Effectiveness of the cardiac-diabetes transcare program: protocol for a randomised controlled trial

Chiung-Jung Jo Wu, John J Atherton, Richard J MacIsaac, Mary Courtney, Anne M Chang, David R Thompson, Karam Kostner, Andrew I MacIsaac, Michael d'Emden, Nick Graves, Steven M McPhail, Chiung-Jung Jo Wu, John J Atherton, Richard J MacIsaac, Mary Courtney, Anne M Chang, David R Thompson, Karam Kostner, Andrew I MacIsaac, Michael d'Emden, Nick Graves, Steven M McPhail

Abstract

Background: This paper presents a protocol for a randomised controlled trial of the Cardiac-Diabetes Transcare program which is a transitional care, multi-modal self-management program for patients with acute coronary syndrome comorbid with type 2 diabetes. Prior research has indicated people hospitalised with dual cardiac and diabetes diagnoses are at an elevated risk of hospital readmissions, morbidity and mortality. The primary aim of this study is to evaluate the effectiveness (and cost-effectiveness) of a Cardiac-Diabetes Transcare intervention program on 6-month readmission rate in comparison to usual care.

Methods/design: A two-armed, randomised controlled trial with blinded outcome assessment will be conducted to evaluate the comparative effectiveness of two modes of care, including a Usual Care Group and a Cardiac-Diabetes Transcare Intervention (in addition to usual care) Group. The primary outcome is 6-month readmission rate, although a range of secondary outcomes will be collected (including self-efficacy) at baseline, 1, 3 and 6 month reassessments. The intervention group will receive in-hospital education tailored for people recovering from an acute coronary syndrome-related hospital admission who have comorbid diabetes, and they will also receive home visits and telephone follow-up by a trained Research Nurse to reinforce and facilitate disease-management-related behaviour change. Both groups will receive usual care interventions offered or referred from participating hospital facilities. A sample size of 432 participants from participating hospitals in the Australian states of Queensland and Victoria will be recruited for 90% power based on the most conservative scenarios modelled for sample size estimates.

Discussion: The study outlined in this protocol will provide valuable insight into the effectiveness of a transitional care intervention targeted for people admitted to hospital with cardiac-related presentations commencing in the inpatient hospital setting and transition to the home environment. The purpose of theory-based intervention comprising face-to-face sessions and telephone follow up for patients with acute coronary syndrome and type 2 diabetes is to increase self-efficacy to enhance self-management behaviours and thus improve health outcomes and reduce hospital readmissions.

Trial registration: This study has been registered with the Australian New Zealand Clinical Trials Registry dated 16/12/2014: ACTRN12614001317684 .

Keywords: Cardiovascular; Diabetes; Protocol; Randomized controlled trial; Readmission; Self-efficacy; Transitional care.

Figures

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Fig. 1
Study design and procedure overview

