The Effects of Primary Care Behavioral Health in Primary Care in Sweden

Mental Disorder Clinical Trial

Official title:

The Effects of Primary Care Behavioral Health in Primary Care in Sweden

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633940
• Other study ID #: 2020-05572
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Region Östergötland
• Contact: Hanna I Larsen, PhD
• Phone: 0046101044207
• Email: hanna.israelsson.larsen[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Symptoms
• Mental Disorder
• Mental Disorders
• Primary Health Care

Intervention

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.

Locations

Country	Name	City	State
Sweden	Primärvårdscentrum	Linköping	Östergötland

Sponsors (3)

Lead Sponsor	Collaborator
Region Östergötland	Region Jönköping County, Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline to 24 months.
Primary	Functional level of the patients.	Measured by Sheehan disability scale.	Baseline to 24 months.
Primary	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.	Baseline to 24 months.
Primary	Experience of primary care behavioral health among the medical staff	Data will be collected through qualitative interviews.	Baseline to 24 months.
Secondary	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).	In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Secondary	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.	2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Secondary	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.	2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Secondary	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.	2 years from baseline (first visit to a health care professional due to a mental health issue, therafter after 6, 12 and 24 months).
Secondary	Referrals to psychiatric care	The number of patients with mental health issues who are referred to psychiatric specialist care.	In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Secondary	Work commitment among the medical staff	Measured by the Utrecht Work Engagement Scale, where higher points mean higher work engagement.	2 years in total: at baseline, therafter at 6, 12 and 24 months.
Secondary	Exhaustion among the medical staff	Measured by the Karolinska exhaustion disorder scale (KEDS), where higher points indicate higher risk for exhaustion disorder.	2 years in total: at baseline, therafter at 6, 12 and 24 months.
Secondary	Fidelity to the core components among the medical staff	Measured by a questionnaire incorporating typical features of work according to primary care behavioral health.	2 years in total: at baseline, therafter at 6, 12 and 24 months.
Secondary	Medical treatment of patients due to mental health issues	Number of patients who are prescribed psychotropic drugs (ATC codes: N05A, N05B, N05C and N06A).	In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.
Secondary	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.	In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.