ePRO Monitoring for Chronic Disease Care Transitions

Recruiting at 1 trial location

Overseen By Anuj Dalal, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Less than 18, Less than two conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital health app (ePRO Application) designed to help manage symptoms after hospital discharge for individuals with multiple chronic conditions. The app aims to detect early warning signs of health issues and alert medical teams to prevent complications. Participants will receive either standard care or use the app to determine if it reduces post-discharge problems. Individuals who have stayed in the hospital for over a day and have conditions like asthma, diabetes, or heart disease might be suitable candidates. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative healthcare solutions and potentially improve their own post-discharge outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ePRO Application is safe for use in chronic disease care transitions?

Research has shown that using the ePRO App for real-time symptom tracking appears promising. Studies have found that electronic patient-reported outcomes (ePROs) can help reduce issues during changes in care. When patients use the app to report symptoms, doctors can quickly identify and address any problems.

The system's safety seems reliable. Patients have used similar tools without major issues. Although specific safety data for the ePRO App itself is not available, electronic monitoring in healthcare has generally been well-received.

For those considering joining a trial that uses ePRO, the app is designed to catch problems early and improve patient care. Safety reports so far suggest it is a low-risk addition to healthcare routines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of an ePRO (electronic Patient-Reported Outcomes) application to enhance chronic disease care transitions. Unlike traditional care, which often relies on periodic in-person visits, this approach leverages digital technology to continuously collect patient data in real-time. This method could lead to more personalized and timely interventions, potentially improving patient outcomes and reducing adverse events after discharge. By integrating patient-reported information seamlessly into the care process, this trial aims to innovate how healthcare providers monitor and respond to chronic disease management.

What evidence suggests that the ePRO Application is effective for minimizing post-discharge adverse events in patients with multiple chronic conditions?

Research has shown that the ePRO (electronic Patient-Reported Outcome) app, which participants in this trial may use, improves patient care by tracking symptoms in real-time. Studies have found that ePRO tools enable patients to report symptoms quickly and accurately. This leads to faster responses from healthcare providers, potentially reducing complications after hospital discharge. ePRO systems are particularly useful for managing long-term conditions by providing timely and detailed patient feedback. This feedback aids doctors in making better decisions and adjusting treatments as needed. Overall, early findings suggest that ePRO enhances patient monitoring and safety during changes in care. ^{1 6 7 8 9}

Who Is on the Research Team?

Anuj K Dalal, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults with two or more chronic conditions like heart disease, diabetes, COPD, etc., who are hospitalized and will be discharged to home or a facility. They must speak English or have an English-speaking healthcare proxy.

Inclusion Criteria

I have two or more chronic conditions from a specified list.

Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)

I or my healthcare proxy can communicate in English.

Exclusion Criteria

No identifiable healthcare proxy or next of kin (i.e., a family caregiver)

Less than two chronic conditions

I was in the hospital for less than a day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Pre-implementation

Development and validation of a predictive model of post-discharge AEs for MCC patients using PRO questionnaires and EHR-derived variables

18 months

Main Trial (RCT) Period

Randomized controlled trial comparing real-time symptom monitoring intervention to usual care for patients with MCCs transitioning out of the hospital

30 months

Follow-up

Participants are monitored for safety and effectiveness after discharge, focusing on adverse events and healthcare utilization

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ePRO Application

Trial Overview The study tests an ePRO application designed to monitor symptoms in real-time and predict adverse events after patients with multiple chronic conditions leave the hospital. It involves developing predictive models and integrating them into digital health apps.

How Is the Trial Designed?

Group I: Intervention (Arm 3) Experimental Treatment 1 Intervention

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.

Group II: Usual Care (Arm 1) Active Control 1 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.

Group III: Usual Care (Arm 2) Active Control 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

RAND

Collaborator

Trials

145

Recruited

617,000+

Published Research Related to This Trial

Older adults with multiple chronic conditions and their families emphasized the importance of being actively involved in managing their care transitions, highlighting that engagement can improve their experiences and outcomes.

