search
Back to results

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

Primary Purpose

Primary Health Care, Mental Disorder, Behavioral Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Implementation of the service delivery model primary care behavioral health
Sponsored by
Region Östergötland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Primary Health Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • PrimärvårdscentrumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Implementation

No implementation

Arm Description

The centers that implement PCBH.

Control centers that do not implement PCBH.

Outcomes

Primary Outcome Measures

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).
Functional level of the patients.
Measured by Sheehan disability scale.
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.
Experience of primary care behavioral health among the medical staff
Data will be collected through qualitative interviews.

Secondary Outcome Measures

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).
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.
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.
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.
Referrals to psychiatric care
The number of patients with mental health issues who are referred to psychiatric specialist care.
Work commitment among the medical staff
Measured by the Utrecht Work Engagement Scale, where higher points mean higher work engagement.
Exhaustion among the medical staff
Measured by the Karolinska exhaustion disorder scale (KEDS), where higher points indicate higher risk for exhaustion disorder.
Fidelity to the core components among the medical staff
Measured by a questionnaire incorporating typical features of work according to primary care behavioral health.
Medical treatment of patients due to mental health issues
Number of patients who are prescribed psychotropic drugs (ATC codes: N05A, N05B, N05C and N06A).
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.

Full Information

First Posted
April 21, 2021
Last Updated
March 28, 2023
Sponsor
Region Östergötland
Collaborators
Region Jönköping County, Region Örebro County
search

1. Study Identification

Unique Protocol Identification Number
NCT05633940
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland
Collaborators
Region Jönköping County, Region Örebro County

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Health Care, Mental Disorder, Behavioral Symptoms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implementation
Arm Type
Experimental
Arm Description
The centers that implement PCBH.
Arm Title
No implementation
Arm Type
No Intervention
Arm Description
Control centers that do not implement PCBH.
Intervention Type
Behavioral
Intervention Name(s)
Implementation of the service delivery model primary care behavioral health
Intervention Description
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 Measure Information:
Title
Accessibility at the health care center, measured in number of visits
Description
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.
Title
Functional level of the patients.
Description
Measured by Sheehan disability scale.
Time Frame
Baseline to 24 months.
Title
Work environment among the medical staff
Description
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.
Title
Experience of primary care behavioral health among the medical staff
Description
Data will be collected through qualitative interviews.
Time Frame
Baseline to 24 months.
Secondary Outcome Measure Information:
Title
Accessibility at the health care center, measured in waiting times.
Description
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.
Title
Quality of life of the patients.
Description
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).
Title
Symptoms of anxiety in the patients.
Description
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).
Title
Symptoms of depression in the patients
Description
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).
Title
Referrals to psychiatric care
Description
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.
Title
Work commitment among the medical staff
Description
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.
Title
Exhaustion among the medical staff
Description
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.
Title
Fidelity to the core components among the medical staff
Description
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.
Title
Medical treatment of patients due to mental health issues
Description
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.
Title
Sick leave of patients due to mental health issues
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanna I Larsen, PhD
Phone
0046101044207
Email
hanna.israelsson.larsen@regionostergotland.se
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Anskär, Med. Lic.
Phone
0046705654329
Email
Eva.Anskar@regionostergotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanna I Larsen, PhD
Organizational Affiliation
region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primärvårdscentrum
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
582 25
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna I Larsen, PhD
Phone
+46101044207
Email
hanna.israelsson.larsen@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Eva Anskär, Med. Lic.
Phone
+46705654329
Email
Eva.Anskar@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Kristin Thomas, PhD
First Name & Middle Initial & Last Name & Degree
Lise Bergman-Nordgren, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD are not planned to be shared with other researchers.

Learn more about this trial

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

We'll reach out to this number within 24 hrs