Interactive Digital Health Tools to Improve Patient Safety in Acute Care

July 21, 2022 updated by: Anuj K. Dalal, MD, Brigham and Women's Hospital

Interactive Patient-Centered Discharge Toolkit to Promote Self-Management During Transitions (PDTK) & PREventing Adverse Events Post-Discharge Through Proactive Identification, Multidisciplinary Communication, and Technology (PREDICT)

Study 1: The goal of this study is to implement and evaluate an interactive patient-centered discharge toolkit (PDTK) to engage patients and care partners in discharge preparation and communication with providers after discharge. The aims of this study are to:

  1. To refine and implement an interactive PDTK on a general medicine unit that patient and caregivers can use to prepare for discharge and communicate with key providers during the transition home.
  2. To evaluate the impact of the PDTK on patient activation (primary outcome). Patient reported self-efficacy after discharge; post-discharge healthcare resource utilization; and perception of patient-provider communication will be measured as secondary outcomes.
  3. To identify barriers and facilitators of implementation, adoption, and use of the PDTK by patients, caregivers, and providers using qualitative and quantitative methods.

Study 2: The goal of this study is to expand the use of previously developed patient safety dashboards and patient-centered discharge checklists to three general medicine units in an affiliated community hospital. The safety dashboard and interactive pre-discharge checklist are cognitive aids for clinicians and patients, respectively, that serve to facilitate early detection of patients at risk for preventable harm, including suboptimal discharge preparation. The aims of this study are to:

  1. Enhance the safety dashboard and interactive pre-discharge checklist to include "smart" notifications for hospital-based clinicians when patients are at high risk for adverse events or have identified specific concerns related to discharge based on their checklist responses.
  2. Expand intervention to general medical units at our community hospital-affiliate, BWFH.
  3. Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.

Study Overview

Status

Status

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

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

Study 1: The transition from the hospital is a vulnerable time for patients and stressful for caregivers-new treatments have been initiated, conditions require close monitoring, and the plan of care is in flux. Achieving a high-quality transition requires effective understanding of the discharge plan by patients/caregivers as well as seamless communication with key inpatient providers to address patients' concerns during and immediately after hospitalization. We designed an interactive patient-centered discharge toolkit (PDTK) that is accessible from an acute care patient portal. The PDTK allows patients and/or caregivers to self-assess discharge preparedness via a validated, pre-discharge checklist tool and communicate directly with key members of the care team. Information entered by the patient regarding their discharge preparedness is presented to the unit-based care team on an interactive safety dashboard so that providers can address any barriers prior to discharge. After discharge, patients can communicate directly with providers about issues or concerns that arise prior to follow-up with their ambulatory providers.

The PDTK will be implemented and evaluated for patients admitted to and discharged from general medicine units. The RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework will be used to inform research questions and methods that guide implementation and evaluation. A pre-post study will be performed in which the primary outcome is analyzed as the proportion of patients with Patient Activation Measure (PAM) Levels 3 or 4 at discharge. Approximately 358 patients will be enrolled to provide adequate power to detect an improvement in the primary outcome from 72% to 84%. Quantitative and qualitative methods will be used to assess implementation, adoption, and use of the intervention.

Study 2: Our project proposes to address gaps in functionality of commercially available EHR systems through evaluation of novel, EHR-integrated HIT tools. We previously designed, developed, and implemented the patient safety dashboard and interactive pre-discharge checklist to engage clinicians and patients in systematically addressing safety threats in each of several domains. By integrating clinical data of several different types, these tools serve to reduce cognitive load and improve decision-making for clinicians. In this way, these tools represent a preventative intervention that mitigates risk in each domain by suggesting corrective action corresponding to institutional safety guidelines.

Studying the effectiveness of these tools on post-discharge outcomes will improve knowledge, technical capability, and clinical practice related to patient safety during transitions of care. Specifically, our project will advance scientific knowledge by quantifying the post-discharge impact of an intervention that changes clinical practice by enabling hospital-based clinicians to proactively institute corrective action for "at risk" patients who may require additional surveillance and supportive services during transitions. Also, we will establish the technical feasibility of spreading customized, third-party digital health applications that fill critical safety gaps in commercially available EHRs; expanding to a community hospital has clear implications for adoption and validation of this technology in different practice settings.

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.
750

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, >18 years of age, English-speaking
  • Caregivers >18 years of age designated by patient or patient's healthcare proxy
  • Male or female healthcare providers of enrolled patients

Exclusion Criteria:

-Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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.
NO_INTERVENTION: Study 1: Pre-intervention 1

Usual care.

Patients/caregivers do not have access to patient portal. Providers have access to safety dashboard without discharge preparation indicator. Providers do not have access to secure patient-provider messaging tools.
EXPERIMENTAL: Study 1: Post-intervention

Patient-Centered Discharge Toolkit: patient portal and provider safety dashboard PLUS patient pre-discharge checklist, provider discharge preparation indicator, secure patient-provider messaging

Patients/caregivers have access to patient portal with discharge module (pre-discharge preparation checklist) and secure patient-provider messaging tools activated. Providers have access to discharge preparation indicator on safety dashboard and secure patient-provider messaging tools.
Behavioral: Interactive Digital Health Tools
Discharge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos
NO_INTERVENTION: Study 1: Pre-intervention 2

Usual care PLUS patient portal and provider safety dashboard.

Patients/caregivers have access to patient portal but not discharge module or secure patient-provider messaging tools. Providers have access to safety dashboard without discharge preparation indicator. Providers do not have access to secure patient-provider messaging tools.
NO_INTERVENTION: Study 2: Pre-intervention

Usual care on three general medicine units.

Patients/caregivers do not have access to the discharge preparation checklist. Providers do not have access to the safety dashboard.
EXPERIMENTAL: Study 2: Post-intervention
Patients/caregivers have access to the discharge preparation checklist. Providers have access to safety dashboard.
Behavioral: Interactive Digital Health Tools
Discharge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos

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
Study 1: Patient or Caregiver Activation at Discharge
Time Frame: 16 months
The short version of the Patient Activation Measure (PAM®) or Caregiver Activation Measure (CAM®) tool will be administered to all enrolled patients or enrolled patient's designated caregivers at discharge.
16 months
Study 2: Potential Post-Discharge Adverse Events
Time Frame: 24 months
Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient
24 months

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
Study 1: Patient Reported Self-Efficacy
Time Frame: 16 months
Patients or designated caregivers will be asked at 30 days after discharge to rate the degree of involvement (5-point Likert scale) in their discharge plan in each of four domains: executing the discharge plan of care; taking discharge medications; self-managing conditions; adhering to the follow-up plan
16 months
Study 1: Patient or Caregiver Activation at 30-days Post-Discharge
Time Frame: 16 months
The short version of the Patient Activation Measure (PAM®) or Caregiver Activation Measure (CAM®) tool will be administered to all enrolled patients or enrolled patient's designated caregivers at 30-days after discharge
16 months
Study 1: Healthcare Resource Utilization
Time Frame: 16 months
Healthcare resource utilization will be measured as the aggregate number of ambulatory clinic visits (PCPs, specialists), emergency department visits, and hospital re-admissions during the 30-day post-discharge period via hospital administrative databases and by asking patients/caregivers about utilization of resources outside our healthcare network on a 30-day post-discharge phone call.
16 months
Study 1: Provider perceptions of patients' discharge preparedness and patient-provider communication regarding the discharge process
Time Frame: 16 months
Assessed using surveys (5-point Likert scale) administered to patients' providers (nurse, attending, residents, physician assistants) at discharge.
16 months
Study 1: Patient perceptions of their discharge preparedness and patient-provider communication regarding the discharge process during hospitalization and the post-discharge transition period.
Time Frame: 16 months
Assessed using surveys (5-point Likert scale) administered to patients/caregivers at discharge, and during the 30-day patient phone call.
16 months
Study 2: Actual Post-Discharge Adverse Events
Time Frame: 24 months
Actual post-discharge adverse events will be measured as the number of adverse events per patient
24 months
Study 2: Preventable Post-Discharge Adverse Events
Time Frame: 24 months
Actual post-discharge adverse events related to preventable harm will be measured as the number of post-discharge adverse events per patient related to a specific safety risk domain identified during index hospitalization
24 months

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.
Brigham and Women's Hospital

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.
Agency for Healthcare Research and Quality (AHRQ)
Crico

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.
January 1, 2017

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.
August 1, 2020

Study Completion (ACTUAL)

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.
December 1, 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).
March 29, 2017

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.
April 13, 2017

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.
April 14, 2017

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.
July 25, 2022

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.
July 21, 2022

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.
July 1, 2022

More Information

Terms related to this study

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.
  • 2016P001137

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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