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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Teresa Molina-López, Pharm Dr contact

637642 411+

mariat.molina.sspa@juntadeandalucia.es

Daniel Palma-Morgado, Pharm G contact

daniel.palma.sspa@juntadeandalucia.es

Spain1 site, 1 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

    Recruiting

Other trials in Spain

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.

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:

    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
  • Control groupBehavioural

    Usual care by FP an PCN

Study groups in NCT05799430
Study groupRoleWhat they receive
InterventionExperimentalThe 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 groupActive comparatorThe 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.

  1. Number of hospitalization episodes

    Registered in Electronic Health Record. In emergency department or in hospital service

    Measured: 12 months

  2. Length of Hospital Stay

    Registered in Electronic Health Record.

    Measured: 12 months

Secondary outcomes (7)
  1. 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

  2. Mortality

    Dead for any cause

    Measured: 12 month

  3. Number of potentially inappropriate drugs

    Total number of potentially inappropriate prescribed drugs based on explicit criteria

    Measured: 12 months

  4. Number of medications

    Total number of drugs chronically prescribed (treatment length: unless 120 days)

    Measured: 12 months

  5. Number of proposal about treatment improvement

    Number of proposal about treatment improvement included in PCP report

    Measured: 7 days

  6. 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

  7. 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.

  1. First posted5 Apr 2023
  2. Study start15 Apr 2023
  3. Primary completion10 Jun 2024 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

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)
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 23142413
  • Weinberger 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 8618584
  • Graham 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 6130389
  • Jencks 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 19339721
  • Acosta-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 32052027
  • Guisado-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 31883776
  • Santos-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 23461444
  • Alfaro-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 24035767
  • Rodriguez-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 31798857
  • Rankin 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 30175841
  • Frazier 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 16190007
  • Fulton 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 15819637
  • Shrank 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 17910560
  • Cardenas 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 19369139
  • Weber 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

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.

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