Clinical trial NCT03116074: Interactive Digital Health Tools to Improve Patient Safety in Acute Care
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transitions of Care
Patient Portals
General Medicine
Discharge Checklist
Patient-provider Communication
Adverse Event
Readmission
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Crico
First posted: 2017-04-14
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Study 1: Patient or Caregiver Activation at Discharge
timeFrame: 16 months
measure: Study 2: Potential Post-Discharge Adverse Events
timeFrame: 24 months
Secondary outcomes:
measure: Study 1: Patient Reported Self-Efficacy
timeFrame: 16 months
measure: Study 1: Patient or Caregiver Activation at 30-days Post-Discharge
timeFrame: 16 months
measure: Study 1: Healthcare Resource Utilization
timeFrame: 16 months
measure: Study 1: Provider perceptions of patients' discharge preparedness and patient-provider communication regarding the discharge process
timeFrame: 16 months
measure: Study 1: Patient perceptions of their discharge preparedness and patient-provider communication regarding the discharge process during hospitalization and the post-discharge transition period.
timeFrame: 16 months
measure: Study 2: Actual Post-Discharge Adverse Events
timeFrame: 24 months
measure: Study 2: Preventable Post-Discharge Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Anuj K Dalal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fuller 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.