Investigating the effect of clinical pharmacist intervention in transitions of care on drug-related hospital readmissions among the elderly: study protocol for a randomised controlled trial

Jonas Kindstedt, Sofia Svahn, Maria Sjölander, Eva-Lotta Glader, Hugo Lövheim, Maria Gustafsson, Jonas Kindstedt, Sofia Svahn, Maria Sjölander, Eva-Lotta Glader, Hugo Lövheim, Maria Gustafsson

Abstract

Introduction: Drug-related problems (DRPs) are a major cause of unplanned hospital admissions among elderly people, and transitions of care have been emphasised as a key area for improving patient safety. We have designed a complex clinical pharmacist intervention that targets people ≥75 years of age undergoing transitions of care from hospital to home and primary care. The main objective is to investigate if the intervention can reduce the risk of unplanned drug-related readmission within the first 180 days after the person is discharged from hospital.

Methods and analysis: This is a randomised, controlled, superiority trial with two parallel arms. A total of 700 people ≥75 years will be assigned to either intervention or routine care (control). The intervention, which aims to find and manage DRPs, is initiated within a week of the person being discharged from hospital and combines repeated medical chart reviews, phone interviews and in some cases medication reviews. People in both study arms may have been the subject of a medication review during their ward stay. As the primary outcome, we will measure time until unplanned drug-related readmission within 180 days of leaving hospital and use log rank tests and Cox proportional hazard models to analyse differences between the groups. Further investigations of subgroup effects and adjustments of the regression models will be based on heart failure and cognitive impairment as prognostic factors.

Ethics and dissemination: The study has been approved by the Regional Ethical Review Board in Umeå (registration numbers 2017-69-31M, 2018-83-32M and 2018-254-32M). We intend to publish the results with open access in international peer-reviewed journals and present our findings at international conferences. The trial is expected to result in more than one published article and form part of two PhD theses.

Trial registration number: NCT03671629.

Keywords: clinical pharmacology; clinical trials; geriatric medicine.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Study flow chart from recruitment to final follow-up.
Figure 2
Figure 2
The key features of the intervention, including both prescheduled phone interviews and repeated medical chart reviews. The intervention is initiated immediately after hospital discharge and goes on for 180 days. *Clinical pharmacist activity. **Interactions between clinical pharmacists and study participants.

