Digital Communication Tool for Post-Hospitalization Care in Older Adults

(DB Trial)

Recruiting in Toronto (>99 mi)

Overseen By Hardeep Singh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Non-English speakers, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

640 Participants Needed

Trial Summary

What is the purpose of this trial?

Older adults who live with multiple chronic conditions are more likely to experience frequent admissions and discharges from hospital. These transitions are often challenging and leave people at risk of readmission. Appropriate, timely and person-centred communication across all health care providers involved in transitions (in and out of hospital) as well as with patients and their families is critical to ensure a smooth and effective transition process. Digital health technologies can play an important role in improving person-centred communication across clinical settings and clinicians. This project will develop and test a Digital Bridge by connecting communication technologies already in use in hospital and primary care/community settings to improve communication between providers in hospital and in primary care, patients and family caregivers from admission to 6 months post-discharge. The investigators will engage with all the technology users to co-design the Digital Bridge, ensuring that how the investigators connect the existing technologies and adopt them into practice will meet the needs of providers, patients and their caregivers. Next hospital partners will adopt the technology into general medicine and rehabilitation services in hospital systems in Toronto (Sinai Health System) and Mississauga (Trillium Health Partners). The investigators will evaluate the Digital Bridge through a pre-post pragmatic trial, assessing impact on patient experience (quality of transition), patient outcomes (quality of life), transition processes (provider communication and teamwork), and system costs (economic evaluation). This project adopts an implementation science lens, allowing the investigators to collect qualitative data on enablers and barriers to adopting the Digital Bridge to help inform development of a scale and spread strategy.

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 seems focused on improving communication during hospital transitions, so it's unlikely to require changes to your medication regimen.

What data supports the effectiveness of the treatment Digital Bridge, Digital Bridge to Home, Care Connector, ePRO tool for post-hospitalization care in older adults?

Research shows that a similar mobile health intervention reduced the risk of rehospitalization by 65% within 90 days and improved physical functioning and medication adherence in older adults. This suggests that digital communication tools can effectively support post-hospitalization care. ^{1 2 3 4 5}

Is the Digital Communication Tool for Post-Hospitalization Care in Older Adults safe for use?

The research suggests that digital tools, like the Digital Bridge, can improve communication and safety during the transition from hospital to home for older adults. These tools aim to reduce medication errors and improve patient safety, indicating they are generally safe for use in humans. ^{2 6 7 8 9}

How is the Digital Communication Tool for Post-Hospitalization Care in Older Adults different from other treatments?

This treatment is unique because it uses digital communication tools to improve post-hospitalization care for older adults by providing automated calls and feedback to both patients and their caregivers, which helps prevent rehospitalization and improves communication and medication adherence. ^{1 2 4 10 11}

Research Team

Carolyn Steele Gray, PhD

Principal Investigator

Sinai Health System

Terence Tang, MD

Principal Investigator

Trillium Health

Michelle Nelson, PhD

Principal Investigator

Sinai Health System

Eligibility Criteria

This trial is for older adults aged 60 and over with complex care needs, defined as having three or more chronic conditions. Participants must speak and read English, be able to respond to surveys, have family or caregivers available if needed, and plan to go home after hospital discharge.

Inclusion Criteria

I am 60 or older with 3 or more long-term health conditions.

Patients with mild cognitive impairment will not be excluded if able to provide informed consent, and engage with the intervention (independently or with caregiver aid).

Patients (or a caregiver) must be able to speak and read English.

Exclusion Criteria

Cannot be contacted by telephone after discharge.

Not applicable as the patient has passed away.

I do not have family or caregivers to help me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Co-design of the Digital Bridge with technology users to ensure it meets the needs of providers, patients, and caregivers

Not specified

Implementation

Adoption of the Digital Bridge technology into general medicine and rehabilitation services in hospital systems

6 months

Ongoing engagement with hospital partners

Follow-up

Participants are monitored for transition quality, quality of life, and goal attainment post-discharge

6 months

Surveys at baseline, 1-2 weeks, 3 months, and 6 months post-discharge

Treatment Details

Interventions

• Digital Bridge

Trial Overview The Digital Bridge tool intervention is being tested. It aims to improve communication between healthcare providers in hospitals and primary care settings, patients, and their families from admission until six months after leaving the hospital.

Participant Groups

Group I: (Digital Bridge intervention) Experimental Treatment 1 Intervention

Experimental (Digital Bridge intervention) participants will complete surveys at 4 time points (baseline, 1-2 weeks, 3 month and 6 months after discharge). The surveys will capture data on demographics, assess their transition quality, self-reported costs, assess their quality of life, and goal attainment. One to two days before discharge, patients will work with their team to develop the PODS in Care Connector. Once the PODS is created, the patient and hospital provider will be prompted to set transition goals using the ePRO tool.

Group II: Control Active Control 1 Intervention

Control: Control participants will complete surveys at 4 time points (baseline, 1-2 weeks, 3 month and 6 months after discharge). The surveys will capture data on demographics, assess their transition quality, self-reported costs, and assess their quality of life. Aside from completion of these surveys, no changes to their usual care will occur.

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

MOUNT SINAI HOSPITAL

Collaborator

Trials

44

Recruited

17,000+

Trillium Health Partners

Collaborator

Trials

8

Recruited

3,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A mobile health intervention for older adults, which included automated assessments and caregiver feedback, significantly reduced the risk of hospital readmissions within 90 days post-discharge by 65% compared to control patients.

