Transitions of CareNCT03116074
Interactive Digital Health Tools to Improve Patient Safety in Acute Care
A study testing Interactive Digital Health Tools in people with Transitions of Care and Patient Portals, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transitions of Care, Patient Portals, General Medicine
- What is being tested?
- Interactive Digital Health Tools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: 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:
- 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.
- 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.
- To identify barriers and facilitators of implementation, adoption, and use of the PDTK by patients, caregivers, and providers using qualitative and quantitative methods.
Read more
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:
- 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.
- Expand intervention to general medical units at our community hospital-affiliate, BWFH.
- Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.
Read the 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.
- Conditions
- Transitions of Care, Patient Portals, General Medicine, Discharge Checklist, Patient-provider Communication, Adverse Event
- Being tested
- Interactive Digital Health Tools
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Digital Health ToolsBehavioural
Discharge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos
| Study group | Role | What they receive |
|---|---|---|
| Study 1: Pre-intervention 1 | No intervention | 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. |
| Study 1: Post-intervention | Experimental | 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. Receives: Behavioral: Interactive Digital Health Tools |
| Study 1: Pre-intervention 2 | No intervention | 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. |
| Study 2: Pre-intervention | No 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. |
| Study 2: Post-intervention | Experimental | Patients/caregivers have access to the discharge preparation checklist. Providers have access to safety dashboard. Receives: Behavioral: Interactive Digital Health Tools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study 1: Patient or Caregiver Activation at Discharge
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.
Measured: 16 months
Study 2: Potential Post-Discharge Adverse Events
Potential post-discharge adverse events will be measured as the number of new or worsening symptoms or signs per patient
Measured: 24 months
Secondary outcomes (7)
Study 1: Patient Reported Self-Efficacy
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
Measured: 16 months
Study 1: Patient or Caregiver Activation at 30-days Post-Discharge
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
Measured: 16 months
Study 1: Healthcare Resource Utilization
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.
Measured: 16 months
Study 1: Provider perceptions of patients' discharge preparedness and patient-provider communication regarding the discharge process
Assessed using surveys (5-point Likert scale) administered to patients' providers (nurse, attending, residents, physician assistants) at discharge.
Measured: 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.
Assessed using surveys (5-point Likert scale) administered to patients/caregivers at discharge, and during the 30-day patient phone call.
Measured: 16 months
Study 2: Actual Post-Discharge Adverse Events
Actual post-discharge adverse events will be measured as the number of adverse events per patient
Measured: 24 months
Study 2: Preventable Post-Discharge Adverse Events
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJan 2017
- Primary completionAug 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transitions of CareStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Crico
- Responsible party
- Principal investigator, Anuj K. Dalal, MD, Brigham and Women's Hospital
- Investigators
- Anuj K Dalal, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116074
- Sponsor's protocol ID
- 2016P001137
- Status last verified
- Jul 2022
- First submitted
- 29 Mar 2017
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dalal AK, Piniella N, Fuller TE, Pong D, Pardo M, Bessa N, Yoon C, Lipsitz S, Schnipper JL. Evaluation of electronic health record-integrated digital health tools to engage hospitalized patients in discharge preparation. J Am Med Inform Assoc. 2021 Mar 18;28(4):704-712. doi: 10.1093/jamia/ocaa321.
PubMed 33463681Fuller TE, Pong DD, Piniella N, Pardo M, Bessa N, Yoon C, Boxer RB, Schnipper JL, Dalal AK. Interactive Digital Health Tools to Engage Patients and Caregivers in Discharge Preparation: Implementation Study. J Med Internet Res. 2020 Apr 28;22(4):e15573. doi: 10.2196/15573.
PubMed 32343248
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03116074
- Acronym / sponsor ID
- 2016P001137
- Conditions
- Transitions of Care, Patient Portals, General Medicine, Discharge Checklist, Patient-provider Communication, Adverse Event
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Crico
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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:
- 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.
- Expand intervention to general medical units at our community hospital-affiliate, BWFH.
- Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Study 1: Pre-intervention 1 | No intervention | –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. |
| Study 1: Post-intervention | Experimental | Behavioral: Interactive Digital Health ToolsPatient-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. |
| Study 1: Pre-intervention 2 | No intervention | –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. |
| Study 2: Pre-intervention | No 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. |
| Study 2: Post-intervention | Experimental | Behavioral: Interactive Digital Health ToolsPatients/caregivers have access to the discharge preparation checklist. Providers have access to safety dashboard. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -Non-English speaking patients for whom we cannot identify an English-speaking healthcare proxy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Digital Health ToolsDischarge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos | Behavioural | Study 1: Post-intervention, Study 2: Post-intervention |
Primary outcome
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.
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
7 secondary outcomes
Study 1: Patient Reported Self-Efficacy
Time frame: 16 months
Study 1: Patient or Caregiver Activation at 30-days Post-Discharge
Time frame: 16 months
Study 1: Healthcare Resource Utilization
Time frame: 16 months
Study 1: Provider perceptions of patients' discharge preparedness and patient-provider communication regarding the discharge process
Time frame: 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
Study 2: Actual Post-Discharge Adverse Events
Time frame: 24 months
Study 2: Preventable Post-Discharge Adverse Events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Derived from this study: PubMed 33463681Dalal AK, Piniella N, Fuller TE, Pong D, Pardo M, Bessa N, Yoon C, Lipsitz S, Schnipper JL. Evaluation of electronic health record-integrated digital health tools to engage hospitalized patients in discharge preparation. J Am Med Inform Assoc. 2021 Mar 18;28(4):704-712. doi: 10.1093/jamia/ocaa321.
- Derived from this study: PubMed 32343248Fuller TE, Pong DD, Piniella N, Pardo M, Bessa N, Yoon C, Boxer RB, Schnipper JL, Dalal AK. Interactive Digital Health Tools to Engage Patients and Caregivers in Discharge Preparation: Implementation Study. J Med Internet Res. 2020 Apr 28;22(4):e15573. doi: 10.2196/15573.
- AHRQ Project SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anuj K Dalal, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Digital Health Tools in people with Transitions of Care and Patient Portals, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study 1: Patient or Caregiver Activation at Discharge (time frame: 16 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.