Medication ReviewNCT05799430
Medication Review in Chronic Complex or Polymedicated Patients After Hospital Discharge.
A study testing Multidisciplinary medication review in people with Medication Review and Polypharmacy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial summary
The goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Review, Polypharmacy, Disease, Chronic
- What is being tested?
- Multidisciplinary medication review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2023to 31 Jul 2024
- 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
- Hospital discharge in the last 48 h and one of the following conditions:
- Polypharmacy: ten o more drugs prescribed in a chronic schedule OR
- Complez Chronic Condition
Who cannot join
- Patients in last days of life
- Major mental health disorder
- Patient on dialysis
- Organ transplant patients
Trial locations and contacts
1 site in 1 country.
Daniel Palma-Morgado, Pharm G contact
Spain1 site, 1 recruiting
- Recruiting
Sevilla Primary Care District
Seville, 41013
Teresa Molina-López, Pharm.Dr., +34637642411, mariat.molina.sspa@juntadeandalucia.es
Daniel Palma-Morgado, Pharm. Bch., daniel.palma.sspa@juntadeandalucia.es
About this study
Official title: Effects of Interdisciplinary Medication Review in Chronic Complex Patients or Patients With Polypharmacy After Hospital Discharge
The goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge.
The multidisciplinary team will be integrated by a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). Patient will be adults aged 65 years and older. Polypharmacy refers to the use of 10 or more drugs based on information in electronic prescription software.
Read more
Research questions are:
In elderly patients with polypharmacy, which is the effect of an interdisciplinary medication review after hospital discharge in comparison with standard care, in terms of:
- new hospitalization episodes?
- number of drugs prescribed?
- prescribed drugs adequacy?
Read the detailed description
Centres will be randomized to medication review intervention or usual care group. Eligible patients will be ask for informed consent. For patients in the intervention group, PCP will collect information about prescribed medication and diseases from the electronic health record and e-prescribing application. The medication review in primary care will be focus to reconcile the medications the patient was taking prior to admission and those initiated in hospital, with the medications they should be taking post-discharge to ensure all changes are intentional and that discrepancies are resolved as soon as possible. The review process will include detection of potential drugs interactions, wrong doses, lack of adherence (based on dispensing recorded data) and adequacy to explicit criteria for potentially inappropriate prescriptions included in different tools: a) STOPP-STAR, STOPP-Pal, LESS-CHRON lists; b) Guideline for Medication Review in Primary Care, a local publication and c) Medication review in patients with polypharmacy. A list of drugs frequently associate with potentially inappropriate prescriptions. Andalusian health Service). PCP will write a report to communicate the results of medication review to primary care physician and nurse. The multidisciplinary team will define a personalized therapeutic plan to be implemented for every patient.
Patients in the control group will receive usual care.
- Conditions
- Medication Review, Polypharmacy, Disease, Chronic
- Being tested
- Multidisciplinary medication review, Control group
- Keywords
- Medication Review, Polypharmacy
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary medication reviewBehavioural
FP communicate to the PCP patients recently discharged. The medication review process consists in 5 steps:
- PCP perform a structured drug review based on information from health record and e-prescribing application. The drug review comprise the appraisal of potentially inappropriate medication based on lists of explicit criteria.
- PCP communicates and discuss the results of medication review with GP and PCN, in a brief meeting face-to-face, with possible adaptation of the recommendations.
- FP, PCN and PCP agree on a personalized therapeutic plan for the patient that includes actions to optimize the therapy.
- FP and PCN share plan with the patient and/or carer with possible adaptation of the recommendations and agree about actions to be implemented.
