PolypharmacyFARMA-CANPNCT04391218
A Multidisciplinary Intervention Including a Clinical Decision Support System and an App for Drug Therapy Management in Older Patients
A study testing Multidisciplinary Approach Group in people with Polypharmacy and Multimorbidity, run by A.O.U. Città della Salute e della Scienza.
Trial summary
"La Casa nel Parco" (CANP) Project is a European Union and Regione Piemonte funded multidisciplinary project aimed to explore innovative technology application in older subject care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Multimorbidity, Aged
- What is being tested?
- Multidisciplinary Approach Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- May 2021to May 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient age ≥ 65 years
- Hospital at Home admission
- Presence of a caregiver
- Written informed consent signed by both the patient and the caregiver
Who cannot join
- Unavailable internet access and/or portable device to install the App on
- Severe cognitive impairment with behavioural symptoms
- Estimated life expectancy less than 3 months
- Death during Hospital at Home stay
- Hospital at Home discharge to an other healthcare facility (i.e. Emergency Department, Nursing Home)
- No regular medications precribed at Hospital at Home discharge.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Applicabilità ed Efficacia di un Approccio Multi-Disciplinare Comprendente un Sistema Informatico di Supporto Per la Decisione Della Terapia di Pazienti Anziani Polipatologici
"La Casa nel Parco" (CANP) Project is a European Union and Regione Piemonte funded multidisciplinary project aimed to explore innovative technology application in older subject care. In this context, FARMA-CANP is a randomized open-label clinical trial evaluating a multidisciplinary intervention in older patients hospitalized at home. The intervention involves physicians, pharmacists, nurses and includes a Clinical Decision Support System to help the processes of therapeutic review and reconciliation, and an end-user App to support patients and/or caregivers in the daily management of drug therapy.
The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.
- Conditions
- Polypharmacy, Multimorbidity, Aged
- Being tested
- Multidisciplinary Approach Group
- Keywords
- Clinical Decision Support System, App, Medication Adherence, Medication Reconciliation, Pharmacist, Inappropriate prescribing
- Medical subject headings
- Alzheimer Disease, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Approach GroupOther
Geriatricians will introduce medication review data on a Clinical Decision Support System, that will help both pharmacists and physicians in medication reconciliation, highligting potentially inappropriate prescriptions according to Beers' criteria and STOPP/START criteria, and potential controindicated and major Drug-Drug Interactions according to Micromedex. Before Hospital at Home discharge, nurses will instruct patients and/or caregivers to the use of an App, where daily drug therapy at discharge will be inserted and scheduled. This App will automatically create an alert everytime a drug dose needs to be taken, alongside an image of the specific drug packaging. The App will register if and when the patient actually takes the drug, or the reason for the delayed/missed dose.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Approach Group | Experimental | Multidisciplinary medication review and reconciliation during hospitalization involving geriatricians, nurses, pharmacists and supported by a Clinical Decision Support System, followed by an end-user App to support patients/caregivers in the correct drug intake after discharge. Receives: Other: Multidisciplinary Approach Group |
| Control Group | No intervention | Medication review and reconciliation will be performed by geriatricians according to Good Clinical Practice and usual habits, that might also include digital and printed supports for medication appropriateness and drug interaction. Drug therapy will be listed and explained to the patient/caregiver at discharge. Patients/caregivers will be allowed to use any tools to support medication adherence, according to their habits and preferences (i.e. calendars, alarms, pill boxes). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a therapeutic adherence index ≥0.8
The therapeutic adherence index is defined as the ratio of number of drug units dispensed on total number of drug units prescribed at discharge.
Data on drug units dispensed will be derived from a central database of territorial pharmaceutical center of A.S.L.Città di Torino.
Measured: 6 months after Hospital at Home discharge
Secondary outcomes (3)
Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Beers' PIP
Beers' PIPs will be identified according to the Beers' 2019 Criteria
Measured: At Hospital at Home discharge, an average of 14 days after group allocation
Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Screening Tool of Older People's Prescriptions (STOPP) PIP
STOPP IPs will be identified according to the Screening Tool of Older People's Prescriptions version 2
Measured: At Hospital at Home discharge, an average of 14 days after group allocation
Number of potential contraindicated and/or major Drug-Drug Interactions (DDI) and number of participants with at least one potential contraindicated and/or major DDI.
Potential contraindicated and major DDIs will be identified using the Micromedex database
Measured: At Hospital at Home discharge, an average of 14 days after group allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startMay 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turin, Italy, Infologic S.r.l., Padova, Italy, Consoft Sistemi S.p.A. Turin, Italy, ASL Città di Torino, Italy
- Responsible party
- Principal investigator, Dott.ssa RENATA MARINELLO, A.O.U. Città della Salute e della Scienza
- Investigators
- Renata Marinello, MD, PhD, Principal investigator, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391218
- Sponsor's protocol ID
- FARMA-CANP
- Acronym
- FARMA-CANP
- Status last verified
- Mar 2021
- First submitted
- 6 May 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.
PubMed 25324330By the 2019 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria(R) for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019 Apr;67(4):674-694. doi: 10.1111/jgs.15767. Epub 2019 Jan 29.
