Clinical trial NCT05633940: The Effects of Primary Care Behavioral Health in Primary Care in Sweden
Official title: The Effects of Primary Care Behavioral Health in Primary Care in Sweden
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Health Care
Mental Disorder
Behavioral Symptoms
Lead sponsor: Region Östergötland
Sponsor class: OTHER
Collaborators: name: Region Jönköping County
name: Region Örebro County
First posted: 2022-12-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Primary outcomes:
measure: Accessibility at the health care center, measured in number of visits
timeFrame: Baseline to 24 months.
measure: Functional level of the patients.
timeFrame: Baseline to 24 months.
measure: Work environment among the medical staff
timeFrame: Baseline to 24 months.
measure: Experience of primary care behavioral health among the medical staff
timeFrame: Baseline to 24 months.
Secondary outcomes:
measure: Accessibility at the health care center, measured in waiting times.
timeFrame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
measure: Quality of life of the patients.
timeFrame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
measure: Symptoms of anxiety in the patients.
timeFrame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
measure: Symptoms of depression in the patients
timeFrame: 2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
measure: Referrals to psychiatric care
timeFrame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
measure: Work commitment among the medical staff
timeFrame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
measure: Exhaustion among the medical staff
timeFrame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
measure: Fidelity to the core components among the medical staff
timeFrame: 2 years in total: at baseline, therafter at 6, 12 and 24 months.
measure: Medical treatment of patients due to mental health issues
timeFrame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
measure: Sick leave of patients due to mental health issues
timeFrame: In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Primärvårdscentrum
state: Östergötland
Study officials:
affiliation: region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum
name: Hanna I Larsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: