Constructivism in innovative models of pharmaceutical care bridging administrative and clinical pharmacist intervention heart failure model

Abstract

Heart failure (HF) was the chosen case model since it is a major cause of death, highly morbid and costly. The quality of life and life expectancy of persons with heart failure can be improved with early diagnosis and treatment. The contribution of the multidisciplinary team can increase the quality of medical treatment, save medical costs and may reduce the need for hospitalisation. Pham1aceutical care is not just about expanding pharmacists' role but about a system that pharmacists help to establish and maintain. The aim of this study was to explore processes to develop a pharmaceutical contribution within evolving multidisciplinary patient-centred models of care adding a cost-effective continuous improvement of the standard of care provided to patients with chronic heart failure. The objectives of the study were to analyse the scenario of the services provided to Heart failure patients identifying gaps and the relevant solutions to establish the best system that could be adopted for standardisation of treatment inducing a better quality of life. After sharing local and international experiences the models of care were proposed and the relevant tools developed, translated, psychometrically evaluated and implemented. The tools designed included the following:

1. Medication Assessment Tool for heart failure - MAT-HF 2. The Minnesota Living with Heart Failure Questionnaire® (MLHFQ) and 3. 'Kwestjonarju ghall-Um tal-Medicina u I-pazjent' I Treatment Adherence Questionnaire (KUMP/TAQ)

Throughout the 780 hours of observation sessions, less than 4 patients in a week visited the HF clinic during 2009-2010. Thirty six patients attending the HF clinic had their medicines reviewed and care Issues were identified with respect to the medicine treatment being administered. Through a validated checklist and backward logical thinking, the gaps within the clinic and the service were identified and relevant actions suggested such as extending the clinic's service. An analysis was undertaken to assess the external and internal attributes affecting the system holistically. The set targets were outlined in a proposal to come up with a backbone for continuity of quality service in O1JeI to improve the care services provided to thc Heart Failure patients.

An extensive literature review was undertaken to identify evidenced-based pharmacotherapy for heart failure treatment management. The Medication Assessment Tool for heart failure (MAT-HF) was designed using an algorithmic structure with 11 criteria. Each criterion includes a qualifying statement and a standard with 6 possible different answer categories. The adherence score was measured by totalling the 'YES'

for each criteria divided by the sum of the applicable standards. The developed MAT- HF tool was validated by six clinical healthcare professionals and four scientists. The

feasibility and inter-rater reliability testing was undertaken by selecting ten patients through convenience sampling. The MAT-HF tool was handed out to an independent reviewer - a medical practitioner, who was duly informed of the methodology within the MAT-HF. The tool was deemed to be appropriate for its purpose with good face and content validity; the Kappa value resulted to be 0.78 (p<0.05) indicating good reproducibility. The average time taken to complete the MAT -HF was of 5-8 minutes for the researcher and approximately 10-12 minutes for the independent rater.

The Minnesota Living with Heart Failure Questionnaire was selected to assess quality of life in heart failure patients. The content of the questionnaire is concise and reflects

the heart failure condition and how the treatments can affect the physical, emotional, social and mental dimensions of quality of life. The questions are mainly coded using a 6-point Likert scale ranging from 0-5, measuring how much each of 21 dimensions prevented the patients from living as desired. A forward translation into Maltese was carried out, consensus meetings with the expert group followed and a backward translation by a linguistic academic was undertaken.

A novel tool to assess treatment adherence in sensitive conditions was compiled. The content of the questionnaire is concise and questions are coded using a 6-point Likert scale ranging from 0-5 to enhance internal consistency. The questionnaire is practical, short, easy to administer and eventually clear to understand. The adherence questionnaire's six possible answers include the range from "Never" to "Always": including in between 4 other variables to capture what the patient really feels and/or perceives. The tool is a 13 domain questionnaire with 12 single item questions and a question consisting of 7 subsections. The questions address patients and tackle condition knowledge, self-care, access to care, communication, and appropriate medicine use.

An expert panel enabled the enhancements of the MLHFQ and KUMP/TAQ questionnaires. The validity and inter-rater reliability was measured by the investigator and the independent assessor - heart failure nurse. Both questionnaires had positive expert review ratings and good face and content validity. The inter-rate reliability for the translated MLHFQ and the KUMP/TAQ were 0.78 and 0.89 respectively - both tools were classified as reproducible. Subsequently, the implementation of the model was undertaken on a patient population selected as per inclusion criteria through admission ward rounds undertaken with six selected clinicians over a three month period. Three hundred and twelve patients' treatment was reviewed and 50 patients were eligible to be assessed using all the tools in the care model. Twenty-one (42%) were males and 29 (58%) were females with a mean age of75.3 years. The average length of stay of the 50 patients was 9 days (5-20). Th~ MAT-Ill' was implemented during LHlmi~~ion ward round~ a::l::llx-}::ling the outcomes of pharmacist contribution to the team using pre (MAT-HFi) and post (MAT-HFp) scenanos.

On undertaking the pre-consultation action assessment using the MAT-HFi, a high adherence was obtained for the use of ACEls, diuretics and their respective monitoring indicating an effective individualized pharmacist contribution. On carrying MAT-HFp, the high adherence was observed for the general status and the anticoagulation treatment. The overall average of the MAT-HFi adherence score after the initial

assessment was 69% (confidence interval (Cl): 65%-74%) and the score for the MAT- HFp after the pharmacist contribution was 90% ( (Cl): 89%-92%) (p<0.05) .

The patients were interviewed once during their stay in hospital, since the MLHFQ questionnaire aims to gather information on the last 4 weeks of the patients' quality of life. The mean score was 27 (n=50) indicating moderate HRQOL (4-57). The treatment adherence questionnaire (KUMP/TAQ) was interviewed once and the mean score was 65.90 (n=50) indicating moderate treatment adherence (40-89). The likert scale of MLHFQ was invited to align the scoring of the KUMP/TAQ scale and combined to

give a total score considering quality of life and adherence. On analysing the mentioned variables there was a statistical significance of correlation within the MAT -HFi and the KUMP/TAQ (p<0.05) and the combined inverted MLHFQ score and the KUMP/TAQ score (p<0.05).

Upon focusing on the entitlement weaknesses the schedule V conditions were increased from :18 to 79 then 81 in 2014, regularizing the the misentitlements. One of the changes included the removal of doses from the entitlement card reducing bureaucracy and assisting patients besides avoiding the need for cardiology clinicians from refilling manual forms. The prescribing rights were also extended to medical practitioners for 5 conditions including systemic hypertension and heart failure. The formulary list was reviewed and mapped according to the schedule v conditions and an electronic application was issued accordingly. A project brief was also compiled for the Entitlement IT system.

With respect to the identified weaknesses in procurement, there was a constant reduction of medicine shortages since 2013, that is, from 56 it went down to an average of 1 item per week in 2016. This happened after mapping the existing functions and undertaking relevant business re-engineering such as adding a new dedicated team to monitor such shortages. Stock turnovers increased and demands by entities were forecasted with the help of regression analysis. Procurement processes are being streamlined according to the particular item and no one size fits all. Data sharing in the lack of an Enterprise Resource Planning has added better quality to the total quality management system of the procurement processes. Most of the weaknesses have been turned into strengths and all the opportunities were taken on board.

On analysing the hospital re-admissions in year 2015 (n=55) versus 2016 (n=51), the readmission rate of the total admitted population during the study period of January till April was reduced by 1.1 %, translating into a direct cost saving with respect to hospital bed night stay of Euro 8,256 (medical unit) - Euro 24,000 (critical care unit); as in 2016 a decrease of four re-admitted patients was observed when compared to 2015. Extrapolating this over the 12 month period this would sum up to a cost saving of Euro 24,768 (medical unit) - Euro 72,000 (critical care unit).

In this study an innovative concept of care models linking the administrative and clinical activities was identified and implemented. This innovative concept is being coined 'Integrated Collaborative Care Models'. The pharmaceutical care models are patient centred methods to deliver appropriate continuity of care through collaborative therapeutic management. Pharmacy practice is synonymous with bridge building. This research managed to adapt policies and financing schemes to models of care. This was possible through the analysis and identification of driving forces securing this transformational change, without losing focus from the patient.