A coordinated PCP-Cardiologist Telemedicine Model (PCTM) in China's community hypertension care: study protocol for a randomized controlled trial

Lei Xu, Wei-Yi Fang, Fu Zhu, Hong-Guang Zhang, Kai Liu, Lei Xu, Wei-Yi Fang, Fu Zhu, Hong-Guang Zhang, Kai Liu

Abstract

Background: Hypertension is a major risk factor for cardiovascular disease, and its control rate has remained low worldwide. Studies have found that telemonitoring blood pressure (BP) helped control hypertension in randomized controlled trials. However, little is known about its effect in a structured primary care model in which primary care physicians (PCPs) are partnering with cardiology specialists in electronic healthcare data sharing and medical interventions. This study aims to identify the effects of a coordinated PCP-cardiologist model that applies telemedicine tools to facilitate community hypertension control in China.

Methods/design: Patients with hypertension receiving care at four community healthcare centers that are academically affiliated to Shanghai Chest Hospital, Shanghai JiaoTong University are eligible if they have had uncontrolled BP in the previous 3 months and access to mobile Internet. Study subjects are randomly assigned to three interventional groups: (1) usual care; (2) home-based BP telemonitor with embedded Global System for Mobile Communications (GSM) module and unlimited data plan, an app to access personal healthcare record and receive personalized lifestyle coaching contents, and proficiency training of their use; or (3) this plus coordinated PCP-cardiologist care in which PCPs and cardiologists share data via a secure CareLinker website to determine interventional approaches. The primary outcome is mean change in systolic blood pressure over a 12-month period. Secondary outcomes are changes of diastolic blood pressure, HbA1C, blood lipids, and medication adherence measured by the eight-item Morisky Medication Adherence Scale.

Discussion: This study will determine whether a coordinated PCP-Cardiologist Telemedicine Model that incorporates the latest telemedicine technologies will improve hypertension care. Success of the model would help streamline the present community healthcare processes and impact a greater number of patients with uncontrolled hypertension.

Trial registration: ClinicalTrials.gov, NCT02919033 . Registered on 23 September 2016.

Keywords: Hypertension; Medication adherence; Primary care; Randomized controlled trial; Telemedicine.

Figures

Fig. 1
Fig. 1
Study design of the coordinated PCP-Cardiologist Telemedicine Model (PCTM)

