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

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.

Study Overview

• Status: Recruiting
• Conditions: Behavioral Symptoms; Primary Health Care; Mental Disorder
• Intervention / Treatment: Behavioral: Implementation of the service delivery model primary care behavioral health

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna I Larsen, PhD; Phone Number: 0046101044207; Email: hanna.israelsson.larsen@regionostergotland.se
• Study Contact Backup: Name: Eva Anskär, Med. Lic.; Phone Number: 0046705654329; Email: Eva.Anskar@regionostergotland.se

Study Locations

• Sweden
  • Östergötland
    • Linköping, Östergötland, Sweden, 582 25
      • Recruiting
      • Primärvårdscentrum
      • Contact: Hanna I Larsen, PhD; Phone Number: +46101044207; Email: hanna.israelsson.larsen@regionostergotland.se
      • Contact: Eva Anskär, Med. Lic.; Phone Number: +46705654329; Email: Eva.Anskar@regionostergotland.se
      • Sub-Investigator: Kristin Thomas, PhD
      • Sub-Investigator: Lise Bergman-Nordgren, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implementation; The centers that implement PCBH.	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.
No Intervention: No implementation; Control centers that do not implement PCBH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Functional level of the patients.	Measured by Sheehan disability scale.	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.	Baseline to 24 months.
Experience of primary care behavioral health among the medical staff	Data will be collected through qualitative interviews.	Baseline to 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Region Östergötland
• Collaborators: Region Jönköping County; Region Örebro County
• Investigators: Principal Investigator: Hanna I Larsen, PhD, region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: November 30, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms
• Other Study ID Numbers: 2020-05572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD are not planned to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No