Interactive Digital Health Tools to Improve Patient Safety in Acute Care

NCT03116074 | Completed

• 1 other identifier: 2016P001137
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.To identify barriers and facilitators of implementation, adoption, and use of the PDTK by patients, caregivers, and providers using qualitative and quantitative methods.
4. 4.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.
5. 5.Expand intervention to general medical units at our community hospital-affiliate, BWFH.
6. 6.Evaluate impact on post-discharge AEs for patients discharged from BWFH who are at risk for preventable harm and hospital readmission.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Study 1: Patient Reported Self-Efficacy

  16 months

• Study 1: Patient or Caregiver Activation at 30-days Post-Discharge

  16 months

• Study 1: Healthcare Resource Utilization

  16 months

• Study 1: Provider perceptions of patients' discharge preparedness and patient-provider communication regarding the discharge process

  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.

  16 months

Study Arms (5)

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.

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.

Behavioral: Interactive Digital Health Tools

Interventions

Interactive Digital Health Tools BEHAVIORAL

Discharge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos

Study 1: Post-intervention; Study 2: Post-intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Crico: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (2)

• 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.

  PMID: 33463681 DERIVED

• 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.

  PMID: 32343248 DERIVED

Related Links

• AHRQ Project Site

Study Officials

• Anuj K Dalal, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Physician

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 14, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)