AzTrials
AzTrials

Hospital Information SystemsNCT06973707

Digital Tools to Engage and Activate Patients During Hospitalization

A study testing Passive Digital Tools and Active Digital Tools in people with Hospital Information Systems, run by Brigham and Women's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hospital Information Systems
What is being tested?
Passive Digital Tools and Active Digital Tools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
No sites listed yet
Study dates
1 Jul 2028to Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jeffrey Schnipper, MD, MPH contact

617-732-7063

jschnipper@bwh.harvard.edu

About this study

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

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?

Read more

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.

Read the 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.

Being tested
Passive Digital Tools, Active Digital Tools
Keywords
Hospitalization, Health information technologies, Patient Engagement, Patient Activation
Medical subject headings
Patient Participation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Passive Digital ToolsBehavioural

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

  • Active Digital ToolsBehavioural

    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

Study groups in NCT06973707
Study groupRoleWhat they receive
Usual CareNo 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 OnlyActive comparatorUsual Care plus: Dynamic organizational chart of care team members. Electronic guide to general medicine service. Electronic Plan for the Day.
Receives: Behavioral: Passive Digital Tools
Passive Plus Active Digital ToolsExperimentalUsual 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.
Receives: Behavioral: Passive Digital Tools; Behavioral: Active Digital Tools

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Hospitalization (up to 30 days)

Secondary outcomes (5)
  1. Knowledge of care team

    Analytic variable: Patient's knowledge of who is in charge of their care (Yes/No) Data source/method: survey

    Measured: Day prior to discharge

  2. Knowledge of care plan

    Analytic variable: Patient's knowledge of the plan for their care (Yes/No) Data source/method: survey

    Measured: Day prior to discharge

  3. Self-efficacy for managing chronic conditions

    Analytic variable: PROMIS Self-efficacy for managing chronic conditions score. T-score of 50 is average, standard deviation 10, higher scores indicate higher self-efficacy.

    Data source/method: survey

    Measured: Day prior to discharge

  4. Improvement in anxiety and depression

    Analytic variable: Hospital Anxiety Depression Scale (HADS) day prior to discharge minus HADS at enrollment. HADS consists of 14 questions with two subscales with 7 questions each for anxiety and depression. Each item is rated 0-3, resulting in a total score of 0-21 for each subscale, with higher scores indicating greater anxiety and depression.

    Data source/method: survey

    Measured: Hospitalization (up to 30 days)

  5. Patient experience

    Analytic variable: Picker Patient Experience Questionnaire score. 15 questions, each scored 1-5, with higher scores indicating greater patient experience.

    Data source/method: survey

    Measured: Day prior to discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start1 Jul 2028 (estimated)
  3. Primary completionOct 2029 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster-randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06973707
Sponsor's protocol ID
2025p000989
Other IDs
R21HS030738
Status last verified
Aug 2026
First submitted
29 Apr 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patient-level demographic data (from the EHR and patient survey). Outcome data (e.g., quality, safety, patient experience, equity) from patient surveys.

Questions about this trial

What is this clinical trial studying?

A study testing Passive Digital Tools and Active Digital Tools in people with Hospital Information Systems, run by Brigham and Women's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeffrey Schnipper, MD, MPH (617-732-7063, jschnipper@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in patient activation (time frame: Hospitalization (up to 30 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in