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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05799430
Other study ID # S0502
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 15, 2023
Est. completion date July 31, 2024

Study information

Verified date April 2023
Source Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Contact Teresa Molina-López, Pharm Dr
Phone 637642 411+
Email mariat.molina.sspa@juntadeandalucia.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 372
Est. completion date July 31, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients in last days of life - Major mental health disorder - Patient on dialysis - Organ transplant patients

Study Design


Intervention

Behavioral:
Multidisciplinary medication review
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 group
Usual care by FP an PCN

Locations

Country Name City State
Spain Sevilla Primary Care District Sevilla

Sponsors (2)

Lead Sponsor Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Andalusian Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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. — View Citation

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. — View Citation

Brehaut JC, Colquhoun HL, Eva KW, Carroll K, Sales A, Michie S, Ivers N, Grimshaw JM. Practice Feedback Interventions: 15 Suggestions for Optimizing Effectiveness. Ann Intern Med. 2016 Mar 15;164(6):435-41. doi: 10.7326/M15-2248. Epub 2016 Feb 23. — View Citation

Brotons C, Arino D, Borras I, Buitrago F, Gonzalez ML, Kloppe P, Orozco D, Pepio JM, Rodriguez P, Rodriguez AI; Equipo Investigador del Estudio PREseAP. [Evaluation of the efficacy of a comprehensive programme of secondary prevention of cardiovascular disease in primary care: the PREseAP Study]. Aten Primaria. 2006 Mar 31;37(5):295-8. doi: 10.1157/13086317. Spanish. — View Citation

Cane J, O'Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012 Apr 24;7:37. doi: 10.1186/1748-5908-7-37. — View Citation

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. — View Citation

Denneboom W, Dautzenberg MG, Grol R, De Smet PA. Analysis of polypharmacy in older patients in primary care using a multidisciplinary expert panel. Br J Gen Pract. 2006 Jul;56(528):504-10. — View Citation

Denneboom W, Dautzenberg MG, Grol R, De Smet PA. Treatment reviews of older people on polypharmacy in primary care: cluster controlled trial comparing two approaches. Br J Gen Pract. 2007 Sep;57(542):723-31. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hanlon JT, Weinberger M, Samsa GP, Schmader KE, Uttech KM, Lewis IK, Cowper PA, Landsman PB, Cohen HJ, Feussner JR. A randomized, controlled trial of a clinical pharmacist intervention to improve inappropriate prescribing in elderly outpatients with polypharmacy. Am J Med. 1996 Apr;100(4):428-37. doi: 10.1016/S0002-9343(97)89519-8. — View Citation

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. Erratum In: N Engl J Med. 2011 Apr 21;364(16):1582. — View Citation

Kirwin JL, Cunningham RJ, Sequist TD. Pharmacist recommendations to improve the quality of diabetes care: a randomized controlled trial. J Manag Care Pharm. 2010 Mar;16(2):104-13. doi: 10.18553/jmcp.2010.16.2.104. — View Citation

Lenaghan E, Holland R, Brooks A. Home-based medication review in a high risk elderly population in primary care--the POLYMED randomised controlled trial. Age Ageing. 2007 May;36(3):292-7. doi: 10.1093/ageing/afm036. Epub 2007 Mar 26. — View Citation

Molina Lopez T, Dominguez Camacho JC, Palma Morgado D, Caraballo Camacho Mde L, Morales Serna JC, Lopez Rubio S. [A review of the medication in polymedicated elderly with vascular risk: a randomised controlled trial]. Aten Primaria. 2012 Aug;44(8):453-60. doi: 10.1016/j.aprim.2011.09.015. Epub 2012 Feb 16. Spanish. — View Citation

Nieto-Martin MD, De la Higuera-Vila L, Bernabeu-Wittel M, Gonzalez-Benitez MA, Alfaro-Lara ER, Baron-Ramos MA, Montero-Aparicio E, Aparicio-Santos R, Baturone MO; list of researchers involved in the IMPACTO study and their affiliations. A multidisciplinary approach for patients with multiple chronic conditions: IMPACTO study. Med Clin (Barc). 2019 Aug 2;153(3):93-99. doi: 10.1016/j.medcli.2019.01.014. Epub 2019 Mar 8. English, Spanish. — View Citation

Parody Rua E, Segu Tolosa J. [Cost-effectiveness and cost calculation in an intervention on medication-related problems in primary care]. Aten Primaria. 2005 May 31;35(9):472-7. doi: 10.1157/13075471. Spanish. — View Citation

Pit SW, Byles JE, Henry DA, Holt L, Hansen V, Bowman DA. A Quality Use of Medicines program for general practitioners and older people: a cluster randomised controlled trial. Med J Aust. 2007 Jul 2;187(1):23-30. doi: 10.5694/j.1326-5377.2007.tb01110.x. — View Citation

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. — View Citation

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. — View Citation

Royal S, Smeaton L, Avery AJ, Hurwitz B, Sheikh A. Interventions in primary care to reduce medication related adverse events and hospital admissions: systematic review and meta-analysis. Qual Saf Health Care. 2006 Feb;15(1):23-31. doi: 10.1136/qshc.2004.012153. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wessell AM, Nietert PJ, Jenkins RG, Nemeth LS, Ornstein SM. Inappropriate medication use in the elderly: results from a quality improvement project in 99 primary care practices. Am J Geriatr Pharmacother. 2008 Mar;6(1):21-7. doi: 10.1016/j.amjopharm.2008.02.001. — View Citation

Zermansky AG, Alldred DP, Petty DR, Raynor DK, Freemantle N, Eastaugh J, Bowie P. Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial. Age Ageing. 2006 Nov;35(6):586-91. doi: 10.1093/ageing/afl075. Epub 2006 Aug 12. — View Citation

* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of hospitalization episodes Registered in Electronic Health Record. In emergency department or in hospital service 12 months
Primary Length of Hospital Stay Registered in Electronic Health Record. 12 months
Secondary Healthcare utilisation Number of visits to primary care services (family physician or primary care nurse) and hospital services (non emergency and without hospitalization) 12 months
Secondary Mortality Dead for any cause 12 month
Secondary Number of potentially inappropriate drugs Total number of potentially inappropriate prescribed drugs based on explicit criteria 12 months
Secondary Number of medications Total number of drugs chronically prescribed (treatment length: unless 120 days) 12 months
Secondary Number of proposal about treatment improvement Number of proposal about treatment improvement included in PCP report 7 days
Secondary 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 7 days
Secondary 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 7 days
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