Shared Care and Usual Health Care for Mental and Comorbid Health Problems
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ClinicalTrials.gov Identifier: NCT03624829 |
Recruitment Status :
Completed
First Posted : August 10, 2018
Last Update Posted : January 15, 2021
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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 |
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Mental Disorders | Other: Shared care |
Study Type : | Observational |
Actual Enrollment : | 19000 participants |
Observational Model: | Other |
Time Perspective: | Other |
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 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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- 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
- 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
- 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
- Number of GP consultations [ Time Frame: 12 months ]Number of patient consultations at the GP center during the period for data extraction
- Number of outpatient consultations [ Time Frame: 12 months ]Number of patient consultations at the outpatient clinic during the period for data extraction
- Number of inpatient days [ Time Frame: 12 months ]Total number of inpatient days across all inpatient stays during the period for data extraction
- 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
- 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
- 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
- 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
- The severity of psychiatric symptoms [ Time Frame: 12 months ]Global Assessment of Functioning - subscale for symptoms (GAF-S), used in mental health services
- 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
- 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.
- 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.
- 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.
- 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).
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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 |
Inclusion Criteria:
- Seen by a GP during the 12 months for extracted data on all contact
Exclusion Criteria:
- No exclusion criteria
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
Study Director: | Tormod Fladby, Dr.Med. | University Hospital, Akershus |
Documents provided by Torleif Ruud, University Hospital, Akershus:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | January 15, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Mental Disorders |