- FP and PCN communicate to PCP final agreement with patient and/or carer
- FP and/or PCN follow-up implantation of agreed recommendations using standard health care procedures
Control groupBehavioural
Usual care by FP an PCN
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group will receive a multidisciplinary medication review and a personalized therapeutic plan in the following 72 hours after hospital discharge. The intervention will be developed by a multidisciplinary team that includes a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). PCP is a pharmacist working in a full-time base for the Pharmacy Service in a Primary Care District in Andalusian Public Health Service. Receives: Behavioral: Multidisciplinary medication review |
| Control group | Active comparator | The control group will receive usual care. Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalization episodes
Registered in Electronic Health Record. In emergency department or in hospital service
Measured: 12 months
Length of Hospital Stay
Registered in Electronic Health Record.
Measured: 12 months
Secondary outcomes (7)
Healthcare utilisation
Number of visits to primary care services (family physician or primary care nurse) and hospital services (non emergency and without hospitalization)
Measured: 12 months
Mortality
Dead for any cause
Measured: 12 month
Number of potentially inappropriate drugs
Total number of potentially inappropriate prescribed drugs based on explicit criteria
Measured: 12 months
Number of medications
Total number of drugs chronically prescribed (treatment length: unless 120 days)
Measured: 12 months
Number of proposal about treatment improvement
Number of proposal about treatment improvement included in PCP report
Measured: 7 days
Number of proposal about treatment improvement agreed with primary care team
Number of proposal about treatment improvement agreed with primary care team in a face face meeting
Measured: 7 days
Number of proposal about treatment improvement accepted by the patient or care
Number of proposal about treatment improvement agreed with primary care team in a face face meeting
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start15 Apr 2023
- Primary completion10 Jun 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Medication ReviewStudies 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
- Model description
- A cluster-randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Health Service
- Responsible party
- Sponsor
- Investigators
- Teresa Molina, Pharm Dr, Principal investigator, Andalusian Health Service. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799430
- Sponsor's protocol ID
- S0502
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Franchi C, Nobili A, Mari D, Tettamanti M, Djade CD, Pasina L, Salerno F, Corrao S, Marengoni A, Iorio A, Marcucci M, Mannucci PM; REPOSI Investigators. Risk factors for hospital readmission of elderly patients. Eur J Intern Med. 2013 Jan;24(1):45-51. doi: 10.1016/j.ejim.2012.10.005. Epub 2012 Nov 8.
PubMed 23142413Weinberger M, Oddone EZ, Henderson WG. Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. N Engl J Med. 1996 May 30;334(22):1441-7. doi: 10.1056/NEJM199605303342206.
PubMed 8618584Graham H, Livesley B. Can readmissions to a geriatric medical unit be prevented? Lancet. 1983 Feb 19;1(8321):404-6. doi: 10.1016/s0140-6736(83)91513-1.
PubMed 6130389Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
PubMed 19339721Acosta-Garcia H, Alfaro-Lara ER, Sanchez-Fidalgo S, Sevilla-Sanchez D, Delgado-Silveira E, Juanes-Borrego A, Santos-Ramos B. Intervention effectiveness by pharmacists integrated within an interdisciplinary health team on chronic complex patients. Eur J Public Health. 2020 Oct 1;30(5):886-899. doi: 10.1093/eurpub/ckz224.
PubMed 32052027Guisado-Gil AB, Mejias-Trueba M, Alfaro-Lara ER, Sanchez-Hidalgo M, Ramirez-Duque N, Santos-Rubio MD. Impact of medication reconciliation on health outcomes: An overview of systematic reviews. Res Social Adm Pharm. 2020 Aug;16(8):995-1002. doi: 10.1016/j.sapharm.2019.10.011. Epub 2019 Oct 17.
PubMed 31883776Santos-Ramos B, Otero Lopez MJ, Galvan-Banqueri M, Alfaro-Lara ER, Vega-Coca MD, Nieto-Martin MD, Ollero-Baturone M. [Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy/the hospital pharmacist]. Farm Hosp. 2012 Nov-Dec;36(6):506-17. doi: 10.7399/FH.2012.36.6.52. Spanish.
