PROF2: Medication Reconciliation in Oncologic Patients

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (Other)

Overall Status

Recruiting

CT.gov ID

NCT04796142

Collaborator

(none)

100

Enrollment

Location

Arm

36.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Reconciliation	Other: medication reconciliation	N/A

Detailed Description

This trial will explore the alliance between a Cancer Institute and the community pharmacies to improve medication reconciliation in healthcare transitions, and will validate a new integrated IT platform.

Cancer patients receiving an oncologic treatment will be asked to choose a pharmacy participating to the trial, and to perform the pharmacological survey before every cycle of chemotherapy.

This will be sent through the new IT platform to the electronic medical record of IRST, and the Oncologist will perform the reconciliation.

Data about concomitant medications and possible interactions will be exensively analyzed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

An Integrated Model to Increase Medication Recognition and Reconciliation in Oncologic Patients

Actual Study Start Date :

Jun 12, 2019

Anticipated Primary Completion Date :

Jan 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reconciliation Interventional trial without drugs	Other: medication reconciliation medication reconciliation

Arm

Intervention/Treatment

Experimental: Reconciliation

Interventional trial without drugs

Other: medication reconciliation

medication reconciliation

Outcome Measures

Primary Outcome Measures

medication recognition and reconciliation maintenance [At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)]
number of reconciliations per patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alessandro Passardi	Meldola	FC	Italy	47014

Sponsors and Collaborators

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

Principal Investigator: martina minguzzi, IRCCS IRST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

ClinicalTrials.gov Identifier:

NCT04796142

Other Study ID Numbers:

IRST 100.40

First Posted:

Mar 12, 2021

Last Update Posted:

Mar 12, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Medication reconciliation

IT platform

Pharmacies

Study Results

No Results Posted as of Mar 12, 2021