Naqvi et al. Trials (2019) 20:488 https://doi.org/10.1186/s13063-019-3540-z STUDY PROTOCOL Open Access Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health- related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial Atta Abbas Naqvi1* , Mohamed Azmi Hassali1, Syed Baqir Shyum Naqvi2 and Muhammad Tariq Aftab3 Abstract Background: The objective of this study is to evaluate the effectiveness of pharmacist intervention in improving disease knowledge, adherence to treatment, health-related quality of life (HRQoL) and direct cost of treatment. The study also documents patient satisfaction with pharmacist counselling as a quality control measure. Methods/design: This is a randomized, single-blind, two-arm, controlled trial in patients with rheumatoid arthritis visiting outpatient rheumatology clinics in Karachi, Pakistan. We will enroll patients with established diagnosis of rheumatoid arthritis over 3 months. The patients would be randomized through a computer-generated list into the control group, i.e., usual care or into the intervention group, i.e., pharmaceutical care, in a ratio of 1:1, after providing signed written consent. The study will take place in two patient-visits over the course of 3 months. Patients in the intervention group would receive intervention from the pharmacist while those in the control group will receive usual care. Primary outcomes include change in mean score from baseline (week 0) and at follow up (week 12) in disease knowledge, adherence to medications and rehabilitation/physical therapy. The secondary outcomes include change in the mean direct cost of treatment, HRQoL and patient satisfaction with pharmacist counselling. Discussion: This is a novel study that evaluates the role of the pharmacist in improving treatment outcomes in patients with rheumatoid arthritis. The results of this trial could set the foundation for future delivery of care for this patient population in Pakistan. The results of this trial would be published in a peer-reviewed journal. Trial registration: ClinicalTrials.gov, NCT03827148. Registered on February 2019. Keywords: Pharmacist intervention, Knowledge, Medication adherence, Rehabilitation, Physical therapy, Quality of life, Direct cost, Rheumatoid arthritis, Pakistan * Correspondence: [email protected] 1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, 11800 Penang, Malaysia Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Naqvi et al. Trials (2019) 20:488 Page 2 of 11 Background Recent evidence that evaluates the pharmacist’s role in Rheumatoid arthritis (RA) is a chronic inflammatory dis- managing RA is scant. Moreover, to date there has been ease that mainly affects the joints and results in pain, no study conducted in Pakistan to evaluate this issue. swelling and decreased mobility. The disease leads to One has to look into the role and scope of pharmacy joint deformity and disability over time. The disease practice in Pakistan’s healthcare system to understand ranks third after osteoarthritis and gout as the major the need for such studies. Pharmacy services are still in cause of disability and affects roughly 1% of the global the developmental phase and have not attained the level population. Reduced mobility results in decreased prod- of healthcare delivery as in many economically devel- uctivity among patients and further worsens their quality oped and developing countries. Pharmacists are not in- of life [1]. While pharmacological treatment may be es- volved in patient care to a great extent and are mostly sential in managing the acute flares and episodic pain as- associated with dispensing medicines. There are several sociated with the disease, self-care and home-based barriers to the delivery of pharmaceutical care services management of RA is another important area of care in Pakistan [9]. The recognition of pharmacists as mem- that patients need to incorporate to effectively manage bers of allied health teams who are involved in direct pa- RA. tient care is limited and is still debated. Studies have Several studies have reported that self-care in RA ef- called for evaluation of the benefits of pharmacist inclu- fectively reduces acute flares [2, 3]. This could be done sion in direct patient care [10]. Cardiovascular and through patient education and counselling. Pharmacists endocrine illnesses are the leading cause of deaths in the provide pharmaceutical care that incorporates these Pakistani population. Studies have been conducted to re- areas of care. Pharmaceutical care is an individualized port the impact of pharmacist-led care in patients with patient-centric health service delivered by pharmacists endocrine and cardiovascular illnesses [11–13]. that incorporates, but is not limited to, disease educa- Musculoskeletal illnesses are a major contributor to tion, therapy management, self-care and self-manage- the individual’s decreased productivity, economic burden ment of disease, therapy and motivational guidance. and mobility. Unlike other noncommunicable diseases, Evidence from several randomized trials indicate these illnesses may not result in death. However, they that pharmacist-driven patient counselling, consult- are the most common cause of persistent pain and im- ation, disease education and advice, as well as tele- paired function [14]. They significantly decrease a per- phonic intervention, have improved patients’ self-care. son’s mobility, productivity and quality of life [15, 16]. Educating patients about managing RA empowers The most common musculoskeletal illnesses are osteo- them in understanding signs and symptoms of disease arthritis, RA and osteoporosis [14, 16]. Data from the In- and devising ways to reduce or limit aggravating fac- stitute of Health Metrics and Evaluation show that the tors. A randomized trial conducted by Petkova that prevalence of RA in Pakistan is 0.22% (0.22–0.25%). involved a community, pharmacy-based, patient edu- However, the figures for years lived with disability cation program and demonstrated improved treatment (YLDs) are high, i.e., 28.59 years (19.12–39.02), and for outcomes in patients with RA [4]. Moreover, Mary disease-adjusted life years (DALYs) were 39.64 years and colleagues demonstrated a positive effect of a (28.84–51.75). These figures further rise to 0.92 (0.52– mobile phone short message service on medication 1.69) deaths due to RA, 40.12 (26.73–54.81) YLDs and adherence in patients with RA [5]. A systematic lit- 56.67 (40.22–75.92) DALYs in female patients with RA. erature review by Leville and colleagues highlighted All figures were reported out of 100,000 patients [17]. the role of the pharmacist as an adviser on issues re- Since disease prevalence has increased in Pakistan of lated to medication management. The intervention late and mainly affects middle-aged individuals, it is ex- performed by pharmacists has shown improvement in pected to affect their productivity, employability and in- patients’ adherence to medication not only in rheum- come. This would worsen their health-related quality of atological conditions but also in other chronic ill- life and adds to the economic burden of this disease on nesses [6, 1]. Another randomized controlled trial society. Therefore, there is a need to evaluate the impact (RCT) by Clifford and colleagues reported a signifi- of pharmaceutical-care-based educational intervention cant drop in non-adherence to medication and in the delivered by the pharmacist on treatment outcomes in incidence of medication-related problems after a 4- Pakistani patients with RA. week follow up. This improvement was reported in patients with RA who had telephone intervention de- Objectives livered by the pharmacist [7]. Moreover, Stockl and The primary objective of the study is to evaluate the ef- colleagues reported improved adherence to medica- fectiveness of a multifactorial educational intervention tion in patients with RA who had telephone consulta- on patient knowledge of RA and adherence to treatment. tions with the pharmacist [8]. This intervention would be provided by a pharmacist. Naqvi et al. Trials (2019) 20:488 Page 3 of 11 The secondary objectives are to assess the impact of the CG. Patients’ baseline data will be recorded. Enrolled pa- intervention on the cost of treatment, quality of life and tients’ demographic data will be documented at baseline. patient satisfaction. Patients will have their anthropometric measurements, i.e., weight, height, etc. noted in addition to their socio- Trial design demographic data. Moreover, the patients will be This trial is designed as a randomized, single-blind, par- assessed for the outcome measures. The patients ran- allel group trial. It has two arms, i.e., a