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Published in: BMC Cardiovascular Disorders 1/2017

Open Access 01-12-2017 | Study protocol

Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial

Authors: Valérie Santschi, Grégoire Wuerzner, Arnaud Chiolero, Bernard Burnand, Philippe Schaller, Lyne Cloutier, Gilles Paradis, Michel Burnier

Published in: BMC Cardiovascular Disorders | Issue 1/2017

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Abstract

Background

Blood pressure (BP) is poorly controlled among a large proportion of hypertensive outpatients. Innovative models of care are therefore needed to improve BP control. The Team-Based Care for improving Hypertension management (TBC-HTA) study aims to evaluate the effect of a team-based care (TBC) interprofessional intervention, involving nurses, community pharmacists and physicians, on BP control of hypertensive outpatients compared to usual care in routine clinical practice.

Methods/design

The TBC-HTA study is a pragmatic randomized controlled study with a 6-month follow-up which tests a TBC interprofessionnal intervention conducted among uncontrolled treated hypertensive outpatients in two ambulatory clinics and among seven nearby community pharmacies in Lausanne and Geneva, Switzerland. A total of 110 patients are being recruited and randomized to TBC (TBC: N = 55) or usual care group (UC: N = 55). Patients allocated to the TBC group receive the TBC intervention conducted by an interprofessional team, involving an ambulatory clinic nurse, a community pharmacist and a physician. A nurse and a community pharmacist meet patients every 6 weeks to measure BP, to assess lifestyle, to estimate medication adherence, and to provide education to the patient about disease, treatment and lifestyle. After each visit, the nurse and pharmacist write a summary report with recommendations related to medication adherence, lifestyle, and changes in therapy. The physician then adjusts antihypertensive therapy accordingly. Patients in the UC group receive usual routine care without sessions with a nurse and a pharmacist. The primary outcome is the difference in daytime ambulatory BP between TBC and UC patients at 6-month of follow-up. Secondary outcomes include patients’ and healthcare professionals’ satisfaction with the TBC intervention and BP control at 12 months (6 months after the end of the intervention).

Discussion

This ongoing study aims to evaluate the effect of a newly developed team-based care intervention engaging different healthcare professionals on BP control in a primary care setting in Switzerland. The results will inform policymakers on implementable strategies for routine clinical practice.

