Digital Tools to Engage and Activate Patients During Hospitalization

NCT ID: NCT06973707

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2028-07-01
• Study Completion Date: 2030-01-31

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.

Conditions

Hospital Information Systems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Passive Digital Tools Only

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

Group Type: ACTIVE_COMPARATOR

Passive Digital Tools

Intervention Type: BEHAVIORAL

Dynamic organizational chart of care team members Guide to general medicine service Plan for the day

Passive Plus Active Digital Tools

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.

Group Type: EXPERIMENTAL

Passive Digital Tools

Intervention Type: BEHAVIORAL

Dynamic organizational chart of care team members Guide to general medicine service Plan for the day

Active Digital Tools

Intervention Type: BEHAVIORAL

Guide: why patient engagement is important Sample questions with answers Ability to create, organize, and store questions to ask the medical team; reminder to ask them during rounds Electronic journal function with categories: symptoms, emotions, function, what I learned; reminder to share with medical team during rounds

Interventions

Passive Digital Tools

Dynamic organizational chart of care team members Guide to general medicine service Plan for the day

Intervention Type: BEHAVIORAL

Active Digital Tools

Guide: why patient engagement is important Sample questions with answers Ability to create, organize, and store questions to ask the medical team; reminder to ask them during rounds Electronic journal function with categories: symptoms, emotions, function, what I learned; reminder to share with medical team during rounds

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L. Schnipper, MD.,MPH.

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jeffrey Schnipper, MD, MPH

Role: CONTACT

jschnipper@bwh.harvard.edu

617-732-7063

Other Identifiers

R21HS030738

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025p000989

Identifier Type: -

Identifier Source: org_study_id