Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic

Kim Engler, Serge Vicente, Yuanchao Ma, Tarek Hijal, Joseph Cox, Sara Ahmed, Marina Klein, Sofiane Achiche, Nitika Pant Pai, Alexandra de Pokomandy, Karine Lacombe, Bertrand Lebouché, Kim Engler, Serge Vicente, Yuanchao Ma, Tarek Hijal, Joseph Cox, Sara Ahmed, Marina Klein, Sofiane Achiche, Nitika Pant Pai, Alexandra de Pokomandy, Karine Lacombe, Bertrand Lebouché

Abstract

Background: Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to systematically capture this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy.

Methods: This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Four HIV physicians and 32 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score through a smartphone application (Opal), before meeting with their physician. Both patients and physicians will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention's adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention's acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2-3) and patient interviews (Times 2-3) will help evaluate the implementation strategy and inform any methodological adaptations.

Discussion: This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation.

Clinical trial registration: ClinicalTrials.gov identifier: NCT04702412; https://clinicaltrials.gov/.

Conflict of interest statement

BL has received research support and consulting fees from ViiV Healthcare, Merck, and Gilead. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Guiding implementation framework and I-Score…
Fig 1. Guiding implementation framework and I-Score intervention logic chain.
Asterisks indicate elements of the logic chain which will be examined as a part of this pilot study.
Fig 2. Relationship between the I-Score implementation…
Fig 2. Relationship between the I-Score implementation strategy and study outcomes.
Asterisks indicate outcomes for which data will be collected as a part of this pilot study.
Fig 3. Pilot study design.
Fig 3. Pilot study design.