Trial registration

ClinicalTrials.gov registration: NCT02511093. Retrospectively registered on 28 July 2015.
Literature
1.
go back to reference Lawes CM, Vander Hoorn S, Rodgers A. Global burden of blood-pressure-related disease, 2001. Lancet. 2008;371(9623):1513–8.CrossRefPubMed Lawes CM, Vander Hoorn S, Rodgers A. Global burden of blood-pressure-related disease, 2001. Lancet. 2008;371(9623):1513–8.CrossRefPubMed
2.
go back to reference Burnier M, Brown RE, Ong SH, Keskinaslan A, Khan ZM. Issues in blood pressure control and the potential role of single-pill combination therapies. Int J Clin Pract. 2009;63:790–8.CrossRefPubMed Burnier M, Brown RE, Ong SH, Keskinaslan A, Khan ZM. Issues in blood pressure control and the potential role of single-pill combination therapies. Int J Clin Pract. 2009;63:790–8.CrossRefPubMed
3.
go back to reference Wolf-Maier K, Cooper RS, Kramer H, Banegas JR, Giampaoli S, Joffres MR, et al. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension. 2004;43:10–7.CrossRefPubMed Wolf-Maier K, Cooper RS, Kramer H, Banegas JR, Giampaoli S, Joffres MR, et al. Hypertension treatment and control in five European countries, Canada, and the United States. Hypertension. 2004;43:10–7.CrossRefPubMed
4.
go back to reference Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA. 2010;303:2043–50.CrossRefPubMed Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA. 2010;303:2043–50.CrossRefPubMed
5.
go back to reference Joffres M, Falaschetti E, Gillespie C, Robitaille C, Loustalot F, Poulter N, et al. Hypertension prevalence, awareness, treatment and control in national surveys from England, the USA and Canada, and correlation with stroke and ischaemic heart disease mortality: a cross-sectional study. BMJ Open. 2013;3:e003423.CrossRefPubMedPubMedCentral Joffres M, Falaschetti E, Gillespie C, Robitaille C, Loustalot F, Poulter N, et al. Hypertension prevalence, awareness, treatment and control in national surveys from England, the USA and Canada, and correlation with stroke and ischaemic heart disease mortality: a cross-sectional study. BMJ Open. 2013;3:e003423.CrossRefPubMedPubMedCentral
6.
go back to reference Danon-Hersch N, Marques-Vidal P, Bovet P, Chiolero A, Paccaud F, Pecoud A, et al. Prevalence, awareness, treatment and control of high blood pressure in a Swiss city general population: the CoLaus study. Eur J Cardiovasc Prev Rehabil. 2009;16:66–72.CrossRefPubMed Danon-Hersch N, Marques-Vidal P, Bovet P, Chiolero A, Paccaud F, Pecoud A, et al. Prevalence, awareness, treatment and control of high blood pressure in a Swiss city general population: the CoLaus study. Eur J Cardiovasc Prev Rehabil. 2009;16:66–72.CrossRefPubMed
7.
go back to reference Giberson SF. Million Hearts(TM): pharmacist-delivered care to improve cardiovascular health. Public Health Rep. 2013;128:2–6.PubMedPubMedCentral Giberson SF. Million Hearts(TM): pharmacist-delivered care to improve cardiovascular health. Public Health Rep. 2013;128:2–6.PubMedPubMedCentral
8.
go back to reference Tsuyuki RT, Johnson JA, Teo KK, Simpson SH, Ackman ML, Biggs RS, et al. A randomized trial of the effect of community pharmacist intervention on cholesterol risk management: the Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP). Arch Intern Med. 2002;162:1149–55.CrossRefPubMed Tsuyuki RT, Johnson JA, Teo KK, Simpson SH, Ackman ML, Biggs RS, et al. A randomized trial of the effect of community pharmacist intervention on cholesterol risk management: the Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP). Arch Intern Med. 2002;162:1149–55.CrossRefPubMed
9.
go back to reference Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse led interventions to improve control of blood pressure in people with hypertension: systematic review and meta-analysis. BMJ. 2010;341:c3995.CrossRefPubMedPubMedCentral Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse led interventions to improve control of blood pressure in people with hypertension: systematic review and meta-analysis. BMJ. 2010;341:c3995.CrossRefPubMedPubMedCentral
10.
go back to reference Martinez-Gonzalez NA, Tandjung R, Djalali S, Huber-Geismann F, Markun S, Rosemann T. Effects of physician-nurse substitution on clinical parameters: a systematic review and meta-analysis. PLoS ONE. 2014;9:e89181.CrossRefPubMedPubMedCentral Martinez-Gonzalez NA, Tandjung R, Djalali S, Huber-Geismann F, Markun S, Rosemann T. Effects of physician-nurse substitution on clinical parameters: a systematic review and meta-analysis. PLoS ONE. 2014;9:e89181.CrossRefPubMedPubMedCentral
11.
go back to reference 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;299:2857–67.CrossRefPubMedPubMedCentral 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;299:2857–67.CrossRefPubMedPubMedCentral
12.
go back to reference 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;310:46–56.CrossRefPubMedPubMedCentral 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;310:46–56.CrossRefPubMedPubMedCentral
13.
