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临床试验/NCT06973707
NCT06973707尚未招募不适用

Digital Tools to Engage and Activate Patients During Hospitalization: A Cluster Randomized Trial

Brigham and Women's Hospital0 个研究点目标入组 520 人开始时间: 2028年7月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
520
主要终点
Improvement in patient activation

研究概览

简要总结

The goal of this clinical trial is to learn about the possible benefits of mobile digital tools used by patients and families, with the help of a digital navigator, while patients are in the hospital. The goals are to better engage patients and their caregivers in their own care. The main questions it aims to answer are:

Will use of these digital tools and digital navigators lead to greater patient activation during the hospitalization than usual care? Will use of passive and active tools lead to greater patient activation than the use of passive tools alone? Will use of these digital tools increase patient knowledge (of the care team and care plan) and patient self-efficacy, reduce patient anxiety, and improve patient experience and post-discharge behavior (filling discharge prescriptions and keeping follow-up appointment visits)? Will use of the digital tools decrease disparities in outcomes by language and area deprivation index?

Participants will:

Be asked to use the digital tools, assisted by a digital navigator, or usual care, including the hospital's patient portal.

Complete surveys while in the hospital regarding baseline characteristics and study outcomes.

If asked, give input into the design of tools and/or participate in interviews regarding their opinions of the digital tools and any barriers to implementation.

详细描述

Patient activation, defined as having the knowledge, skills, and confidence to manage one's health condition, allows patients to better manage their medical symptoms and conditions, engage in activities that benefit their health, be involved in shared decision-making, and navigate the health care system. In the hospital, patient activation is often low. As a result, patients may receive suboptimal care during and after hospitalization. Digital tools such as patient portals have shown some promise to increase patient activation, but few studies have been conducted in the inpatient setting or have shown equivocal results due to low digital literacy.

The broad, long-term objectives of this work are to develop patient-facing digital tools, and assist patients with using them, in the hospital setting to increase patient activation and improve quality of care. The specific aims are: 1) Design and develop two sets of digital tools, passive and active, to better engage patients and their caregivers while in the hospital; 2) Pilot implementation of the two digital interventions on general medicine; and 3) Evaluate the effect of passive and active digital tools and digital navigators on patient activation, knowledge, and self-efficacy, patient behavior, patient experience, and equity.

During the R21 phase of the study, digital tools, built on top of the existing patient portal, will be developed and iteratively refined using user-centered design principles, with extensive input from patients, caregivers, and providers. Passive tools will provide additional information not available in our current patient portal, such as a dynamic organizational chart of each patient's care team. Active tools will provide customized answers to commonly asked questions and encourage patients to participate in their care, e.g., to ask their own questions during rounds and to keep (and share) a journal of their symptoms, function, and mood. A digital navigator will be recruited and trained to assist patients with the tools. Feasibility, acceptability, appropriateness, and usability will be evaluated using mixed methods, and a final implementation plan will be created. During the subsequent R33 phase, outcomes will be evaluated in a three-arm cluster-randomized controlled trial: usual care, passive tools only, or passive and active tools. Outcomes will include patient activation, patient experience, and downstream behaviors such as filling discharge prescriptions and keeping follow-up appointments. Mixed methods will be used to evaluate the reliability, validity, and usability of the tools and their impact on clinicians. An implementation guide will be created to facilitate widespread adoption and sustainability based on an evaluation of barriers and facilitators of implementation. Study findings will be disseminated to a variety of stakeholders to further the impact of this project on future care delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients admitted to the general medicine service at Brigham and Women's Hospital during the 12-month trial enrollment period
  • English or Spanish speakers
  • Age 18 or older
  • Able to provide informed consent

排除标准

  • Residence in a nursing home, rehab facility, or group home
  • Undomiciled
  • Pregnant women, prisoners, or institutionalized individuals
  • Likely to be discharged somewhere other than home in the opinion of the care team

研究组 & 干预措施

Usual Care

No Intervention

Access to hospital's patient portal. Written materials regarding patient portal and structure of inpatient medical service. White board with plan of the day.

Passive Digital Tools Only

Active Comparator

Usual Care plus: Dynamic organizational chart of care team members. Electronic guide to general medicine service. Electronic Plan for the Day.

干预措施: Passive Digital Tools (Behavioral)

Passive Plus Active Digital Tools

Experimental

Usual Care plus Passive Tools plus: guide to why patient engagement is important. Sample medical questions with customized answers. Ability to create, organize, and store questions to ask the medical team. Electronic journal to keep track of symptoms, emotions, function, what patient learned.

干预措施: Passive Digital Tools (Behavioral)

Passive Plus Active Digital Tools

Experimental

Usual Care plus Passive Tools plus: guide to why patient engagement is important. Sample medical questions with customized answers. Ability to create, organize, and store questions to ask the medical team. Electronic journal to keep track of symptoms, emotions, function, what patient learned.

干预措施: Active Digital Tools (Behavioral)

结局指标

主要结局

Improvement in patient activation

时间窗: Hospitalization (up to 30 days)

Analytic variable: Patient Activation Measure (PAM)-13 day prior to discharge minus PAM-13 at enrollment. PAM-13 ranges from 0 to 100, with higher scores indicating greater patient activation (better outcome). Data source/method: survey

次要结局

  • Knowledge of care team(Day prior to discharge)
  • Knowledge of care plan(Day prior to discharge)
  • Self-efficacy for managing chronic conditions(Day prior to discharge)
  • Improvement in anxiety and depression(Hospitalization (up to 30 days))
  • Patient experience(Day prior to discharge)

研究者

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

Jeffrey L. Schnipper, MD.,MPH.

Research Director, Division of General Internal Medicine, Brigham and Women's Hospital

Brigham and Women's Hospital

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