Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol

Carmen Corral-Partearroyo, Alba Sánchez-Viñas, Montserrat Gil-Girbau, Maria Teresa Peñarrubia-María, Ignacio Aznar-Lou, Carmen Gallardo-González, María Del Carmen Olmos-Palenzuela, Maria Rubio-Valera, Carmen Corral-Partearroyo, Alba Sánchez-Viñas, Montserrat Gil-Girbau, Maria Teresa Peñarrubia-María, Ignacio Aznar-Lou, Carmen Gallardo-González, María Del Carmen Olmos-Palenzuela, Maria Rubio-Valera

Abstract

Introduction: Medication non-initiation, or primary non-adherence, is a persistent public health problem that increases the risk of adverse clinical outcomes. The initial medication adherence (IMA) intervention is a complex multidisciplinary intervention to improve adherence to cardiovascular and diabetes treatments in primary care by empowering the patient and promoting informed prescriptions based on shared decision-making. This paper presents the development and implementation strategy of the IMA intervention and the process evaluation protocol embedded in a cluster randomised controlled trial (the IMA-cRCT) to understand and interpret the outcomes of the trial and comprehend the extent of implementation and fidelity, the active mechanisms of the IMA intervention and in what context the intervention is implemented and works.

Methods and analysis: We present the protocol for a mixed-methods process evaluation including quantitative and qualitative methods to measure implementation and fidelity and to explore the active mechanisms and the interactions between the intervention, participants and its context. The process evaluation will be conducted in primary care centres and community pharmacies from the IMA-cRCT, and participants include healthcare professionals (general practitioners, nurses and community pharmacists) as well as patients. Quantitative data collection methods include data extraction from the intervention operative records, patient clinical records and participant feedback questionnaires, whereas qualitative data collection involves semistructured interviews, focus groups and field diaries. Quantitative and qualitative data will be analysed separately and triangulated to produce deeper insights and robust results.

Ethics and dissemination: Ethical approval has been obtained from the Research Ethics Comittee (CEIm) at IDIAP Jordi Gol (codeCEIm 21/051 P). Findings will be disseminated through publications and conferences, as well as presentations to healthcare professionals and stakeholders from healthcare organisations.

Trial registration number: NCT05026775.

Keywords: primary care; protocols & guidelines; public health; statistics & research methods.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
IMA intervention phases: development, feasibility, evaluation and implementation. cRCT, cluster randomised controlled trial; IMA, initial medication adherence; PC, primary care.
Figure 2
Figure 2
IMA intervention logic model. CVD, cardiovascular disease; GP, general practitioner; HCP, healthcare professional; IMA, Initial Medication Adherence.
Figure 3
Figure 3
Domains and theoretical framework of the IMA-cRCT process evaluation (adapted from Moore et al37). GP, generalpractitioner; IMA, Initial Medication Adherence.
Figure 4
Figure 4
Process evaluation timeline. *Pretrial: September 2021 until February 2022; trial: March 2022 until September 2022; Post-trial: September 2022 until December 2022. cRCT, cluster randomised controlled trial.

