Care Transition Patient Experience Study With Electronic Tool

March 10, 2020 updated by: Trillium Health Partners

Evaluating the Impact of an Electronic Communication Tool on Patient Experience, ED Visits and Re-hospitalization, and Care Transitions in Hospitalized Patients (Including Those With Dementia): a Mixed Methods Study

Patients being admitted to hospital are becoming more complex and they often require a team of health professionals (doctors from different disciplines, nurses, and allied health professionals) working together to meet their needs. Effective communication among this team and with patients is essential to providing high quality patient-centered care. Care Connector is an electronic tool that was developed to help health professionals communicate about patient care with each other. It also incorporates best practice whenever possible (such as the used of Patient Oriented Discharge Summary [PODS] developed at University Health Network) during care transitions. We want to understand whether using electronic tools can address the communication issues faced by patients/families, and whether they impact on repeat visits to the Emergency Department or the hospital after discharge. In this study, we will be asking patients and families who have recently been discharged from hospital to describe their experience with communication and care transitions through a brief telephone survey. All of them will be discharged from units where Care Connector was used. However, some of the units would have used the PODS feature while others will not. A small group will also be invited to participate in an in-depth telephone interview. The results of this study will be used to improve Care Connector and to enhance communication and patient experience in general.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this mixed methods study, we examine how electronic tools impact patient/family experience of communication in hospital and care transitions from hospital to home. Care Connector is an electronic interprofessional communication and collaboration platform initially designed to address communication challenges faced by interprofessional care team. It has been augmented to support care transitions through a care transition module (that include the generation of provider-facing discharge summary and PODS). This study examines the impact of this care transition module on patient/family experience of in-hospital communication and care transitions. The quantitative component is a controlled study where baseline data is collected on 4 medicine wards. The care transition module is then introduced to 2 of the 4 medicine wards (intervention) while the other 2 (control) wards continue to operate without the explicit use of the care transition module. Data is then collected again on all 4 wards to understand impact of patient/family experience, as well as objective outcomes of ED visits and re-admission within 30 days. A number of care transition process measures will also be obtained. In the qualitative component, we will interview patients/families, as well as healthcare providers to understand how technology can or cannot address these issues.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
        • Trillium Health Partners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. General medical patients cared for and discharged by the Hospitalist service
  2. Be 18 years of age and above
  3. Length of stay for hospitalization is at least 48 hours
  4. The discharge destination is home (with or without support), or retirement home
  5. Has the cognitive ability to, or has a substitute decision maker (SDM) (if patient is not capable) able to, provide informed consent for this research study
  6. Can be contacted by telephone up to 30 days post discharge
  7. Able to respond to survey questions over telephone (assistance from family member or other caregiver at the time of telephone survey is permitted)

Exclusion Criteria:

  1. Discharged from a non-Medicine ward (e.g. medicine patient bed spaced to a surgical ward) or from the Emergency Department directly
  2. Previously participated in this study (in case of re-admission)
  3. Discharge destination is another acute care facility, rehab, palliative care unit, complex continuing care, long term care, or any other facility not listed in inclusion criteria 4.
  4. Died in hospital
  5. Unable to give informed consent due to language barrier and lack of suitable assistance from family members and/or caregivers and/or SDM (if patient is not capable)
  6. Cannot be contacted by telephone after discharge
  7. Unable to respond to telephone survey questions for any reason (e.g. hearing impairment, language barrier) and lack of availability of family members and/or other caregivers willing and able to provide assistance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Two of the 4 Medicine wards will have implemented the care transition module of Care Connector
Other: Care Connector care transition module
Care Connector is an electronic interprofessional communication and collaboration tool. Its features include Physician Sign-Out, documentation, interprofessional care planner, messaging, and flow planner. The newest module is a care transition module which allows physicians to electronically generate discharge summaries as well as incorporation of allied health recommendation, but also will pull information into the PODS (Patient Oriented Discharge Summary) format designed by University Health Network. This results in a patient friendly discharge instruction sheet that can be provided to patient. The intervention arm will have access to the care transition feature, while the control wards do not.
No Intervention: Control
Remaining 2 of 4 Medicine wards will use all other aspects of Care Connector (except for care transition module)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Care transition measure 3
Time Frame: Up to 30 days post discharge
This is a validated measure developed by Coleman et al (Med Care. 2008 Mar;46(3):317-22) to measure quality of care transitions. It contains 3 questions (please see reference for questions).
Up to 30 days post discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
In-hospital communication
Time Frame: Up to 30 days post discharge
Subset of questions from the Canadian Patient Experience Survey - Inpatient Care (CPES-IC)
Up to 30 days post discharge
ED visit
Time Frame: 30 days post discharge
ED visit to any site at Trillium Health Partners
30 days post discharge
Hospitalization
Time Frame: 30 days post discharge
Hospitalization to any site at Trillium Health Partners
30 days post discharge
Presence of follow up plan in discharge summary
Time Frame: At the time of patient discharge (0 days)
Binary (yes/no) assessment of whether the dictated discharge summary contains a follow-up plan section.
At the time of patient discharge (0 days)
Proportion of appointments with date/time confirmed at discharge
Time Frame: At time of patient discharge (0 days)
Number of appoints with date/time confirmed / total number of appointments
At time of patient discharge (0 days)
Proportion of patients referred to community support services
Time Frame: At time of patient discharge (0 days)
Number of patients referred to community support services / total number of patients
At time of patient discharge (0 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subgroup analysis of patients with dementia
Time Frame: Up to 30 days post patient discharge
We will determine whether a patient has dementia by reviewing all dictated consultation notes and discharge summaries in the medical record to look for mention of dementia.
Up to 30 days post patient discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trillium Health Partners

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Aging and Brain Health Innovation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Terence Tang, MD, Trillium Health Partners

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 828

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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