Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project)

Alexandra Prados-Torres, Isabel Del Cura-González, Daniel Prados-Torres, Juan A López-Rodríguez, Francisca Leiva-Fernández, Amaia Calderón-Larrañaga, Fernando López-Verde, Luis A Gimeno-Feliu, Esperanza Escortell-Mayor, Victoria Pico-Soler, Teresa Sanz-Cuesta, Mª Josefa Bujalance-Zafra, Mariel Morey-Montalvo, José Ramón Boxó-Cifuentes, Beatriz Poblador-Plou, José Manuel Fernández-Arquero, Francisca González-Rubio, María D Ramiro-González, Carlos Coscollar-Santaliestra, Jesús Martín-Fernández, Mª Pilar Barnestein-Fonseca, José María Valderas-Martínez, Alessandra Marengoni, Christiane Muth, Multi-PAP Group, Mercedes Aza-Pascual-Salcedo, Marta Alcaraz-Borrajo, José Mª Ruiz-San-Basilio, Ángel Mataix-San-Juan, Ana Mª López-León, Antonio Poncel-Falcó, Carmina Mateos-Sancho, Antonio Gimeno-Miguel, Virginia Hernández-Santiago, Ana Cristina Bandrés-Liso, Francisca García de-Blas, Nuria García-Agua, Ricardo Rodríguez-Barrientos, Rubén Vázquez-Alarcón, Clara Laguna-Berna, Maria Isabel Márquez-Chamizo, Javier Marta-Moreno, Amaya Azcoaga-Lorenzo, José María Abad-Díez, Luis Sánchez-Perruca, Elena Polentinos-Castro, Mercedes Clerencia-Sierra, Gloria Ariza-Cardiel, Ana Isabel González-González, Milagros Rico-Blázquez, Marisa Rogero-Blanco, Mª Eugenia Tello-Bernabé, Mar Álvarez-Villalba, Mercedes Rumayor-Zarzuelo, Alexandra Prados-Torres, Isabel Del Cura-González, Daniel Prados-Torres, Juan A López-Rodríguez, Francisca Leiva-Fernández, Amaia Calderón-Larrañaga, Fernando López-Verde, Luis A Gimeno-Feliu, Esperanza Escortell-Mayor, Victoria Pico-Soler, Teresa Sanz-Cuesta, Mª Josefa Bujalance-Zafra, Mariel Morey-Montalvo, José Ramón Boxó-Cifuentes, Beatriz Poblador-Plou, José Manuel Fernández-Arquero, Francisca González-Rubio, María D Ramiro-González, Carlos Coscollar-Santaliestra, Jesús Martín-Fernández, Mª Pilar Barnestein-Fonseca, José María Valderas-Martínez, Alessandra Marengoni, Christiane Muth, Multi-PAP Group, Mercedes Aza-Pascual-Salcedo, Marta Alcaraz-Borrajo, José Mª Ruiz-San-Basilio, Ángel Mataix-San-Juan, Ana Mª López-León, Antonio Poncel-Falcó, Carmina Mateos-Sancho, Antonio Gimeno-Miguel, Virginia Hernández-Santiago, Ana Cristina Bandrés-Liso, Francisca García de-Blas, Nuria García-Agua, Ricardo Rodríguez-Barrientos, Rubén Vázquez-Alarcón, Clara Laguna-Berna, Maria Isabel Márquez-Chamizo, Javier Marta-Moreno, Amaya Azcoaga-Lorenzo, José María Abad-Díez, Luis Sánchez-Perruca, Elena Polentinos-Castro, Mercedes Clerencia-Sierra, Gloria Ariza-Cardiel, Ana Isabel González-González, Milagros Rico-Blázquez, Marisa Rogero-Blanco, Mª Eugenia Tello-Bernabé, Mar Álvarez-Villalba, Mercedes Rumayor-Zarzuelo

Abstract

Background: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care.

Methods/design: Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient.

Scope: PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain).

Population: patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months).

Sample size: n = 400 (200 per study arm).

Intervention: complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview.

Outcomes: MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables.

Statistical analysis: primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle.

Discussion: It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes.

Trial registration: Clinicaltrials.gov, NCT02866799.

