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

NCT ID: NCT05633940

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2026-12-31

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.

Conditions

Primary Health Care; Mental Disorder; Behavioral Symptoms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Implementation

The centers that implement PCBH.

Group Type: EXPERIMENTAL

Implementation of the service delivery model primary care behavioral health

Intervention Type: BEHAVIORAL

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 implementation

Control centers that do not implement PCBH.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• Health care professionals employed at a participating centre.

Exclusion Criteria

• Not capable to leave informed consent.

Medical staff:

• Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Jönköping County

OTHER_GOV

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: collaborator

Region Östergötland

OTHER

Sponsor Role: lead

Responsible Party

Hanna Israelsson Larsen

Adjunct Senior Lecturer/resident physician in general medicin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanna I Larsen, PhD

Role: PRINCIPAL_INVESTIGATOR

region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum

Locations

Primärvårdscentrum

Linköping, Östergötland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Hanna I Larsen, PhD

Role: CONTACT

hanna.israelsson.larsen@regionostergotland.se

0046101044207

Eva Anskär, Med. Lic.

Role: CONTACT

Eva.Anskar@regionostergotland.se

0046705654329

Facility Contacts

Hanna I Larsen, PhD

Role: primary

hanna.israelsson.larsen@regionostergotland.se

+46101044207

Eva Anskär, Med. Lic.

Role: backup

Eva.Anskar@regionostergotland.se

+46705654329

References

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.

Reference Type: DERIVED

PMID: 39164634 (View on PubMed)

Other Identifiers

2020-05572

Identifier Type: -

Identifier Source: org_study_id