NCT03624829

Brief Summary

The aim is to study the impact on patients and health care by an adaption of the Hamilton Family Health Team model of shared care between general practitioners (GPs), mental health services and other primary or specialized services. The study is done at six GP centers with 30 GPs in three boroughs in Oslo, Norway. At each GP center with shared care one clinical psychologist from a CMHC works two and a half day a week and a psychiatrist 1-2 hours a week. They are available for the GPs for discussions, and they give assessment and brief treatment as requested by the GPs. Other primary health and social care and other specialized mental health or substance addiction services are consulted according to needs of the patients. The study is a cluster randomized controlled study of GP patients and their health care in GP centers with shared care (experimental group) compared with usual health care in other GP centers (control group). In each of three boroughs one GP center is randomized to shared care for 18 months while another center continues with usual health care. Register data on patients and services are extracted for 12 months (T0) before implementation of shared care and for 12 months (T1) with shared care after 6 months implementation. The register data on patients and health care are extracted from the GP patient records, mental health and substance abuse services, and NAV (social/welfare services). The cohorts at T0 and T2 include all patients 16-65 years old seen by the GPs. Patient-reported mental health, functional impairment due to health problems, overall quality of life and satisfaction with health services are studied for a sub-sample of the register cohort at both T0 and T1. A qualitative sub-study of experiences with collaboration, the shared care model, implementation of the model, facilitators and barriers is done at the end of the 18 months period of shared care. The informants include patients, GPs and coworkers, and managers and professionals involved with shared care. The study protocol was approved by the regional and national committees on medical and health research, as well as by the data protection officer at health trust. Progress and status are described in Detailed description. Data analysis starts in September 2018.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
19,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

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

May 18, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3.1 years

First QC Date

August 5, 2018

Last Update Submit

November 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Referrals from GPs to mental health outpatient clinics

    Referrals from GPs to mental health outpatient clinics during the period for data extraction

    12 months

Secondary Outcomes (15)

  • Referrals from GPs to mental health inpatient wards

    12 months

  • Waiting time from the referral to the first consultation

    12 months

  • Number of GP consultations

    12 months

  • Number of outpatient consultations

    12 months

  • Number of inpatient days

    12 months

  • +10 more secondary outcomes

Study Arms (2)

Exp: Patients of GPs with shared care

All patients 16-65 years old who during 12 months have been in contact with a GP in any of the three GP centers that are randomized to shared care before the 12 months.

Other: Shared care

Con: Patients of GPs without shared care

All patients 16-65 years old who during 12 months have been in contact with a GP in any of the three GP centers that are not randomized to shared care before the 12 months, and all patients 16-65 years old who during 12 months have been in contact with a GP in any of the six GP center before the randomization and implementation of shared care.

Interventions

The intervention is an adapted version of shared care with close collaboration by services and professional groups, mainly localized in three GP centers. At each GP center one clinical psychologist specialist from the community mental health center (CMHC) works two and a half day a week, and a psychiatrist from the CMHC work at each GP center 1-2 hours a week. The psychologist and the psychiatrist are available for the GPs for consultation and discussions, and they give assessments and brief treatments to patients as requested by the GPs. Other primary health and social care and other specialized mental health or substance addiction services are involved or consulted according to needs of the patients.

Exp: Patients of GPs with shared care

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The total sample of patients seen by any of the GPs at the six participating GP centers during the 12 months of retrospective data extraction from patient registers before randomization of GP centers to shared care, and patients seen by any of the GPs at the six participating GP centers during the 12 months of retrospective data extraction from patient registers during the period where three of the GP centers have shared care. The samples from the two time periods are different, but they may partly overlap as many patients are expected to se GPs during both periods.

You may qualify if:

  • Seen by a GP during the 12 months for extracted data on all contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • Smith SM, Allwright S, O'Dowd T. Effectiveness of shared care across the interface between primary and specialty care in chronic disease management. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004910. doi: 10.1002/14651858.CD004910.pub2.

    PMID: 17636778BACKGROUND
  • Harkness EF, Bower PJ. On-site mental health workers delivering psychological therapy and psychosocial interventions to patients in primary care: effects on the professional practice of primary care providers. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD000532. doi: 10.1002/14651858.CD000532.pub2.

    PMID: 19160181BACKGROUND
  • Butler M, Kane RL, McAlpine D, Kathol R, Fu SS, Hagedorn H, Wilt T. Does integrated care improve treatment for depression? A systematic review. J Ambul Care Manage. 2011 Apr-Jun;34(2):113-25. doi: 10.1097/JAC.0b013e31820ef605.

