PDF(Pubmed)
Abstract：
BACKGROUND: Low health literacy is costly and observed among justice-impacted adults (JIA), a group that often faces numerous barriers in accessing healthcare and a disproportionate burden of illness. Health literacy interventions for JIA are critically needed to improve healthcare access and related outcomes.
METHODS: This manuscript describes the protocol for a longitudinal mixed-methods randomized clinical trial that assesses the effectiveness of a coach-guided health literacy intervention on JIA\'s healthcare access. The intervention was previously piloted with justice impacted adults. We will recruit 300 JIA ages 18 + in San Diego, California. Participants will be randomized 1:1 to the Treatment Group (i.e., coach-guided intervention providing 12 sessions of individualized health coaching and service navigation over 6 months) or the Control Group (i.e., self-study of the health coaching program, and brief service navigation support). We will quantitatively assess JIA\'s healthcare access defined as: use of healthcare, health insurance status, and regular source of care at 6-months as the primary outcomes. Participants will also be surveyed at 12-months. Statistical analyses will incorporate the intent-to-treat (ITT) principle and we will estimate mixed-effects logistic regression for the primary outcomes. We will also conduct qualitative interviews at 6 and 12-months with 40 purposively sampled participants, stratified by study arm, who reported healthcare access barriers at baseline. Interviews will explore participants\' satisfaction with the intervention, healthcare attitudes, self-efficacy for and barriers to healthcare access over time, perceived contribution of the intervention to health and well-being, and diffusion of intervention-related information within participants\' social networks. We will conduct deductive thematic analyses of qualitative data.
CONCLUSIONS: Low health literacy among JIA is a foundational challenge requiring tailored intervention strategies. Findings from this trial may inform policies and the structure of service delivery models to build health literacy among JIA in institutional and community settings throughout the United States and elsewhere.
BACKGROUND: This study is registered with the United States\' ClinicalTrials.gov registry under protocol # 161,903.
METHODS: This manuscript describes the protocol for a longitudinal mixed-methods randomized clinical trial that assesses the effectiveness of a coach-guided health literacy intervention on JIA\'s healthcare access. The intervention was previously piloted with justice impacted adults. We will recruit 300 JIA ages 18 + in San Diego, California. Participants will be randomized 1:1 to the Treatment Group (i.e., coach-guided intervention providing 12 sessions of individualized health coaching and service navigation over 6 months) or the Control Group (i.e., self-study of the health coaching program, and brief service navigation support). We will quantitatively assess JIA\'s healthcare access defined as: use of healthcare, health insurance status, and regular source of care at 6-months as the primary outcomes. Participants will also be surveyed at 12-months. Statistical analyses will incorporate the intent-to-treat (ITT) principle and we will estimate mixed-effects logistic regression for the primary outcomes. We will also conduct qualitative interviews at 6 and 12-months with 40 purposively sampled participants, stratified by study arm, who reported healthcare access barriers at baseline. Interviews will explore participants\' satisfaction with the intervention, healthcare attitudes, self-efficacy for and barriers to healthcare access over time, perceived contribution of the intervention to health and well-being, and diffusion of intervention-related information within participants\' social networks. We will conduct deductive thematic analyses of qualitative data.
CONCLUSIONS: Low health literacy among JIA is a foundational challenge requiring tailored intervention strategies. Findings from this trial may inform policies and the structure of service delivery models to build health literacy among JIA in institutional and community settings throughout the United States and elsewhere.
BACKGROUND: This study is registered with the United States\' ClinicalTrials.gov registry under protocol # 161,903.
摘要：
背景：在受司法影响的成年人（JIA）中，低健康素养成本高昂，一个在获得医疗保健方面经常面临许多障碍和不成比例的疾病负担的群体。JIA的健康素养干预措施对于改善医疗保健获取和相关结果至关重要。
方法：本手稿描述了一项纵向混合方法随机临床试验的方案，该方案评估了教练指导的健康素养干预对JIA医疗保健服务的有效性。该干预措施以前是在受司法影响的成年人中进行试验的。我们将在圣地亚哥招募300名18岁以上的JIA，加州参与者将以1：1的比例随机分配到治疗组(即，教练指导的干预在6个月内提供12次个性化健康教练和服务导航)或对照组(即，自学健康教练计划，和简短的服务导航支持)。我们将定量评估JIA的医疗保健访问权限，定义为：医疗保健的使用，健康保险状况，以6个月时的定期护理为主要结局。参与者也将在12个月接受调查。统计分析将纳入意向治疗（ITT）原则，我们将估计主要结果的混合效应逻辑回归。我们还将在6个月和12个月对40名有意抽样的参与者进行定性访谈，按研究臂分层，他们在基线时报告了医疗保健准入障碍。访谈将探索参与者对干预的满意度，医疗保健态度，随着时间的推移，医疗服务的自我效能和障碍，感知干预对健康和福祉的贡献，以及干预相关信息在参与者社交网络中的传播。我们将对定性数据进行演绎专题分析。
结论：JIA的健康素养低下是一项基本挑战，需要量身定制的干预策略。这项试验的结果可能会为政策和服务提供模型的结构提供信息，以在美国和其他地方的机构和社区环境中建立JIA的健康素养。
背景：本研究在美国ClinicalTrials.gov注册中心注册，协议#161,903。
方法：本手稿描述了一项纵向混合方法随机临床试验的方案，该方案评估了教练指导的健康素养干预对JIA医疗保健服务的有效性。该干预措施以前是在受司法影响的成年人中进行试验的。我们将在圣地亚哥招募300名18岁以上的JIA，加州参与者将以1：1的比例随机分配到治疗组(即，教练指导的干预在6个月内提供12次个性化健康教练和服务导航)或对照组(即，自学健康教练计划，和简短的服务导航支持)。我们将定量评估JIA的医疗保健访问权限，定义为：医疗保健的使用，健康保险状况，以6个月时的定期护理为主要结局。参与者也将在12个月接受调查。统计分析将纳入意向治疗（ITT）原则，我们将估计主要结果的混合效应逻辑回归。我们还将在6个月和12个月对40名有意抽样的参与者进行定性访谈，按研究臂分层，他们在基线时报告了医疗保健准入障碍。访谈将探索参与者对干预的满意度，医疗保健态度，随着时间的推移，医疗服务的自我效能和障碍，感知干预对健康和福祉的贡献，以及干预相关信息在参与者社交网络中的传播。我们将对定性数据进行演绎专题分析。
结论：JIA的健康素养低下是一项基本挑战，需要量身定制的干预策略。这项试验的结果可能会为政策和服务提供模型的结构提供信息，以在美国和其他地方的机构和社区环境中建立JIA的健康素养。
背景：本研究在美国ClinicalTrials.gov注册中心注册，协议#161,903。
