Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study)

Emilie Ferrat, Sylvie Bastuji-Garin, Elena Paillaud, Philippe Caillet, Pascal Clerc, Laura Moscova, Amel Gouja, Vincent Renard, Claude Attali, Julien Le Breton, Etienne Audureau, Emilie Ferrat, Sylvie Bastuji-Garin, Elena Paillaud, Philippe Caillet, Pascal Clerc, Laura Moscova, Amel Gouja, Vincent Renard, Claude Attali, Julien Le Breton, Etienne Audureau

Abstract

Introduction: Older patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs.

Methods and analysis: The Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders.

Ethics and dissemination: The protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care.

Trial registration number: NCT02664454; Pre-results.

Keywords: clusterrandomisedtrial; geriatric assessment; patient-centredapproach; primary care.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
CONSORT flow chart. CONSORT, Consolidated Standards of Reporting Trials; GP, general practitioner.
Figure 2
Figure 2
Intervention components. GP, general practitioner.

References

    1. Salisbury C, Johnson L, Purdy S, et al. . Epidemiology and impact of multimorbidity in primary care: a retrospective cohort study. Br J Gen Pract 2011;61:12–21. 10.3399/bjgp11X548929
    1. Eurostat. 1 out of every 8 persons in the EU could be 80 or above by 2080. 2015.
    1. Rolland Y, Benetos A, Gentric A, et al. . [Frailty in older population: a brief position paper from the French society of geriatrics and gerontology]. Geriatr Psychol Neuropsychiatr Vieil 2011;9:387–90. 10.1684/pnv.2011.0311
    1. Song X, Mitnitski A, Rockwood K. Prevalence and 10-year outcomes of frailty in older adults in relation to deficit accumulation. J Am Geriatr Soc 2010;58:681–7. 10.1111/j.1532-5415.2010.02764.x
    1. Fried LP, Tangen CM, Walston J, et al. . Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001;56:M146–M157. 10.1093/gerona/56.3.M146
    1. Barker LA, Gout BS, Crowe TC, et al. . Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health 2011;8:514–27. 10.3390/ijerph8020514
    1. Soriano TA, DeCherrie LV, Thomas DC. Falls in the community-dwelling older adult: a review for primary-care providers. Clin Interv Aging 2007;2:545–53. 10.2147/CIA.S1080
    1. Prina AM, Cosco TD, Dening T, et al. . The association between depressive symptoms in the community, non-psychiatric hospital admission and hospital outcomes: a systematic review. J Psychosom Res 2015;78:25–33. 10.1016/j.jpsychores.2014.11.002
    1. Maher RL, Hanlon J, Hajjar ER. Clinical consequences of polypharmacy in elderly. Expert Opin Drug Saf 2014;13:57–65. 10.1517/14740338.2013.827660
    1. Elsawy B, Higgins KE. The geriatric assessment. Am Fam Physician 2011;83:48–56.
    1. Puts MT, Santos B, Hardt J, et al. . An update on a systematic review of the use of geriatric assessment for older adults in oncology. Ann Oncol 2014;25:307–15. 10.1093/annonc/mdt386
    1. Caillet P, Laurent M, Bastuji-Garin S, et al. . Optimal management of elderly cancer patients: usefulness of the comprehensive geriatric assessment. Clin Interv Aging 2014;9:1645–60. 10.2147/CIA.S57849
    1. Mann E, Koller M, Mann C, et al. . Comprehensive geriatric assessment (CGA) in general practice: results from a pilot study in Vorarlberg, Austria. BMC Geriatr 2004;4:4:4 10.1186/1471-2318-4-4
    1. Weiss CO, Varadhan R, Puhan MA, et al. . Multimorbidity and evidence generation. J Gen Intern Med 2014;29:653–60. 10.1007/s11606-013-2660-5
    1. Rizza A, Kaplan V, Senn O, et al. . Age- and gender-related prevalence of multimorbidity in primary care: the Swiss FIRE project. BMC Fam Pract 2012;13:113 10.1186/1471-2296-13-113
    1. Barnett K, Mercer SW, Norbury M, et al. . Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet 2012;380:37–43. 10.1016/S0140-6736(12)60240-2
    1. Le Reste JY, Nabbe P, Lingner H, et al. . What research agenda could be generated from the European general practice research network concept of multimorbidity in family practice? BMC Fam Pract 2015;16:125 10.1186/s12875-015-0337-3
    1. American Geriatrics Society Expert Panel on the Care of Older Adults with Multimorbidity. Patient-centered care for older adults with multiple chronic conditions: a stepwise approach from the American geriatrics society: American geriatrics society expert panel on the care of older adults with multimorbidity. J Am Geriatr Soc 2012;60:1957–68. 10.1111/j.1532-5415.2012.04187.x
    1. Gaboreau Y, Imbert P, Jacquet JP, et al. . What are key factors influencing malnutrition screening in community-dwelling elderly populations by general practitioners? A large cross-sectional survey in two areas of France. Eur J Clin Nutr 2013;67:1193–9. 10.1038/ejcn.2013.161
