Medication Error

SHORT REPORT

Improving medication appropriateness in nursing home residents by enhancing interprofessional cooperation: A study protocol Dagmar Schaffler-Schadena, Stefan Pitzerb, Magdalena Schreierb, Johanna Dellingerb, Beate Brandauer-Sticklerb, Miriam Lainera, Maria Flamma, and Jürgen Osterbrinkb

aInstitute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria; bInstitute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria

ABSTRACT Polypharmacy in elderly people is an increasing challenge for health professionals. Drug-Drug interac- tions, dosing or administration errors can cause preventable incidents and hospitalizations. Due to chronic illness and multi-morbidity, older people are considered as a particularly vulnerable group of patients. Furthermore, it is well known that communication between health professionals is often insufficient. The aim of this study is to improve the appropriateness of medication of nursing home residents by establishing a long-term structured medication review process and to enhance the inter- professional communication between general practitioners (GPs), nurses and pharmacists. GPs review and adapt medication of residents, nurses perform structured monitoring of residents for drug-related symptoms. Pharmacists check the appropriateness of prescribed therapy by performing a medication analysis. For this purpose, a special electronic platform (SiM-Pl) is developed to extend the original health documentation system with additional tools. SiM-Pl enables participants to gain access to relevant information regardless of time and place and shall facilitate health documentation and exchange of information. All involved health professionals receive a topic-related, specific education. The study is designed as a non-randomized, controlled trial. Health-related benefits and improved quality of life are expected for the participating residents.

ARTICLE HISTORY Received 7 July 2017 Revised 4 December 2017 Accepted 1 March 2018

KEYWORDS Interprofessional communication; medication review; nursing home residents; polypharmacy

Introduction

The incidence of chronic illnesses and multi-morbidity is higher in elderly people and exposure to inappropriate med- ication is common in this group of patients. Adverse drug events can lead to pathologic conditions or even hospital admissions, a challenge that the involved health professionals are faced with daily (Patel, Patel, Patel, Naik, & Tripathi, 2017). The importance of good communication between healthcare professionals for the clinical outcome of patients is well known (Rice et al., 2010). Nevertheless, interprofes- sional communication and cooperation are often insufficient, with deficiencies in clinical documentation and exchange of information leading to potentially harmful consequences in patient care (Wilson, Palmer, Levett-Jones, Gilligan, & Outram, 2016).

The SiMbA (Sicherheit der Medikamententherapie bei Altenpflegeheimbewohnern – ‘safety of drug therapy in nur- sing home residents’) study aims to improve appropriateness of medication in nursing home residents by implementing a long-term structured medication review process and intends to enhance the interprofessional communication and coopera- tion between general practitioners (GPs), pharmacists and nurses to improve safety of drug therapy in nursing homes.

The study will have the following research questions: Is it possible to improve the appropriateness of nursing home residents` medication by complex intervention in the SiMbA study? Can the SiMbA intervention encourage a change in interprofessional communication and cooperation? Can the SiMbA intervention furthermore help to alleviate symptoms associated with drug therapy like delirium, restricted mobility, and poor nutritional status?

Methods

Study type and study population

The study is designed as a non-randomized, controlled trial. Nursing homes and hence their residents are non-randomly assigned to the interventional or control group to minimize the risk of contamination bias due to close structural and personal relationships within and between potentially partici- pating nursing homes (one common holding company).

The study will be conducted in nursing homes in Austria for a duration of 2.5 years. The population includes general practitioners and their patients in nursing homes, the nursing staff of the participating nursing homes and the providing pharmacists.

CONTACT Dagmar Schaffler-Schaden dagmar.schaffler@pmu.ac.at Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Strubergasse 21, 5020 Salzburg, Austria. Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/ijic.

Supplemental data for this article can be access on the publisher’s website.

JOURNAL OF INTERPROFESSIONAL CARE 2018, VOL. 34, NO. 2, 517–520 https://doi.org/10.1080/13561820.2018.1448372

© 2018 Taylor & Francis

Recruitment and inclusion criteria

Recruitment of study participants includes several steps: GPs who have a treatment contract with residents in participating nursing homes are contacted primarily. They inform their patients and invite them to participate in the SiMbA study. Participation of nursing staff and providing pharmacists depends on successfully recruiting at least one GP and his or her patients per nursing home. All residents or their legal representatives as well as all participating professionals have to give informed consent.

