Measuring the effect of nurse practitioner (NP)-led care on health-related quality of life in adult patients with atrial fibrillation: study protocol for a randomized controlled trial

Marcie J Smigorowsky, Colleen M Norris, Micheal Sean McMurtry, Ross T Tsuyuki, Marcie J Smigorowsky, Colleen M Norris, Micheal Sean McMurtry, Ross T Tsuyuki

Abstract

Background: Atrial fibrillation (AF) is a common arrhythmia associated with significant morbidity, mortality, and healthcare resource use. The prevalence of AF is increasing with a growing and aging population, and timely access to care for these patients is a concern. Nontraditional models of care delivery, such as nurse practitioner (NP)-led clinics, may improve access to care and quality of care, but they require formal assessment. The objective of this study is to assess the effect of NP-led care on the health-related quality of life (HRQoL) of adult patients with AF.

Methods/design: We plan a randomized controlled trial comparing NP-led care vs. standard care. Inclusion criteria are ≥18 years of age, documented nonvalvular AF, willingness to give informed consent, and capacity to complete questionnaires. Patients referred for electrophysiological intervention who are clinically unstable or unable to attend follow-up visits will not be eligible to participate. Patients will be asked for verbal consent during the initial triage phone call from the nurse. Randomization will occur via a secure website. The intervention includes an NP consult, including medical history, physical examination, patient teaching, treatment plan, and follow-up at 3 and 6 months. The control arm involves usual cardiologist consultation with follow-up determined by the cardiologist's practice pattern. The primary outcome will be the difference in change in Atrial Fibrillation Effect on Quality of Life Survey scores at 6 months between groups. Secondary outcomes will include difference in change of EQ-5D scores at 6 months between groups, difference in composite outcomes of death resulting from cardiovascular cause, hospitalizations and emergency department visits between groups, and satisfaction with NP-led care measured by the Consultant Satisfaction Questionnaire. A sample size of 70 per group will ensure adequate power despite a potential 10% loss to follow-up.

Discussion: Our study will determine the effect of NP-led AF care on HRQoL in patients with AF, as well as measure its impact on relevant outcomes such as death, hospitalization, and emergency department visits. Our findings may have implications for delivery of care to patients with AF.

Trial registration: ClincalTrials.gov, NCT02745236 . Registered on 16 April 2016.

Keywords: Atrial fibrillation; Health-related quality of life; Nurse practitioner; Patient satisfaction; Sustainable models of healthcare.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval has been obtained from the University of Alberta Research Ethics Office (reference number Pro00055990). The patient information sheet and consent form were also reviewed by the research ethics office and have been approved under the same approval reference number.

Consent for publication

Not applicable.

Competing interests

RTT has received investigator-initiated grants from Merck Canada, Sanofi, and AstraZeneca, and as president of SmHeart Consulting, Inc., has received consulting and speaking fees received from Merck. All of the other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient flow diagram. AFEQT Atrial Fibrillation Effect on QualiTy of life survey, EASE Ensuring Accessed and Speedy Evaluation, ER Emergency room, GP General practitioner, NP Nurse practitioner, RN Registered nurse
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram. AFEQT Atrial Fibrillation Effect on QualiTy of life survey, CV Cardiovascular

