NCT04796142

Brief Summary

To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

March 9, 2021

Last Update Submit

December 4, 2024

Conditions

Medication Reconciliation

Keywords

Medication reconciliationIT platformPharmacies

Outcome Measures

Primary Outcomes (1)

  • medication recognition and reconciliation maintenance

    number of reconciliations per patient

    At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)

Study Arms (1)

Reconciliation

EXPERIMENTAL

Interventional trial without drugs

Other: medication reconciliation

Interventions

medication reconciliationOTHER

medication reconciliation

Reconciliation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ≥18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Patients receiving an anticancer treatment
  • Clear understanding of the Italian language; written informed consent.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alessandro Passardi

Meldola, FC, 47014, Italy

Location

Related Publications (1)

  • Passardi A, Serra P, Donati C, Fiori F, Prati S, Vespignani R, Taglioni G, Farfaneti Ghetti P, Martinelli G, Nanni O, Altini M, Frassineti GL, Minguzzi MV. An Integrated Model to Improve Medication Reconciliation in Oncology: Prospective Interventional Study. J Med Internet Res. 2021 Dec 20;23(12):e31321. doi: 10.2196/31321.

    PMID: 34932001DERIVED

MeSH Terms

Interventions

Medication Reconciliation

Intervention Hierarchy (Ancestors)

Medication ErrorsDrug TherapyTherapeuticsMedical ErrorsHealth ServicesHealth Care Facilities Workforce and ServicesMedication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • martina minguzzi

    IRCCS IRST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

June 12, 2019

Primary Completion

June 15, 2023

Study Completion

September 15, 2023

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations

IT(1)