go back to reference 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:e000718.CrossRefPubMedPubMedCentral 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:e000718.CrossRefPubMedPubMedCentral
14.
go back to reference Weber CA, Ernst ME, Sezate GS, Zheng S, Carter BL. Pharmacist-physician comanagement of hypertension and reduction in 24-h ambulatory blood pressures. Arch Intern Med. 2010;170:1634–9.CrossRefPubMedPubMedCentral Weber CA, Ernst ME, Sezate GS, Zheng S, Carter BL. Pharmacist-physician comanagement of hypertension and reduction in 24-h ambulatory blood pressures. Arch Intern Med. 2010;170:1634–9.CrossRefPubMedPubMedCentral
15.
go back to reference Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009;169:1748–55.PubMedPubMedCentral Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009;169:1748–55.PubMedPubMedCentral
16.
go back to reference Santschi V, Lord A, Berbiche D, Lamarre D, Corneille L, Prud’homme L, et al. Impact of collaborative and multidisciplinary care on management of hypertension in chronic kidney disease outpatients. J Pharm Health Serv Res. 2011;2:79–87.CrossRef Santschi V, Lord A, Berbiche D, Lamarre D, Corneille L, Prud’homme L, et al. Impact of collaborative and multidisciplinary care on management of hypertension in chronic kidney disease outpatients. J Pharm Health Serv Res. 2011;2:79–87.CrossRef
17.
go back to reference Walsh JM, McDonald KM, Shojania KG, Sundaram V, Nayak S, Lewis R, et al. Quality improvement strategies for hypertension management: a systematic review. Med Care. 2006;44:646–57.CrossRefPubMed Walsh JM, McDonald KM, Shojania KG, Sundaram V, Nayak S, Lewis R, et al. Quality improvement strategies for hypertension management: a systematic review. Med Care. 2006;44:646–57.CrossRefPubMed
18.
go back to reference Chisholm-Burns MA, Kim Lee J, Spivey CA, Slack M, Herrier RN, Hall-Lipsy E, et al. US pharmacists’ effect as team members on patient care: systematic review and meta-analyses. Med Care. 2010;48:923–33.CrossRefPubMed Chisholm-Burns MA, Kim Lee J, Spivey CA, Slack M, Herrier RN, Hall-Lipsy E, et al. US pharmacists’ effect as team members on patient care: systematic review and meta-analyses. Med Care. 2010;48:923–33.CrossRefPubMed
19.
go back to reference Santschi V, Chiolero A, Paradis G, Colosimo AL, Burnand B. Pharmacist interventions to improve cardiovascular disease risk factors in diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care. 2012;35:2706–17.CrossRefPubMedPubMedCentral Santschi V, Chiolero A, Paradis G, Colosimo AL, Burnand B. Pharmacist interventions to improve cardiovascular disease risk factors in diabetes: a systematic review and meta-analysis of randomized controlled trials. Diabetes Care. 2012;35:2706–17.CrossRefPubMedPubMedCentral
20.
go back to reference Coburn KD, Marcantonio S, Lazansky R, Keller M, Davis N. Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial. PLoS Med. 2012;9:e1001265.CrossRefPubMedPubMedCentral Coburn KD, Marcantonio S, Lazansky R, Keller M, Davis N. Effect of a community-based nursing intervention on mortality in chronically ill older adults: a randomized controlled trial. PLoS Med. 2012;9:e1001265.CrossRefPubMedPubMedCentral
21.
go back to reference Zenzano T, Allan JD, Bigley MB, Bushardt RL, Garr DR, Johnson K, et al. The roles of healthcare professionals in implementing clinical prevention and population health. Am J Prev Med. 2011;40:261–7.CrossRefPubMed Zenzano T, Allan JD, Bigley MB, Bushardt RL, Garr DR, Johnson K, et al. The roles of healthcare professionals in implementing clinical prevention and population health. Am J Prev Med. 2011;40:261–7.CrossRefPubMed
22.
go back to reference Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, et al. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011;171:1173–80.CrossRefPubMed Bosworth HB, Powers BJ, Olsen MK, McCant F, Grubber J, Smith V, et al. Home blood pressure management and improved blood pressure control: results from a randomized controlled trial. Arch Intern Med. 2011;171:1173–80.CrossRefPubMed
23.
go back to reference Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse-led interventions used to improve control of high blood pressure in people with diabetes: a systematic review and meta-analysis. Diab Med. 2011;28:250–61. Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse-led interventions used to improve control of high blood pressure in people with diabetes: a systematic review and meta-analysis. Diab Med. 2011;28:250–61.
24.
go back to reference Rudd P, Miller NH, Kaufman J, Kraemer HC, Bandura A, Greenwald G, et al. Nurse management for hypertension. A systems approach. Am J Hyper. 2004;17:921–7. Rudd P, Miller NH, Kaufman J, Kraemer HC, Bandura A, Greenwald G, et al. Nurse management for hypertension. A systems approach. Am J Hyper. 2004;17:921–7.
25.
go back to reference Santschi V, Wuerzner G, Chiolero A, Burnand B, Paradis G, Burnier M. [Team-based care involving pharmacists and nurses to improve the management of hypertension]. Rev Med Suisse. 2012;8:1694-6, 8. Santschi V, Wuerzner G, Chiolero A, Burnand B, Paradis G, Burnier M. [Team-based care involving pharmacists and nurses to improve the management of hypertension]. Rev Med Suisse. 2012;8:1694-6, 8.
