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

Primary Purpose

Patient Safety, Adverse Drug Event

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HomeTeam Toolkit
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Safety

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • surgery patients

Sites / Locations

  • Johns Hopkins Univ Armstrong Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Pre-intervention

Post-intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2018
Last Updated
January 27, 2020
Sponsor
Johns Hopkins University
Collaborators
The University of Texas at Arlington
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1. Study Identification

Unique Protocol Identification Number
NCT03544034
Brief Title
Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design
Official Title
Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Withdrawn
Why Stopped
not funded
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
The University of Texas at Arlington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The 'HomeTeam will be developed and evaluated by completing 3 specific aims: Aim #1: Develop components of a multi-faceted program (HomeTeam) that consolidates evidence-based practices in patient and family activation and engagement related to medication safety, with the goal to adequately and reliably support transitions from the hospital to the patient home "work system" for medication management. Inpatient stays and the hospital discharge periods will be targeted as opportunities in activating, engaging, and enabling patients and family members to improve medication safety. (1a) Identify evidence-based practices in patient and family activation and engagement related to medication safety during care transitions. b) Develop program components (e.g., action-oriented patient/ family education, improved medication reconciliation, patient-centered rounds, learning systems through systematic feedback from home care professionals)-including tools to assess, prioritize, streamline, and integrate existing practices- aimed at engaging patients and families and supporting medication use safety during care transitions from hospital to home with a participatory design (PD) approach. Aim #2: Refine and implement the HomeTeam program in two organizations (one academic, one community hospital), with a peer-to-peer assessment methodology to identify and refine patient and family engagement practices for transitional care medication safety. a) Refine HomeTeam program through participatory design approach and peer-to-peer assessment (2b) Implement and pilot test HomeTeam in all participating sites Aim #3: Evaluate the implementation process and the impact of the toolkit 'HomeTeam' on medication safety after hospital discharge. Investigators will use a pre-post design to evaluate the impact of the toolkit over a one year period, focusing on 65 years of age and older medicine patients. The primary outcome is preventable and ameliorable adverse drug events (ADEs) after discharge. Secondary outcomes include 30-day post-discharge readmissions and ED visits due to medication-related issues process improvement assessment, patient-reported outcomes, and toolkit adoption assessment (e.g., acceptability, feasibility). Qualitative methods (post-implementation interviews with clinicians and patient/ family members) will be used as part of the evaluation. Hypothesis: Investigators hypothesize that the HomeTeam Medication Safety Program will reduce preventable and ameliorable post-discharge 30-day ADEs in the following subpopulations: older adults with at least 5 medications discharged from hospital to home on (H01) anticoagulants, (H0b) opioids, (H0c) diabetes agents. The project will be conducted in two hospitals: Bayview Medical Center (academic) and Howard County Medical Center (community). Dissemination plans include national medication safety organizations (e.g., Institute for Safe Medication Practices), patient safety organizations (e.g., Batz Patient Safety Foundation), and professional societies (e.g., Society of Hospital Medicine). Different dissemination modalities are planned, including story-telling through social media and short videos targeted for patients and clinicians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Safety, Adverse Drug Event

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
No masking
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-intervention
Arm Type
No Intervention
Arm Description
Routine/ standard care and retrospective chart review for identifying preventable and ameliorable Adverse drug events as baseline
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
Hometeam toolkit interventions (including improved discharge education, proactive medication safety assessment in daily rounds and handoffs, safety briefings) applied in all hospitalist services.
Intervention Type
Behavioral
Intervention Name(s)
HomeTeam Toolkit
Intervention Description
A multi-component intervention (8S's) Safety at home through partnership. Safety risk assessment at the admission Safety agenda setting for coordinating efforts among professionals to prepare patient/ family for self-management Safety tools. Cognitive tools to support patient/family after discharge Safety education. Enhanced Patient/ family medication safety education Safety briefings with patient/family A mechanism to proactively address common and patient/family specific risks. Safety through learning routines across the care continuum Safety assessment after discharge
Primary Outcome Measure Information:
Title
Preventable adverse drug events
Description
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.
Time Frame
30 days after hospital discharge
Title
Ameliorable adverse drug events
Description
Ameliorable ADEs are injuries whose severity could have been substantially reduced if different actions or procedures had been performed or followed.
Time Frame
30 days after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 65 and older medicine patients hospitalized from home English speaking no cognitive problems/ can consent Exclusion Criteria: surgery patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Gurses
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Univ Armstrong Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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