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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Conditions
- Multiple Chronic Conditions, Adverse Event
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care (Arm 1) | No intervention | During 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 intervention | During 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) | Experimental | During 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.
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
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)
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
Post-discharge healthcare utilization events (hospital readmissions)
Hospital readmissions
Measured: Up to 30-days after discharge from index hospitalization
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.
- First posted16 Mar 2022
- Study start1 Feb 2022
- Primary completion15 May 2026
- Study completion15 May 2026
Why it stopped: Grant Terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Chronic ConditionsStudies 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 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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RAND, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Anuj K. Dalal, MD, Brigham and Women's Hospital
- Investigators
- Anuj Dalal, MD, Principal investigator, Brigham and Women's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions
- ClinicalTrials.gov ID
- NCT05282654
- Acronym / sponsor ID
- 2021P002593
- Conditions
- Multiple Chronic Conditions, Adverse Event
- Keywords
- Digital Health, Patient Reported Outcomes, Symptom Monitoring, Predictive Model, Care Transitions, Post Acute Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Grant Terminated by Sponsor
- Enrolment
- 937 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- RAND, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 16 Mar 2022 (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.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Arm 1) | No intervention | –During 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 intervention | –During 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) | Experimental | Behavioral: ePRO ApplicationDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| ePRO ApplicationThe 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. | Behavioural | Intervention (Arm 3) |
Primary outcome
Actual adverse events (AEs)
Time frame: Up to 30-days after discharge from index hospitalization
The number of actual AEs during the 30-day post-discharge period
Actual preventable adverse events (AEs)
Time frame: Up to 30-days after discharge from index hospitalization
The number of actual AEs during the 30-day post-discharge period
3 secondary outcomes
Potential adverse events (AEs)
Time frame: Up to 30-days after discharge from index hospitalization
Post-discharge healthcare utilization events (hospital readmissions)
Time frame: Up to 30-days after discharge from index hospitalization
Post-discharge healthcare utilization (ambulatory events)
Time frame: Up to 30-days after discharge from index hospitalization
Results and safety
The study was stopped early (reason given: Grant Terminated by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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. This study is not recruiting at the moment.
Anuj Dalal, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
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.