Medication ReconciliationPROF2NCT04796142
Medication Reconciliation in Oncologic Patients
A study testing medication reconciliation in people with Medication Reconciliation, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Reconciliation
- What is being tested?
- medication reconciliation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2019to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Integrated Model to Increase Medication Recognition and Reconciliation in Oncologic Patients
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.
Read the 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.
- Conditions
- Medication Reconciliation
- Being tested
- medication reconciliation
- Keywords
- Medication reconciliation, IT platform, Pharmacies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication reconciliationOther
medication reconciliation
| Study group | Role | What they receive |
|---|---|---|
| Reconciliation | Experimental | Interventional trial without drugs Receives: Other: medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
medication recognition and reconciliation maintenance
number of reconciliations per patient
Measured: At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start12 Jun 2019
- Primary completion15 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication ReconciliationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- martina minguzzi, Principal investigator, IRCCS IRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796142
- Sponsor's protocol ID
- IRST 100.40
- Acronym
- PROF2
- Status last verified
- Dec 2024
- First submitted
- 9 Mar 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Publications
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.
PubMed 34932001
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Model to Increase Medication Recognition and Reconciliation in Oncologic Patients
- ClinicalTrials.gov ID
- NCT04796142
- Acronym / sponsor ID
- PROF2 / IRST 100.40
- Conditions
- Medication Reconciliation
- Keywords
- Medication reconciliation, IT platform, Pharmacies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reconciliation | Experimental | Other: medication reconciliationInterventional trial without drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication reconciliationmedication reconciliation | Other | Reconciliation |
Primary outcome
medication recognition and reconciliation maintenance
Time frame: At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)
number of reconciliations per patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 34932001Passardi 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.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
martina minguzzi principal investigator
IRCCS IRST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medication reconciliation in people with Medication Reconciliation, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medication recognition and reconciliation maintenance (time frame: At day 1 of each cycle of treatment (each cycle might be 14, 21 or 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.