    1. Ministère des Affaires sociales et de la Santé. Projet de cahier des charges des projets pilotes PAERPA. 2013.
    1. Pilotto A, Cella A, Pilotto A, et al. . Three decades of comprehensive geriatric assessment: evidence coming from different healthcare settings and specific clinical conditions. J Am Med Dir Assoc 2017;18:192.e1–192.e11. 10.1016/j.jamda.2016.11.004
    1. Beswick AD, Rees K, Dieppe P, et al. . Complex interventions to improve physical function and maintain independent living in elderly people: a systematic review and meta-analysis. Lancet 2008;371:725–35. 10.1016/S0140-6736(08)60342-6
    1. Bouman A, van Rossum E, Nelemans P, et al. . Effects of intensive home visiting programs for older people with poor health status: a systematic review. BMC Health Serv Res 2008;8:74 10.1186/1472-6963-8-74
    1. Conroy SP, Stevens T, Parker SG, et al. . A systematic review of comprehensive geriatric assessment to improve outcomes for frail older people being rapidly discharged from acute hospital: ’interface geriatrics'. Age Ageing 2011;40:436–43. 10.1093/ageing/afr060
    1. Kuo HK, Scandrett KG, Dave J, et al. . The influence of outpatient comprehensive geriatric assessment on survival: a meta-analysis. Arch Gerontol Geriatr 2004;39:245–54. 10.1016/j.archger.2004.03.009
    1. Stuck AE, Siu AL, Wieland GD, et al. . Comprehensive geriatric assessment: a meta-analysis of controlled trials. Lancet 1993;342:1032–6. 10.1016/0140-6736(93)92884-V
    1. Huss A, Stuck AE, Rubenstein LZ, et al. . Multidimensional preventive home visit programs for community-dwelling older adults: a systematic review and meta-analysis of randomized controlled trials. J Gerontol A Biol Sci Med Sci 2008;63:298–307.
    1. Frese T, Deutsch T, Keyser M, et al. . In-home preventive comprehensive geriatric assessment (CGA) reduces mortality-a randomized controlled trial. Arch Gerontol Geriatr 2012;55:639–44. 10.1016/j.archger.2012.06.012
    1. McCusker J, Verdon J. Do geriatric interventions reduce emergency department visits? A systematic review. J Gerontol A Biol Sci Med Sci 2006;61:53–62. 10.1093/gerona/61.1.53
    1. Li CM, Chen CY, Li CY, et al. . The effectiveness of a comprehensive geriatric assessment intervention program for frailty in community-dwelling older people: a randomized, controlled trial. Arch Gerontol Geriatr 2010;50(Suppl 1):S39–42. 10.1016/S0167-4943(10)70011-X
    1. Campbell MK, Piaggio G, Elbourne DR, et al. . Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661 10.1136/bmj.e5661
    1. de Hoop E, Teerenstra S, van Gaal BG, et al. . The "best balance" allocation led to optimal balance in cluster-controlled trials. J Clin Epidemiol 2012;65:132–7. 10.1016/j.jclinepi.2011.05.006
    1. Raab GM, Butcher I. Randomization inference for balanced cluster-randomized trials. Clin Trials 2005;2:130–40. 10.1191/1740774505cn075oa
    1. Carter BR, Hood K. Balance algorithm for cluster randomized trials. BMC Med Res Methodol 2008;8:65 10.1186/1471-2288-8-65
    1. HAS. Fiche points clés et solutions - comment prendre en charge les personnes âgées fragiles en ambulatoire? 2013.
    1. Shay LA, Lafata JE. Where is the evidence? A systematic review of shared decision making and patient outcomes. Med Decis Making 2015;35:114–31. 10.1177/0272989X14551638
    1. Baumann C, Erpelding ML, Perret-Guillaume C, et al. . Health-related quality of life in French adolescents and adults: norms for the DUKE Health Profile. BMC Public Health 2011;11:401 10.1186/1471-2458-11-401
    1. Katz S, Ford AB, Moskowitz RW, et al. . Studies of illness in the aged. The index of adl: a standardized measure of biological and psychosocial function. JAMA 1963;185:914–9.
    1. HAS. Note méthodologique et de synthèse documentaire. Comment prendre en charge les personnes âgées fragiles en ambulatoire? 2013.
    1. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials and statistics in medicine. Stat Med 2007;26:2–19. 10.1002/sim.2731
    1. Suijker JJ, van Rijn M, Buurman BM, et al. . Effects of nurse-led multifactorial care to prevent disability in community-living older people: cluster randomized trial. PLoS One 2016;11:e0158714 10.1371/journal.pone.0158714
    1. Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982;143:29–36. 10.1148/radiology.143.1.7063747
    1. White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med 2011;30:377–99. 10.1002/sim.4067
    1. Lewin SA, Skea ZC, Entwistle V, et al. . Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev 2001;4:CD003267 10.1002/14651858.CD003267
    1. Dwamena F, Holmes-Rovner M, Gaulden CM, et al. . Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev 2012;12:CD003267 10.1002/14651858.CD003267.pub2

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