    PMID: 21415610BACKGROUND
  • Hviding K, Bugge P, Ekern P, Brelin P, Høifødt TS, Nessa J, Flottorp S (2006). Samhandling om pasienter med alvorlige psykiske problemer i allmennpraksis. [Collaboration regarding patients with severe mental problems in general practice]. Rapport Nr 1-2008. Oslo, Nasjonalt kunnskapssenter for helsetjenesten, 2008.

    BACKGROUND
  • Craven MA, Bland R. Better practices in collaborative mental health care: an analysis of the evidence base. Can J Psychiatry. 2006 May;51(6 Suppl 1):7S-72S.

    PMID: 16786824BACKGROUND
  • Kates N, Mazowita G, Lemire F et al (2011a). The Evolution of Collaborative Mental Health Care in Canada; A shared vision for the future. Position paper. The Canadian Journal of Psychiatry 56(5).

    BACKGROUND
  • Kates N, McPherson-Doe C, George L. Integrating mental health services within primary care settings: the Hamilton Family Health Team. J Ambul Care Manage. 2011 Apr-Jun;34(2):174-82. doi: 10.1097/JAC.0b013e31820f6435.

    PMID: 21415615BACKGROUND
  • Eldridge S, Kerry S. A practical guide to cluster randomised trials in health services research. John Wiley & Sons, Chichester, UK, 2012

    BACKGROUND
  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.

    PMID: 20334633BACKGROUND
  • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; Consolidated Standards of Reporting Trials Group. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010 Aug;63(8):e1-37. doi: 10.1016/j.jclinepi.2010.03.004. Epub 2010 Mar 25.

    PMID: 20346624BACKGROUND
  • Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, Mellor-Clark J, Richards D, Unsworth G, Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies, Counselling and Psychotherapy Research: Linking research with practice, 2013. 13(1):1-13,

    BACKGROUND
  • Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.

    PMID: 11983645BACKGROUND
  • Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.

    PMID: 10443245BACKGROUND
  • Piiksi Dahli M, Brekke M, Ruud T, Haavet OR. Prevalence and distribution of psychological diagnoses and related frequency of consultations in Norwegian urban general practice. Scand J Prim Health Care. 2020 Jun;38(2):124-131. doi: 10.1080/02813432.2020.1783477. Epub 2020 Jun 27.

  • Rugkasa J, Tveit OG, Berteig J, Hussain A, Ruud T. Collaborative care for mental health: a qualitative study of the experiences of patients and health professionals. BMC Health Serv Res. 2020 Sep 9;20(1):844. doi: 10.1186/s12913-020-05691-8.

  • Kann IC, Dahli MP, Ruud T. New collaborative model for patients with mental health problems: Impact on sickness abscence or rehabilitation benefits? [Ny samhandlingsmodell for pasienter med psykiske lidelser: Påvirkes sykefravær eller arbeidsavklaringspenger?] Arbeid og velferd 2019 (2): 27-41

    RESULT
  • Dahli MP, Saltyte-Benth J, Haavet OR, Ruud T, Brekke M. Somatic symptoms and associations with common psychological diagnoses: a retrospective cohort study from Norwegian urban general practice. Fam Pract. 2021 Nov 24;38(6):766-772. doi: 10.1093/fampra/cmab038.

  • Haavet OR, Saltyte Benth J, Gjelstad S, Hanssen-Bauer K, Dahli MP, Kates N, Ruud T. Detecting young people with mental disorders: a cluster-randomised trial of multidisciplinary health teams at the GP office. BMJ Open. 2021 Dec 24;11(12):e050036. doi: 10.1136/bmjopen-2021-050036.

  • Tveit OG, Ruud T, Hanssen-Bauer K, Haavet OR, Hussain A. An explorative study of factors associated with treatment in specialized mental health care centers among GP patients in Norway. BMC Health Serv Res. 2021 Sep 13;21(1):960. doi: 10.1186/s12913-021-06982-4.

  • Dahli MP, Haavet OR, Ruud T, Brekke M. GPs' identification of patients with mental distress: a coupled questionnaire and cohort study from norwegian urban general practice. BMC Prim Care. 2022 Oct 9;23(1):260. doi: 10.1186/s12875-022-01865-x.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Tormod Fladby, Dr.Med.

    University Hospital, Akershus

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, Professor emeritus

Study Record Dates

First Submitted

August 5, 2018

First Posted

August 10, 2018

Study Start

May 18, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

November 27, 2024

Record last verified: 2024-11