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

NCT05633940 | Recruiting

• 1 other identifier: 2020-05572
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Health Care; Mental Disorder; Behavioral Symptoms

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• Accessibility at the health care center, measured in waiting times.

  In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.

• Quality of life of the patients.

  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.

  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

  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

  In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.

Study Arms (2)

Implementation

EXPERIMENTAL

The centers that implement PCBH.

Behavioral: Implementation of the service delivery model primary care behavioral health

No implementation

NO INTERVENTION

Control centers that do not implement PCBH.

Interventions

Implementation of the service delivery model primary care behavioral health 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.

Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not capable to leave informed consent.
• Medical staff:
• Health care professionals employed at a participating centre.
• Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.

Sponsors & Collaborators

• Region Östergötland: lead
• Region Jönköping County: collaborator
• Region Örebro County: collaborator

Study Sites (1)

Primärvårdscentrum

Linköping, Östergötland County, 582 25, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 39164634 DERIVED

MeSH Terms

Conditions

Mental Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hanna I Larsen, PhD

  region östergötland/Primärvårdscentrum/Vårdcentralen Cityhälsan centrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna I Larsen, PhD

CONTACT

0046101044207; hanna.israelsson.larsen@regionostergotland.se

Eva Anskär, Med. Lic.

CONTACT

0046705654329; Eva.Anskar@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Senior Lecturer/resident physician in general medicin

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: December 1, 2022
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)