Integrating the clinical pharmacist into the emergency department interdisciplinary team: a study protocol for a multicentre trial applying a non-randomised stepped-wedge study design

Introduction The ‘emergency department (ED) pharmacist’ is an integrated part of the ED interdisciplinary team in many countries, which have shown to improve medication safety and reduce costs related to hospitalisations. In Norway, few EDs are equipped with ED pharmacists, and research describing effects on patients has not been conducted. The aim of this study is to investigate the impact of introducing clinical pharmacists to the interdisciplinary ED team. In this multicentre study, the intervention will be pragmatically implemented in the regular operation of three EDs in Northern Norway; Tromsø, Bodø and Harstad. Clinical pharmacists will work as an integrated part of the ED team, providing pharmaceutical care services such as medication reconciliation, review and/or counselling. The primary endpoint is ‘time in hospital during 30 days after admission to the ED’, combining (1) time in ED, (2) time in hospital (if hospitalised) and (3) time in ED and/or hospital if re-hospitalised during 30 days after admission. Secondary endpoints include time to rehospitalisation, length of stay in ED and hospital and rehospitalisation and mortality rates. Methods and analysis We will apply a non-randomised stepped-wedge study design, where we in a staggered way implement the ED pharmacists in all three EDs after a 3, 6 and 9 months control period, respectively. We will include all patients going through the three EDs during the 12-month study period. Patient data will be collected retrospectively from national data registries, the hospital system and from patient records. Ethics and dissemination The Regional Committee for Medical and Health Research Ethics and Local Patient Protection Officers in all hospitals have approved the study. Patients will be informed about the ongoing study on a general basis with ads on posters and flyers. Trial registration number NCT04722588.

[1]  Chih-Fen Huang,et al.  Clinical and economic impact of clinical pharmacist intervention in a hematology unit , 2020, Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners.

[2]  C. J. Cabilan,et al.  The effectiveness of pharmacist- led discharge medication counselling in the emergency department (ExPLAIN): A pilot quasi-experimental study. , 2019, Patient education and counseling.

[3]  M. Hedström,et al.  Assessment tool for hospital admissions related to medications: development and validation in older patients , 2018, International Journal of Clinical Pharmacy.

[4]  Karla Hemming,et al.  Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration , 2018, British Medical Journal.

[5]  Juliette Brown,et al.  Better care: reducing length of stay and bed occupancy on an older adult psychiatric ward , 2018, BMJ open quality.

[6]  J. Kelly,et al.  Clinical pharmacy services in the emergency department , 2018, The American journal of emergency medicine.

[7]  Candice L. Garwood,et al.  Post-discharge Medication Reconciliation: Reduction in Readmissions in a Geriatric Primary Care Clinic , 2018, Journal of aging and health.

[8]  B. Başgut,et al.  The role of the pharmacist in the multidisciplinary approach to the prevention and resolution of drug-related problems in cancer chemotherapy , 2018, Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners.

[9]  I. Al-Zakwani,et al.  Impact of medication reconciliation and review and counselling, on adverse drug events and healthcare resource use , 2018, International Journal of Clinical Pharmacy.

[10]  A. Bahtiar,et al.  Evaluation of a Clinical Pharmacist Intervention on Clinical and Drug-Related Problems Among Coronary Heart Disease Inpatients: A pre-experimental prospective study at a general hospital in Indonesia. , 2018, Sultan Qaboos University medical journal.

[11]  M. Scott,et al.  Impact of antimicrobial stewardship programme on hospitalized patients at the intensive care unit: a prospective audit and feedback study , 2018, British journal of clinical pharmacology.

[12]  M. Climente-Martí,et al.  Improvement on prescribing appropriateness after implementing an interdisciplinary pharmacotherapy quality programme in a long-term care hospital , 2018, European journal of hospital pharmacy. Science and practice.

[13]  K. McGrail,et al.  Impact of early in-hospital medication review by clinical pharmacists on health services utilization , 2017, PloS one.

[14]  J. Hallas,et al.  Improving Medication Adherence in Patients with Hypertension: A Randomized Trial. , 2015, The American journal of medicine.

[15]  Dennis Grauer,et al.  Effects of a hospitalwide pharmacy practice model change on readmission and return to emergency department rates. , 2014, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[16]  D. Moher,et al.  SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) , 2014 .

[17]  M. Afilalo,et al.  Detection and correction of prescription errors by an emergency department pharmacy service. , 2014, CJEM.

[18]  D. Gerritsen,et al.  Stepped wedge designs could reduce the required sample size in cluster randomized trials. , 2013, Journal of clinical epidemiology.

[19]  Michael C. Thomas,et al.  A prospective, multicenter study of pharmacist activities resulting in medication error interception in the emergency department. , 2012, Annals of emergency medicine.

[20]  I. Claudius,et al.  Impact of an Emergency Department Pharmacy on Medication Omission and Delay , 2012, Pediatric emergency care.

[21]  Celia A Taylor nee Brown,et al.  Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. , 2011, Journal of clinical epidemiology.

[22]  Shadi Farsaei,et al.  Role of clinical pharmacists’ interventions in detection and prevention of medication errors in a medical ward , 2011, International Journal of Clinical Pharmacy.

[23]  David W Bates,et al.  Medication errors recovered by emergency department pharmacists. , 2009, Annals of emergency medicine.

[24]  K. Viktil,et al.  The impact of clinical pharmacists on drug-related problems and clinical outcomes. , 2008, Basic & clinical pharmacology & toxicology.

[25]  Jamie N. Brown,et al.  Effect of pharmacists on medication errors in an emergency department. , 2008, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[26]  J. McElnay,et al.  An innovative approach to integrated medicines management. , 2007, Journal of evaluation in clinical practice.

[27]  C. Raehl,et al.  Clinical Pharmacy Services, Pharmacy Staffing, and Hospital Mortality Rates , 2007, Pharmacotherapy.

[28]  J. Hughes,et al.  Design and analysis of stepped wedge cluster randomized trials. , 2007, Contemporary clinical trials.

[29]  Jeffrey L Schnipper,et al.  Clinical pharmacists and inpatient medical care: a systematic review. , 2006, Archives of internal medicine.

[30]  H. Cohen,et al.  A method for assessing drug therapy appropriateness. , 1992, Journal of clinical epidemiology.

[31]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance. , 2013, International journal of nursing studies.