References

    1. Organisation for Economic Co-operation and Development OECD . Health at a Glance 2011: OECD Indicators. Paris: OECD Publishing; 2011.
    1. Australian Institute of Health and Welfare . Cardiovascular disease, diabetes and chronic kidney disease –Australian facts: Prevalence and incidence. Cardiovascular, diabetes and chronic kidney disease series no. 2. Cat. no. CDK 2. Canberra: AIHW; 2014.
    1. Tanamas SK. The Australian diabetes, obesity and lifestyle study. In: Baker IDI Heart and Diabetes Institute, editor. 2013.
    1. Wu CJJ, Chang AM. Audit of patients with type 2 diabetes following a critical cardiac event. Int Nurs Rev. 2008;55(3):327–332. doi: 10.1111/j.1466-7657.2008.00636.x.
    1. Edmondson D, Green P, Ye S, Halazun HJ, Davidson KW. Psychological stress and 30-day all-cause hospital readmission in acute coronary syndrome patients: An observational cohort study. PLoS One. 2014;9(3):e91477. doi: 10.1371/journal.pone.0091477.
    1. Smith SM, Soubhi H, Fortin M, Hudon C, O’Dowd T. Managing patient with multimorbidity: systematic review of interventions in primary care and community settings. BMJ. 2012;345:e5205. doi: 10.1136/bmj.e5205.
    1. Liddy C, Blazkho V, Mill K. Challenges of self-management when living with multiple chronic conditions: Systematic review of the qualitative literature. .
    1. Courtney M, Edwards H, Chang A, Parker A, Finlayson K, Hamilton K. Fewer emergency readmissions and better quality of life for older adults at risk of hospital readmission: A randomized controlled trial to determine the effectiveness of a 24‐week exercise and telephone follow‐up program. J Am Geriatr Soc. 2009;57(3):395–402. doi: 10.1111/j.1532-5415.2009.02138.x.
    1. Shepperd S, Lannin NA, Clemson LM, McCluskey A, Cameron ID, Barras SL. Discharge planning from hospital to home. Cochrane Database Syst Rev. 2013;Issue 1:CD000313.
    1. Sol BGM, van der Graal Y, van Petersen R, Visseren FLJ. The effect of self-efficacy on cardiovascular lifestyle. Eur J Cardiovasc Nurs. 2011;10(3):180–186. doi: 10.1016/j.ejcnurse.2010.06.005.
    1. Wu C-JJ, Chang AM, Courtney M, Shortridge-Baggett LM, Kostner K. Development and pilot test of a peer-support based Cardiac-Diabetes Self-Management Program: A study protocol. BMC Health Serv Res. 2011;11(1):74. doi: 10.1186/1472-6963-11-74.
    1. Jo Wu C-J, Chang AM, Courtney M, Kostner K. Peer supporters for cardiac patients with diabetes: a randomised controlled trial. Int Nurs Rev. 2012;59(3):345–352. doi: 10.1111/j.1466-7657.2012.00998.x.
    1. Wu CJJ, Chang AM, Courtney M, Ramis MA. Using user‐friendly telecommunications to improve cardiac and diabetes self‐management programme: a pilot study. J Eval Clin Pract. 2012;18(3):695–697. doi: 10.1111/j.1365-2753.2010.01621.x.
    1. Wu CJJ, Chang AM, McDowell J. Innovative self‐management programme for diabetics following coronary care unit admission. Int Nurs Rev. 2009;56(3):396–399. doi: 10.1111/j.1466-7657.2009.00725.x.
    1. Jo Wu C-J, Atherton J, Chang AM, Courtney M, Strodl E, Clark A, Thompson DR, Ramis M, McPhail SM. Australian patients using a cardiac-diabetes web-based intervention program: contributions to person-centered clinical practice. Eur J Person Centered Healthc. 2015;3(2):168–174. doi: 10.5750/ejpch.v3i2.907.
    1. Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977;84(2):191. doi: 10.1037/0033-295X.84.2.191.
    1. Bandura A. Self-efficacy: The exercise of control: Macmillan. 1997.
    1. Boutwell A, Hwu S. Effective Interventions to reduce rehospitalizations: A survey of the published evidence. Cambridge: Institute for Healthcare Improvement; 2009.
    1. Chew D, Allan R, Aroney C, Sheerin N. National data elements for the clinical management of acute coronary syndromes. Med J Aust. 2005;182(9 Suppl):S1–S16.
    1. Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of health-related quality of life. Qual Life Res. 1999;8:209–224. doi: 10.1023/A:1008815005736.
    1. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program for patients with chronic disease. Eff Clin Pract. 2001;4:256–262.
    1. Sherbourne C, Stewart A. The MOS Social Support Survey. Soc Sc Med. 1991;32:705–714. doi: 10.1016/0277-9536(91)90150-B.
    1. Mortimer D, et al. Protocol for economic evaluation alongside the IMPLEMENT cluster randomised controlled trial. Implement Sci. 2008;3:12. doi: 10.1186/1748-5908-3-12.
    1. Chew DP, French J, Briffa TG, et al. Acute coronary syndrome care across Australia and New Zealand: the SNAPSHOT ACS study. MJA. 2013;199:1–7.
    1. Briffa TG, Nedkoff L, Knuiman M, Norman P, Hung J, Hankey G, Thompson P, Geelhoed E, Hickling S, Sanfilippo F, Bremner A, Hobbs M. Downward trend in the prevalence of hospitalisation for atherothrombotic disease. Int J Cardiol. 2013;163(2):185–192. doi: 10.1016/j.ijcard.2011.06.122.
    1. Smimms AD, Batin PD, Kurian J, Durham N, Gale CP. Acute coronary syndromes: an old age problem. J Geriatr Cardiol. 2012;9(2):192–196. doi: 10.3724/SP.J.1263.2012.01312.
    1. Panagioti M, Richardson G, Small N, Murray E, Rogers A, Kennedy A, Newman S, Bower P. Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis. BMC Health Serv Res. 2014;14:356. doi: 10.1186/1472-6963-14-356.
    1. Grace SL, Oh PI, Marzolini S, Colella T, Tan Y, Alter DA. Observing temporal trends in cardiac rehabilitation from 1996 to 2010 in Ontario: characteristics of referred patients, programme participation and mortality rates. BMJ Open. 2015;5:e009523. doi: 10.1136/bmjopen-2015-009523.
    1. Listerman J, Bittner V, Sanderson BK, Brown TM. Cardiac rehabilitation outcomes: Impact of comorbidities and age. J Cardiopulm Rehabil Prev. 2011;31(6):342–348. doi: 10.1097/HCR.0b013e31822f189c.
    1. Graves N, Courtney M, Edwards H, Chang A, Parker T, Finlayson K. Cost-effectiveness of an intervention to reduce emergency readmissions to hospital among older patients. PLoS ONE. 2009;4(10):e7455. doi: 10.1371/journal.pone.0007455.

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