PubMed 23461444Alfaro-Lara ER, Vega-Coca MD, Galvan-Banqueri M, Nieto-Martin MD, Perez-Guerrero C, Santos-Ramos B. [Pharmacological treatment conciliation methodology in patients with multiple conditions]. Aten Primaria. 2014 Feb;46(2):89-99. doi: 10.1016/j.aprim.2013.07.002. Epub 2013 Sep 12. Spanish.
PubMed 24035767Rodriguez-Perez A, Alfaro-Lara ER, Sierra-Torres MI, Villalba-Moreno A, Nieto-Martin MD, Galvan-Banqueri M, Santos-Ramos B. Validation of the LESS-CHRON criteria: reliability study of a tool for deprescribing in patients with multimorbidity. Eur J Hosp Pharm. 2019 Nov;26(6):334-338. doi: 10.1136/ejhpharm-2017-001476. Epub 2018 May 30.
PubMed 31798857Rankin A, Cadogan CA, Patterson SM, Kerse N, Cardwell CR, Bradley MC, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD008165. doi: 10.1002/14651858.CD008165.pub4.
PubMed 30175841Frazier SC. Health outcomes and polypharmacy in elderly individuals: an integrated literature review. J Gerontol Nurs. 2005 Sep;31(9):4-11. doi: 10.3928/0098-9134-20050901-04.
PubMed 16190007Fulton MM, Allen ER. Polypharmacy in the elderly: a literature review. J Am Acad Nurse Pract. 2005 Apr;17(4):123-32. doi: 10.1111/j.1041-2972.2005.0020.x.
PubMed 15819637Shrank WH, Polinski JM, Avorn J. Quality indicators for medication use in vulnerable elders. J Am Geriatr Soc. 2007 Oct;55 Suppl 2:S373-82. doi: 10.1111/j.1532-5415.2007.01345.x. No abstract available.
PubMed 17910560Cardenas Valladolid J, Mena Mateo J, Canada Dorado MM, Rodriguez Morales D, Sanchez Perruca L. [Implementation and improvement in a care program for the elderly on multiple medications in a primary care area]. Rev Calid Asist. 2009 Feb;24(1):24-31. doi: 10.1016/S1134-282X(09)70072-7. Epub 2009 Feb 23. Spanish.
PubMed 19369139Weber V, White A, McIlvried R. An electronic medical record (EMR)-based intervention to reduce polypharmacy and falls in an ambulatory rural elderly population. J Gen Intern Med. 2008 Apr;23(4):399-404. doi: 10.1007/s11606-007-0482-z.
PubMed 18373136
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interdisciplinary Medication Review in Chronic Complex Patients or Patients With Polypharmacy After Hospital Discharge
- ClinicalTrials.gov ID
- NCT05799430
- Acronym / sponsor ID
- S0502
- Conditions
- Medication Review, Polypharmacy, Disease, Chronic
- Keywords
- Medication Review, Polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Collaborators
- Andalusian Health Service
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 5 Apr 2023 (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.
The goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge.
The multidisciplinary team will be integrated by a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). Patient will be adults aged 65 years and older. Polypharmacy refers to the use of 10 or more drugs based on information in electronic prescription software.
Research questions are:
In elderly patients with polypharmacy, which is the effect of an interdisciplinary medication review after hospital discharge in comparison with standard care, in terms of:
- new hospitalization episodes?
- number of drugs prescribed?
- prescribed drugs adequacy?
Detailed description
Centres will be randomized to medication review intervention or usual care group. Eligible patients will be ask for informed consent. For patients in the intervention group, PCP will collect information about prescribed medication and diseases from the electronic health record and e-prescribing application. The medication review in primary care will be focus to reconcile the medications the patient was taking prior to admission and those initiated in hospital, with the medications they should be taking post-discharge to ensure all changes are intentional and that discrepancies are resolved as soon as possible. The review process will include detection of potential drugs interactions, wrong doses, lack of adherence (based on dispensing recorded data) and adequacy to explicit criteria for potentially inappropriate prescriptions included in different tools: a) STOPP-STAR, STOPP-Pal, LESS-CHRON lists; b) Guideline for Medication Review in Primary Care, a local publication and c) Medication review in patients with polypharmacy. A list of drugs frequently associate with potentially inappropriate prescriptions. Andalusian health Service). PCP will write a report to communicate the results of medication review to primary care physician and nurse. The multidisciplinary team will define a personalized therapeutic plan to be implemented for every patient.