References

    1. Yang G, Wang Y, Zeng Y, Gao GF, Liang X, Zhou M, et al. Rapid health transition in China, 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2013;381(9882):1987–2015. doi: 10.1016/S0140-6736(13)61097-1.
    1. Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338:b1665. doi: 10.1136/bmj.b1665.
    1. Dickinson HO, Mason JM, Nicolson DJ, Campbell F, Beyer FR, Cook JV, et al. Lifestyle interventions to reduce raised blood pressure: a systematic review of randomized controlled trials. J Hypertens. 2006;24(2):215–33. doi: 10.1097/01.hjh.0000199800.72563.26.
    1. Sundstrom J, Arima H, Woodward M, Jackson R, Karmali K, Lloyd-Jones D, et al. Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data. Lancet. 2014;384(9943):591–8. doi: 10.1016/S0140-6736(14)61212-5.
    1. Kumar N, Khunger M, Gupta A, Garg N. A content analysis of smartphone-based applications for hypertension management. J Am Soc Hypertens. 2015;9(2):130–6. doi: 10.1016/j.jash.2014.12.001.
    1. Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008;10(3):160–8. doi: 10.1089/dia.2008.0283.
    1. Pfaeffli Dale L, Whittaker R, Jiang Y, Stewart R, Rolleston A, Maddison R. Text message and Internet support for coronary heart disease self-management: results From the Text4Heart randomized controlled trial. J Med Internet Res. 2015;17(10):e237. doi: 10.2196/jmir.4944.
    1. Fernandez-Granero MA, Sanchez-Morillo D, Leon-Jimenez A. Computerised analysis of telemonitored respiratory sounds for predicting acute exacerbations of COPD. Sensors (Basel) 2015;15(10):26978–96. doi: 10.3390/s151026978.
    1. Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011;34(9):1934–42. doi: 10.2337/dc11-0366.
    1. Omboni S, Caserini M, Coronetti C. Telemedicine and m-health in hypertension management: technologies, applications and clinical evidence. High Blood Press Cardiovasc Prev. 2016;23(3):187–96. doi: 10.1007/s40292-016-0143-6.
    1. Omboni S, Gazzola T, Carabelli G, Parati G. Clinical usefulness and cost effectiveness of home blood pressure telemonitoring: meta-analysis of randomized controlled studies. J Hypertens. 2013;31(3):455–67. doi: 10.1097/HJH.0b013e32835ca8dd.
    1. Quinn CC, Gruber-Baldini AL, Shardell M, Weed K, Clough SS, Peeples M, et al. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials. 2009;30(4):334–46. doi: 10.1016/j.cct.2009.02.004.
    1. Quinn CC, Sareh PL, Shardell ML, Terrin ML, Barr EA, Gruber-Baldini AL. Mobile diabetes intervention for glycemic control: impact on physician prescribing. J Diabetes Sci Technol. 2014;8(2):362–70. doi: 10.1177/1932296813514503.
    1. Quinn CC, Shardell MD, Terrin ML, Barr EA, Park D, Shaikh F, et al. Mobile diabetes intervention for glycemic control in 45- to 64-year-old persons with type 2 diabetes. J Appl Gerontol. 2016;35(2):227–43. doi: 10.1177/0733464814542611.
    1. Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, et al. A successful multifaceted trial to improve hypertension control in primary care: why did it work? J Gen Intern Med. 2015;30(11):1665–72. doi: 10.1007/s11606-015-3355-x.
    1. O'Connor PJ, Schmittdiel JA, Pathak RD, Harris RI, Newton KM, Ohnsorg KA, et al. Randomized trial of telephone outreach to improve medication adherence and metabolic control in adults with diabetes. Diabetes Care. 2014;37(12):3317–24. doi: 10.2337/dc14-0596.
    1. Weltermann B, Viehmann A, Kersting C. Hypertension management in primary care: study protocol for a cluster randomized controlled trial. Trials. 2015;16:105. doi: 10.1186/s13063-015-0627-z.
    1. Heisler M, Hofer TP, Klamerus ML, Schmittdiel J, Selby J, Hogan MM, et al. Study protocol: the Adherence and Intensification of Medications (AIM) study—a cluster randomized controlled effectiveness study. Trials. 2010;11:95. doi: 10.1186/1745-6215-11-95.
    1. Xu L, Zhang Y, Chen Y, Li YJ, Chen D, Wang T, et al. The role of pharmacist-led hypertension management in China’s community medical care service: a retrospective analysis of real-world big-data samples. Precision Med Cardiol. 2016;1(1):19–26.
