Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Protocol for a Randomized Controlled Trial

Veronica Artanian, Valeria E Rac, Heather J Ross, Emily Seto, Veronica Artanian, Valeria E Rac, Heather J Ross, Emily Seto

Abstract

Background: Guideline-directed medical therapy (GDMT), optimized to maximum tolerated doses, has been shown to improve clinical outcomes in patients with heart failure (HF). Timely use and optimization of GDMT can improve HF symptoms, reduce the burden of hospitalization, and increase survival rates, whereas GDMT deferral may worsen the progression of HF, decrease survival rates, and predispose patients to poor outcomes. However, studies indicate that GDMT remains underused, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.

Objective: The primary objective of this study is to evaluate the impact of remote titration facilitated by telemonitoring on health care outcomes, with a primary outcome measure being the proportion of patients achieving target doses. The secondary objective is to identify the barriers and facilitators that can affect the implementation and effectiveness of the intervention.

Methods: A mixed methods study of a smartphone-based telemonitoring system is being conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside the assessment of clinical outcomes. The effectiveness research component is assessed by a two-arm randomized controlled trial (RCT) aiming to enroll 108 patients. The RCT compares a remote titration strategy that uses data from a smartphone-based telemonitoring system with a standard titration program consisting of in-office visits. The implementation research component consists of a qualitative study based on semistructured interviews with a purposive sample of clinicians and patients.

Results: Patient recruitment began in January 2019 at PMCC, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group). The final analysis is expected to be completed by the winter of 2021.

Conclusions: This study will be among the first to provide evidence on the implementation of remote titration facilitated by telemonitoring and its impact on patient health outcomes. The successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and support the development of a care delivery model that combines clinic visits with virtual follow-ups.

Trial registration: ClinicalTrials.gov NCT04205513; https://ichgcp.net/clinical-trials-registry/NCT04205513.

International registered report identifier (irrid): DERR1-10.2196/19705.

Keywords: heart failure; mHealth; remote titration; telemedicine; telemonitoring.

Conflict of interest statement

Conflicts of Interest: Members of the research team (ES and HR) have the intellectual property rights of the Medly system.

©Veronica Artanian, Valeria E Rac, Heather J Ross, Emily Seto. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.10.2020.