Patients in the control group will receive usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A cluster-randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Multidisciplinary medication reviewThe intervention group will receive a multidisciplinary medication review and a personalized therapeutic plan in the following 72 hours after hospital discharge. The intervention will be developed by a multidisciplinary team that includes a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). PCP is a pharmacist working in a full-time base for the Pharmacy Service in a Primary Care District in Andalusian Public Health Service. |
| Control group | Active comparator | Behavioral: Control groupThe control group will receive usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Hospital discharge in the last 48 h and one of the following conditions:
- Polypharmacy: ten o more drugs prescribed in a chronic schedule OR
- Complez Chronic Condition
Key exclusion criteria (4 listed)
- Patients in last days of life
- Major mental health disorder
- Patient on dialysis
- Organ transplant patients
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 medication reviewFP communicate to the PCP patients recently discharged. The medication review process consists in 5 steps: 1. PCP perform a structured drug review based on information from health record and e-prescribing application. The drug review comprise the appraisal of potentially inappropriate medication based on lists of explicit criteria. 2. PCP communicates and discuss the results of medication review with GP and PCN, in a brief meeting face-to-face, with possible adaptation of the recommendations. 3. FP, PCN and PCP agree on a personalized therapeutic plan for the patient that includes actions to optimize the therapy. 4. FP and PCN share plan with the patient and/or carer with possible adaptation of the recommendations and agree about actions to be implemented. 5. FP and PCN communicate to PCP final agreement with patient and/or carer 6. FP and/or PCN follow-up implantation of agreed recommendations using standard health care procedures | Behavioural | Intervention |
| Control groupUsual care by FP an PCN | Behavioural | Control group |
Primary outcome
Number of hospitalization episodes
Time frame: 12 months
Registered in Electronic Health Record. In emergency department or in hospital service
Length of Hospital Stay
Time frame: 12 months
Registered in Electronic Health Record.
7 secondary outcomes
Healthcare utilisation
Time frame: 12 months
Mortality
Time frame: 12 month
Number of potentially inappropriate drugs
Time frame: 12 months
Number of medications
Time frame: 12 months
Number of proposal about treatment improvement
Time frame: 7 days
Number of proposal about treatment improvement agreed with primary care team
Time frame: 7 days
Number of proposal about treatment improvement accepted by the patient or care
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Background: PubMed 23142413Franchi C, Nobili A, Mari D, Tettamanti M, Djade CD, Pasina L, Salerno F, Corrao S, Marengoni A, Iorio A, Marcucci M, Mannucci PM; REPOSI Investigators. Risk factors for hospital readmission of elderly patients. Eur J Intern Med. 2013 Jan;24(1):45-51. doi: 10.1016/j.ejim.2012.10.005. Epub 2012 Nov 8.
- Background: PubMed 8618584Weinberger M, Oddone EZ, Henderson WG. Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. N Engl J Med. 1996 May 30;334(22):1441-7. doi: 10.1056/NEJM199605303342206.
- Background: PubMed 6130389Graham H, Livesley B. Can readmissions to a geriatric medical unit be prevented? Lancet. 1983 Feb 19;1(8321):404-6. doi: 10.1016/s0140-6736(83)91513-1.
- Background: PubMed 19339721Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563.
- Background: PubMed 32052027Acosta-Garcia H, Alfaro-Lara ER, Sanchez-Fidalgo S, Sevilla-Sanchez D, Delgado-Silveira E, Juanes-Borrego A, Santos-Ramos B. Intervention effectiveness by pharmacists integrated within an interdisciplinary health team on chronic complex patients. Eur J Public Health. 2020 Oct 1;30(5):886-899. doi: 10.1093/eurpub/ckz224.