    1. Oliveira-Filho AD, Barreto-Filho JA, Neves SJ, Lyra Junior DP. Association between the 8-item Morisky Medication Adherence Scale (MMAS-8) and blood pressure control. Arq Bras Cardiol. 2012;99(1):649–58. doi: 10.1590/S0066-782X2012005000053.
    1. Liu LS. 2010 Chinese guidelines for the management of hypertension. Zhonghua Xin Xue Guan Bing Za Zhi. 2011;39(7):579–615.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Zhang HG, Liu K, Kong WJ, Tian F, Yang YR, Feng C, et al. A mobile health solution for chronic disease managment at retail pharmacy. 2016 IEEE 18th International Conference on e-Health Networking, Applications and Services (Healthcom). 2016. p.1-5. doi:10.1109/HealthCom.2016.7749455.
    1. Wu Y, Liu X, Li X, Li Y, Zhao L, Chen Z, et al. Estimation of 10-year risk of fatal and nonfatal ischemic cardiovascular diseases in Chinese adults. Circulation. 2006;114(21):2217–25. doi: 10.1161/CIRCULATIONAHA.105.607499.
    1. Collaborative Group A study on evaluation of the risk of ischemic cardiovascular diseases in Chinese and the development of simplified tools for the evaluation. Chin J Cardiol. 2003;31(12):893–901.
    1. Li LM, Rao KQ, Kong LZ, Yao CH, Xiang HD, Zhai FY, et al. A description on the Chinese national nutrition and health survey in 2002. Zhonghua Liu Xing Bing Xue Za Zhi. 2005;26(7):478–84.
    1. Sheng CS, Liu M, Kang YY, Wei FF, Zhang L, Li GL, et al. Prevalence, awareness, treatment and control of hypertension in elderly Chinese. Hypertens Res. 2013;36(9):824–28. doi: 10.1038/hr.2013.57.
    1. Wang L, Kong L, Wu F, Bai Y, Burton R. Preventing chronic diseases in China. Lancet. 2005;366(9499):1821–24. doi: 10.1016/S0140-6736(05)67344-8.
    1. Yang G, Kong L, Zhao W, Wan X, Zhai Y, Chen LC, et al. Emergence of chronic non-communicable diseases in China. Lancet. 2008;372(9650):1697–705. doi: 10.1016/S0140-6736(08)61366-5.
    1. Hallberg I, Taft C, Ranerup A, Bengtsson U, Hoffmann M, Hofer S, et al. Phases in development of an interactive mobile phone-based system to support self-management of hypertension. Integr Blood Press Control. 2014;7:19–28. doi: 10.2147/IBPC.S59030.
    1. Glynn LG, Hayes PS, Casey M, Glynn F, Alvarez-Iglesias A, Newell J, et al. SMART MOVE — a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial. Trials. 2013;14:157. doi: 10.1186/1745-6215-14-157.
    1. Zullig LL, Melnyk SD, Goldstein K, Shaw RJ, Bosworth HB. The role of home blood pressure telemonitoring in managing hypertensive populations. Curr Hypertens Rep. 2013;15(4):346–55. doi: 10.1007/s11906-013-0351-6.
    1. Kirwan M, Vandelanotte C, Fenning A, Duncan MJ. Diabetes self-management smartphone application for adults with type 1 diabetes: randomized controlled trial. J Med Internet Res. 2013;15(11):e235. doi: 10.2196/jmir.2588.
    1. Logan AG, Irvine MJ, McIsaac WJ, Tisler A, Rossos PG, Easty A, et al. Effect of home blood pressure telemonitoring with self-care support on uncontrolled systolic hypertension in diabetics. Hypertension. 2012;60(1):51–7. doi: 10.1161/HYPERTENSIONAHA.111.188409.
    1. Stoddart A, Hanley J, Wild S, Pagliari C, Paterson M, Lewis S, et al. Telemonitoring-based service redesign for the management of uncontrolled hypertension (HITS): cost and cost-effectiveness analysis of a randomised controlled trial. BMJ Open. 2013;3(5). doi: 10.1136/bmjopen-2013-002681.
    1. Thiboutot J, Sciamanna CN, Falkner B, Kephart DK, Stuckey HL, Adelman AM, et al. Effects of a web-based patient activation intervention to overcome clinical inertia on blood pressure control: cluster randomized controlled trial. J Med Internet Res. 2013;15(9):e158. doi: 10.2196/jmir.2298.
    1. Kim JY, Wineinger NE, Steinhubl SR. The influence of wireless self-monitoring program on the relationship between patient activation and health behaviors, medication adherence, and blood pressure levels in hypertensive patients: a substudy of a randomized controlled trial. J Med Internet Res. 2016;18(6):e116. doi: 10.2196/jmir.5429.
