Interactive Digital Health Tools to Improve Patient Safety in Acute Care

Adverse Event Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116074
• Other study ID #: 2016P001137
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: July 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Event
• Discharge Checklist
• General Medicine
• Patient Portals
• Patient-provider Communication
• Readmission
• Transitions of Care

Intervention

Behavioral:
• Interactive Digital Health Tools
Discharge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Agency for Healthcare Research and Quality (AHRQ), Crico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 months
Primary	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	24 months
Secondary	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	16 months
Secondary	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	16 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	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.	16 months
Secondary	Study 2: Actual Post-Discharge Adverse Events	Actual post-discharge adverse events will be measured as the number of adverse events per patient	24 months
Secondary	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	24 months