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NCT Number: NCT06973707

Digital Tools to Engage and Activate Patients During Hospitalization

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive Digital Tools

Behavioral

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

Active Digital Tools

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Knowledge of care team

    Time frame: Day prior to discharge

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

  2. Knowledge of care plan

    Time frame: Day prior to discharge

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

  3. Self-efficacy for managing chronic conditions

    Time frame: Day prior to discharge

    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

  4. Improvement in anxiety and depression

    Time frame: Hospitalization (up to 30 days)

    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

  5. Patient experience

    Time frame: Day prior to discharge

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

    Data source/method: survey

Other outcomes

  1. Post-discharge medication adherence

    Time frame: 0-3 days after discharge

    Analytic variable: Proportion of new medication prescriptions at discharge filled in the 3 days after discharge Data source/method: EHR discharge data, SureScripts prescription fill data

  2. Keeping post-discharge appointments

    Time frame: 0-30 days after discharge

    Analytic variable: Proportion of scheduled appointments kept in the 30 days after discharge Data source/method: EHR appointment data

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey Schnipper, MD, MPH

CONTACT

[email protected]

617-732-7063

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2028
Primary completion
2029
Study completion
2030
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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