References

    1. Kall M, Marcellin F, Harding R, Lazarus JV, Carrieri P. Patient-reported outcomes to enhance person-centred HIV care. The Lancet HIV. 2020;7(1):68. doi: 10.1016/S2352-3018(19)30345-5
    1. Kjær ASHK Rasmussen TA, Hjollund NH Rodkjaer LO, Storgaard M. Patient-reported outcomes in daily clinical practise in HIV outpatient care. Int J Infect Dis. 2018;69:108–114. doi: 10.1016/j.ijid.2018.02.015
    1. Boyce M, Browne J. Does providing feedback on patient-reported outcomes to healthcare professionals result in better outcomes for patients? A systematic review. Qual Life Res. 2013;22(9):2265–2278. doi: 10.1007/s11136-013-0390-0
    1. Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, et al.. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008;17(2):179–193. doi: 10.1007/s11136-007-9295-0
    1. Ishaque S, Karnon J, Chen G, Nair R, Salter AB. A systematic review of randomised controlled trials evaluating the use of patient-reported outcome measures (proms). Qual Life Res. 2019;28(3):567–592. doi: 10.1007/s11136-018-2016-z
    1. Rutherford C, Campbell R, King M, Speerin R, Soars L, Butcher A, et al.. Implementing patient-reported outcome measures into clinical practice across nsw: mixed methods evaluation of the first year. Applied Research in Quality of Life. 2020.
    1. Marandino L, Necchi A, Aglietta M, Di Maio M. COVID-19 emergency and the need to speed up the adoption of electronic patient-reported outcomes in cancer clinical practice. JCO Oncol Pract. 2020;16(6):295–298. doi: 10.1200/OP.20.00237
    1. Bezabhe WM, Chalmers L, Bereznicki LR, Peterson GM. Adherence to antiretroviral therapy and virologic failure: a meta-analysis. Medicine (Baltimore). 2016;95(15):e3361. doi: 10.1097/MD.0000000000003361
    1. Ortego C, Huedo-Medina TB, Llorca J, Sevilla L, Santos P, Rodriguez E, et al.. Adherence to highly active antiretroviral therapy (HAART): a meta-analysis. AIDS Behav. 2011;15(7):1381–1396. doi: 10.1007/s10461-011-9942-x
    1. Cohen J, Beaubrun A, Bashyal R, Huang A, Li J, Baser O. Real-world adherence and persistence for newly-prescribed HIV treatment: single versus multiple tablet regimen comparison among US medicaid beneficiaries. AIDS Res Ther. 2020;17:12. doi: 10.1186/s12981-020-00268-1
    1. Clay PG, Yuet WC, Moecklinghoff CH, Duchesne I, Tronczyński KL, Shah S, et al.. A meta-analysis comparing 48-week treatment outcomes of single and multi-tablet antiretroviral regimens for the treatment of people living with HIV. AIDS Res Ther. 2018. Oct 30;15(1):17. doi: 10.1186/s12981-018-0204-0
    1. Department of Health and Human Services (DHHS). Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. AdultandAdolescentGL.pdf. (accessed April 7, 2020).
    1. Barfod TS, Hecht FM, Rubow C, Gerstoft J. Physicians’ communication with patients about adherence to HIV medication in San Francisco and Copenhagen: a qualitative study using Grounded Theory. BMC Health Serv Res. 2006;6:154. doi: 10.1186/1472-6963-6-154
    1. Beach MC, Roter DL, Saha S, Korthuis PT, Eggly S, Cohn J, et al.. Impact of a brief patient and provider intervention to improve the quality of communication about medication adherence among HIV patients. Patient Educ Couns. 2015;98(9):1078–1083. doi: 10.1016/j.pec.2015.05.011
    1. Malta M, Petersen ML, Clair S, Freitas F, Bastos FI. Adherence to antiretroviral therapy: a qualitative study with physicians from Rio de Janeiro, Brazil. Cad Saúde Pública. 2005;21(5):1424–1432. doi: 10.1590/s0102-311x2005000500015
    1. Laws MB, Beach MC, Lee Y, Rogers WH, Saha S, Korthuis PT, et al.. Provider-patient adherence dialogue in HIV care: results of a multisite study. AIDS Behav. 2013;17(1):148–159. doi: 10.1007/s10461-012-0143-z
    1. Wilson IB, Laws MB, Safren SA, Lee Y, Lu M, Coady W, et al.. Provider-focused intervention increases adherence-related dialogue but does not improve antiretroviral therapy adherence in persons with HIV. J Acquir Immune Defic Syndr. 2010;53(3):338–347. doi: 10.1097/QAI.0b013e3181c7a245
    1. Fredericksen R, Crane PK, Tufano J, Ralston J, Schmidt S, Brown T, et al.. Integrating a web-based, patient-administered assessment into primary care for HIV-infected adults. J AIDS HIV Res. 2012;4(2):47–55. doi: 10.5897/jahr11.046
    1. Miller LG, Liu H, Hays RD, Golin CE, Beck CK, Asch SM, et al.. How well do clinicians estimate patients’ adherence to combination antiretroviral therapy?. J Gen Intern Med. 2002;17(1):1–11. doi: 10.1046/j.1525-1497.2002.09004.x
    1. Engler K, Lènàrt A, Lessard D, Toupin I, Lebouché B. Barriers to antiretroviral therapy adherence in developed countries: a qualitative synthesis to develop a conceptual framework for a new patient-reported outcome measure. Aids Care. 2018;30(Sup1):17–28. doi: 10.1080/09540121.2018.1469725
    1. Shubber Z, Mills EJ, Nachega JB, Vreeman R, Freitas M, Bock P, et al.. Patient-reported barriers to adherence to antiretroviral therapy: A systematic review and meta-analysis. PLoS Med. 2016;13(11):e1002183. doi: 10.1371/journal.pmed.1002183
    1. Genberg BL, Lee Y, Rogers WH, Wilson IB. Four types of barriers to adherence of antiretroviral therapy are associated with decreased adherence over time. AIDS Behav. 2015;19(1):85–92. doi: 10.1007/s10461-014-0775-2
