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Abstract：
BACKGROUND: People with serious mental illness (SMI) and people with intellectual disabilities/developmental disabilities (ID/DD) are at higher risk for COVID-19 and more severe outcomes. We compare a tailored versus general best practice COVID-19 prevention program in group homes (GHs) for people with SMI or ID/DD in Massachusetts (MA).
METHODS: A hybrid effectiveness-implementation cluster randomized control trial compared a four-component implementation strategy (Tailored Best Practices: TBP) to dissemination of standard prevention guidelines (General Best-Practices: GBP) in GHs across six MA behavioral health agencies. GBP consisted of standard best practices for preventing COVID-19. TBP included GBP plus four components including: (1) trusted-messenger peer testimonials on benefits of vaccination; (2) motivational interviewing; (3) interactive education on preventive practices; and (4) fidelity feedback dashboards for GHs. Primary implementation outcomes were full COVID-19 vaccination rates (baseline: 1/1/2021-3/31/2021) and fidelity scores (baseline: 5/1/21-7/30/21), at 3-month intervals to 15-month follow-up until October 2022. The primary effectiveness outcome was COVID-19 infection (baseline: 1/1/2021-3/31/2021), measured every 3 months to 15-month follow-up. Cumulative incidence of vaccinations were estimated using Kaplan-Meier curves. Cox frailty models evaluate differences in vaccination uptake and secondary outcomes. Linear mixed models (LMMs) and Poisson generalized linear mixed models (GLMMs) were used to evaluate differences in fidelity scores and incidence of COVID-19 infections.
RESULTS: GHs (n=415) were randomized to TBP (n=208) and GBP (n=207) including 3,836 residents (1,041 ID/DD; 2,795 SMI) and 5,538 staff. No differences were found in fidelity scores or COVID-19 incidence rates between TBP and GBP, however TBP had greater acceptability, appropriateness, and feasibility. No overall differences in vaccination rates were found between TBP and GBP. However, among unvaccinated group home residents with mental disabilities, non-White residents achieved full vaccination status at double the rate for TBP (28.6%) compared to GBP (14.4%) at 15 months. Additionally, the impact of TBP on vaccine uptake was over two-times greater for non-White residents compared to non-Hispanic White residents (ratio of HR for TBP between non-White and non-Hispanic White: 2.28, p = 0.03).
CONCLUSIONS: Tailored COVID-19 prevention strategies are beneficial as a feasible and acceptable implementation strategy with the potential to reduce disparities in vaccine acceptance among the subgroup of non-White individuals with mental disabilities.
BACKGROUND: ClinicalTrials.gov, NCT04726371, 27/01/2021. https://clinicaltrials.gov/study/NCT04726371 .
METHODS: A hybrid effectiveness-implementation cluster randomized control trial compared a four-component implementation strategy (Tailored Best Practices: TBP) to dissemination of standard prevention guidelines (General Best-Practices: GBP) in GHs across six MA behavioral health agencies. GBP consisted of standard best practices for preventing COVID-19. TBP included GBP plus four components including: (1) trusted-messenger peer testimonials on benefits of vaccination; (2) motivational interviewing; (3) interactive education on preventive practices; and (4) fidelity feedback dashboards for GHs. Primary implementation outcomes were full COVID-19 vaccination rates (baseline: 1/1/2021-3/31/2021) and fidelity scores (baseline: 5/1/21-7/30/21), at 3-month intervals to 15-month follow-up until October 2022. The primary effectiveness outcome was COVID-19 infection (baseline: 1/1/2021-3/31/2021), measured every 3 months to 15-month follow-up. Cumulative incidence of vaccinations were estimated using Kaplan-Meier curves. Cox frailty models evaluate differences in vaccination uptake and secondary outcomes. Linear mixed models (LMMs) and Poisson generalized linear mixed models (GLMMs) were used to evaluate differences in fidelity scores and incidence of COVID-19 infections.
RESULTS: GHs (n=415) were randomized to TBP (n=208) and GBP (n=207) including 3,836 residents (1,041 ID/DD; 2,795 SMI) and 5,538 staff. No differences were found in fidelity scores or COVID-19 incidence rates between TBP and GBP, however TBP had greater acceptability, appropriateness, and feasibility. No overall differences in vaccination rates were found between TBP and GBP. However, among unvaccinated group home residents with mental disabilities, non-White residents achieved full vaccination status at double the rate for TBP (28.6%) compared to GBP (14.4%) at 15 months. Additionally, the impact of TBP on vaccine uptake was over two-times greater for non-White residents compared to non-Hispanic White residents (ratio of HR for TBP between non-White and non-Hispanic White: 2.28, p = 0.03).
CONCLUSIONS: Tailored COVID-19 prevention strategies are beneficial as a feasible and acceptable implementation strategy with the potential to reduce disparities in vaccine acceptance among the subgroup of non-White individuals with mental disabilities.
