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Multiple Chronic ConditionsPhase 1/2NCT05282654

Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions

A Phase 1/2 study testing ePRO Application in people with Multiple Chronic Conditions and Adverse Event, run by Brigham and Women's Hospital at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Chronic Conditions, Adverse Event
What is being tested?
ePRO Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
937 participants
Where
2 sitesUnited States
Study dates
1 Feb 2022to 15 May 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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 (18 years or older)
  • Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours
  • Have a discharge status of home, home with services, or facility
  • English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  • Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)
  • Two or more chronic conditions: Anxiety, Asthma*, Arthritis (Osteoarthritis, Rheumatoid), Atrial Fibrillation, Cancer*, Cerebral vascular accident, Chronic kidney disease*, Chronic obstructive pulmonary disease (COPD)*, Cirrhosis, Coronary artery disease/Ischemic heart disease, Dementia, Depression, Diabetes mellitus*, End-stage renal disease*, Heart failure*, Hepatitis B, C*, HIV/AIDs, Hyperlipidemia, Hypertension, Inflammatory bowel disease, Osteoporosis, Sickle cell disease, Substance abuse (Alcohol/Opioid)

Who cannot join

  • Less than 18 years of age
  • Less than two chronic conditions
  • Hospitalized less than 24 hours
  • No identifiable healthcare proxy or next of kin (i.e., a family caregiver)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Brigham and Women's Faulkner Hospital

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.

Read the detailed description

Adverse events (AE) during care transitions range from 19-28% and may lead to readmissions, representing an ongoing threat to patient safety. Early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians is critical, especially for patients with multiple chronic conditions (MCC). Clinically integrated digital health apps have the potential to more accurately predict post-discharge AEs and improve communication for patients, their caregivers, and the care team. Such tools can provide individualized risk assessments of AEs by systematically collecting relevant patient-reported outcomes (PROs) and leveraging standardized application programming interfaces (API) to combine them with electronic health record (EHR) data. While patient-reported outcomes (PROs) are increasingly used in ambulatory settings, their use for real-time symptom monitoring and escalation during transitions from the hospital is novel and potentially transformative-by both empowering patients to better understand their individualized risks of post-discharge AEs, and improving monitoring while transitioning out of the hospital. Our proposed intervention is grounded in evidence-based frameworks for care transitions, and scaling and spread of digital health tools. To inform our intervention, we propose developing and validating a predictive model of post-discharge AEs for 450 MCC patients using relevant PRO questionnaires and electronic health record (EHR) derived variables during our baseline pre-implementation period. Simultaneously, we will combine, adapt, extend, and refine our previously developed EHR-integrated hospital and ambulatory-focused digital health infrastructure to support MCC patients in real-time symptom monitoring using PROs when transitioning out of the hospital. Our intervention uses interoperable, data exchange standards and APIs to seamlessly integrate with existing vendor patient portal offerings, thereby addressing critical gaps and supporting the complete continuum of care. Our multidisciplinary team uses principles of user-centered design and agile software development to rapidly identify, design, develop, refine, and implement requirements from patients and clinicians. Our team will rigorously evaluate this intervention in a large-scale randomized controlled trial of 850 in which we compare our real-time symptom monitoring intervention (425) to usual care (425) for patients with MCCs transitioning out of the hospital. Finally, we will conduct a robust mixed methods evaluation to generate new knowledge and best practices for disseminating, implementing, and using this interoperable intervention at similar institutions with different EHR vendors

Being tested
ePRO Application
Keywords
Digital Health, Patient Reported Outcomes, Symptom Monitoring, Predictive Model, Care Transitions, Post Acute Care
Medical subject headings
Multiple Chronic Conditions

What participants receive

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

  • ePRO ApplicationBehavioural

    The intervention consists of a patient portal, EHR-integrated web-app to communicate risk of post-discharge adverse events using patient-reported outcome questionnaires, discharge preparation checklist during hospitalization. After discharge, the intervention will provide real-time symptom monitoring using ePROs and facilitate communication with clinicians based on prediction model-informed ePRO score trends exceeding escalation thresholds.

Study groups in NCT05282654
Study groupRoleWhat they receive
Usual Care (Arm 1)No interventionDuring the 18-month Baseline Period (Arm 1, n=450) patients will be enrolled and receive usual care to develop the initial predictive model.
Usual Care (Arm 2)No interventionDuring the 30-month Main Trial (RCT) Period, patients will be randomized to usual care (Arm 2, n=425). Data collection for post-discharge AE determination will occur during both periods.
Intervention (Arm 3)ExperimentalDuring the 30-month Main Trial (RCT) Period, patients will be randomized to the intervention (Arm 3, n=425). Data collection for post-discharge AE determination will occur during both periods.
Receives: Behavioral: ePRO Application

What is being measured

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

  1. Actual adverse events (AEs)

    The number of actual AEs during the 30-day post-discharge period

    Measured: Up to 30-days after discharge from index hospitalization

  2. Actual preventable adverse events (AEs)

    The number of actual AEs during the 30-day post-discharge period

    Measured: Up to 30-days after discharge from index hospitalization

Secondary outcomes (3)
  1. Potential adverse events (AEs)

    The number of new or worsening symptoms reported by the patient

    Measured: Up to 30-days after discharge from index hospitalization

  2. Post-discharge healthcare utilization events (hospital readmissions)

    Hospital readmissions

    Measured: Up to 30-days after discharge from index hospitalization

  3. Post-discharge healthcare utilization (ambulatory events)

    Composite of unanticipated ambulatory, urgent care, ED visits

    Measured: Up to 30-days after discharge from index hospitalization

Timeline

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

  1. First posted16 Mar 2022
  2. Study start1 Feb 2022
  3. Primary completion15 May 2026
  4. Study completion15 May 2026

Why it stopped: Grant Terminated by Sponsor

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Baseline (phase 1), pre-implementation period (usual care arm 1) and main trial (RCT, phase 2) period (usual care arm 2 and intervention/experimental arm 3)
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
937 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05282654
Sponsor's protocol ID
2021P002593
Other IDs
R01HS028662
Status last verified
Oct 2026
First submitted
11 Feb 2022
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ePRO Application in people with Multiple Chronic Conditions and Adverse Event, run by Brigham and Women's Hospital at 2 sites in United States.

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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Grant Terminated by Sponsor). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Actual adverse events (AEs) (time frame: Up to 30-days after discharge from index hospitalization). The study lists 2 primary outcomes in all. 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 21 Oct 2026.

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