References

    1. Vrijens B, De Geest S, Hughes DA, et al. . A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol 2012;73:691–705. 10.1111/j.1365-2125.2012.04167.x
    1. Hutchins DS, Zeber JE, Roberts CS, et al. . Initial medication Adherence-Review and recommendations for good practices in outcomes research: an ISPOR medication adherence and persistence special interest group report. Value Health 2015;18:690–9. 10.1016/j.jval.2015.02.015
    1. Lemstra M, Nwankwo C, Bird Y, et al. . Primary nonadherence to chronic disease medications: a meta-analysis. Patient Prefer Adherence 2018;12:721–31. 10.2147/PPA.S161151
    1. Zeber JE, Manias E, Williams AF, et al. . A systematic literature review of psychosocial and behavioral factors associated with initial medication adherence: a report of the ISPOR medication adherence & persistence special interest group. Value Health 2013;16:891–900. 10.1016/j.jval.2013.04.014
    1. Aznar-Lou I, Fernández A, Gil-Girbau M, et al. . Initial medication non-adherence: prevalence and predictive factors in a cohort of 1.6 million primary care patients. Br J Clin Pharmacol 2017;83:1328–40. 10.1111/bcp.13215
    1. Menckeberg TT, Bouvy ML, Bracke M, et al. . Patients' understanding of the reasons for starting and discontinuing inhaled corticosteroids. Br J Clin Pharmacol 2008;66:255–60. 10.1111/j.1365-2125.2008.03168.x
    1. Gil-Girbau M, Aznar-Lou I, Peñarrubia-María MT, et al. . Reasons for medication non-initiation: a qualitative exploration of the patients' perspective. Res Social Adm Pharm 2020;16:663–72. 10.1016/j.sapharm.2019.08.002
    1. World Health Organization . Adherence to long-term therapies: evidence for action [Internet]. Geneva: World Health Organization, 2003.
    1. Bouchard M-H, Dragomir A, Blais L, et al. . Impact of adherence to statins on coronary artery disease in primary prevention. Br J Clin Pharmacol 2007;63:698–708. 10.1111/j.1365-2125.2006.02828.x
    1. Bitton A, Choudhry NK, Matlin OS, et al. . The impact of medication adherence on coronary artery disease costs and outcomes: a systematic review. Am J Med 2013;126:357.e7–357.e27. 10.1016/j.amjmed.2012.09.004
    1. Xu T, Yu X, Ou S, et al. . Adherence to antihypertensive medications and stroke risk: a dose-response meta-analysis. J Am Heart Assoc 2017;6:e006371. 10.1161/JAHA.117.006371
    1. Kim Y-Y, Lee J-S, Kang H-J, et al. . Effect of medication adherence on long-term all-cause-mortality and hospitalization for cardiovascular disease in 65,067 newly diagnosed type 2 diabetes patients. Sci Rep 2018;8:12190. 10.1038/s41598-018-30740-y
    1. Aznar-Lou I, Fernández A, Gil-Girbau M, et al. . Impact of initial medication non-adherence on use of healthcare services and sick leave: a longitudinal study in a large primary care cohort in Spain. Br J Gen Pract 2017;67:e614–22. 10.3399/bjgp17X692129
    1. Cutler RL, Fernandez-Llimos F, Frommer M, et al. . Economic impact of medication non-adherence by disease groups: a systematic review. BMJ Open 2018;8:e016982. 10.1136/bmjopen-2017-016982
    1. Derose SF, Green K, Marrett E, et al. . Automated outreach to increase primary adherence to cholesterol-lowering medications. JAMA Intern Med 2013;173:38–43. 10.1001/2013.jamainternmed.717
    1. Fischer MA, Choudhry NK, Bykov K, et al. . Pharmacy-based interventions to reduce primary medication nonadherence to cardiovascular medications. Med Care 2014;52:1050–4. 10.1097/MLR.0000000000000247
    1. Fischer MA, Jones JB, Wright E, et al. . A randomized telephone intervention trial to reduce primary medication nonadherence. J Manag Care Spec Pharm 2015;21:124–31. 10.18553/jmcp.2015.21.2.124
    1. O'Connor PJ, Schmittdiel JA, Pathak RD, et al. . Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes. Diabetes Care 2014;37:3317–24. 10.2337/dc14-0596
    1. Kerner DE, Knezevich EL. Use of communication tool within electronic medical record to improve primary nonadherence. J Am Pharm Assoc 2017;57:S270–3. 10.1016/j.japh.2017.03.009
    1. McCarthy ML, Ding R, Roderer NK, et al. . Does providing prescription information or services improve medication adherence among patients discharged from the emergency department? A randomized controlled trial. Ann Emerg Med 2013;62:212–23. 10.1016/j.annemergmed.2013.02.002
    1. Tedla YG, Bautista LE. Factors associated with false-positive self-reported adherence to antihypertensive drugs. J Hum Hypertens 2017;31:320–6. 10.1038/jhh.2016.80
    1. Stirratt MJ, Dunbar-Jacob J, Crane HM, et al. . Self-report measures of medication adherence behavior: recommendations on optimal use. Transl Behav Med 2015;5:470–82. 10.1007/s13142-015-0315-2
    1. Saheb Kashaf M, McGill ET, Berger ZD. Shared decision-making and outcomes in type 2 diabetes: a systematic review and meta-analysis. Patient Educ Couns 2017;100:2159–71. 10.1016/j.pec.2017.06.030
    1. Mathijssen EGE, van den Bemt BJF, van den Hoogen FHJ, et al. . Interventions to support shared decision making for medication therapy in long term conditions: a systematic review. Patient Educ Couns 2020;103:254–65. 10.1016/j.pec.2019.08.034
