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临床试验/NCT05715463
NCT05715463进行中(未招募)不适用

Achieving Equity in Inflammatory Arthritis Care: An Adaptive Trial To Understand and Address Social Determinants of Health

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
101
试验地点
2
主要终点
Patient no-shows

研究概览

简要总结

Social determinants of health (SDoH), defined by the World Health Organization as "the conditions in which people are born, grow, work, live and age and the wider set of forces and systems shaping the conditions of daily life" are estimated to be responsible for nearly 90 percent of a person's health outcomes. SDoH are key contributors to racial, ethnic and socioeconomic disparities in care healthcare access and health outcomes. The goal of this clinical trial is to identify patients with inflammatory arthritis or with a systemic rheumatic condition with arthritis who may respond to the simplest and least expensive intervention to address their SDoH-related needs- a tailored list of resources, those who benefit from a community-based resource specialist to help address specific needs, and those who require a nurse-trained navigator to help both coordinate the services provided by the community-based specialist, and their medical and mental health care and needs. The main questions the clinical trial aims to answer are:

  1. To test the efficacy of a rheumatology clinic-based nurse navigator and community resource specialist to reduce appointment no-shows and same-day cancellations in patients with systemic rheumatic conditions with arthritis.
  2. To examine the cost-effectiveness of each of the different study interventions for individuals with systemic rheumatic conditions with arthritis with SDoH-related needs using questionnaires and cost-related care metrics.

Participants will be randomly assigned to 1 of 3 arms. In Arm 1, patients will receive a cultivated list of resources related to the needs that patients indicate on the social determinants of health questionnaire. Arm 1 is the control arm which receives the current standard of care. In Arm 2, patients will receive the assistance of a community resource specialist (CRS) - an individual without formal medical training with community-based expertise. In Arm 3, patients will receive the assistance of a nurse patient navigator with additional systemic rheumatic condition-specific training who will work with the CRS.

After 6 months, patients who do not respond to Arm 1 will move to Arm 2. Patients who do not respond to Arm 2, will move to Arm 3. Patients who do not respond to Arm 3 will remain in Arm 3. Patients who respond to any arm will graduate the program at 6 months. The patients who do not respond be in their new arm for 6 months. At 12 months, all patients remaining in the study will graduate.

详细描述

Social determinants of health (SDoH), defined by the World Health Organization as "the conditions in which people are born, grow, work, live and age and the wider set of forces and systems shaping the conditions of daily life" are estimated to be responsible for nearly 90 percent of a person's health outcomes. SDoH are key contributors to racial, ethnic and socioeconomic disparities in care healthcare access and health outcomes. Among patients with chronic rheumatic conditions, SDoH including poverty, insurance status, and inadequate access to care have been shown to contribute to delayed diagnoses, frequent emergency department visits, medication nonadherence, worse quality of life, increased disease-related damage and poorer outcomes. Individuals with inflammatory arthritis often require complex, costly medication regimens and suffer from a high burden of comorbid conditions and physical disabilities. They face unique healthcare challenges including a high risk of care fragmentation from multiple subspecialty providers and medications that are both expensive and challenging to adhere to as prescribed. The role of SDoH on the care and outcomes of patients with inflammatory arthritis is understudied but living conditions, socioeconomic status and neighborhood income have been shown to contribute to treatments received and the likelihood of remission at 12 months. Disparities in inflammatory arthritis care and outcomes are likely multifactorial and involve both delayed access to subspecialty care as well as ongoing barriers to sustained, high quality care once referred. Separate comprehensive interventions are required to address the challenges at every stage of care.

Our ongoing quality improvement initiative aims to collect and document social determinants of health data for people with inflammatory arthritis across this multi-hospital system. In this initiative the investigators developed a standard of care where patients have their needs assessed and if they indicate that they would like information to help address these needs, they are sent resource lists. A community resource specialist is also available when indicated to help address needs. In this study, the investigators aim to test different interventions to address the needs that the investigators uncover using the SDoH screening protocol. Using an adaptive strategy, patients with SDoH-related needs and appointment no shows in the past, will be randomized to one of three arms, with the ability to change arms if they do not improve in their assigned arm. Cost-effectiveness analyses will also be conducted.

