Digital Tools to Engage and Activate Patients During Hospitalization
2 other identifiers
interventional
520
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2028
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 15, 2025
CompletedStudy Start
First participant enrolled
July 1, 2028
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
Study Completion
Last participant's last visit for all outcomes
January 1, 2030
May 15, 2025
May 1, 2025
1.3 years
April 29, 2025
May 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in patient activation
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
Hospitalization (up to 30 days)
Secondary Outcomes (5)
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
Other Outcomes (2)
Post-discharge medication adherence
0-3 days after discharge
Keeping post-discharge appointments
0-30 days after discharge
Study Arms (3)
Usual Care
NO INTERVENTIONAccess 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 COMPARATORUsual Care plus: Dynamic organizational chart of care team members. Electronic guide to general medicine service. Electronic Plan for the Day.
Passive Plus Active Digital Tools
EXPERIMENTALUsual 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.
Interventions
Dynamic organizational chart of care team members Guide to general medicine service Plan for the day
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director, Division of General Internal Medicine, Brigham and Women's Hospital
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 15, 2025
Study Start (Estimated)
July 1, 2028
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
January 1, 2030
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Study data will be made available as soon as possible and no later than one year after the end of the award period. Data will be available for 10 years.
- Access Criteria
- Data will be restricted using a controlled access repository. Requests for data will be reviewed by the Co-PIs per established policies and procedures; the investigators may establish data use restrictions (e.g., only for research studies); a data user's institution will need to complete a Data Use Agreement; data users may need to produce a data security plan.
Patient-level demographic data (from the EHR and patient survey). Outcome data (e.g., quality, safety, patient experience, equity) from patient surveys.