References

    1. Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CS, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123–33. doi: 10.1016/j.jacc.2013.11.053.
    1. Butrous H, Hummel SL. Heart failure in older adults. Can J Cardiol. 2016 Sep;32(9):1140–7. doi: 10.1016/j.cjca.2016.05.005.
    1. Blais C, Dai S, Waters C, Robitaille C, Smith M, Svenson LW, Reimer K, Casey J, Puchtinger R, Johansen H, Gurevich Y, Lix LM, Quan H, Tu K. Assessing the burden of hospitalized and community-care heart failure in Canada. Can J Cardiol. 2014 Mar;30(3):352–8. doi: 10.1016/j.cjca.2013.12.013.
    1. Ponikowski P, Anker SD, AlHabib KF, Cowie MR, Force TL, Hu S, Jaarsma T, Krum H, Rastogi V, Rohde LE, Samal UC, Shimokawa H, Budi Siswanto B, Sliwa K, Filippatos G. Heart failure: preventing disease and death worldwide. ESC Heart Fail. 2014 Sep;1(1):4–25. doi: 10.1002/ehf2.12005. doi: 10.1002/ehf2.12005.
    1. Cook C, Cole G, Asaria P, Jabbour R, Francis DP. The annual global economic burden of heart failure. Int J Cardiol. 2014 Feb 15;171(3):368–76. doi: 10.1016/j.ijcard.2013.12.028.
    1. Tran DT, Ohinmaa A, Thanh NX, Howlett JG, Ezekowitz JA, McAlister FA, Kaul P. The current and future financial burden of hospital admissions for heart failure in Canada: a cost analysis. CMAJ Open. 2016;4(3):E365–70. doi: 10.9778/cmajo.20150130.
    1. Atherton J, Hickey A. Expert comment: is medication titration in heart failure too complex? Card Fail Rev. 2017 Apr;3(1):25–32. doi: 10.15420/cfr.2017:1:2.
    1. Zaman S, Zaman SS, Scholtes T, Shun-Shin MJ, Plymen CM, Francis DP, Cole GD. The mortality risk of deferring optimal medical therapy in heart failure: a systematic comparison against norms for surgical consent and patient information leaflets. Eur J Heart Fail. 2017 Nov;19(11):1401–9. doi: 10.1002/ejhf.838. doi: 10.1002/ejhf.838.
    1. Gracia E, Hamid A, Butler J. Timely management of new-onset heart failure. Circulation. 2019 Aug 20;140(8):621–3. doi: 10.1161/CIRCULATIONAHA.118.035452.
    1. Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc M, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 comprehensive update of the Canadian cardiovascular society guidelines for the management of heart failure. Can J Cardiol. 2017 Nov;33(11):1342–433. doi: 10.1016/j.cjca.2017.08.022.
    1. Maggioni AP, Anker SD, Dahlström U, Filippatos G, Ponikowski P, Zannad F, Amir O, Chioncel O, Leiro MC, Drozdz J, Erglis A, Fazlibegovic E, Fonseca C, Fruhwald F, Gatzov P, Goncalvesova E, Hassanein M, Hradec J, Kavoliuniene A, Lainscak M, Logeart D, Merkely B, Metra M, Persson H, Seferovic P, Temizhan A, Tousoulis D, Tavazzi L, Heart Failure Association of the ESC Are hospitalized or ambulatory patients with heart failure treated in accordance with European Society of Cardiology guidelines? Evidence from 12,440 patients of the ESC heart failure long-term registry. Eur J Heart Fail. 2013 Oct;15(10):1173–84. doi: 10.1093/eurjhf/hft134. doi: 10.1093/eurjhf/hft134.
    1. Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical therapy for heart failure with reduced ejection fraction: the CHAMP-HF registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351–66. doi: 10.1016/j.jacc.2018.04.070.
    1. Carroll R, Mudge A, Suna J, Denaro C, Atherton J. Prescribing and up-titration in recently hospitalized heart failure patients attending a disease management program. Int J Cardiol. 2016 Aug 1;216:121–7. doi: 10.1016/j.ijcard.2016.04.084.
    1. Virani SA, Bains M, Code J, Ducharme A, Harkness K, Howlett JG, Ross H, Sussex B, Zieroth S, Board and Membership of the Canadian Heart Failure Society The need for heart failure advocacy in Canada. Can J Cardiol. 2017 Nov;33(11):1450–4. doi: 10.1016/j.cjca.2017.08.024.
    1. Sevilla-Cazes J, Ahmad FS, Bowles KH, Jaskowiak A, Gallagher T, Goldberg LR, Kangovi S, Alexander M, Riegel B, Barg FK, Kimmel SE. Heart failure home management challenges and reasons for readmission: a qualitative study to understand the patient's perspective. J Gen Intern Med. 2018 Oct;33(10):1700–7. doi: 10.1007/s11606-018-4542-3.
    1. Cafazzo JA, Seto E. The hospital at home: advances in remote patient monitoring. Biomed Instrum Technol. 2010;Suppl Home Healthcare:47–52.
    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 Mar;50(3):217–26. doi: 10.1097/MLR.0b013e3182408812.
    1. Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials. Stat Med. 1990;9(1-2):65–71; discussion 71. doi: 10.1002/sim.4780090113.
    1. Howlett JG, Chan M, Ezekowitz JA, Harkness K, Heckman GA, Kouz S, Leblanc M, Moe GW, O'Meara E, Abrams H, Ducharme A, Grzeslo A, Hamilton PG, Koshman SL, Lepage S, McDonald M, McKelvie R, Rajda M, Swiggum E, Virani S, Zieroth S, Canadian Cardiovascular Society Heart Failure Guidelines Panels The Canadian cardiovascular society heart failure companion: bridging guidelines to your practice. Can J Cardiol. 2016 Mar;32(3):296–310. doi: 10.1016/j.cjca.2015.06.019.
    1. Fonarow GC, Albert NM, Curtis AB, Stough WG, Gheorghiade M, Heywood JT, McBride ML, Inge PJ, Mehra MR, O'Connor CM, Reynolds D, Walsh MN, Yancy CW. Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the registry to improve the use of evidence-based heart failure therapies in the outpatient setting (IMPROVE HF) Circulation. 2010 Aug 10;122(6):585–96. doi: 10.1161/CIRCULATIONAHA.109.934471.