    1. Hosseininasab M, Jahangard-Rafsanjani Z, Mohagheghi A, Sarayani A, Rashidian A, Javadi M, et al. Self-monitoring of blood pressure for improving adherence to antihypertensive medicines and blood pressure control: a randomized controlled trial. Am J Hypertens. 2014;27(11):1339–45. doi: 10.1093/ajh/hpu062.
    1. McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, et al. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet. 2010;376(9736):163–72. doi: 10.1016/S0140-6736(10)60964-6.
    1. Hirsch JD, Steers N, Adler DS, Kuo GM, Morello CM, Lang M, et al. Primary care-based, pharmacist-physician collaborative medication-therapy management of hypertension: a randomized, pragmatic trial. Clin Ther. 2014;36(9):1244–54. doi: 10.1016/j.clinthera.2014.06.030.
    1. Carter BL, Ardery G, Dawson JD, James PA, Bergus GR, Doucette WR, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. 2009;169(21):1996–2002. doi: 10.1001/archinternmed.2009.358.
    1. Carter BL, Coffey CS, Ardery G, Uribe L, Ecklund D, James P, et al. Cluster-randomized trial of a physician/pharmacist collaborative model to improve blood pressure control. Circ Cardiovasc Qual Outcomes. 2015;8(3):235–43. doi: 10.1161/CIRCOUTCOMES.114.001283.
    1. O'Neill JL, Cunningham TL, Wiitala WL, Bartley EP. Collaborative hypertension case management by registered nurses and clinical pharmacy specialists within the Patient Aligned Care Teams (PACT) model. J Gen Intern Med. 2014;29(Suppl 2):S675–81. doi: 10.1007/s11606-014-2774-4.
    1. Hunt JS, Siemienczuk J, Pape G, Rozenfeld Y, MacKay J, LeBlanc BH, et al. A randomized controlled trial of team-based care: impact of physician-pharmacist collaboration on uncontrolled hypertension. J Gen Intern Med. 2008;23(12):1966–72. doi: 10.1007/s11606-008-0791-x.
    1. Qudah B, Albsoul-Younes A, Alawa E, Mehyar N. Role of clinical pharmacist in the management of blood pressure in dialysis patients. Int J Clin Pharm. 2016;38(4):931–40. doi: 10.1007/s11096-016-0317-2.
    1. Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, et al. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008;299(24):2857–67. doi: 10.1001/jama.299.24.2857.
    1. Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013;6(2):157–63. doi: 10.1161/CIRCOUTCOMES.112.968172.
    1. Green BB, Anderson ML, Ralston JD, Catz SL, Cook AJ. Blood pressure 1 year after completion of web-based pharmacist care. JAMA Intern Med. 2013;173(13):1250–2. doi: 10.1001/jamainternmed.2013.1037.
    1. Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, et al. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013;310(1):46–56. doi: 10.1001/jama.2013.6549.
    1. Omboni S, Sala E. The pharmacist and the management of arterial hypertension: the role of blood pressure monitoring and telemonitoring. Expert Rev Cardiovasc Ther. 2015;13(2):209–21. doi: 10.1586/14779072.2015.1001368.
    1. Lee P, Liu JC, Hsieh MH, Hao WR, Tseng YT, Liu SH, et al. Cloud-based BP system integrated with CPOE improves self-management of the hypertensive patients: a randomized controlled trial. Comput Methods Programs Biomed. 2016;132:105–13. doi: 10.1016/j.cmpb.2016.04.003.
    1. Omboni S, Guarda A. Impact of home blood pressure telemonitoring and blood pressure control: a meta-analysis of randomized controlled studies. Am J Hypertens. 2011;24(9):989–98. doi: 10.1038/ajh.2011.100.
    1. van Vugt M, de Wit M, Cleijne WH, Snoek FJ. Use of behavioral change techniques in web-based self-management programs for type 2 diabetes patients: systematic review. J Med Internet Res. 2013;15(12):e279. doi: 10.2196/jmir.2800.
    1. AbuDagga A, Resnick HE, Alwan M. Impact of blood pressure telemonitoring on hypertension outcomes: a literature review. Telemed J E Health. 2010;16(7):830–8. doi: 10.1089/tmj.2010.0015.
    1. Santschi V, Chiolero A, Colosimo AL, Platt RW, Taffe P, Burnier M, et al. Improving blood pressure control through pharmacist interventions: a meta-analysis of randomized controlled trials. J Am Heart Assoc. 2014;3(2):e000718. doi: 10.1161/JAHA.113.000718.

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