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Shared Care and Usual Health Care for Mental and Comorbid Health Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624829
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Torleif Ruud, University Hospital, Akershus

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.


Condition or disease Intervention/treatment
Mental Disorders Other: Shared care

Show Show detailed description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 19000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Shared Care and Usual Health Care for Mental and Comorbid Health Problems. A Cluster Randomized Trial
Actual Study Start Date : May 18, 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.

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.



Primary Outcome Measures :
  1. Referrals from GPs to mental health outpatient clinics [ Time Frame: 12 months ]
    Referrals from GPs to mental health outpatient clinics during the period for data extraction


Secondary Outcome Measures :
  1. Referrals from GPs to mental health inpatient wards [ Time Frame: 12 months ]
    Referrals from GPs to mental health inpatient wards during the period for data extraction

  2. Waiting time from the referral to the first consultation [ Time Frame: 12 months ]
    Days from the outpatient clinic has received a referral to the first consultation for a referral during the period for data extraction

  3. Number of GP consultations [ Time Frame: 12 months ]
    Number of patient consultations at the GP center during the period for data extraction

  4. Number of outpatient consultations [ Time Frame: 12 months ]
    Number of patient consultations at the outpatient clinic during the period for data extraction

  5. Number of inpatient days [ Time Frame: 12 months ]
    Total number of inpatient days across all inpatient stays during the period for data extraction

  6. Length of an outpatient treatment episode [ Time Frame: 12 months ]
    Days from first consultation to last consultation of a series of outpatient consultations after a referral to the outpatient clinic during the period for data extraction

  7. Length of an inpatient stay [ Time Frame: 12 months ]
    Days from the inpatient admission to discharge after a referral to the inpatient ward during the period for data extraction

  8. Length of sick leave [ Time Frame: 12 months ]
    Days from first to last day of a period of sick leave clinic during the period for data extraction

  9. Type of health problem [ Time Frame: 12 months ]
    ICPC-2 codes in PG practices and/or ICD-10 diagnosis in mental health care during the period for data extraction

  10. The severity of psychiatric symptoms [ Time Frame: 12 months ]
    Global Assessment of Functioning - subscale for symptoms (GAF-S), used in mental health services

  11. The severity of impairment in functioning [ Time Frame: 12 months ]
    Global Assessment of Functioning - subscale for functional impairment (GAF-F), used in mental health services

  12. Self-reported mental health problems [ Time Frame: 2 weeks ]
    In the questionnaire to patients: Clinical Outcome in Routine Evaluation (CORE-10) with 10 items on mental health problems (Barkham 2013). Each item is answered on a 5-point scale of frequency from 0="not at all" to 4="most of the time". The 10 items comprise the following: depression (2 items), anxiety (2 items), functioning (3 items, 1 each for 'general' 'social', and 'close'); trauma (1 item); physical (1 item); and suicidal risk (1 item). Two of the items are positively framed. The ten items are summed (reversing the two positive items) to a total score with a range from 0 to 40, where a higher total sum score means more severe mental health problems.

  13. Self-reported impairment in functioning due to health problems [ Time Frame: 2 weeks ]
    In the questionnaire to patients: Work and Social Adjustment Scale (WSAS) with five items on impairment of functioning in various domains due to health problems (Mundt 2002). Each item is answered on a 5-point scale of degree of impairment from 0="not at all" to 4="very much" (adapted from the original 9-point scale from 0 to 8 to fit with the 5-point scales in the rest of the brief questionnaire). The five items comprise the following: Work/education, housework, social activities, activities alone, contact/relationship with family/others. The five items are summed to a total score with a range from 0 to 20, where a higher total sum score means more severe impairment of functioning due to health problems.

  14. Patient satisfaction with health services [ Time Frame: 2 weeks ]
    In the questionnaire to patients and developed for the study: Three items for a subscale on satisfaction with the GP (for access, met with respect, get help as needed), three items for a subscale on satisfaction with the mental health services (for access, met with respect, get help as needed) if such contact last 12 months, and three items for a subscale on satisfaction with the collaboration between the health services (their collaboration, their understanding of the situation, the usefulness of their total help). Each item is answered on a 5-point scale of degree of impairment from 1="very dissatisfied" to 5="very satisfied". For each subscale the three items are summed to a total score with a range from 3 to 15, where a higher total sum score means a higher degree of satisfaction with the specific services.

  15. Overall quality of life (MANSA) [ Time Frame: 2 weeks ]
    In the questionnaire to patients: A single question on overall quality of life is taken from the Manchester Short Assessment of Quality of Life (MANSA), which is a questionnaire on quality of life used in many recent studies (Priebe 1999). The question is answered on a 5-point scale of degree of satisfaction with overall quality of life from 1="very dissatisfied" to 5="very satisfied" (adapted from the original 7-point scale in MANSA to fit with the 5-point scales in the rest of the brief questionnaire).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624829


Sponsors and Collaborators
University Hospital, Akershus
Investigators
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Study Director: Tormod Fladby, Dr.Med. University Hospital, Akershus
  Study Documents (Full-Text)

Documents provided by Torleif Ruud, University Hospital, Akershus:
Study Protocol  [PDF] February 12, 2014

Additional Information:

Publications of Results:
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.
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).
Eldridge S, Kerry S. A practical guide to cluster randomised trials in health services research. John Wiley & Sons, Chichester, UK, 2012
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,

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Torleif Ruud, Senior Researcher, Professor emeritus, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT03624829    
Other Study ID Numbers: 273932
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mental Disorders