The Effects of Primary Care Behavioral Health in Primary Care in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Accessibility at the health care center, measured in number of visits
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Health care professionals employed at a participating centre.
排除标准
- •Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.
结局指标
主要结局
Accessibility at the health care center, measured in number of visits
时间窗: Baseline to 24 months.
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.
时间窗: Baseline to 24 months.
Measured by Sheehan disability scale.
Work environment among the medical staff
时间窗: Baseline to 24 months.
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
时间窗: Baseline to 24 months.
Data will be collected through qualitative interviews.
次要结局
- 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).)
- Referrals to psychiatric care(In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.)
- 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).)
- Work commitment among the medical staff(2 years in total: at baseline, therafter at 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).)
- Fidelity to the core components among the medical staff(2 years in total: at baseline, therafter at 6, 12 and 24 months.)
- Medical treatment of patients due to mental health issues(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(In total 3 years: one year before baseline (baseline: when implementation starts), thereafter during 2 year from baseline.)
- Exhaustion among the medical staff(2 years in total: at baseline, therafter at 6, 12 and 24 months.)
研究者
Hanna Israelsson Larsen
Adjunct Senior Lecturer/resident physician in general medicin
Region Östergötland