27.
go back to reference Carter BL, Bosworth HB, Green BB. The hypertension team: the role of the pharmacist, nurse, and teamwork in hypertension therapy. J Clin Hyper. 2012;14:51–65.CrossRef Carter BL, Bosworth HB, Green BB. The hypertension team: the role of the pharmacist, nurse, and teamwork in hypertension therapy. J Clin Hyper. 2012;14:51–65.CrossRef
28.
go back to reference Frieden TR, Berwick DM. The “Million Hearts” initiative--preventing heart attacks and strokes. NEJM. 2011;365:e27.CrossRefPubMed Frieden TR, Berwick DM. The “Million Hearts” initiative--preventing heart attacks and strokes. NEJM. 2011;365:e27.CrossRefPubMed
29.
go back to reference Kaczorowski J, Chambers LW, Dolovich L, Paterson JM, Karwalajtys T, Gierman T, et al. Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP). BMJ. 2011;342:d442.CrossRefPubMedPubMedCentral Kaczorowski J, Chambers LW, Dolovich L, Paterson JM, Karwalajtys T, Gierman T, et al. Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP). BMJ. 2011;342:d442.CrossRefPubMedPubMedCentral
30.
go back to reference McLean DL, McAlister FA, Johnson JA, King KM, Makowsky MJ, Jones CA, et al. A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Arch Intern Med. 2008;168:2355–61.CrossRefPubMed McLean DL, McAlister FA, Johnson JA, King KM, Makowsky MJ, Jones CA, et al. A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN). Arch Intern Med. 2008;168:2355–61.CrossRefPubMed
32.
go back to reference Santschi V, Rodondi N, Bugnon O, Burnier M. Impact of electronic monitoring of drug adherence on blood pressure control in primary care: a cluster 12-month randomised controlled study. Eur J Intern Med. 2008;19:427–34.CrossRefPubMed Santschi V, Rodondi N, Bugnon O, Burnier M. Impact of electronic monitoring of drug adherence on blood pressure control in primary care: a cluster 12-month randomised controlled study. Eur J Intern Med. 2008;19:427–34.CrossRefPubMed
33.
go back to reference Community Preventive Services Task F. Team-based care to improve blood pressure control: recommendation of the community preventive services task force. Am J Prev Med. 2014;47:100–2.CrossRef Community Preventive Services Task F. Team-based care to improve blood pressure control: recommendation of the community preventive services task force. Am J Prev Med. 2014;47:100–2.CrossRef
34.
go back to reference Proia KK, Thota AB, Njie GJ, Finnie RK, Hopkins DP, Mukhtar Q, et al. Team-based care and improved blood pressure control: a community guide systematic review. Am J Prev Med. 2014;47:86–99.CrossRefPubMedPubMedCentral Proia KK, Thota AB, Njie GJ, Finnie RK, Hopkins DP, Mukhtar Q, et al. Team-based care and improved blood pressure control: a community guide systematic review. Am J Prev Med. 2014;47:86–99.CrossRefPubMedPubMedCentral
35.
go back to reference Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.CrossRefPubMedPubMedCentral Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008;337:a2390.CrossRefPubMedPubMedCentral
36.
go back to reference Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009;27:2121–58.CrossRefPubMed Mancia G, Laurent S, Agabiti-Rosei E, Ambrosioni E, Burnier M, Caulfield MJ, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009;27:2121–58.CrossRefPubMed
37.
go back to reference Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hyper. 2008;10:348–54.CrossRef Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hyper. 2008;10:348–54.CrossRef
38.
go back to reference Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67–74.CrossRefPubMed Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986;24:67–74.CrossRefPubMed
39.
go back to reference Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol. Blood Press Monit. 2007;12:185–8.CrossRefPubMed Stergiou GS, Giovas PP, Gkinos CP, Patouras JD. Validation of the Microlife WatchBP Home device for self home blood pressure measurement according to the International Protocol. Blood Press Monit. 2007;12:185–8.CrossRefPubMed
40.
go back to reference Bochud M, Bovet P, Elston RC, Paccaud F, Falconnet C, Maillard M, et al. High heritability of ambulatory blood pressure in families of East African descent. Hypertension. 2005;45:445–50.CrossRefPubMed Bochud M, Bovet P, Elston RC, Paccaud F, Falconnet C, Maillard M, et al. High heritability of ambulatory blood pressure in families of East African descent. Hypertension. 2005;45:445–50.CrossRefPubMed
41.
go back to reference Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011;171:1441–53.CrossRefPubMed Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011;171:1441–53.CrossRefPubMed
Metadata
Title
Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial
Authors
Valérie Santschi
Grégoire Wuerzner
Arnaud Chiolero
Bernard Burnand
Philippe Schaller
Lyne Cloutier
Gilles Paradis
Michel Burnier
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cardiovascular Disorders / Issue 1/2017
Electronic ISSN: 1471-2261
DOI
https://doi.org/10.1186/s12872-017-0472-y

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