- Background: PubMed 31883776Guisado-Gil AB, Mejias-Trueba M, Alfaro-Lara ER, Sanchez-Hidalgo M, Ramirez-Duque N, Santos-Rubio MD. Impact of medication reconciliation on health outcomes: An overview of systematic reviews. Res Social Adm Pharm. 2020 Aug;16(8):995-1002. doi: 10.1016/j.sapharm.2019.10.011. Epub 2019 Oct 17.
- Background: PubMed 23461444Santos-Ramos B, Otero Lopez MJ, Galvan-Banqueri M, Alfaro-Lara ER, Vega-Coca MD, Nieto-Martin MD, Ollero-Baturone M. [Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy/the hospital pharmacist]. Farm Hosp. 2012 Nov-Dec;36(6):506-17. doi: 10.7399/FH.2012.36.6.52. Spanish.
- Background: PubMed 24035767Alfaro-Lara ER, Vega-Coca MD, Galvan-Banqueri M, Nieto-Martin MD, Perez-Guerrero C, Santos-Ramos B. [Pharmacological treatment conciliation methodology in patients with multiple conditions]. Aten Primaria. 2014 Feb;46(2):89-99. doi: 10.1016/j.aprim.2013.07.002. Epub 2013 Sep 12. Spanish.
- Background: PubMed 31798857Rodriguez-Perez A, Alfaro-Lara ER, Sierra-Torres MI, Villalba-Moreno A, Nieto-Martin MD, Galvan-Banqueri M, Santos-Ramos B. Validation of the LESS-CHRON criteria: reliability study of a tool for deprescribing in patients with multimorbidity. Eur J Hosp Pharm. 2019 Nov;26(6):334-338. doi: 10.1136/ejhpharm-2017-001476. Epub 2018 May 30.
- Background: PubMed 30175841Rankin A, Cadogan CA, Patterson SM, Kerse N, Cardwell CR, Bradley MC, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD008165. doi: 10.1002/14651858.CD008165.pub4.
- Background: PubMed 16190007Frazier SC. Health outcomes and polypharmacy in elderly individuals: an integrated literature review. J Gerontol Nurs. 2005 Sep;31(9):4-11. doi: 10.3928/0098-9134-20050901-04.
- Background: PubMed 15819637Fulton MM, Allen ER. Polypharmacy in the elderly: a literature review. J Am Acad Nurse Pract. 2005 Apr;17(4):123-32. doi: 10.1111/j.1041-2972.2005.0020.x.
- Estrategia para la seguridad del paciente. Plan estratégico de calidad del Sistema Sanitario Público de Andalucía. Consejería de Salud y Familias. 2019Link provided by the sponsor.
- Lown Institute. Medication Overload: America's Other Drug Problem. How the drive to prescribe is harming older adults. 2019Link provided by the sponsor.
- Scottish Government Polypharmacy Model of Care Group. Polypharmacy Guidance, Realistic Prescribing. 3ª edition, 2018. Scottish GovernmentLink provided by the sponsor.
- Medicines Optimization. Quality standard \[QS120\] NICE. 2016Link provided by the sponsor.
- Atención a Pacientes Pluripatológicos. Proceso Asistencial Integrado. Consejería de Salud 2018.Link provided by the sponsor.
- Plan Andaluz de Atención Integrada a Pacientes con Enfermedades Crónicas. Consejería de Salud. 2012Link provided by the sponsor.
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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.
Daniel Palma-Morgado, Pharm G contact
Teresa Molina, Pharm Dr principal investigator
Andalusian Health Service. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary medication review in people with Medication Review and Polypharmacy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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 4 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 15 Sep 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Molina-López, Pharm Dr (637642 411+, mariat.molina.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospitalization episodes (time frame: 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 NCT05799430, which also lists 30 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 15 Sep 2023.