Clinical trial NCT06973707: Digital Tools to Engage and Activate Patients During Hospitalization
Official title: Digital Tools to Engage and Activate Patients During Hospitalization: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hospital Information Systems
Keywords: Hospitalization
Health information technologies
Patient Engagement
Patient Activation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement in patient activation
timeFrame: Hospitalization (up to 30 days)
Secondary outcomes:
measure: Knowledge of care team
timeFrame: Day prior to discharge
measure: Knowledge of care plan
timeFrame: Day prior to discharge
measure: Self-efficacy for managing chronic conditions
timeFrame: Day prior to discharge
measure: Improvement in anxiety and depression
timeFrame: Hospitalization (up to 30 days)
measure: Patient experience
timeFrame: Day prior to discharge
Other outcomes:
measure: Post-discharge medication adherence
timeFrame: 0-3 days after discharge
measure: Keeping post-discharge appointments
timeFrame: 0-30 days after discharge
Locations:
Study officials:
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