References

    1. Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC) Europace. 2010;12(10):1360–420. doi: 10.1093/europace/euq350.
    1. Heart and Stroke Foundation of Canada. Atrial fibrillation statistics. . Accessed 29 July 2017.
    1. Steinbrook R. Private health care in Canada. N Engl J Med. 2006;354(16):1661–4. doi: 10.1056/NEJMp068064.
    1. Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev. 2011;89(9):46–52.
    1. Liaropoulos L, Goranitis I. Health care financing and the sustainability of health systems. Int J Equity Health. 2015;14:80. doi: 10.1186/s12939-015-0208-5.
    1. Cairns JA, Healey JS, Macle L, Mitchell LB. Verma A; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. The new Canadian Cardiovascular Society algorithm for antithrombotic therapy of atrial fibrillation is appropriately based on current epidemiologic data. Can J Cardiol. 2015;31(1):20–3. doi: 10.1016/j.cjca.2014.11.021.
    1. Canadian Institute for Health Information. National Health Expenditure Trends, 1975 to 2016; 2017:1–42. . Accessed 29 July 2017.
    1. Skinner BJ, Rovere M. Canada’s Medicare bubble: is government health spending sustainable without user-based funding? Studies in Health Care Policy. Vancouver, BC, Canada: Fraser Institute; 2011.
    1. O’Reilly DJ, Hopkins RB, Healey JS, Dorian P, Sauriol L, Tarride JE, et al. The burden of atrial fibrillation on the hospital sector in Canada. Can J Cardiol. 2013;29(2):229–35. doi: 10.1016/j.cjca.2012.03.023.
    1. Esmail N. Canada’s physician supply. Fraser Forum. Mar/Apr 2011. p. 12–6.
    1. College and Association of Registered Nurses of Alberta (CARNA). Nurse practitioner (NP) competencies. Edmonton, AB, Canada: CARNA; Jan 2011. . Accessed 27 Jul 2017.
    1. Canadian Nurses Association. Nurse Practitioners: CNA; 2017. Available from: . Accessed 29 July 2017.
    1. Shum C, Humphreys A, Wheeler D, Cochrane MA, Skoda S, Clement S. Nurse management of patients with minor illnesses in general practice: multicentre, randomised controlled trial. BMJ. 2000;320(7241):1038–43. doi: 10.1136/bmj.320.7241.1038.
    1. Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, et al. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting “same day” consultations in primary care. BMJ. 2000;320(7241):1043–8. doi: 10.1136/bmj.320.7241.1043.
    1. Seale C, Anderson E, Kinnersley P. Comparison of GP and nurse practitioner consultations: an observational study. Br J Gen Pract. 2005;55(521):938–43.
    1. Spencer P, Hanania NA. Optimizing safety of COPD treatments: role of the nurse practitioner. J Multidiscip Healthc. 2013;6:53–63. doi: 10.2147/JMDH.S35711.
    1. Thrasher C, Purc-Stephenson R. Patient satisfaction with nurse practitioner care in emergency departments in Canada. J Am Acad Nurse Pract. 2008;20(5):231–7. doi: 10.1111/j.1745-7599.2008.00312.x.
    1. Charlton CR, Dearing KS, Berry JA, Johnson MJ. Nurse practitioners’ communication styles and their impact on patient outcomes: an integrated literature review. J Am Acad Nurse Pract. 2008;20(7):382–8. doi: 10.1111/j.1745-7599.2008.00336.x.
    1. Taylor SJ, Candy B, Bryar RM, Ramsay J, Vrijhoef HJ, Esmond G, et al. Effectiveness of innovations in nurse led chronic disease management for patients with chronic obstructive pulmonary disease: systematic review of evidence. BMJ. 2005;331(7515):485. doi: 10.1136/bmj.38512.664167.8F.
    1. Bakerjian D. Care of nursing home residents by advanced practice nurses: a review of the literature. Res Gerontol Nurs. 2008;1(3):177–85. doi: 10.3928/00220124-20091301-01.
    1. Richardson GC, Derouin AL, Vorderstrasse AA, Hipkens J, Thompson JA. Nurse practitioner management of type 2 diabetes. Perm J. 2014;18(2):e134–40. doi: 10.7812/TPP/13-108.
    1. Russell GM, Dahrouge S, Hogg W, Geneau R, Muldoon L, Tuna M. Managing chronic disease in Ontario primary care: the impact of organizational factors. Ann Fam Med. 2009;7(4):309–18. doi: 10.1370/afm.982.
