PolypharmacyREMEINCT02275572
Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients
A study testing Pharmacist Intervention in people with Polypharmacy and Elderly, run by Consorci Sanitari del Maresme.
Trial summary
Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Polypharmacy, Elderly
- What is being tested?
- Pharmacist Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to May 2012
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or more
- Currently receiving eight or more drugs, except ointments and administered via topical nonprescription
- Give their informed written consent to participate in the study.
Who cannot join
- Estimated life expectancy less than 6 months.
- Active cancer
- Participation in any other clinical trial or program for evaluation of medication in the elderly.
- Institutionalized in nursing homes.
- Surgical intervention scheduled for the next 6 months
About this study
Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized.
Design: randomized, open, multicenter and two branches of parallel intervention clinical trial.
Read more
Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Control intervention: usual procedure.
Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP consultations, hospital emergency department and hospital admissions for acute illness, c) pharmaceutical expenditure, d) restart medication e) complications underlying diseases. Follow-up control at 1 month (security) and at 3, 6 and 12 months.
- Conditions
- Polypharmacy, Elderly
- Being tested
- Pharmacist Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist InterventionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Intervention | Experimental | Primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Receives: Procedure: Pharmacist Intervention |
| Control | No intervention | Usual procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with medications discontinued, reduced dose or changed.
Measured: baseline, 3, 6 and 12 months
Number of discontinued medications, changed or changing doses.
Measured: baseline, 3, 6 and 12 months
Secondary outcomes (6)
Resumption of medication
Measured: 3, 6 and 12 months
Medication adherence
Morisky-Green questionnaire
Measured: baseline, 3 and 6 months
Quality of life
EuroQoL questionnaire
Measured: baseline, 3 and 6 months
Pharmaceutical recommendations acceptance rate
Measured: baseline
Healthcare resource consumption
Number of visits to Primary care center, Number of visits to hospital emergency department, Number of hospital admission, Number of outpatients hospital visits.
Measured: 3, 6 and 12 months
Mortality
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startMar 2012
- Primary completionMay 2012
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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275572
- Sponsor's protocol ID
- 05/12
- Acronym
- REMEI
- Status last verified
- Oct 2014
- First submitted
- 21 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
Publications
Campins L, Serra-Prat M, Gozalo I, Lopez D, Palomera E, Agusti C, Cabre M; REMEI Group. Randomized controlled trial of an intervention to improve drug appropriateness in community-dwelling polymedicated elderly people. Fam Pract. 2017 Feb;34(1):36-42. doi: 10.1093/fampra/cmw073. Epub 2016 Sep 7.
PubMed 27605543
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economical Assessment of an Intervention to Reduce Potentially Inappropriate Medication in Polymedicated Elderly Patients
- ClinicalTrials.gov ID
- NCT02275572
- Acronym / sponsor ID
- REMEI / 05/12
- Conditions
- Polypharmacy, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- First posted
- 27 Oct 2014 (estimated)
- 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.
Objective: To evaluate the clinical and economic impact of the application of an algorithm to improve the adequacy and safety of pharmacotherapy in elderly polymedicated (receiving 8 or more medications), not institutionalized.
Design: randomized, open, multicenter and two branches of parallel intervention clinical trial.
Intervention Study: primary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. Control intervention: usual procedure.
Main outcome measures: a) Discontinued medications, changed or changing doses, b) GP consultations, hospital emergency department and hospital admissions for acute illness, c) pharmaceutical expenditure, d) restart medication e) complications underlying diseases. Follow-up control at 1 month (security) and at 3, 6 and 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Intervention | Experimental | Procedure: Pharmacist InterventionPrimary care pharmacist apply the GP-GP algorithm to each drug with the support of STOPP criteria, Beers and / or recommendations CatSalut. The pharmacist submit to doctor his findings and reach a consensus and decide which recommendations will be presented to patient. |
| Control | No intervention | –Usual procedure. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 70 years or more
- Currently receiving eight or more drugs, except ointments and administered via topical nonprescription
- Give their informed written consent to participate in the study.
Key exclusion criteria (5 listed)
- Estimated life expectancy less than 6 months.
- Active cancer
- Participation in any other clinical trial or program for evaluation of medication in the elderly.
- Institutionalized in nursing homes.
- Surgical intervention scheduled for the next 6 months
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 |
|---|---|---|
| Pharmacist Intervention | Procedure or surgery | Pharmacist Intervention |
Primary outcome
Number of patients with medications discontinued, reduced dose or changed.
Time frame: baseline, 3, 6 and 12 months
Number of discontinued medications, changed or changing doses.
Time frame: baseline, 3, 6 and 12 months
6 secondary outcomes
Resumption of medication
Time frame: 3, 6 and 12 months
Medication adherence
Time frame: baseline, 3 and 6 months
Quality of life
Time frame: baseline, 3 and 6 months
Pharmaceutical recommendations acceptance rate
Time frame: baseline
Healthcare resource consumption
Time frame: 3, 6 and 12 months
Mortality
Time frame: 3, 6 and 12 months
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 27 Oct 2014.
- Derived from this study: PubMed 27605543Campins L, Serra-Prat M, Gozalo I, Lopez D, Palomera E, Agusti C, Cabre M; REMEI Group. Randomized controlled trial of an intervention to improve drug appropriateness in community-dwelling polymedicated elderly people. Fam Pract. 2017 Feb;34(1):36-42. doi: 10.1093/fampra/cmw073. Epub 2016 Sep 7.
Related trials for Polypharmacy
Not yet recruiting
Impact of Pharmacotherapy Optimization in Polymedicated Lebanese Older Adults in Primary Health Care Centers
Older Adults (65 Years and Older), Polypharmacy (People Under Treatment With 5 or More Drugs)
Active, not recruiting
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions
Prescribing Decisions, Diabetes
Recruiting
Polypharmacy on Healthy Aging in People Living With HIV Over the Age of 75
Virus-HIV
Active, not recruiting
Improving Medication Management in World Trade Center Responders
Polypharmacy
Recruiting
PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
Pharmacogenomic Drug Interaction
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Intervention in people with Polypharmacy and Elderly, run by Consorci Sanitari del Maresme.
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 3 inclusion and 5 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 27 Oct 2014. 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?
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?
Number of patients with medications discontinued, reduced dose or changed. (time frame: baseline, 3, 6 and 12 months). The study lists 2 primary outcomes in all. 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 NCT02275572, 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 27 Oct 2014.