BACKGROUND: ClinicalTrials.gov, NCT04726371, 27/01/2021. https://clinicaltrials.gov/study/NCT04726371 .
摘要：
背景：患有严重精神疾病（SMI）和智力障碍/发育障碍（ID/DD）的人发生COVID-19的风险更高，结果更严重。我们比较了针对马萨诸塞州（MA）患有SMI或ID/DD的人群的团体住宅（GHs）中量身定制的最佳实践COVID-19预防计划和一般最佳实践预防计划。
方法：一项混合有效性实施整群随机对照试验，比较了四个组成部分的实施策略（量身定制的最佳实践：TBP）与标准预防指南（一般最佳实践：GBP）在六个MA行为卫生机构的GH中传播。英镑由预防COVID-19的标准最佳实践组成。TBP包括英镑以及四个组成部分，其中包括：（1）关于疫苗接种益处的可信赖信使同伴推荐；（2）动机性访谈；（3）关于预防实践的交互式教育；（4）GHs的保真度反馈仪表板。主要实施结果是完整的COVID-19疫苗接种率（基线：2021年1月1日至2021年3月31日）和保真度评分（基线：5/1/21-7/30/21），间隔3个月至15个月随访，直至2022年10月。主要有效性结果是COVID-19感染（基线：2021年1月1日至2021年3月31日），每3个月至15个月随访一次。使用Kaplan-Meier曲线估计疫苗接种的累积发生率。Cox脆弱模型评估疫苗接种摄取和次要结局的差异。线性混合模型（LMM）和泊松广义线性混合模型（GLMM）用于评估保真度评分和COVID-19感染发生率的差异。
结果：GHs（n=415）随机分为TBP（n=208）和GBP（n=207），包括3,836名居民（1,041ID/DD；2,795SMI）和5,538名工作人员。TBP和GBP之间的保真度评分或COVID-19发病率没有差异，然而TBP有更大的可接受性，适当性，和可行性。TBP和GBP之间没有发现疫苗接种率的总体差异。然而,在未接种疫苗的智障家庭居民中，非白人居民在15个月时TBP(28.6%)比GBP(14.4%)高出一倍,达到完全疫苗接种状态.此外,与非西班牙裔白人居民相比,非白人居民TBP对疫苗接种的影响超过2倍(非白人和非西班牙裔白人TBP的HR比:2.28,p=0.03).
结论：量身定做的COVID-19预防策略作为一种可行和可接受的实施策略是有益的，有可能减少非白人精神残疾患者亚组之间疫苗接受度的差异。
背景：ClinicalTrials.gov，NCT04726371，2021年1月27日。https://clinicaltrials.gov/study/NCT04726371.
方法：一项混合有效性实施整群随机对照试验，比较了四个组成部分的实施策略（量身定制的最佳实践：TBP）与标准预防指南（一般最佳实践：GBP）在六个MA行为卫生机构的GH中传播。英镑由预防COVID-19的标准最佳实践组成。TBP包括英镑以及四个组成部分，其中包括：（1）关于疫苗接种益处的可信赖信使同伴推荐；（2）动机性访谈；（3）关于预防实践的交互式教育；（4）GHs的保真度反馈仪表板。主要实施结果是完整的COVID-19疫苗接种率（基线：2021年1月1日至2021年3月31日）和保真度评分（基线：5/1/21-7/30/21），间隔3个月至15个月随访，直至2022年10月。主要有效性结果是COVID-19感染（基线：2021年1月1日至2021年3月31日），每3个月至15个月随访一次。使用Kaplan-Meier曲线估计疫苗接种的累积发生率。Cox脆弱模型评估疫苗接种摄取和次要结局的差异。线性混合模型（LMM）和泊松广义线性混合模型（GLMM）用于评估保真度评分和COVID-19感染发生率的差异。
结果：GHs（n=415）随机分为TBP（n=208）和GBP（n=207），包括3,836名居民（1,041ID/DD；2,795SMI）和5,538名工作人员。TBP和GBP之间的保真度评分或COVID-19发病率没有差异，然而TBP有更大的可接受性，适当性，和可行性。TBP和GBP之间没有发现疫苗接种率的总体差异。然而,在未接种疫苗的智障家庭居民中，非白人居民在15个月时TBP(28.6%)比GBP(14.4%)高出一倍,达到完全疫苗接种状态.此外,与非西班牙裔白人居民相比,非白人居民TBP对疫苗接种的影响超过2倍(非白人和非西班牙裔白人TBP的HR比:2.28,p=0.03).
结论：量身定做的COVID-19预防策略作为一种可行和可接受的实施策略是有益的，有可能减少非白人精神残疾患者亚组之间疫苗接受度的差异。
背景：ClinicalTrials.gov，NCT04726371，2021年1月27日。https://clinicaltrials.gov/study/NCT04726371.
