An interventional study of Implementation of the service delivery model primary care behavioral health in Primary Health Care, Mental Disorder and Behavioral Symptoms, sponsored by Region Östergötland. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Region Östergötland · Not applicable, Interventional, and Other
The novel multi-professional service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. In this multicenter mixed-methods pragmatic clinical trial, the implementation of PCBH in routine primary health care in a region in Sweden is investigated.
Psychosocial and mental health problems is a growing public health concern and challenge for primary care where resources are scarce. The multi-professional novel service delivery model "Primary Care Behavioural Health" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care. The model offer high accessibility to brief interventions, is clinically intuitively attractive and has been disseminated in primary care organizations globally, as well as in Sweden. However, more research is needed on its effect and implementation in routine care. The objective is to investigate the effect of the new service delivery model PCBH on organization- staff- and patient outcomes, and to investigate the implementation of PCBH in terms of how and to which degree the new way of working is normalised in practice routines. This multicenter mixed-methods interventional study is designed as a controlled pragmatic clinical trial. The effect of PCBH will be investigated on organizational, staff and patient levels. Variables include waiting lists, symptoms, medication prescriptions, quality of life and working environment aspects. Study participants will be patients, staff and managers at the included primary care centers. Implementation of PCBH will be investigated regarding the implementation process and degree of implementation. Data will be both qualitative (individual interviews) and quantitative (registers, biomarkers and questionnaires). At least 24 intervention centers will be compared to an equal number of control centers. The research project will be conducted in several regions in Sweden during a period of 4 years. PCBH seems to offer a solution the challenges in modern primary care, but evidence is low. This study will provide much-needed clinically meaningful data regarding PCBH that hopefully could be used for future development of primary healthcare.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Region Östergötland is the lead sponsor of 29 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients:
Inclusion Criteria, one of following:
Exclusion Criteria:
Medical staff:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The centers that implement PCBH.
Behavioral: Implementation of the service delivery model primary care behavioral health
Control centers that do not implement PCBH.
The research project will study a real-world implementation of PCBH in routine primary care. The implementation is facilitated by a regional implementation group of psychologists with special training in PCBH. The active implementation period for each intervention center is 12 months, where continuous support, materials and training are offered by the implementation group.
Accessibility at the health care center, measured in number of visits
Number of visits to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).
Time frame: Baseline to 24 months.
Functional level of the patients.
Measured by Sheehan disability scale.
Time frame: Baseline to 24 months.
Work environment among the medical staff
Measured by the COPSOQ III questionnaire , which is an instrument that measures psychosocial factors, stress, and the well-being of employees.
Time frame: Baseline to 24 months.
Experience of primary care behavioral health among the medical staff
Data will be collected through qualitative interviews.
Time frame: Baseline to 24 months.
Accessibility at the health care center, measured in waiting times.
Waiting times to first visit to health care professionals treating patients for mental health issues (i.e. behavioral health consultants and physicians).
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Quality of life of the patients.
Measured by Euroqol 5 dimensions 5 levels, on a scale from 1 to 5 on each item where 1 means no problems and 5 means severe problems.
Time frame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Symptoms of anxiety in the patients.
Measured by Generalised Anxiety Disorder Assessment (GAD-7), on a scale from 0-21, where higher points means higher risk for anxiety.
Time frame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Symptoms of depression in the patients
Measured by the patient health questionnaire (PHQ-9) on a scale from 0-27, where higher points means higher risk for depression.
Time frame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Referrals to psychiatric care
The number of patients with mental health issues who are referred to psychiatric specialist care.
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Work commitment among the medical staff
Measured by the Utrecht Work Engagement Scale, where higher points mean higher work engagement.
Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Exhaustion among the medical staff
Measured by the Karolinska exhaustion disorder scale (KEDS), where higher points indicate higher risk for exhaustion disorder.
Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Fidelity to the core components among the medical staff
Measured by a questionnaire incorporating typical features of work according to primary care behavioral health.
Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
Medical treatment of patients due to mental health issues
Number of patients who are prescribed psychotropic drugs (ATC codes: N05A, N05B, N05C and N06A).
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Sick leave of patients due to mental health issues
Number of patients who are on sick leave due to mental health issues (defined as sick leave due to one or more F- or Z-diagnoses according to the International Classification of Diseases (ICD-10) codes in the F00-F99, Z56, Z63 and Z73 sections.
Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Plan to share: No — IPD are not planned to be shared with other researchers.
No publications or documents are linked to this record.
Started Jan 2021 (actual). Primary completion is estimated for Dec 2026, 71 months after the start.
Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 71 months is above that.
Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.
Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
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Region Östergötland