The Effects of Primary Care Behavioral Health in Primary Care in Sweden
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implementation of the service delivery model primary care behavioral health.
- Who it may be relevant to
- Registry conditions: Primary Health Care, Mental Disorder, Behavioral Symptoms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Behavioral Implementation of the service delivery model primary care behavioral health
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.
Primary outcome measures
- Accessibility at the health care center, measured in number of visits [Time frame: Baseline to 24 months.]
- Functional level of the patients. [Time frame: Baseline to 24 months.]
- Work environment among the medical staff [Time frame: Baseline to 24 months.]
- Experience of primary care behavioral health among the medical staff [Time frame: Baseline to 24 months.]
Secondary outcome measures (10)
- Accessibility at the health care center, measured in waiting times. [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. [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. [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 [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 [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 [Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.]
- Exhaustion among the medical staff [Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.]
- Fidelity to the core components among the medical staff [Time frame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.]
- Medical treatment of patients due to mental health issues [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 [Time frame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.]
Eligibility criteria
Patients:
Inclusion Criteria, one of following:
- Adult patients who seek care for mental health problems at a participating centre,
- Adult patients who have received any following International Classification of Diseases diagnose: F00-F99, Z56, Z73
- Adult patients who are prescribed any psychotropic drugs with ATC codes: N05A-C, N06A) at a participating centre.
- Adult patients who has an appointment to a behavioral health consultant at a participating centre.
Exclusion criteria
- Not capable to leave informed consent.
Medical staff:
Inclusion criteria
- Health care professionals employed at a participating centre.
Exclusion criteria
- Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Sweden · 1 center
- Primärvårdscentrum — Linköping
Publications
- Larsen HI, Thomas K, Nordgren LB, Ruiz ES, Koshnaw K, Nilsen P. Implementing primary care behavioral health in Swedish primary care - study protocol for a pragmatic stepped wedge cluster trial. BMC Prim Care. 2024 Aug 20;25(1):310. doi: 10.1186/s12875-024-02515-0. PMID 39164634
Identifiers
NCT: NCT05633940 · 2020-05572