- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03544034
Partnering With Patients for Improving Medication Safety During Transitions of Care: Implications for Work System Design
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21202
- Johns Hopkins Univ Armstrong Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 65 and older
- medicine patients
- hospitalized from home
- English speaking
- no cognitive problems/ can consent
Exclusion Criteria:
- surgery patients
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Pre-intervention
Routine/ standard care and retrospective chart review for identifying preventable and ameliorable Adverse drug events as baseline
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Experimental: Post-intervention
Hometeam toolkit interventions (including improved discharge education, proactive medication safety assessment in daily rounds and handoffs, safety briefings) applied in all hospitalist services.
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A multi-component intervention (8S's)
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Preventable adverse drug events
Zeitfenster: 30 days after hospital discharge
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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.
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30 days after hospital discharge
|
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Ameliorable adverse drug events
Zeitfenster: 30 days after hospital discharge
|
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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Ayse Gurses, Johns Hopkins University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00175392
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
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