The Impact of Clinical Pharmacist Intervention on Asthmatic Patient's Outcomes at the University of Gondar Comprehensive and Specialized Hospital, Northwest Ethiopia, 2022: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change in the level of asthma control
研究概览
简要总结
The goal of this trial is to determine whether or not clinical pharmacist led intervention for 3 months improves asthma control of asthmatic patients' outcomes as compared to the usual care 2023. The main question it aims to answer is does clinical pharmacist led interventions improve patient outcomes of asthmatic patients? Patients in the intervention group will receive a protocol-defined intervention at the start of the study and at the 1- , 3 and 6-month follow-up visits. Patients in the control group will receive the usual pharmacist care.
详细描述
There are poor patient outcomes in the study area as it is evident in previous studies where almost ninety five percent of patients had not well controlled Asthma. Moreover, the rate of non-adherence to inhalational anti asthmatics is high and more than half of asthmatic patients received inappropriate treatment. All those poor patient outcomes can be easily prevented and those studies have recommended that patient education and proper patient consultation to optimize the benefits of treatment by integrating clinical pharmacists. Thus, pharmacists are at sealing point at which most of medication information must be provided if a conducive system is created which can greatly improve patient's treatment outcome.
This study will generate strong evidence on the impact of clinical pharmacists at improving asthma control. It will also be an excellent tool in ascertaining and promoting what a well-trained clinical pharmacist can contribute to the health care through patient centered practice. Currently, there are a great number of clinical pharmacists who are wasting their knowledge and skill in a routine and traditional way of dispensing despite they are well trained to provide a patient centered care which in turn curb many limitations of a traditional way of dispensing with a minimal patient contact time and provision of in adequate information to them.
Despite the importance of clinical pharmacists services to the improvement of asthma outcomes, clinical pharmacists face many challenges in the involvement of asthma patients, such as poor awareness among general public, lack of specific legislation and recognition from other health care providers Previously done studies have shown that clinical pharmacist led interventions had improvements in asthma outcomes. However, evidence for different interventions is not totally conclusive; Therefore, the present randomized controlled trial will set up to study the hypothesis that such pharmacist intervention will result in an improved asthma control in adult patients over a 6-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessor assessing patient outcomes will be blind. The participants and the intervention providers (Clinical pharmacists) will not be blind for patient assignment to one of the trial groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older
- •Physician's diagnosis of asthma
排除标准
- •Participation in another asthma education program
- •Pregnancy
- •Communication difficulties
- •Seasonal asthma (asthma symptoms that only occur in a seasonal pattern)
- •Other pathologies such as COPD, emphysema, lung cancer, respiratory infection
- •Terminal illness (any disease that is reasonably expected to result in the patient's death)
- •Having an asthma control test level of <15 (indicating seriously uncontrolled asthma; for ethical reasons, these patients will be immediately referred ) or
- •Having an asthma control test level equaling 25 (indicating complete asthma control; no room for improvement) will be excluded from the study.
结局指标
主要结局
Change in the level of asthma control
时间窗: change in asthma control at 1,3 and 6 month
A blinded investigator will assess change in asthma control using the Asthma control test score (ACT). This is a clinically validated asthma control measure that consists of five questions with five alternative responses (classified by decreasing level of asthma control, scored from 5 to 1). The ACT score (range 5-25) is calculated by adding the responses to the five questions; the higher the score, the better asthma control. The ACT will be completed at randomization, as well as 1, 3, and 6 months later. Patients with a maximum score of 25 will be considered "completely controlled," while those with an ACT score of 20-24 will be considered as having "well-managed" asthma, and those with a score of 15-19 will be categorized as "uncontrolled" asthma.
次要结局
- change in Knowledge about disease and treatment(6 month)
- Improvement in Adherence level(6 month)
- Number of Drug therapy problems reduced(6 month)
- Number of exacerbations of asthma(6 month)
- Change in Inhalation technique skill(6 month)
- Change in Asthma Quality of life(6 month)
研究者
Eden Abetu Mehari
Principal investigator
University of Gondar