Department of Psychology, Faculty of Health and Life Sciences, Linnaeus University, Växjö, Sweden.
School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
BMC Health Serv Res. 2023 Oct 31;23(1):1188. doi: 10.1186/s12913-023-10180-9.
Providing comprehensive and continuous care for patients whose conditions have mental or behavioral components is a central challenge in primary care and an important part of improving universal health coverage. There is a great need for high and routine availability of psychological interventions, but traditional methods for delivering psychotherapy often result in low reach and long wait times. Primary Care Behavioral Health (PCBH) is a method for organizing primary care in which behavioral health staff provide brief, flexible interventions to a large part of the population in active collaboration with other providers. While PCBH holds promise in addressing important challenges, it has not yet been thoroughly evaluated.
This cluster randomized trial will assess 17 primary care centers (PCCs) that are starting a PCBH implementation process. The PCCs will be divided into two groups, with one starting immediate implementation and the other acting as a control, implementing six months later. The purpose of the study is to strengthen the evidence base for PCBH regarding implementation-, organization-, and patient-level outcomes, taking into consideration that there is a partially dependent relationship between the three levels. Patient outcomes (such as increased daily functioning and reduction of symptoms) may be dependent on organizational changes (such as availability of treatment, waiting times and interprofessional teamwork), which in turn requires change in implementation outcomes (most notably, model fidelity). In addition to the main analysis, five secondary analyses will compare groups based on different combinations of randomization and time periods, specifically before and after each center achieves sufficient PCBH fidelity.
A randomized comparison of PCBH and traditional primary care has, to our knowledge, not been made before. While the naturalistic setting and the intricacies of implementation pose certain challenges, we have designed this study in an effort to evaluate the causal effects of PCBH despite these complex aspects. The results of this project will be helpful in guiding decisions on how to organize the delivery of behavioral interventions and psychological treatment within the context of primary care in Sweden and elsewhere.
ClinicalTrials.gov: NCT05335382. Retrospectively registered on March 13th, 2022.
为那些存在心理或行为问题的患者提供全面且持续的护理是基层医疗的核心挑战，也是改善全民健康覆盖的重要内容。因此非常需要高频且常规地提供心理干预措施，但传统的心理治疗方法往往导致覆盖范围有限且等待时间长。初级保健中的行为健康（PCBH）是一种组织初级保健的方法，行为健康工作人员与其他提供者密切合作，为大部分人群提供简短、灵活的干预措施。虽然 PCBH 在解决重要挑战方面具有很大的潜力，但它尚未得到全面评估。
本项集群随机试验将评估 17 个正在开始实施 PCBH 的初级保健中心（PCC）。这些 PCC 将被分为两组，一组立即开始实施，另一组作为对照组，在六个月后开始实施。研究的目的是加强 PCBH 在实施、组织和患者水平结果方面的证据基础，同时考虑到这三个层面之间存在部分依存关系。患者结果（如日常功能的提高和症状的减轻）可能取决于组织上的变化（如治疗的可用性、等待时间和跨专业团队合作），而这些变化又需要实施结果的改变（最显著的是，模型的一致性）。除了主要分析外，还将进行五项次要分析，根据随机分组和时间段的不同组合对两组进行比较，特别是在每个中心达到足够的 PCBH 一致性前后。
据我们所知，PCBH 与传统初级保健的随机对照比较以前从未进行过。虽然自然的环境和实施的复杂性带来了一定的挑战，但我们设计了这项研究，以努力评估 PCBH 的因果效应，尽管存在这些复杂的方面。该项目的结果将有助于指导如何在瑞典和其他地方的初级保健背景下组织行为干预和心理治疗的提供决策。
ClinicalTrials.gov：NCT05335382。于 2022 年 3 月 13 日进行回顾性注册。