The intervention not only decreased readmission rates but also improved physical functioning, medication adherence, and communication quality with caregivers, highlighting its effectiveness in enhancing post-hospitalization support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of Post-Hospitalization Accessible Health Technology and Caregiver Support on 90-Day Acute Care Use and Self-Care Assistance: A Randomized Clinical Trial. Piette, JD., Striplin, D., Aikens, JE., et al.[2021]

This rapid review aims to identify how digital health solutions can improve the transition of older adults from hospital to home, addressing challenges that may arise during this process.

The study will generate a conceptual map of roles and functions that support these transitions and identify existing digital health solutions, ultimately informing the design of future interventions to enhance care for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How digital health solutions align with the roles and functions that support hospital to home transitions for older adults: a rapid review study protocol. Singh, H., Armas, A., Law, S., et al.[2021]

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]

The trial involves 846 older adults with chronic conditions and aims to improve post-hospitalization support through automated communication and caregiver involvement, potentially reducing 30-day readmission rates.

The intervention uniquely supports both patients and their informal caregivers, providing tailored feedback and resources, which may enhance self-care and reduce caregiver stress during the transition from hospital to home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Post-Hospitalization Transition Outcomes through Accessible Health Information Technology and Caregiver Support: Protocol for a Randomized Controlled Trial. Piette, JD., Striplin, D., Marinec, N., et al.[2020]

Amedisys implemented a care transitions initiative that showed promise in reducing avoidable rehospitalizations among vulnerable patients, particularly the elderly and frail, over a 12-month observation period across three academic institutions.

The initiative highlights the importance of the home health industry in enhancing patient quality of life and managing healthcare costs effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient outcomes with better care transitions: the role for home health. Fleming, MO., Haney, TT.[2013]

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 study highlights the challenges in communication during patient transitions from hospital to home care, particularly focusing on the CMS 485 form used for transferring patient information.

The project aims to improve this process by restructuring and automating the CMS 485 within an electronic health record system, with plans for further evaluation and development of a web-based communication system in the next phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the transition to home healthcare by rethinking the purpose and structure of the CMS 485: first steps. Siegler, EL., Murtaugh, CM., Rosati, RJ., et al.[2019]

The review identified various healthcare provider roles that are crucial for supporting older adults during hospital-to-home transitions, emphasizing the importance of continuity of care in informational, management, and relational aspects.

Digital health interventions primarily focused on management continuity, such as follow-up and monitoring, but less on informational and relational continuity, indicating a need for future technologies to better align with the comprehensive roles of providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for the Design and Delivery of Transitions-Focused Digital Health Interventions: Rapid Review. Singh, H., Tang, T., Steele Gray, C., et al.[2022]

A qualitative study involving 23 stakeholders revealed significant challenges in transferring medication information across care settings, including incomplete patient records and a lack of interoperability between different medicine management systems.

Participants emphasized the need for a patient-centered integrated health record to improve medication optimization, highlighting that effective digital tools require collaboration among healthcare professionals and adherence to established digital information standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Opportunities for the Use of Digital Tools in Medicines Optimization Across the Interfaces of Care: Stakeholder Interviews in the United Kingdom. Tolley, C., Seymour, H., Watson, N., et al.[2023]

The literature review identified ten existing tools and additional resources aimed at improving communication during hospital-to-home transitions, but no specific communication tool for post-discharge in primary care was found.

Future communication tools should focus on enhancing patient education and engagement, empowering patients to initiate communication with healthcare providers, which could ultimately reduce errors and improve safety during care transitions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of communication tools applicable to patients and their primary care providers after discharge from hospital. Spencer, RA., Singh Punia, H.[2021]

The study found that the United States Core Data for Interoperability (USCDI) fails to cover 74% of the essential home healthcare (HHC) data classes that are faxed to primary care, and 95% of the data classes that are not faxed, highlighting significant gaps in data sharing.

Improving interoperability by expanding the USCDI to include more comprehensive patient data could enhance communication between home healthcare providers and primary care teams, potentially reducing rehospitalization risks for patients after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions of Care: Completeness of the Interoperability Data Standard for Communication from Home Health Care to Primary Care. Chou, E., Sockolow, PS.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Impacts of Post-Hospitalization Accessible Health Technology and Caregiver Support on 90-Day Acute Care Use and Self-Care Assistance: A Randomized Clinical Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

How digital health solutions align with the roles and functions that support hospital to home transitions for older adults: a rapid review study protocol. [2021]

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

Improving Post-Hospitalization Transition Outcomes through Accessible Health Information Technology and Caregiver Support: Protocol for a Randomized Controlled Trial. [2020]

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

Improving patient outcomes with better care transitions: the role for home health. [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Improving the transition to home healthcare by rethinking the purpose and structure of the CMS 485: first steps. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Recommendations for the Design and Delivery of Transitions-Focused Digital Health Interventions: Rapid Review. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Barriers and Opportunities for the Use of Digital Tools in Medicines Optimization Across the Interfaces of Care: Stakeholder Interviews in the United Kingdom. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

A scoping review of communication tools applicable to patients and their primary care providers after discharge from hospital. [2021]

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

Transitions of Care: Completeness of the Interoperability Data Standard for Communication from Home Health Care to Primary Care. [2022]