Using an adaptive intervention, this trial will help identify patients who may respond to the simplest and least expensive intervention - a tailored list of resources, those who benefit from a community-based resource specialist to help address specific SDoH-related needs, and those who require a nurse-trained navigator to help both coordinate the services provided by the community-based specialist, and their medical and mental health care and needs. A cost effectiveness analysis of the interventions will be conducted. The knowledge gained by this trial will help guide care and advocacy for vulnerable populations both in resource poor settings and at major medical centers that have not previously allocated the services needed to care for the highest risk populations. The overall goal of this study is to provide these essential data to advocate for a scalable, sustainable program to meet the needs of the most vulnerable patients with chronic rheumatic conditions with arthritis that can be scaled to other chronic systemic rheumatic diseases and other complex, subspecialty-managed conditions.

Specific Aims:

  1. To conduct a randomized controlled trial with an adaptive intervention to test the efficacy of a rheumatology clinic-based nurse patient navigator and community resource specialist intervention to reduce appointment no shows. This intervention will allow for an understanding of these needs and test three strategies to begin to address them. The investigators anticipate that all of the interventions will benefit to some degree through connection to resources. The investigators currently have no data as to whether one type of intervention is better than another for patients with systemic rheumatic conditions with arthritis and therefore, the investigators are testing two types of navigator interventions with the ultimate goal of determining the most beneficial and cost-effective intervention for high-risk patients based on their specific needs. The adaptive nature of the intervention will allow the study team to study this further and will allow for as many individuals as possible to derive potential benefit from this study.
  2. To examine the cost-effectiveness of each of the different study arms for individuals with systemic rheumatic conditions with arthritis with SDoH-related needs using the ED-5D questionnaire and cost-related care metrics.

研究设计

研究类型
Interventional
分配方式
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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • English or Spanish-speaking
  • 18+ years of age
  • diagnosis of a systemic rheumatic condition with arthritis
  • 1+ prior no-show(s) or same day cancellation(s) to an ambulatory care provider in the past year
  • 1+ social determinants of health needs on Mass General Brigham questionnaire (excluding unemployment and education)
  • Receiving rheumatology care at a Mass General Hospital, Brigham and Women's Hospital or Faulkner Hospital affiliated clinic

排除标准

  • Incarcerated individuals
  • Indicated through our EHR that they do not want to be contacted for research
  • Patients already actively enrolled in an integrated care management program through their primary care provider
  • Medical complexity that requires urgent nursing involvement and thus not medically appropriate for randomization

结局指标

主要结局

Patient no-shows

时间窗: -12 months through +12 months

Patient no-shows will be measured through EPIC data from EDW, manual chart review and RPDR. The outcome will measure number of times that a patient has been designated 'no show' to an appointment with an ambulatory care provider.

次要结局

  • Reduction of Social Determinants of Health-related needs in institution-created questionnaire(-12 months through +12 months)
  • Medication adherence through patient questionnaire(0 through +12 months)
  • Lupus Checklist(0 through +12 months)
  • Acute care use overall(0 through +12 months)
  • Acute care use for avoidable conditions(0 through +12 months)
  • Patient discrimination(0 through +12 months)
  • Patient trust in providers(0 through + 12 months)
  • Self efficacy(0 through +12 months)
  • Patient stress(0 through +12 months)
  • Reduction of Social Determinants of Health-related needs in EHR data(-12 months through +12 months)
  • Treat-to-target metrics(0 through +12 months)
  • Patient anxiety & depression(0 through +12 months)
  • Inflammatory Arthritis Checklist(0 through +12 months)
  • Medication adherence through medication refill data(0 through +12 months)
  • Disability metric(0 through +12 months)
  • Patient satisfaction(0 through +12 months)
  • Literacy(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Candace Hillary Feldman, MD

Assistant Professor

Brigham and Women's Hospital

研究点 (2)

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