Improving SCD Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 279
- 试验地点
- 15
- 主要终点
- Change in Patient-perceived quality of ED pain treatment.
研究概览
简要总结
The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a record of patients' SCD genotype and will include analgesic medication recommendations developed by the SCD provider. In this project, we will provide access to the IPP for both adult patients with SCD and ED providers. The proposed multisite study will use a pre-post study design, with a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources. The EHR-embedded IPP will be available for all adult ED providers to use as their routine practice, and patients will be invited to participate and enroll in the study. We will use a simplified Technology Acceptance Model to explain the use of the IPP and the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention.
详细描述
The study aims are as follows:
Aim 1: Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting. We will evaluate the effectiveness of the intervention on both patients and providers using a pre-post study design.
Sub-aim 1.a. To examine effectiveness of the EHR-embedded IPP on improving patients' perceived quality of ED pain treatment. We hypothesize that among enrolled patients with at least one ED VOE visit during the intervention period, the perceived quality of ED pain treatment will increase by 0.5 standard deviation (primary outcome) after an ED VOE visit when compared with the last ED VOE visits made by these patients within 90 days before enrollment. We will measure change pre- and post-intervention in secondary patient outcomes, including hospital admission rate within 12 months, ED VOE revisit rate, ED VOE readmission rate, and time to first dosage of pain medication provided in the ED.
Sub-aim 1.b. To examine the effectiveness of the EHR-embedded IPP on improving providers' self-efficacy in treating pain for patients with SCD and perceived quality of ED pain treatment. We hypothesize that the intervention will increase providers' self-efficacy in treating VOEs and managing pain for patients with SCD when compared with self-efficacy before the intervention. We will also explore the effect of the intervention on ED providers' perceived quality of ED pain treatment.
Aim 2: Assess the reach, adoption, implementation, and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site. We will use the RE-AIM framework to evaluate intervention outcomes in addition to intervention effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion Criteria:
- •Age 18 years up to and including 45 years
- •English speaking
- •Confirmed SCD diagnoses . Confirmed is defined as supported by documentation in the medical record of a positive test for one of the following : Hb SS, Hb SC, Hb S -thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.
- •Access to a cellular/mobile smart phone with access to text messaging (either Android or iPhone acceptable) .
- •At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency Department (ED) the past 90 days from enrollment
- •At least one visit at the study site sickle cell disease clinic within the past 12 months
- •Willing and cognitively able to give informed consent
排除标准
- •Patient's sickle cell provider states patient should not have a protocol or should not be administered opioids
- •Provider Inclusion Criteria:
- •Provides pain treatment in one of the participating study Emergency Departments for a patient participant with a qualified ED visit .
结局指标
主要结局
Change in Patient-perceived quality of ED pain treatment.
时间窗: Baseline, 96 hours
Three questions from the Adult Sickle Cell Quality of Life Measure (ASCQ-Me) and Quality of Care (QOC) measure will be used to measure the patient perceived quality of ED pain treatment
次要结局
- Hospital readmission rate measured by EHR retrieval(Day 30)
- Time to first dose of pain medication measured by EHR retrieval(Baseline)
- ED revisit rate as measured by EHR retrieval(Day 30)