    1. Coronado-Vázquez V, Canet-Fajas C, Delgado-Marroquín MT, et al. . Interventions to facilitate shared decision-making using decision AIDS with patients in primary health care: a systematic review. Medicine 2020;99:e21389. 10.1097/MD.0000000000021389
    1. Milky G, Thomas J. Shared decision making, satisfaction with care and medication adherence among patients with diabetes. Patient Educ Couns 2020;103:661–9. 10.1016/j.pec.2019.10.008
    1. Elwyn G, Edwards A, Kinnersley P, et al. . Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices. Br J Gen Pract 2000;50:892–9.
    1. Elwyn G, Frosch D, Thomson R, et al. . Shared decision making: a model for clinical practice. J Gen Intern Med 2012;27:1361–7. 10.1007/s11606-012-2077-6
    1. Légaré F, Adekpedjou R, Stacey D, et al. . Interventions for increasing the use of shared decision making by healthcare professionals. Cochrane Database Syst Rev 2018;7:CD006732. 10.1002/14651858.CD006732.pub4
    1. Craig P, Dieppe P, Macintyre S, et al. . Developing and evaluating complex interventions: the new medical Research Council guidance. BMJ 2008;337:a1655. 10.1136/bmj.a1655
    1. Skivington K, Matthews L, Simpson SA, et al. . Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update. Health Technol Assess 2021;25:1–132. 10.3310/hta25570
    1. Vilaplana-Carnerero C, Aznar-Lou I, Peñarrubia-María MT, et al. . Initiation and single dispensing in cardiovascular and insulin medications: prevalence and explanatory factors. Int J Environ Res Public Health 2020;17:3358. 10.3390/ijerph17103358
    1. Peñarrubia-María MT, Gil-Girbau M, Gallardo-González MC, et al. . Non-initiation of prescribed medication from a Spanish health professionals' perspective: a qualitative exploration based on Grounded theory. Health Soc Care Community 2022;30:e213–21. 10.1111/hsc.13431
    1. Corral-Partearroyo C, Sánchez‐Viñas A, Gil‐Girbau M, et al. . Improving initial medication adherence to cardiovascular diseases and diabetes treatments in primary care: pilot trial of a complex intervention 2022.
    1. Sánchez-Viñas A, Corral-Partearroyo C, Gil-Girbau M, et al. . Effectiveness and cost-effectiveness of an intervention to improve Initial Medication Adherence to treatments for cardiovascular diseases and diabetes in primary care: study protocol for a pragmatic cluster randomised controlled trial and economic model (the IMA-cRCT study). BMC Prim Care 2022;23:170. 10.1186/s12875-022-01727-6
    1. Oakley A, Strange V, Bonell C, et al. . Process evaluation in randomised controlled trials of complex interventions. BMJ 2006;332:413–6. 10.1136/bmj.332.7538.413
    1. Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: medical Research Council guidance. BMJ 2015;350:h1258. 10.1136/bmj.h1258
    1. Eisman AB, Kilbourne AM, Dopp AR, et al. . Economic evaluation in implementation science: making the business case for implementation strategies. Psychiatry Res 2020;283:112433. 10.1016/j.psychres.2019.06.008
    1. Pawson R, Tilley N. Realist evaluation. London: SAGE, 1997: 256.
    1. May C, Finch T, Mair F, et al. . Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Serv Res 2007;7:148. 10.1186/1472-6963-7-148
    1. Elwyn G, Légaré F, van der Weijden T, et al. . Arduous implementation: does the normalisation process model explain why it's so difficult to embed decision support technologies for patients in routine clinical practice. Implement Sci 2008;3:57. 10.1186/1748-5908-3-57
    1. May C, Finch T. Implementing, embedding, and integrating practices: an outline of normalization process theory. Sociology 2009;43:535–54. 10.1177/0038038509103208
    1. Saldana L, Chamberlain P, Bradford WD, et al. . The cost of implementing new strategies (coins): a method for mapping implementation resources using the stages of implementation completion. Child Youth Serv Rev 2014;39:177–82. 10.1016/j.childyouth.2013.10.006
    1. Bernal-Delgado E, Garcia-Armesto S, Oliva J, et al. . Spain: health system review. Health Syst Transit 2018;20:1–179.
    1. SIDIAP . Sistema d’Informació per al desenvolupament de la Investigació en Atenció Prim ria [Internet]. Available:
    1. Russell J, Berney L, Stansfeld S, et al. . The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence. Trials 2016;17:396. 10.1186/s13063-016-1497-8
    1. Gale NK, Heath G, Cameron E, et al. . Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 2013;13:117. 10.1186/1471-2288-13-117
    1. Green J, Thorogood N. Qualitative methods for health research. London: SAGE, 2018: 440.
    1. O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed methods studies. BMJ 2010;341:c4587. 10.1136/bmj.c4587
    1. Tonkin-Crine S, Anthierens S, Hood K, et al. . Discrepancies between qualitative and quantitative evaluation of randomised controlled trial results: achieving clarity through mixed methods triangulation. Implement Sci 2016;11:66. 10.1186/s13012-016-0436-0
    1. European Union . Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance. [Internet]. Available:
    1. Gobierno de España . Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los ensayos clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos. [Internet]. Available:

Source: PubMed

스폰서 및 공동 작업자

건강 상태

약물 개입

3
구독하다