Inclusion criteria for nursing home residents are, at least 65 years old, written informed consent of the resident or legal representative, at least one prescription, no acute life- threatening situation or isolation due to multidrug-resistant infectious diseases. Inclusion criteria for health professionals: GPs treating patients in nursing homes, pharmacists provid- ing medication to nursing homes and nurses with at least 50% part-time employment.

Data collection and outcomes

SiMbA utilizes quantitative face-to-face and self-administered assessments as well as data from the nursing homes` docu- mentary system about medical conditions of residents to collect data for the following primary and secondary outcomes:

● Primary outcome: Appropriateness of medication mea- sured by the medication appropriateness index, (MAI) (Hanlon & Schmader, 2013) . The MAI is an assessment instrument to evaluate the appropriateness of a patients` medication. The Mai score includes 10 items (e.g. indi- cation for the drug, correct dosage of the drug, drug- drug interactions, drug-disease interactions and other), the summated MAI scores will be calculated by a clinical pharmacist. For the calculation of the MAI the current diagnoses and complete medication lists of the residents are required.

● Secondary outcomes: Assessment of the residents’ mobi- lity and tendency of falls, occurrence of delirium, the registration of potential malnutrition and the evaluation of health related quality of life (Table 1 – see online supplementary file).

The improvement of cooperation and communication between the participating health care professionals will be investigated via qualitative individual interviews. The MAI scoring will be carried out by independent clinical pharmacists.

Data collection will be performed at t0 (baseline data collection), at t1 (after 12 months) and at t2 (after 18 months). The collection and evaluation of the endpoint data sets at t0, t1, and t2 will be conducted by trained study nurses and the SiMbA project team.

Intervention

The study intervention is semi-standardised and includes three components. First, education for GPs, nurses, and

pharmacists focusing on pharmacotherapy in older adults, drug risk management and related topics—combined as pro- blem-based, interprofessional face-to-face and specific online teaching suitable for each group, respectively. The training is accredited and finishes with a multiple choice testing. The training is divided into three parts, for those who are not able to participate onsite, all lectures are video-recorded. The training lectures are designed and conducted by a multipro- fessional team consisting of two clinical pharmacists, one nursing scientist and one specialist in internal medicine with particular expertise in polypharmacy. The training starts with an event with compulsory attendance for all professionals together. This first meeting lasts about three hours and includes the following topics: special characteristics of phar- macotherapy in the elderly, pharmacokinetics and dynamics, adverse drug reactions, medication errors, medication review process and various legal aspects (e.g., mandatory reporting of adverse drug events). The e-learning sessions are specially designed for GPs, nurses, and pharmacists. For that purpose, all participants gain access to the online learning platform of the Paracelsus Medical University and are invited to complete the online training before taking part in the third section of the training. The training is completed after another onsite session with all professional groups. This second meeting focuses on the handling of the SiM-Pl online tool. A telephone hotline will be available to study participants who have ques- tions concerning the online platform, too.

Second, an online tool, the SiMbA-Platform (SiM-Pl), is introduced to improve the structured exchange of information and medication review between healthcare professionals. It is the key tool for the interprofessional therapy check process. The nursing staff of the participating homes within the SiMbA study is already using a structured digital documentation sys- tem. With the integration of SiM-Pl, the original documentary system is extended by additional tools to avoid unnecessary duplication. GPs and pharmacists can check and edit informa- tion regardless of place and time using mobile devices. Obligatory documentation for GPs and nurses shall be facili- tated by SiM-Pl. GPs may access patient information via the platform easily. Changes within medication may be transferred to nursing staff immediately. Use of data is secured electroni- cally and each professional gets an individual key access. The platform meets current data protection regulations.

Third, medication of nursing home residents is checked by a structured medication review process including the three professional groups via SiM-Pl (Figure 1 - see online supple- mentary file). After completion of the specific education pro- gramme mentioned above, GPs check and if necessary adapt the medication lists of their respective participating patients within SiM-Pl. Medication lists are then released to the care staff. As a next step within the process, pharmacists perform a structured medication analysis type 1 (Bundesvereinigung Deutscher Apothekerverbände, 2014). The medication analy- sis type I may reveal drug-drug interactions, double prescrip- tions, a potential inadequate time of administration or dosing interval. The GPs may consider the pharmacists’ recommen- dation regarding a medication modification and inform nurses and residents. Feedback to the pharmacists from the GPs whether the medication is changed after the analysis or