Figures

Fig. 1
Fig. 1
Flow diagram
Fig. 2
Fig. 2
Complex intervention pat plot. QoL quality of life, MOOC Massive Online Open Courses

References

    1. Valderas JM, Starfield B, Sibbald B, Salisbury C, Roland M. Defining comorbidity: implications for understanding health and health services. Ann Fam Med. 2009;7:357–63. doi: 10.1370/afm.983.
    1. Prados-Torres A, Poblador-Plou B, Calderon-Larrañaga A, Gimeno-Feliu LA, Gonzalez-Rubio F, Poncel-Falco A, et al. Multimorbidity patterns in primary care: interactions among chronic diseases using factor analysis. PLoS One. 2012;7:e32190.
    1. Violan C, Foguet-Boreu Q, Flores-Mateo G, Salisbury C, Blom J, Freitag M, et al. Prevalence, determinants and patterns of multimorbidity in primary care: a systematic review of observational studies. PLoS One. 2014;9:e102149. doi: 10.1371/journal.pone.0102149.
    1. Harrison C, Britt H, Miller G, Henderson J. Examining different measures of multimorbidity, using a large prospective cross-sectional study in Australian general practice. BMJ Open. 2014;4:e004694. doi: 10.1136/bmjopen-2013-004694.
    1. Fortin M, Bravo G, Hudon C, Lapointe L, Almirall J, Dubois M-FF, et al. Relationship between multimorbidity and health-related quality of life of patients in primary care. Qual Life Res. 2006;15:83–91. doi: 10.1007/s11136-005-8661-z.
    1. Gijsen R, Hoeymans N, Schellevis FG, Ruwaard D, Satariano WA, van den Bos GAMM. Causes and consequences of comorbidity: a review. J Clin Epidemiol. 2001;54:661–74. doi: 10.1016/S0895-4356(00)00363-2.
    1. Wolff JL, Starfield B, Anderson G. Prevalence, expenditures, and complications of multiple chronic conditions in the elderly. Arch Intern Med. 2002;162:2269–76. doi: 10.1001/archinte.162.20.2269.
    1. Starfield B. New paradigms for quality in primary care. Br J Gen Pract. 2001;51:303–9.
    1. Starfield B, Lemke KW, Bernhardt T, Foldes SS, Forrest CB, Weiner JP. Comorbidity: implications for the importance of primary care in “case” management. Ann Fam Med. 2003;1:8–14. doi: 10.1370/afm.1.
    1. Valderas JM. Multimorbidity, not a health condition or complexity by another name. Eur J Gen Pract. 2015;21:213–4. doi: 10.3109/13814788.2015.1108404.
    1. Mangin D, Heath I, Jamoulle M. Beyond diagnosis: rising to the multimorbidity challenge. BMJ. 2012;344:e3526. doi: 10.1136/bmj.e3526.
    1. Tinetti ME, Bogardus STSTJ, Agostini JV. Potential pitfalls of disease-specific guidelines for patients with multiple conditions. N Engl J Med. 2004;351:2870–4. doi: 10.1056/NEJMsb042458.
    1. Blasco Patiño F, de Letona JML, Villares P, Jiménez A, et al. El paciente anciano polimedicado : efectos sobre su salud y sobre el sistema sanitario. Inf Ter del Sist Nac Salud. 2005;29:152–62.
    1. Luijks HD, Loeffen MJW, Lagro-Janssen AL, van Weel C, Lucassen PL, Schermer TR, et al. GPs’ considerations in multimorbidity management: a qualitative study. Br J Gen Pract. 2012;62:e503–10. doi: 10.3399/bjgp12X652373.
    1. Jyrkkä J, Enlund H, Korhonen MJ, Sulkava R, Hartikainen S. Polypharmacy status as an indicator of mortality in an elderly population. Drugs Aging. 2009;26:1039–48. doi: 10.2165/11319530-000000000-00000.
    1. Galván-Banqueri M, González-Méndez AI, Alfaro-Lara ER, Nieto-Martín MD, Pérez-Guerrero C, Santos-Ramos B. Evaluación de la adecuación del tratamiento farmacológico en pacientes pluripatológicos. Aten Primaria. 2013;45:235–43. doi: 10.1016/j.aprim.2012.11.010.
    1. Ramírez FB. Methods for measuring the suitability of pharmacological treatment in the elderly with multiple conditions and on multiple drugs. Aten Primaria. 2013;45:19–20. doi: 10.1016/j.aprim.2012.09.015.
    1. Beers MH. Explicit criteria for determining potentially inappropriate medication use by the elderly. An update Arch Intern Med. 1997;157:1531–6. doi: 10.1001/archinte.1997.00440350031003.
    1. Leendertse AJ, Egberts ACG, Stoker LJ, van den Bemt PML. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med. 2008;168:1890–6.
    1. Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, et al. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007;370:173–84. doi: 10.1016/S0140-6736(07)61091-5.
    1. Hanlon JT, Schmader KE, Samsa GP, Weinberger M, Uttech KM, Lewis IK, et al. A method for assessing drug therapy appropriateness. J Clin Epidemiol. 1992;45:1045–51. doi: 10.1016/0895-4356(92)90144-C.
    1. Gavilán Moral E, Villafaina Barroso A, Aranguez Ruiz A, Sánchez Robles GA, Suliman Criado S, Jiménez de Gracia L. Índice de adecuación de los medicamentos - Versión española modificada manual de usuario. Plasencia: Laboratorio de Prácticas Innovadoras en Polimedicación y Salud. 2012.