    1. Campbell NC, Ritchie LD, Thain J, Deans HG, Rawles JM, Squair JL. Secondary prevention in coronary heart disease: a randomised trial of nurse led clinics in primary care. Heart. 1998;80(5):447–52. doi: 10.1136/hrt.80.5.447.
    1. Murchie P, Campbell NC, Ritchie LD, Simpson JA, Thain J. Secondary prevention clinics for coronary heart disease: four year follow up of a randomised controlled trial in primary care. BMJ. 2003;326(7380):84. doi: 10.1136/bmj.326.7380.84.
    1. Ducharme A, Doyon O, White M, Rouleau JL, Brophy JM. Impact of care at a multidisciplinary congestive heart failure clinic: a randomized trial. CMAJ. 2005;173(1):40–5. doi: 10.1503/cmaj.1041137.
    1. Gustafsson F, Arnold JM. Heart failure clinics and outpatient management: review of the evidence and call for quality assurance. Eur Heart J. 2004;25(18):1596–604. doi: 10.1016/j.ehj.2004.06.023.
    1. Strömberg A, Dahlström U. Heart failure clinics have decreased mortality and hospitalisation rates in Sweden. Eur Heart J. 2004;25(15):1368–9. doi: 10.1016/j.ehj.2004.04.039.
    1. Meyers S, Miers L. Cardiovascular surgeon and acute care nurse practitioner: collaboration on postoperative outcomes. AACN Clin Issues. 2005;16(2):149–58. doi: 10.1097/00044067-200504000-00005.
    1. Raftery JP, Yao GL, Murchie P, Campbell NC, Ritchie LD. Cost effectiveness of nurse led secondary prevention clinics for coronary heart disease in primary care: follow up of a randomised controlled trial. BMJ. 2005;330(7493):707. doi: 10.1136/bmj.38342.665417.8F.
    1. Stewart S, Blue L, Walker A, Morrison C, McMurray JJ. An economic analysis of specialist heart failure nurse management in the UK; can we afford not to implement it? Eur Heart J. 2002;23(17):1369–78. doi: 10.1053/euhj.2001.3114.
    1. Oliver GM, Pennington L, Revelle S, Rantz M. Impact of nurse practitioners on health outcomes of Medicare and Medicaid patients. Nurs Outlook. 2014;62(6):440–7. doi: 10.1016/j.outlook.2014.07.004.
    1. Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, et al. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012;33(21):2692–9. doi: 10.1093/eurheartj/ehs071.
    1. Bungard TJ, Smigorowsky MJ, Lalonde LD, Hogan T, Maier E, Archer SL. Cardiac EASE (Ensuring Access and Speedy Evaluation)—design of a single point of entry and a multidisciplinary team to reduce waiting times in the Canadian health care system. Healthc Manage Forum. 2008;21(3):35–40. doi: 10.1016/S0840-4704(10)60273-6.
    1. Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro Heart Survey on Atrial Fibrillation. Chest. 2010;137(2):263–72. doi: 10.1378/chest.09-1584.
    1. Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010;138(5):1093–100. doi: 10.1378/chest.10-0134.
    1. Dorian P, Cvitkovic SS, Kerr CR, Crystal E, Gillis AM, Guerra PG, et al. A novel, simple scale for assessing the symptom severity of atrial fibrillation at the bedside: the CCS-SAF scale. Can J Cardiol. 2006;22(5):383–6. doi: 10.1016/S0828-282X(06)70922-9.
    1. Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, et al. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011;4(1):15–25. doi: 10.1161/CIRCEP.110.958033.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5 L) Qual Life Res. 2011;20(10):1727–36. doi: 10.1007/s11136-011-9903-x.
    1. Baker R. Development of a questionnaire to assess patients’ satisfaction with consultations in general practice. Br J Gen Pract. 1990;40(341):487–90.
    1. Norris CM, Ghali WA, Saunders LD, Brant R, Galbraith D, Faris P, et al. Ordinal regression model and the linear regression model were superior to the logistic regression models. J Clin Epidemiol. 2006;59(5):448–56. doi: 10.1016/j.jclinepi.2005.09.007.
    1. Norman GR, Streiner DL. Biostatistics: the bare essentials. 3. Hamilton, ON, Canada: B.C. Decker; 2008. More than two groups: one-way ANOVA; pp. 77–89.
    1. Norman GR, Streiner DL. Biostatistics: the bare essentials. 3. Hamilton, ON, Canada: B.C. Decker; 2008. Screwups, oddballs, and other vagaries of science: locating outliers, handling missing data, and transformations; pp. 302–12.

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