PubMed 30693946
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicabilità ed Efficacia di un Approccio Multi-Disciplinare Comprendente un Sistema Informatico di Supporto Per la Decisione Della Terapia di Pazienti Anziani Polipatologici
- ClinicalTrials.gov ID
- NCT04391218
- Acronym / sponsor ID
- FARMA-CANP / FARMA-CANP
- Conditions
- Polypharmacy, Multimorbidity, Aged
- Keywords
- Clinical Decision Support System, App, Medication Adherence, Medication Reconciliation, Pharmacist, Inappropriate prescribing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- University of Turin, Italy, Infologic S.r.l., Padova, Italy, Consoft Sistemi S.p.A. Turin, Italy, ASL Città di Torino, Italy
- Study start
- May 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 18 May 2020 (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.
"La Casa nel Parco" (CANP) Project is a European Union and Regione Piemonte funded multidisciplinary project aimed to explore innovative technology application in older subject care. In this context, FARMA-CANP is a randomized open-label clinical trial evaluating a multidisciplinary intervention in older patients hospitalized at home. The intervention involves physicians, pharmacists, nurses and includes a Clinical Decision Support System to help the processes of therapeutic review and reconciliation, and an end-user App to support patients and/or caregivers in the daily management of drug therapy.
The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Approach Group | Experimental | Other: Multidisciplinary Approach GroupMultidisciplinary medication review and reconciliation during hospitalization involving geriatricians, nurses, pharmacists and supported by a Clinical Decision Support System, followed by an end-user App to support patients/caregivers in the correct drug intake after discharge. |
| Control Group | No intervention | –Medication review and reconciliation will be performed by geriatricians according to Good Clinical Practice and usual habits, that might also include digital and printed supports for medication appropriateness and drug interaction. Drug therapy will be listed and explained to the patient/caregiver at discharge. Patients/caregivers will be allowed to use any tools to support medication adherence, according to their habits and preferences (i.e. calendars, alarms, pill boxes). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patient age ≥ 65 years
- Hospital at Home admission
- Presence of a caregiver
- Written informed consent signed by both the patient and the caregiver
Key exclusion criteria (6 listed)
- Unavailable internet access and/or portable device to install the App on
- Severe cognitive impairment with behavioural symptoms
- Estimated life expectancy less than 3 months
- Death during Hospital at Home stay
- Hospital at Home discharge to an other healthcare facility (i.e. Emergency Department, Nursing Home)
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 |
|---|---|---|
| Multidisciplinary Approach GroupGeriatricians will introduce medication review data on a Clinical Decision Support System, that will help both pharmacists and physicians in medication reconciliation, highligting potentially inappropriate prescriptions according to Beers' criteria and STOPP/START criteria, and potential controindicated and major Drug-Drug Interactions according to Micromedex. Before Hospital at Home discharge, nurses will instruct patients and/or caregivers to the use of an App, where daily drug therapy at discharge will be inserted and scheduled. This App will automatically create an alert everytime a drug dose needs to be taken, alongside an image of the specific drug packaging. The App will register if and when the patient actually takes the drug, or the reason for the delayed/missed dose. | Other | Multidisciplinary Approach Group |
Primary outcome
Number of participants with a therapeutic adherence index ≥0.8
Time frame: 6 months after Hospital at Home discharge
The therapeutic adherence index is defined as the ratio of number of drug units dispensed on total number of drug units prescribed at discharge. Data on drug units dispensed will be derived from a central database of territorial pharmaceutical center of A.S.L.Città di Torino.
3 secondary outcomes
Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Beers' PIP
Time frame: At Hospital at Home discharge, an average of 14 days after group allocation
Number of Potentially Inappropriate Prescriptions (PIP) and number of participants with at least one Screening Tool of Older People's Prescriptions (STOPP) PIP
Time frame: At Hospital at Home discharge, an average of 14 days after group allocation
Number of potential contraindicated and/or major Drug-Drug Interactions (DDI) and number of participants with at least one potential contraindicated and/or major DDI.
Time frame: At Hospital at Home discharge, an average of 14 days after group allocation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Background: PubMed 25324330O'Mahony D, O'Sullivan D, Byrne S, O'Connor MN, Ryan C, Gallagher P. STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing. 2015 Mar;44(2):213-8. doi: 10.1093/ageing/afu145. Epub 2014 Oct 16.
- Background: PubMed 30693946By the 2019 American Geriatrics Society Beers Criteria(R) Update Expert Panel. American Geriatrics Society 2019 Updated AGS Beers Criteria(R) for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019 Apr;67(4):674-694. doi: 10.1111/jgs.15767. Epub 2019 Jan 29.
- Micromedex® online database. International Business Machines Corporation (IBM) Watson Health, Greenwood Village, Colorado, USA.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Renata Marinello, MD, PhD principal investigator
A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Approach Group in people with Polypharmacy and Multimorbidity, run by A.O.U. Città della Salute e della Scienza.
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 6 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: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Marinello, MD, PhD (0116334771 ext. +39, rmarinello@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a therapeutic adherence index ≥0.8 (time frame: 6 months after Hospital at Home discharge). 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 NCT04391218, which also lists 2 linked publications.
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 5 Mar 2021.