References

    1. Alhawassi TM, Krass I, Bajorek BV, et al. . A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clin Interv Aging 2014;9:2079–86. 10.2147/CIA.S71178
    1. Patel H, Bell D, Molokhia M, et al. . Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998-2005. BMC Clin Pharmacol 2007;7:9. 10.1186/1472-6904-7-9
    1. Wittenberg R, Sharpin L, McCormick B, et al. . The ageing society and emergency hospital admissions. Health Policy 2017;121:923–8. 10.1016/j.healthpol.2017.05.007
    1. Beijer HJM, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002;24:46–54. 10.1023/A:1015570104121
    1. Salvi F, Marchetti A, D'Angelo F, et al. . Adverse drug events as a cause of hospitalization in older adults. Drug Saf 2012;35 Suppl 1:29–45. 10.1007/BF03319101
    1. Chan M, Nicklason F, Vial JH. Adverse drug events as a cause of hospital admission in the elderly. Intern Med J 2001;31:199–205. 10.1046/j.1445-5994.2001.00044.x
    1. McLachlan CYL, Yi M, Ling A, et al. . Adverse drug events are a major cause of acute medical admission. Intern Med J 2014;44:633–8. 10.1111/imj.12455
    1. Gustafsson M, Sjölander M, Pfister B, et al. . Drug-related hospital admissions among old people with dementia. Eur J Clin Pharmacol 2016;72:1143–53. 10.1007/s00228-016-2084-3
    1. Forster AJ, Murff HJ, Peterson JF, et al. . The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003;138:161–7. 10.7326/0003-4819-138-3-200302040-00007
    1. Moore C, Wisnivesky J, Williams S, et al. . Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med 2003;18:646–51. 10.1046/j.1525-1497.2003.20722.x
    1. Pérez T, Moriarty F, Wallace E, et al. . Prevalence of potentially inappropriate prescribing in older people in primary care and its association with hospital admission: longitudinal study. BMJ 2018;363:k4524. 10.1136/bmj.k4524
    1. World Health Organisation Transitions of care: technical series on safer primary care. Geneva: World Health Organisation, 2016.
    1. Haynes RB, Montague P, Oliver T, et al. . Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev 2000;2:Cd000011. 10.1002/14651858.CD000011
    1. Stewart RB, Caranasos GJ. Medication compliance in the elderly. Med Clin North Am 1989;73:1551–63. 10.1016/S0025-7125(16)30616-2
    1. Hayes TL, Larimer N, Adami A, et al. . Medication adherence in healthy elders: small cognitive changes make a big difference. J Aging Health 2009;21:567–80. 10.1177/0898264309332836
    1. Rosen OZ, Fridman R, Rosen BT, et al. . Medication adherence as a predictor of 30-day hospital readmissions. Patient Prefer Adherence 2017;11:801–10. 10.2147/PPA.S125672
    1. Hughes LD, Witham MD. Causes and correlates of 30 day and 180 day readmission following discharge from a medicine for the elderly rehabilitation unit. BMC Geriatr 2018;18:197. 10.1186/s12877-018-0883-3
    1. Ruppar TM, Cooper PS, Mehr DR, et al. . Medication adherence interventions improve heart failure mortality and readmission rates: systematic review and meta-analysis of controlled trials. J Am Heart Assoc 2016;5. 10.1161/JAHA.115.002606
    1. American College of Clinical Pharmacy The definition of clinical pharmacy. Pharmacotherapy 2008;28:816–7. 10.1592/phco.28.6.816
    1. Graabaek T, Kjeldsen LJ. Medication reviews by clinical pharmacists at hospitals lead to improved patient outcomes: a systematic review. Basic Clin Pharmacol Toxicol 2013;112:359–73. 10.1111/bcpt.12062
    1. Altowaijri A, Phillips CJ, Fitzsimmons D. A systematic review of the clinical and economic effectiveness of clinical pharmacist intervention in secondary prevention of cardiovascular disease. J Manag Care Pharm 2013;19:408–16. 10.18553/jmcp.2013.19.5.408
    1. Thomas R, Huntley AL, Mann M, et al. . Pharmacist-led interventions to reduce unplanned admissions for older people: a systematic review and meta-analysis of randomised controlled trials. Age Ageing 2014;43:174–87. 10.1093/ageing/aft169
    1. Jokanovic N, Tan EC, Sudhakaran S, et al. . Pharmacist-led medication review in community settings: an overview of systematic reviews. Res Social Adm Pharm 2017;13:661–85. 10.1016/j.sapharm.2016.08.005
    1. Rankin A, Cadogan CA, Patterson SM, et al. . Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev 2018;9:Cd008165. 10.1002/14651858.CD008165.pub4
    1. Gustafsson M, Sjölander M, Pfister B, et al. . Pharmacist participation in hospital ward teams and hospital readmission rates among people with dementia: a randomized controlled trial. Eur J Clin Pharmacol 2017;73:827–35. 10.1007/s00228-017-2249-8
    1. Gillespie U, Alassaad A, Henrohn D, et al. . A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med 2009;169:894–900. 10.1001/archinternmed.2009.71
    1. Lenssen R, Schmitz K, Griesel C, et al. . Comprehensive pharmaceutical care to prevent drug-related readmissions of dependent-living elderly patients: a randomized controlled trial. BMC Geriatr 2018;18:135. 10.1186/s12877-018-0814-3
    1. Ravn-Nielsen LV, Duckert M-L, Lund ML, et al. . Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission: a randomized clinical trial. JAMA Intern Med 2018;178:375–82. 10.1001/jamainternmed.2017.8274
    1. Odeh M, Scullin C, Fleming G, et al. . Ensuring continuity of patient care across the healthcare interface: telephone follow-up post-hospitalization. Br J Clin Pharmacol 2019;85:616–25. 10.1111/bcp.13839
    1. Kee KW, Char CWT, Yip AYF. A review on interventions to reduce medication discrepancies or errors in primary or ambulatory care setting during care transition from hospital to primary care. J Family Med Prim Care 2018;7:501–6. 10.4103/jfmpc.jfmpc_196_17
    1. Lövheim H, Gustafsson M, Isaksson U, et al. . Gottfries' cognitive scale for staff proxy rating of cognitive function among nursing home residents. J Alzheimers Dis 2019;72:1251–60. 10.3233/JAD-190599
    1. Adolfsson R, Gottfries CG, Nyström L, et al. . Prevalence of dementia disorders in institutionalized Swedish old people. The work load imposed by caring for these patients. Acta Psychiatr Scand 1981;63:225–44. 10.1111/j.1600-0447.1981.tb00670.x
    1. Gustafsson M, Isaksson U, Karlsson S, et al. . Behavioral and psychological symptoms and psychotropic drugs among people with cognitive impairment in nursing homes in 2007 and 2013. Eur J Clin Pharmacol 2016;72:987–94. 10.1007/s00228-016-2058-5
    1. Mjörndal T, Boman MD, Hägg S, et al. . Adverse drug reactions as a cause for admissions to a department of internal medicine. Pharmacoepidemiol Drug Saf 2002;11:65–72. 10.1002/pds.667
    1. Hellström LM, Bondesson A, Höglund P, et al. . Impact of the Lund Integrated Medicines Management (LIMM) model on medication appropriateness and drug-related Hospital revisits. Eur J Clin Pharmacol 2011;67:741–52. 10.1007/s00228-010-0982-3
    1. Mahler C, Hermann K, Horne R, et al. . Assessing reported adherence to pharmacological treatment recommendations. translation and evaluation of the Medication Adherence Report Scale (MARS) in Germany. J Eval Clin Pract 2010;16:574–9. 10.1111/j.1365-2753.2009.01169.x
    1. Bäck A, Andersson Sundell K, Horne R, et al. . The Medication Adherence Report Scale (MARS-5) in a Swedish sample with bipolar disorder - a pilot study. Int J Pers Centered Med 2012;2:263–70.
    1. Burström K, Johannesson M, Diderichsen F. Swedish population health-related quality of life results using the EQ-5D. Qual Life Res 2001;10:621–35. 10.1023/A:1013171831202
    1. Quinn PM. Qualitative research & evaluation methods. London, England: SAGE Publications, 2002: 342–60.
    1. Mikael H, Simon L, Marco N. Introduktion till samhällsvetenskaplig analys [Introduction to Social Scientific Analysis]. Malmö, Sweden: Gleerups Utbildning, 2010: 114–8.
    1. Schulz KF, Altman DG, Moher D, et al. . CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. 10.1136/bmj.c332
    1. International Committee of Medical Journal Editors Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals: International Committee of Medical Journal Editors, 2018. Available: [Accessed 1 November 2019].

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren