person-centered care in the clinic

Post-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of psychotic illness in accordance with ICD-10
  • Medically ready for discharge as deemed by ward psychiatrist

You may not qualify if:

  • Severe cognitive disability
  • Lack of basic Swedish language skills

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychosis Clinic, Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (28)

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    PMID: 15925493BACKGROUND
  • von Hausswolff-Juhlin Y, Bjartveit M, Lindstrom E, Jones P. Schizophrenia and physical health problems. Acta Psychiatr Scand Suppl. 2009;(438):15-21. doi: 10.1111/j.1600-0447.2008.01309.x.

    PMID: 19132962BACKGROUND
  • Tiihonen J, Lonnqvist J, Wahlbeck K, Klaukka T, Niskanen L, Tanskanen A, Haukka J. 11-year follow-up of mortality in patients with schizophrenia: a population-based cohort study (FIN11 study). Lancet. 2009 Aug 22;374(9690):620-7. doi: 10.1016/S0140-6736(09)60742-X.

    PMID: 19595447BACKGROUND
  • Lasalvia A, Boggian I, Bonetto C, Saggioro V, Piccione G, Zanoni C, Cristofalo D, Lamonaca D. Multiple perspectives on mental health outcome: needs for care and service satisfaction assessed by staff, patients and family members. Soc Psychiatry Psychiatr Epidemiol. 2012 Jul;47(7):1035-45. doi: 10.1007/s00127-011-0418-0. Epub 2011 Aug 18.

    PMID: 21850522BACKGROUND
  • Hamann J, Langer B, Winkler V, Busch R, Cohen R, Leucht S, Kissling W. Shared decision making for in-patients with schizophrenia. Acta Psychiatr Scand. 2006 Oct;114(4):265-73. doi: 10.1111/j.1600-0447.2006.00798.x.

    PMID: 16968364BACKGROUND
  • Hamann J, Cohen R, Leucht S, Busch R, Kissling W. Do patients with schizophrenia wish to be involved in decisions about their medical treatment? Am J Psychiatry. 2005 Dec;162(12):2382-4. doi: 10.1176/appi.ajp.162.12.2382.

    PMID: 16330606BACKGROUND
  • 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
  • Malm U, Ivarsson B, Allebeck P, Falloon IR. Integrated care in schizophrenia: a 2-year randomized controlled study of two community-based treatment programs. Acta Psychiatr Scand. 2003 Jun;107(6):415-23. doi: 10.1034/j.1600-0447.2003.00085.x.

    PMID: 12752017BACKGROUND
  • Malm UI, Ivarsson BA, Allebeck P. Durability of the efficacy of integrated care in schizophrenia: a five-year randomized controlled study. Psychiatr Serv. 2014 Aug 1;65(8):1054-7. doi: 10.1176/appi.ps.201300164.

    PMID: 24932858BACKGROUND
  • Ekman I, Wolf A, Olsson LE, Taft C, Dudas K, Schaufelberger M, Swedberg K. Effects of person-centred care in patients with chronic heart failure: the PCC-HF study. Eur Heart J. 2012 May;33(9):1112-9. doi: 10.1093/eurheartj/ehr306. Epub 2011 Sep 15.

    PMID: 21926072BACKGROUND
  • Olsson LE, Karlsson J, Ekman I. Effects of nursing interventions within an integrated care pathway for patients with hip fracture. J Adv Nurs. 2007 Apr;58(2):116-25. doi: 10.1111/j.1365-2648.2007.04209.x.

    PMID: 17445014BACKGROUND
  • Chenoweth L, Forbes I, Fleming R, King MT, Stein-Parbury J, Luscombe G, Kenny P, Jeon YH, Haas M, Brodaty H. PerCEN: a cluster randomized controlled trial of person-centered residential care and environment for people with dementia. Int Psychogeriatr. 2014 Jul;26(7):1147-60. doi: 10.1017/S1041610214000398. Epub 2014 Mar 26.

    PMID: 24666667BACKGROUND
  • Brownie S, Nancarrow S. Effects of person-centered care on residents and staff in aged-care facilities: a systematic review. Clin Interv Aging. 2013;8:1-10. doi: 10.2147/CIA.S38589. Epub 2013 Jan 3.

    PMID: 23319855BACKGROUND
  • Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010 Sep;61(9):933-6. doi: 10.1176/ps.2010.61.9.933.

    PMID: 20810594BACKGROUND
  • Ahlfors UG, Lewander T, Lindstrom E, Malt UF, Lublin H, Malm U. Assessment of patient satisfaction with psychiatric care. Development and clinical evaluation of a brief consumer satisfaction rating scale (UKU-ConSat). Nord J Psychiatry. 2001;55 Suppl 44:71-90. doi: 10.1080/080394801317084437.

    PMID: 11860667BACKGROUND
  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801BACKGROUND
  • Kinter ET, Schmeding A, Rudolph I, dosReis S, Bridges JF. Identifying patient-relevant endpoints among individuals with schizophrenia: an application of patient-centered health technology assessment. Int J Technol Assess Health Care. 2009 Jan;25(1):35-41. doi: 10.1017/S0266462309090059.

    PMID: 19126249BACKGROUND
  • Nolte, Ellen, and Martin McKee, eds. Caring for people with chronic conditions: a health system perspective. McGraw-Hill Education (UK), 2008.

    BACKGROUND
  • Ashburner C, Meyer J, Johnson B, Smith C. Using action research to address loss of personhood in a continuing care setting. Illness, Crisis & Loss. 2004;12(1):23-37.

    BACKGROUND
  • Opler MG, Yang LH, Caleo S, Alberti P. Statistical validation of the criteria for symptom remission in schizophrenia: preliminary findings. BMC Psychiatry. 2007 Jul 24;7:35. doi: 10.1186/1471-244X-7-35.

    PMID: 17650312BACKGROUND
  • Endicott J, Spitzer RL, Fleiss JL, Cohen J. The global assessment scale. A procedure for measuring overall severity of psychiatric disturbance. Arch Gen Psychiatry. 1976 Jun;33(6):766-71. doi: 10.1001/archpsyc.1976.01770060086012.

    PMID: 938196BACKGROUND
  • Krippendorff, Klaus. Content analysis: An introduction to its methodology. Sage, 2004.

    BACKGROUND
  • Braun, Virginia, and Victoria Clarke.

    BACKGROUND
  • Goulding A, Wiktorsson S, Allerby K, Ali L, Waern M. Service User and Next-of-Kin Experiences of Psychosis Inpatient Care After a Person-Centred Care Intervention. Issues Ment Health Nurs. 2025 Feb;46(2):138-147. doi: 10.1080/01612840.2024.2437429. Epub 2025 Jan 6.

  • Allerby K, Gremyr A, Ali L, Waern M, Goulding A. Increasing person-centeredness in psychosis inpatient care: care consumption before and after a person-centered care intervention. Nord J Psychiatry. 2023 Aug;77(6):600-607. doi: 10.1080/08039488.2023.2199726. Epub 2023 Apr 21.

  • Allerby K, Goulding A, Ali L, Waern M. Increasing person-centeredness in psychosis inpatient care: staff experiences from the Person-Centered Psychosis Care (PCPC) project. BMC Health Serv Res. 2022 May 3;22(1):596. doi: 10.1186/s12913-022-08008-z.

  • Allerby K, Goulding A, Ali L, Waern M. Striving for a more person-centered psychosis care: results of a hospital-based multi-professional educational intervention. BMC Psychiatry. 2020 Nov 4;20(1):523. doi: 10.1186/s12888-020-02871-y.

  • Goulding A, Allerby K, Ali L, Gremyr A, Waern M. Study protocol design and evaluation of a hospital-based multi-professional educational intervention: Person-Centred Psychosis Care (PCPC). BMC Psychiatry. 2018 Aug 30;18(1):269. doi: 10.1186/s12888-018-1852-2.

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Margda Waern, Professor

    Göteborg University & Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR
  • Anneli Goulding, Phd

    Sahlgrenska University Hospital & Göteborg University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Non-randomized before and after design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

June 9, 2017

Study Start

April 25, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations