ePRO Monitoring for Chronic Disease Care Transitions

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Anuj K Dalal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brigham and Women's Hospital

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the ePRO Application treatment for chronic disease care transitions?

Research shows that using telecommunications and surveillance technologies in care transitions can help monitor patients' conditions after hospital discharge, reducing the risk of negative health outcomes. This suggests that the ePRO Application, which likely uses similar technology, could be effective in improving care transitions for patients with chronic diseases. ^{1 2 3 4 5}

Is the ePRO Monitoring for Chronic Disease Care Transitions generally safe for humans?

The research articles focus on medication safety during care transitions and suggest that electronic tools, like medication reconciliation applications, can help reduce risks associated with medication discrepancies. While these studies do not directly address the safety of ePRO Monitoring, they indicate that electronic interventions in care transitions are generally aimed at improving safety. ^{6 7 8 9 10}

How is the ePRO Application treatment different from other treatments for chronic disease care transitions?

The ePRO Application is unique because it uses electronic patient-reported outcomes to monitor patients' conditions after they leave the hospital, helping to prevent negative health outcomes by keeping healthcare providers informed and engaged in real-time. ^{3 4 5 11 12}

Research Team

Anuj K Dalal, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• ePRO Application (Behavioral Intervention)

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.

Participant Groups

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+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

RAND

Collaborator

Trials

145

Recruited

617,000+

Rand Sutherland

RAND

Chief Medical Officer since 2024

MD from University of Chicago

Jason Matheny

RAND

Chief Executive Officer since 2022

PhD in Public Policy, Harvard University

Findings from Research

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]

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]

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 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]

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 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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluation of electronic health record-integrated digital health tools to engage hospitalized patients in discharge preparation. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Development of a measurement instrument to assess patient safe transition at hospital discharge. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The effectiveness of tele-transitions of care interventions in high-risk older adults: A systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Use of participatory visual narrative methods to explore older adults' experiences of managing multiple chronic conditions during care transitions. [2019]

5. United States 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. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Understanding Hazards for Adverse Drug Events Among Older Adults After Hospital Discharge: Insights From Frontline Care Professionals. [2023]

7. England 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. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Interventions to improve patient safety in transitional care--a review of the evidence. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an Electronic Module for Reconciling Medications in Home Health Plans of Care. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Transitions between SNF and home-based care in patients with multiple sclerosis. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

An electronic health record-based intervention to increase follow-up office visits and decrease rehospitalization in older adults. [2022]