    1. Lessard D, Engler K, Toupin I, Routy J-P, Lebouché B. Evaluation of a project to engage patients in the development of a patient-reported measure for HIV care (the I-score study). Health Expectations. 2019;22(2):209–225. doi: 10.1111/hex.12845
    1. Toupin I, Engler K, Lessard D, Wong L, Lènàrt A, Spire B, et al.. Developing a patient-reported outcome measure for HIV care on perceived barriers to antiretroviral adherence: assessing the needs of HIV clinicians through qualitative analysis. Qual Life Res. 2018;27(2):379–388. doi: 10.1007/s11136-017-1711-5
    1. Kildea J, Battista J, Cabral B, Hendren L, Herrera D, Hijal T, et al.. Design and development of a person-centered patient portal using participatory stakeholder co-design. Journal of Medical Internet Research. 2019;21(2):11371. doi: 10.2196/11371
    1. Stover AM, Haverman L, van Oers HA, Greenhalgh J, Potter CM; ISOQOL. Using an implementation science approach to implement and evaluate patient-reported outcome measures (PROM) initiatives in routine care settings. Qual Life Res. 2020. Epub 2020 Jul 10. doi: 10.1007/s11136-020-02564-9
    1. Murray E, Hekler EB, Andersson G, Collins LM, Doherty A, Hollis C, et al.. Evaluating digital health interventions: key questions and approaches. Am J Prev Med. 2016;51(5):843–851. doi: 10.1016/j.amepre.2016.06.008
    1. Greenhalgh J, Dalkin S, Gooding K, Gibbons E, Wright J, Meads D, et al.. Functionality and feedback: a realist synthesis of the collation, interpretation and utilisation of patient-reported outcome measures data to improve patient care. Health Serv Deliv Res. 2017;5(2). doi: 10.3310/hsdr05020
    1. Greenhalgh J, Long AF, Flynn R. The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory? Social Sci Med. 2005;60:833e43. doi: 10.1016/j.socscimed.2004.06.022
    1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implementation Science. 2009;4(1). doi: 10.1186/1748-5908-4-50
    1. Santana MJ, Feeny D. Framework to assess the effects of using patient-reported outcome measures in chronic care management. Qual Life Res. 2014;23(5):1505–13. doi: 10.1007/s11136-013-0596-1
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–226. doi: 10.1097/MLR.0b013e3182408812
    1. Peters DH, Tran NT, Adam T. Implementation research in health: a practical guide. Alliance for Health Policy and Systems Research. World Health Organization; 2013.
    1. Creswell JW, Plano-Clark VL. Designing and Conducting Mixed Methods Research. 2nd Edition. London, UK: Sage Publications; 2011.
    1. O’Cathain A, Murphy E, Nicholl J. The quality of mixed methods studies in health services research. J Health Serv Res Policy. 2008;13(2):92–98. doi: 10.1258/jhsrp.2007.007074
    1. Pinnock H, Barwick M, Carpenter CR, Eldridge S, Grandes G, Griffiths CJ, et al.. Standards for reporting implementation studies (StaRI) statement. BMJ. 2017;356:i6795. doi: 10.1136/bmj.i6795
    1. Cox J, Linthwaite B, Engler K, Lessard D, Lebouché B, Kronfli N. A type ii implementation-effectiveness hybrid quasi-experimental pilot study of a clinical intervention to re-engage people living with hiv into care, ’lost & found’: an implementation science protocol. Pilot and Feasibility Studies. 2020;6:29–29. doi: 10.1186/s40814-020-0559-6
    1. Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. Journal of Clinical Epidemiology. 2011;65:301–308. doi: 10.1016/j.jclinepi.2011.07.011
    1. Institut national de santé publique du Québec [INSPQ]. Expert Consensus: Viral Load and the Risk of HIV Transmission. Report. Direction des risques biologiques et de la santé au travail, 2014. Retrieved November 25, 2020 from: .
    1. Public Health Agency of Canada. Summary: Estimates of HIV Incidence, Prevalence and Canada’s Progress on Meeting the 90-90-90 HIV targets, 2016. Public Health Agency of Canada, 2018. Retrieved August 7, 2020 from: .
    1. Ministère de la santé et des services sociaux. La thérapie antirétrovirale pour les adultes infectés par le VIH—Guide pour les professionnels de la santé du Québec. Gouvernement du Québec. Last updated February 2, 2019. Retrieved August 7, 2020 from: .
    1. Engler K, Ahmed S, Lessard D, Vicente S, Lebouché B. Assessing the content validity of a new patient-reported measure of barriers to antiretroviral therapy adherence for electronic administration in routine HIV care: proposal for a web-based Delphi study. JMIR Res Protoc. 2019;8(8):e12836. doi: 10.2196/12836
    1. Foster A, Croot L, Brazier J, Harris J, O’Cathain A. The facilitators and barriers to implementing patient reported outcome measures in organisations delivering health related services: a systematic review of reviews. J Patient Rep Outcomes. 2018;2:46. doi: 10.1186/s41687-018-0072-3
    1. Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, et al.. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012;69(2):123–157. doi: 10.1177/1077558711430690
    1. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al.. A refined compilation of implementation strategies: results from the expert recommendations for implementing change (eric) project. Implement Sci. 2015;10:21–21. doi: 10.1186/s13012-015-0209-1