    1. Fortin M, Dionne J, Pinho G, Gignac J, Almirall J, Lapointe L, et al. Randomized controlled trials : do they have external validity for patients with multiple comorbidities ? Ann Fam Med. 2006;4:104–8. doi: 10.1370/afm.516.
    1. Smith SM, Soubhi H, Fortin M, Hudon C, O’Dowd T. Interventions for improving outcomes in patients with multimorbidity in primary care and community settings. Cochrane Database Syst Rev. 2012;4:CD006560.
    1. Patterson SM, Cadogan CA, Kerse N, Cardwell CR, Bradley MC, Ryan C, et al. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2014;10:CD008165.
    1. Pham CB, Dickman RL. Minimizing adverse drug events in older patients. Am Fam Physician. 2007;76:1837–44.
    1. Stevenson FA, Cox K, Britten N, Dundar Y. A systematic review of the research on communication between patients and health care professionals about medicines: the consequences for concordance. Heal Expect. 2004;7:235–45. doi: 10.1111/j.1369-7625.2004.00281.x.
    1. Muth C, van den Akker M, Blom JW, Mallen CD, Rochon J, Schellevis FG, et al. The Ariadne principles: how to handle multimorbidity in primary care consultations. BMC Med. 2014;12:223. doi: 10.1186/s12916-014-0223-1.
    1. England NHS. Tools for shared decision making. 2014.
    1. Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. BMJ. 2010;341:c5146. doi: 10.1136/bmj.c5146.
    1. Da Silva D. Helping people share decision making. Heal. Found. London: Health Foundation; 2012.
    1. Bower P. Better management of multimorbidity: a critical look at the “Ariadne principles”. BMC Med. 2014;12:222. doi: 10.1186/s12916-014-0222-2.
    1. National Institute for Health and Care Excellence . Multimorbidity: clinical assessment and management. 2016.
    1. O’Halloran J, Miller GC, Britt H. Defining chronic conditions for primary care with ICPC-2. Fam Pract. 2004;21:381–6. doi: 10.1093/fampra/cmh407.
    1. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57:785–94. doi: 10.1016/j.jclinepi.2003.12.013.
    1. Perera R, Heneghan C, Yudkin P. Graphical method for depicting randomised trials of complex interventions. BMJ. 2007;334:127–9. doi: 10.1136/bmj.39045.396817.68.
    1. Samsa GP, Hanlon JT, Schmader KE, Weinberger M, Clipp EC, Uttech KM, et al. A summated score for the medication appropriateness index: development and assessment of clinimetric properties including content validity. J Clin Epidemiol. 1994;47:891–6. doi: 10.1016/0895-4356(94)90192-9.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L) Qual Life Res. 2011;20:1727–36. doi: 10.1007/s11136-011-9903-x.
    1. van Hout B, Janssen MFF, Feng Y-SS, Kohlmann T, Busschbach J, Golicki D, et al. Interim scoring for the EQ-5D-5L: mapping the EQ-5D-5L to EQ-5D-3L value sets. Value Health. 2012;15:708–15. doi: 10.1016/j.jval.2012.02.008.
    1. Otero López MJ, Codina Jané C, Tamés Alonso MJ, Pérez EM. Medication errors: standarizing the terminology and taxomany. Ruiz Jarabo 2000 grand results. Farm Hosp. 2003;27:137–49.
    1. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67–74. doi: 10.1097/00005650-198601000-00007.
    1. Haynes RB, Sackett DL, Taylor DW. How to detect and manage low patient compliance in chronic illness. Geriatrics. 1980;35:91–3.
    1. Bellón Saameño JA, Delgado Sánchez A, Luna del Castillo JD, Lardelli Claret P. Validity and reliability of the Duke-UNC-11 questionnaire of functional social support. Aten Primaria. 1996;18:153–6.
    1. Domingo-Salvany A, Bacigalupe A, Carrasco JM, Espelt A, Ferrando J, Borrell C. Propuestas de clase social neoweberiana y neomarxista a partir de la Clasificación Nacional de Ocupaciones 2011. Gac Sanit. 2013;27:263–72. doi: 10.1016/j.gaceta.2012.12.009.
    1. Muth C, Harder S, Uhlmann L, Rochon J, Fullerton B, Güthlin C, et al. Pilot study to test the feasibility of a trial design and complex intervention on PRI oritising MU ltimedication in M ultimorbidity in general practices (PRIMUM pilot) BMJ Open. 2016;6:e011613. doi: 10.1136/bmjopen-2016-011613.
    1. Volandes AE, Kennedy WJ, Davis AD, Gillick MR, Paasche-Orlow MK. The new tools: what 21st century education can teach us. Healthc. 2013;1:79–81. doi: 10.1016/j.hjdsi.2013.07.011.
    1. World Health Organization Declaration of Helsinki World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Med Assoc. 2013;310:2191–4. doi: 10.1001/jama.2013.281053.

Source: PubMed

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