The study identified key areas for improvement in care transitions, including enhancing support for person- and family-centered care, ensuring active engagement of older adults and families, and providing better resources to navigate transitions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of participatory visual narrative methods to explore older adults' experiences of managing multiple chronic conditions during care transitions. Backman, C., Stacey, D., Crick, M., et al.[2019]

A study involving 38 hospital-based professionals identified multiple hazards to medication safety for older adults during care transitions, highlighting issues such as complex dosing and knowledge gaps in medication management.

The research revealed that medication-related harms stem from both hospital work systems and challenges faced at home, emphasizing the need for improved communication and support for patients and caregivers post-discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Hazards for Adverse Drug Events Among Older Adults After Hospital Discharge: Insights From Frontline Care Professionals. Xiao, Y., Smith, A., Abebe, E., et al.[2023]

The electronic medication reconciliation module significantly improved the accuracy of identifying and resolving medication discrepancies compared to the traditional paper-based method, with participants leaving fewer discrepancies unaddressed (0.45 vs. 1.55 discrepancies).

Although the electronic system did not reduce the time taken for reconciliation, it was highly rated for usability, with 17 out of 19 physicians preferring it over the paper method, indicating a positive reception for future integration into electronic medical records.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Electronic Module for Reconciling Medications in Home Health Plans of Care. Kramer, HS., Gibson, B., Livnat, Y., et al.[2018]

Tele-transitions of care interventions significantly reduce readmission rates (by 41%) and mortality rates (by 28%) in older adults at high risk for readmission, based on a systematic review of 14 studies involving randomized controlled trials.

These interventions also improve health-related quality of life, although they do not significantly reduce emergency department visits or improve functional status, indicating a targeted benefit in managing post-discharge health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of tele-transitions of care interventions in high-risk older adults: A systematic review and meta-analysis. Soh, YY., Zhang, H., Toh, JJY., et al.[2023]

A postdischarge clinic (PDC) intervention significantly reduced rehospitalization rates from 23% to 14% within 30 days after skilled nursing facility (SNF) discharge, indicating improved patient outcomes.

Patients receiving the PDC intervention also experienced fewer acute care inpatient days, demonstrating the effectiveness of comprehensive care coordination at discharge in reducing hospital utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of a transitional care clinic on subsequent 30-day hospitalizations and emergency department visits in individuals discharged from a skilled nursing facility. Park, HK., Branch, LG., Bulat, T., et al.[2013]

The implementation of EHR-integrated digital health tools, including a checklist and video for discharge preparation, did not significantly increase patient activation levels at discharge, with only a slight increase observed (59.8% vs 56.7%).

Patients using the digital tools experienced a significantly longer average length of stay in the hospital (10.13 days) compared to those who did not use the tools (6.21 days), suggesting that while the tools may have helped identify patient concerns, they did not improve discharge outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of electronic health record-integrated digital health tools to engage hospitalized patients in discharge preparation. Dalal, AK., Piniella, N., Fuller, TE., et al.[2022]

A new measurement instrument was developed to assess the quality of care transitions and patient safety during hospital discharge, based on input from nurses and validated by a committee of experts.

The instrument consists of 37 items across six domains, achieving a high Content Validity Index of 0.93, indicating strong agreement on its relevance and importance for improving patient safety in Brazil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a measurement instrument to assess patient safe transition at hospital discharge. Acosta, AM., Lima, MADDS., Marques, GQ., et al.[2023]

The electronic health record-based intervention did not significantly improve the rate of timely office visits to primary care providers within 7 days after hospital discharge for older adults, with 27.7% in the intervention group and 28.3% in the control group attending visits.

There was no significant difference in the rehospitalization rates within 30 days after discharge between the intervention group (18.8%) and the control group (19.9%), indicating that the intervention did not effectively reduce the risk of rehospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electronic health record-based intervention to increase follow-up office visits and decrease rehospitalization in older adults. Gurwitz, JH., Field, TS., Ogarek, J., et al.[2022]

Elderly patients, especially those who are frail and have complex health issues, are at high risk for adverse events during transitions from hospital to home, which can lead to readmissions and other serious outcomes.

The systematic review identified various effective interventions, such as improved communication strategies and discharge planning, that can enhance patient safety during these transitions, suggesting that multi-component and multidisciplinary approaches are most beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve patient safety in transitional care--a review of the evidence. Laugaland, K., Aase, K., Barach, P.[2018]

The use of a computerized medication reconciliation tool significantly reduced potential adverse drug events (PADEs) in hospitalized patients, with a decrease from 1.44 PADEs per patient in the control group to 1.05 in the intervention group, indicating improved safety in medication management.

The effectiveness of the intervention varied between hospitals, suggesting that the integration of the medication reconciliation tool into existing systems is crucial for its success in reducing medication discrepancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. Schnipper, JL., Hamann, C., Ndumele, CD., et al.[2022]

The Smart Pillbox study identified significant barriers to implementing an electronic pillbox designed to improve medication adherence after hospital discharge, including issues with portability, time demands on pharmacists, and external policies like insurance coverage.

Despite these challenges, many patients reported satisfaction with the pillbox and believed it effectively helped them manage their medications, highlighting the potential benefits of such interventions in enhancing medication safety during transitions of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electronic pillbox intervention designed to improve medication safety during care transitions: challenges and lessons learned regarding implementation and evaluation. Shahani, A., Nieva, HR., Czado, K., et al.[2022]

Patients with multiple sclerosis (MS) who had recently used home care were less likely to be admitted to an acute care hospital and showed higher physical disability upon entering a skilled nursing facility (SNF), indicating that prior home care may influence care transitions.

Factors such as Medicaid insurance and the presence of informal caregivers were linked to the likelihood of utilizing home care services after a stay in a SNF, suggesting that these elements play a crucial role in post-SNF care pathways for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions between SNF and home-based care in patients with multiple sclerosis. Noyes, K., Bajorska, A., Wasserman, EB., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8726765/

Assessing the Implementation and Effectiveness of ... This study aims to evaluate the implementation and effectiveness of the electronic Patient-Reported Outcome (ePRO) mobile app and portal system.

2. shmpublications.onlinelibrary.wiley.com shmpublications.onlinelibrary.wiley.com/doi/10.1002/jhm.70013?af=R

Real‐time symptom monitoring using electronic patient ... Real-time symptom monitoring using electronic patient-reported outcomes: A prospective study protocol to improve safety during care transitions ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0270929524000901

Electronic Collection of Patient-Reported Outcomes to ... We define kidney ePRO systems as ambulatory, noninvasive digital technologies that enable people with kidney disease to report and record PRO data ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02917954

Electronic Patient Reported Outcome (ePRO) Mobile ... Surveys capture patient demographics, assessment of quality-of-life, chronic disease management, primary care experience, and Electronic Patient Reported ...

5. ascopubs.org ascopubs.org/doi/10.1200/CCI.20.00015

Electronic Patient-Reported Outcome–Based Interventions ... We performed a systematic and mapping review of the scientific literature on the current ePRO-based approaches used for palliative cancer care.

6. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/real-time-symptom-monitoring-using-epros-prevent-adverse-events-during-care-transitions

Real-Time Symptom Monitoring Using ePROs to Prevent ... Using real-time patient-reported outcomes of hospitalized patients has the potential to reduce adverse events during care transitions.

7. psll.bwh.harvard.edu psll.bwh.harvard.edu/epro-transitions-2/

ePRO Transitions The app will collect patient-reported outcomes (PROs) and provide personalized AE risk assessments by integrating PROs with electronic health record (EHR) data.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39956797/

Real-time symptom monitoring using electronic patient ... Real-time symptom monitoring using electronic patient-reported outcomes: A prospective study protocol to improve safety during care transitions ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05282654

Real-time Symptom Monitoring Using ePROs to Prevent ... This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of ...