    1. Mercieca-Bebber R, Palmer MJ, Brundage M, Calvert M, Stockler MR, King MT. Design, implementation and reporting strategies to reduce the instance and impact of missing patient-reported outcome (PRO) data: a systematic review. BMJ Open. 2016;6:e010938. doi: 10.1136/bmjopen-2015-010938
    1. International Society for Quality of Life Research [ISOQOL] (prepared by Aaronson N, Choucair A, Elliott T, Greenhalgh J, Halyard M, Hess R, et al.). User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice, Version: November 11, 2011.
    1. Keith RE, Crosson JC, O’Malley AS, Cromp D, Taylor EF. Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation. Implement Sci. 2017;12:15. doi: 10.1186/s13012-017-0550-7
    1. Schnall R, Cho H, Liu J. Health information technology usability evaluation scale (health-itues) for usability assessment of mobile health technology: validation study. JMIR Mhealth and Uhealth. 2018;6(1):4. doi: 10.2196/mhealth.8851
    1. Mahmood A, Kedia S, Wyant DK, Ahn S, Bhuyan SS. Use of mobile health applications for health-promoting behavior among individuals with chronic medical conditions. Digit Health. 2019;5:2055207619882181. doi: 10.1177/2055207619882181
    1. Balapour A, Reychav I, Sabherwal R, Azuri J. Mobile technology identity and self-efficacy: implications for the adoption of clinically supported mobile health apps. International Journal of Information Management. 2019;49:58–68.
    1. Hennink MM, Kaiser BN, Marconi VC. Code saturation versus meaning saturation: how many interviews are enough? Qualitative Health Research. 2017;27(4):591–608. doi: 10.1177/1049732316665344
    1. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al.. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10:1. doi: 10.1186/1471-2288-10-1
    1. Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care. Appl Nurs Res. 2011;24(1):53–58. doi: 10.1016/j.apnr.2009.04.003
    1. National Health Service England. NHS England Review of the Friends and Family Test. 2014. Retrieved August 13, 2020 from .
    1. Moore G, Benbasat I. Development of an instrument to measure the perceptions of adopting an information technology innovation. Information Systems Research. 1991;2(3):192–222.
    1. Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, et al.. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):1–12. doi: 10.1186/s13012-016-0533-0
    1. Feldman BJ, Fredericksen RJ, Crane PK, Safren SA, Mugavero MJ, Willig JH, et al.. Evaluation of the single-item self-rating adherence scale for use in routine clinical care of people living with HIV. AIDS Behav. 2013;17(1):307–318. doi: 10.1007/s10461-012-0326-7
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, et al.. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011;38(2):65–76. doi: 10.1007/s10488-010-0319-7
    1. Hamilton DF, Lane JV, Gaston P, Patton JT, Macdonald DJ, Simpson AH, et al.. Assessing treatment outcomes using a single question: the net promoter score. Bone Joint J. 2014;96-B(5):622–8. doi: 10.1302/0301-620X.96B5.32434
    1. Stirling P, Jenkins PJ, Clement ND, Duckworth AD, McEachan JE. The Net Promoter Scores with Friends and Family Test after four hand surgery procedures. J Hand Surg Eur. 2019;44(3):290–295. doi: 10.1177/1753193418819686
    1. Elo S, Kyngäs H. Original methodology: the qualitative content analysis process. J Adv Nurs. 2008;62(1):107–115. doi: 10.1111/j.1365-2648.2007.04569.x
    1. Vaismoradi M, Turunen H, Bondas T. Content analysis and thematic analysis: implications for conducting a qualitative descriptive study. Nursing and Health Sciences. 2014;15(3):398–405.
    1. Damschroder L, Hall C, Gillon L, Reardon C, Kelley C, Sparks J, et al.. The Consolidated Framework for Implementation Research (CFIR): progress to date, tools and resources, and plans for the future. Implementation Sci. 2015;10(Suppl 1):A12.
    1. Taylor MJ, McNicholas C, Nicolay C, Darzi A, Bell D, Reed JE. Systematic review of the application of the plan–do–study–act method to improve quality in healthcare. BMJ Qual Saf. 2014;23:290–298. doi: 10.1136/bmjqs-2013-001862
    1. Williams AB, Amico KR, Bova C, Womack JA. A proposal for quality standards for measuring medication adherence in research. AIDS Behav. 2013;17(1):284–297. doi: 10.1007/s10461-012-0172-7
    1. Wilson IB, Carter AE, Berg KM. Improving the self-report of HIV antiretroviral medication adherence: is the glass half full or half empty? Curr HIV/AIDS Rep. 2009. Nov;6(4):177–86. doi: 10.1007/s11904-009-0024-x
    1. Greenhalgh J, Gooding K, Gibbons E, Dalkin S, Wright J, Valderas J, et al. How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis. J Patient Rep Outcomes. 2018;2:42. doi: 10.1186/s41687-018-0061-6
    1. American Medical Association. AMA quick guide to telemedicine in practice. Updated June 22, 2020. Access July 3, 2020. .
    1. Royal College of Physicians and Surgeons of Canada. Telemedicine and virtual care guidelines (and other clinical resources for COVID-19). Updated May 21, 2020. Accessed July 3, 2020. .
    1. Rigby M, Georgiou A, Hyppönen H, Ammenwerth E, de Keizer N, Magrabi F, et al.. Patient portals as a means of information and communication technology support to patient-centric care coordination–the missing evidence and the challenges of evaluation. Yearbook of Medical Informatics. 2015;24(01):148–159.

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