518 D. SCHAFFLER-SCHADEN ET AL.

not seems useful. The information exchange is performed via SiM-Pl and becomes immediately apparent in the documen- tary system. Nurses perform a systematic observation of resi- dents particularly with regard to possible side effects of the drug therapy. For this purpose, the therapy monitoring form (Thürmann & Jaehde, 2015) is adapted for the study. The therapy monitoring form was developed by a German research team to document notable symptoms possibly related to a change of medication. The monitoring form is available via SiM-Pl and includes items as mentioned below. Monitoring of the residents after alteration or new prescrip- tion of medication shall be performed daily during 5 days by nurses and includes the following items: allergic reactions, bleedings, gastrointestinal, cardiovascular and respiratory symptoms, neurologic and psychiatric symptoms, as well. Noticeable symptoms are documented and reported to the GPs via SiM-Pl. As long as there is no change of medication, regular monitoring will be performed by nurses once a week. GPs and nurses can request medication analysis whenever they see a need for it via SiM-Pl.

The therapy check process is divided into two phases: Within the first 12 months, study participants will be accompanied by the study team closely. In the second phase between t1 and t2, study participants should be able to continue the medication check process without the support of the project team.

Control group

The included residents in nursing homes receive usual care by nurses, general practitioners, and pharmacists, respectively.

Hypothesis and required sample size

Based on existing evidence within literature and considering the assessment inherent weighting of important items of medication appropriateness, the minimal important difference was defined for the primary outcome MAI as 3.0. We hypothesize, that the interventional group will show at least a −3.0 points better MAI- score compared to the control group at t1 and, therefore, an increased appropriateness of prescribed medication. We expect that the SiMbA interven- tion positively influences known health-related outcomes which had been associated with inappropriate medication (risk of unintentional weight loss, delirium, health-related quality of life and mobility).

Furthermore, interprofessional collaboration and commu- nication between GPs, nurses, and pharmacists shall be improved in the interventional group. All mentioned improvements are expected to persist at the third data collec- tion point (t2). The required sample size is calculated for the minimal important difference of MAI as n = 29 per group (α = 0.05; β = 0.20). Considering an expected dropout rate of 37% (death of residents during the study period, refusal to stay in the study), reaching n = 29 at t2 requires a sample size of 46 per group at t0. Since refusal to participate is assumed to be 75% in physicians and 50% in residents, n = 46 at t0 is reached, if the recruitment of GPs, which care for a total of 369 nursing home residents, is attempted.

Ethical considerations

All study participants or their legal representatives have to give informed consent. SiM-PL meets current legal data protection requirements in Austria. The study was approved by the ethics committee of lower Austria (GS4-EK-4/377–2016) and Carinthia (MZ 24/16) and the SimbA study protocol was regis- tered via DRKS (DRKS00012246)

Discussion

Unplanned hospitalizations of elderly people can be related to preventable adverse drug reactions (Albert, Colombi, & Hanlon, 2010) and polypharmacy in elderly people can be associated with impaired physical and mental health (Jyrkka, Enlund, Lavikainen, Sulkava, & Hartikainen, 2011). Improving relevant health outcomes and health-related qual- ity of life of nursing home residents is, therefore, the main goal of the interventions of the SiMbA study. Drug surveil- lance and adaption of the most complex medication in multi- morbid patients can be a challenging process for all healthcare professionals involved (Ferrah, Lovell, & Ibrahim, 2017). Errors may occur in several fields of the therapeutic treatment chain - prescription, transcription, ordering, dispensing or administration of medication. The SiMbA project will enable the involved professionals to perform a structured surveillance of the medication. Moreover, GPs can benefit from the com- petent support of pharmacists and pharmacists have the opportunity to bring in their expertise in the complex medical treatment of multi-morbid patients, respectively. According to our experience, the expertise of pharmacists is often not included in a structured medication process (Costa, Van, Abbott, & Krass, 2015). A recent German study has shown that GPs would welcome the competent support of a pharma- cist in the complex medical treatment of multi-morbid patients (Loffler et al., 2017). Subsequently, the communica- tion and cooperation of the involved health professionals would be improved by using the SiM-Pl online tool.

Declaration of interest

The authors report no conflicts of interests. The authors alone are responsible for the content and writing of this article.

Funding

This study is funded by Senecura Kliniken-und Heimebetriebs GmbH, Austria.

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