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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Hospital Information Systems
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Passive Digital Tools |
| 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. 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.
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)
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
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
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
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)
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.
- First posted15 May 2025
- Study start1 Jul 2028 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Information SystemsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L. Schnipper, MD.,MPH., Brigham and Women's Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Tools to Engage and Activate Patients During Hospitalization: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06973707
- Acronym / sponsor ID
- 2025p000989
- Conditions
- Hospital Information Systems
- Keywords
- Hospitalization, Health information technologies, Patient Engagement, Patient Activation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2028 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Passive Digital ToolsUsual 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 | Experimental | Behavioral: Passive Digital Tools, Behavioral: Active Digital ToolsUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive Digital ToolsDynamic organizational chart of care team members Guide to general medicine service Plan for the day | Behavioural | Passive Digital Tools Only, Passive Plus Active Digital Tools |
| Active Digital ToolsGuide: 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 | Behavioural | Passive Plus Active Digital Tools |
Primary outcome
Improvement in patient activation
Time frame: 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
5 secondary outcomes
Knowledge of care team
Time frame: Day prior to discharge
Knowledge of care plan
Time frame: Day prior to discharge
Self-efficacy for managing chronic conditions
Time frame: Day prior to discharge
Improvement in anxiety and depression
Time frame: Hospitalization (up to 30 days)
Patient experience
Time frame: Day prior to discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Patient-level demographic data (from the EHR and patient survey). Outcome data (e.g., quality, safety, patient experience, equity) from patient surveys.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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.