NCT04287192

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
3.1 years until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

October 3, 2025

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

February 25, 2020

Last Update Submit

September 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Care Transitions Measure (CTM3)

    The CTM3 is a patient-reported measure of transition quality focusing on person-centredness and communication; appropriate as the focus of the Digital Bridge is to improve person-centred communication during transitions. The CTM-3 survey has been validated in similar patient populations transitioning from hospital to home and primary care, and in a systematic review of transitions measures was deemed to be the most acceptable measure of quality transitions.

    At 1-2 weeks post-discharge

Secondary Outcomes (6)

  • Assessment for Quality of Life Scale 4D -AQoL-4D

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

  • Patient information sheet

    Baseline

  • Provider information sheet

    Baseline

  • Post-Study System Usability Questionnaire: PSSUQ

    At 1-2weeks, 3 and 6 months post-discharge

  • Patient/Caregiver self-reported costs

    At 3 and 6 months post-discharge

  • +1 more secondary outcomes

Study Arms (2)

Control

NO 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.

(Digital Bridge intervention)

EXPERIMENTAL

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.

Other: Digital Bridge:Tool Intervention

Interventions

Our Digital Bridge is an integration of the Care Connector and ePRO technologies that will support care transitions by: 1) inviting PCPs to access Care Connector while the patient is in hospital, allowing for asynchronous communication via the messaging feature for proactive discharge planning, 2) facilitating the inclusion of inter-professional recommendations in the discharge module (e.g. diet and mobility) typically missing from traditional physician generated discharge summaries, 3) electronic generation of PODS for use in patient-centred discharge teaching, 4) providing patients electronic access to PODS post discharge to facilitate use of information at home, 5) adoption of digital enabled goal-oriented process to engage patients and families in discharge process, and 6) providing ongoing self-management support for patients using ePRO for the vulnerable period 6 months post discharge.

(Digital Bridge intervention)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with anticipated discharge home will be recruited at the time of admission to one of the services (i.e medicine or rehab) in the study. Patients aged 60 and over, with CCN defined as presenting with 3 or more chronic conditions from the 16 most prominent in the population, which is an established method to identifying patients with CCN. As the technology is only currently available in English, patients (or a caregiver) must be able to speak and read English. 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).

You may not qualify if:

  • Previously participated in the study (in case of re-admission); discharge destination is another acute care facility, palliative care unit, complex continuing care, or long term care; died in hospital, cannot be contacted by telephone after discharge; unable to respond to survey question for any reason and lack of availability of family members and/or other caregivers willing and able to provide assistance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinai Health

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Related Publications (2)

  • Singh H, Armas A, Law S, Tang T, Steele Gray C, Cunningham HV, Thombs R, Ellen M, Sritharan J, Nie JX, Plett D, Jarach CM, Thavorn K, Nelson MLA. How digital health solutions align with the roles and functions that support hospital to home transitions for older adults: a rapid review study protocol. BMJ Open. 2021 Feb 25;11(2):e045596. doi: 10.1136/bmjopen-2020-045596.

  • Steele Gray C, Tang T, Armas A, Backo-Shannon M, Harvey S, Kuluski K, Loganathan M, Nie JX, Petrie J, Ramsay T, Reid R, Thavorn K, Upshur R, Wodchis WP, Nelson M. Building a Digital Bridge to Support Patient-Centered Care Transitions From Hospital to Home for Older Adults With Complex Care Needs: Protocol for a Co-Design, Implementation, and Evaluation Study. JMIR Res Protoc. 2020 Nov 25;9(11):e20220. doi: 10.2196/20220.

Study Officials

  • Carolyn Steele Gray, PhD

    Sinai Health System

    PRINCIPAL INVESTIGATOR
  • Terence Tang, MD

    Trillium Health

    PRINCIPAL INVESTIGATOR
  • Michelle Nelson, PhD

    Sinai Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The investigators will conduct a non-randomized control trial to understand the impact of the intervention. For each site (Sinai Health System and THP - both Mississauga and Credit Valley sites) and each service, half of the participating wards will be designated as control while the other half will be designated as intervention. The investigators will collect baseline data from all wards (control and intervention) during phase 1 while co-design is on-going and the intervention has not been deployed. During phase 2, after co-design is complete, the co-designed technology intervention and workflow will be rolled out to only the intervention wards. The investigators will then collect data (identical to what was collected at baseline) from all wards (control and intervention) to understand the impact of technology by examining the differential change between control and intervention wards (difference in difference approach).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 27, 2020

Study Start

April 15, 2023

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

October 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

The reported data (which includes patient information at the aggregate level) will be disseminated widely via reports, conference presentations, peer reviewed journal articles and other standard modes of knowledge translation.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will be available through 2022-2024.
Access Criteria
Open access peer reviewed journal publication

Locations