Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design

NCT03544034 | Withdrawn DMC

• 1 other identifier: IRB00175392
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This project is to develop, implement, pilot evaluate, and disseminate a medication safety program (HomeTeam) that consolidates strategies to help patients by partnering with patients and their informal caregivers during transitions from hospital to home. Care transitions, especially from hospital to home, are high-risk periods for medication errors, and are frequently associated with serious adverse drug events (ADEs) and preventable readmissions. Older adults with multi-morbid conditions who have complex medication regimes are especially prone to these risks. Patients and family caregivers may experience a dramatic transition in roles and responsibilities immediately after hospital discharge. Patients and family caregivers are relatively passive recipients in their care and medication management in the hospital, but when patients arrive at home, patients have the primary responsibility for their care and medication use (with professional care providers switching to a 'supporting' function). Although this significant transition in the nature and intensity of patient work needs to be managed actively, often patients and family members are not adequately engaged and prepared in the hospital, and not effectively supported for safe medication use after hospital discharge. More specifically, patients and family members may not understand essential steps in the management of their condition, and have difficulty contacting appropriate health care practitioners for guidance. Although most organizations deploy multiple layers of interventions for improving care transitions, reducing postdischarge adverse drug events (ADEs), 30-day readmissions and emergency department (ED) visits, their impact to date has been small, and there remains significant and urgent need to fundamentally redesign the hospital-to-home care transition process. Investigators believe that one practical and potentially effective way for this 'much-needed' redesign is through engaging and supporting patients and families in safe medication use. Investigators' proposed program 'HomeTeam' will contain evidence-based tools and methods for engaging patients and shifting culture towards a truly patient-centered care for medication safety.

Conditions

Patient Safety; Adverse Drug Event

Outcome Measures

Primary Outcomes (2)

• Preventable adverse drug events

  Preventable ADEs are injuries that could have bee n avoided, that is, an injury judged to probably be the result of an error or a system design flaw.

  30 days after hospital discharge

• Ameliorable adverse drug events

  Ameliorable ADEs are injuries whose severity could have been substantially reduced if different actions or procedures had been performed or followed.

  30 days after hospital discharge

Study Arms (2)

Pre-intervention

NO INTERVENTION

Routine/ standard care and retrospective chart review for identifying preventable and ameliorable Adverse drug events as baseline

Post-intervention

EXPERIMENTAL

Hometeam toolkit interventions (including improved discharge education, proactive medication safety assessment in daily rounds and handoffs, safety briefings) applied in all hospitalist services.

Behavioral: HomeTeam Toolkit

Interventions

HomeTeam Toolkit BEHAVIORAL

A multi-component intervention (8S's) 1. Safety at home through partnership. 2. Safety risk assessment at the admission 3. Safety agenda setting for coordinating efforts among professionals to prepare patient/ family for self-management 4. Safety tools. Cognitive tools to support patient/family after discharge 5. Safety education. Enhanced Patient/ family medication safety education 6. Safety briefings with patient/family A mechanism to proactively address common and patient/family specific risks. 7. Safety through learning routines across the care continuum 8. Safety assessment after discharge

Post-intervention

Eligibility Criteria

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

You may qualify if:

• and older
• medicine patients
• hospitalized from home
• English speaking
• no cognitive problems/ can consent

You may not qualify if:

• surgery patients

Sponsors & Collaborators

• Johns Hopkins University: lead
• The University of Texas at Arlington: collaborator

Study Sites (1)

Johns Hopkins Univ Armstrong Institute

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

• Ayse Gurses

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pre-post study in two hospitals. Implementation will be done at the organization level (for all 65 and older patients admitted to hospitalist service in these two hospitals.

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 1, 2018
• Study Start: December 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)