    1. Fowler MB, Lottes SR, Nelson JJ, Lukas MA, Gilbert EM, Greenberg B, Massie BM, Abraham WT, Franciosa JA, COHERE Participant Physicians Beta-blocker dosing in community-based treatment of heart failure. Am Heart J. 2007 Jun;153(6):1029–36. doi: 10.1016/j.ahj.2007.03.010.
    1. Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Developing healthcare rule-based expert systems: case study of a heart failure telemonitoring system. Int J Med Inform. 2012 Aug;81(8):556–65. doi: 10.1016/j.ijmedinf.2012.03.001.
    1. Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909.
    1. Ware P, Ross HJ, Cafazzo JA, Boodoo C, Munnery M, Seto E. Outcomes of a heart failure telemonitoring program implemented as the standard of care in an outpatient heart function clinic: pretest-posttest pragmatic study. J Med Internet Res. 2020 Feb 8;22(2):e16538. doi: 10.2196/16538.
    1. Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015 Sep;42(5):533–44. doi: 10.1007/s10488-013-0528-y.
    1. Hsieh H, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277–88. doi: 10.1177/1049732305276687.
    1. Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65–76. doi: 10.1007/s10488-010-0319-7.
    1. Chaudoir SR, Dugan AG, Barr CH. Measuring factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures. Implement Sci. 2013 Feb 17;8:22. doi: 10.1186/1748-5908-8-22.
    1. Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. Br Med J. 2007 May 5;334(7600):942. doi: 10.1136/bmj.39156.536968.55.
    1. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Böhm M, Boll H, Kim SS, Koehler K, Lücke S, Honold M, Heinze P, Schweizer T, Braecklein M, Kirwan B, Gelbrich G, Anker SD, TIM-HF Investigators Telemedical interventional monitoring in heart failure (TIM-HF), a randomized, controlled intervention trial investigating the impact of telemedicine on mortality in ambulatory patients with heart failure: study design. Eur J Heart Fail. 2010 Dec;12(12):1354–62. doi: 10.1093/eurjhf/hfq199. doi: 10.1093/eurjhf/hfq199.
    1. Kotb A, Cameron C, Hsieh S, Wells G. Comparative effectiveness of different forms of telemedicine for individuals with heart failure (HF): a systematic review and network meta-analysis. PLoS One. 2015;10(2):e0118681. doi: 10.1371/journal.pone.0118681.
    1. Zhu Y, Gu X, Xu C. Effectiveness of telemedicine systems for adults with heart failure: a meta-analysis of randomized controlled trials. Heart Fail Rev. 2020 Mar;25(2):231–43. doi: 10.1007/s10741-019-09801-5.
    1. Seto E, Leonard KJ, Masino C, Cafazzo JA, Barnsley J, Ross HJ. Attitudes of heart failure patients and health care providers towards mobile phone-based remote monitoring. J Med Internet Res. 2010 Nov 29;12(4):e55. doi: 10.2196/jmir.1627.
    1. Ware P, Ross HJ, Cafazzo JA, Laporte A, Gordon K, Seto E. Evaluating the implementation of a mobile phone-based telemonitoring program: longitudinal study guided by the consolidated framework for implementation research. JMIR Mhealth Uhealth. 2018 Jul 31;6(7):e10768. doi: 10.2196/10768.
    1. Fairbrother P, Ure J, Hanley J, McCloughan L, Denvir M, Sheikh A, McKinstry B, Telescot programme team Telemonitoring for chronic heart failure: the views of patients and healthcare professionals - a qualitative study. J Clin Nurs. 2014 Jan;23(1-2):132–44. doi: 10.1111/jocn.12137.
    1. D'Onofrio A, Palmisano P, Rapacciuolo A, Ammendola E, Calò L, Ruocco A, Bianchi V, Maresca F, Del Giorno G, Martino A, Mauro C, Campari M, Valsecchi S, Accogli M. Effectiveness of a management program for outpatient clinic or remote titration of beta-blockers in CRT patients: the RESTORE study. Int J Cardiol. 2017 Jun 1;236:290–5. doi: 10.1016/j.ijcard.2017.02.015.
    1. Palmisano P, Ammendola E, D'Onofrio A, Accogli M, Calò L, Ruocco A, Rapacciuolo A, Del Giorno G, Bianchi V, Malacrida M, Valsecchi S, Gronda E. Evaluation of synergistic effects of resynchronization therapy and a β-blocker up-titration strategy based on a predefined patient-management program: the RESTORE study. Clin Cardiol. 2015 Jan;38(1):2–7. doi: 10.1002/clc.22352. doi: 10.1002/clc.22352.
    1. Spaeder J, Najjar SS, Gerstenblith G, Hefter G, Kern L, Palmer JG, Gottlieb SH, Kasper EK. Rapid titration of carvedilol in patients with congestive heart failure: a randomized trial of automated telemedicine versus frequent outpatient clinic visits. Am Heart J. 2006 Apr;151(4):844.e1–10. doi: 10.1016/j.ahj.2005.06.044.
    1. Steckler AE, Bishu K, Wassif H, Sigurdsson G, Wagner J, Jaenicke C, Vats S, Rector T, Anand IS. Telephone titration of heart failure medications. J Cardiovasc Nurs. 2011;26(1):29–36. doi: 10.1097/JCN.0b013e3181ec1223.
    1. Moyer-Knox D, Mueller TM, Vuckovic K, Mischke L, Williams RE. Remote titration of carvedilol for heart failure patients by advanced practice nurses. J Card Fail. 2004 Jun;10(3):219–24. doi: 10.1016/j.cardfail.2003.09.009.
    1. Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Perceptions and experiences of heart failure patients and clinicians on the use of mobile phone-based telemonitoring. J Med Internet Res. 2012 Feb 10;14(1):e25. doi: 10.2196/jmir.1912.

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