The Impact of Clinical Pharmacist Intervention on Asthmatic Patient's Outcomes

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Clincal pharmacist intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eden A Mehari, Msc; Phone Number: +251988214167; Email: edenabetu@gmail.com

Study Locations

• Ethiopia
  • Gondar, Ethiopia
    • Recruiting
    • University of Gondar Specialized and Comprehensive Hospital
    • Contact: Eden A Mehari, Msc; Phone Number: +251988214167; Email: edenabetu@gmail.com
    • Contact: Abrham W Dagne, PhD; Email: leabrham@gmail.com
    • Principal Investigator: Eden A Mehari, Msc &MPH
    • Sub-Investigator: Abrham W Dagne, PhD
    • Sub-Investigator: Esileman A Muche, Msc
    • Sub-Investigator: Sewnet A Kebede, MPH
    • Sub-Investigator: Gebrehiwot L Legese, MD
    • Sub-Investigator: Faisel D Sema, Msc
    • Sub-Investigator: Gizework A Mekonnen, Msc
    • Sub-Investigator: Rahel B Abebe, Msc
    • Sub-Investigator: Abebech T Gelaye, Msc
    • Sub-Investigator: Leila K Kemal, Msc
    • Sub-Investigator: Abdulwase M Seid, Msc
    • Sub-Investigator: Abdisa G Jara, Msc
    • Sub-Investigator: Abiyot E Gurmu, Msc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age of 18 years or older
• Physician's diagnosis of asthma

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients in the intervention group will receive a protocol-defined clinical pharmacist intervention at the start of the study and at the 1- , 3 and 6-month follow-up visits.	Behavioral: Clincal pharmacist intervention; 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 for education on disease and treatment 40 minutes, administration and dosage 6 minutes, drug interaction and other drug therapy problems 20 minutes for a total of 66 minutes. The intervention will include education about asthma triggers and the need of minimizing them, asthma symptoms, warning signs, proper inhalation use technique, cigarette smoking cession when appropriate, the need of adherence and they will also counseled to wash their mouth after the use of controller medications. In addition, pharmaceutical care evaluation will be carried out and any drug therapy problems will be addressed accordingly and finally every intervention provided will be recorded.
No Intervention: Control; Patients in the control group will receive the usual pharmacist care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of asthma control	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.	change in asthma control at 1,3 and 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of exacerbations of asthma	Asthma exacerbation is one that necessitates the use of oral glucocorticoids, as well as a trip to the emergency room or hospitalization	6 month
Improvement in Adherence level	Two validated measures of adherence will be used to assess adherence throughout the study: prescription refill rates and self reporting. During the trial period, the number of units of controller medicine provided to each patient will be documented, and adherence will be computed. The test of adherence to inhaler instrument (TAI) will be used to assess self reported adherence at the end of the trial (TAI).) The TAI is a reliable and homogeneous questionnaire to identify easily non-adherence and to classify from a clinical perspective the barriers related to the use of inhalers in asthma TAI scores 50, 46-49 and less than 45 will be considered as adherent, intermediate adherent and non-adherent respectively.	6 month
Change in Inhalation technique skill	The inhalation technique will be rated using an eight-point checklist for metered dosage inhalers (MDI). One point will be awarded for each correct step, and the total score for the inhalation technique will be given as a percentage of correct steps. Patients who make serious inhalation technique errors (failure to remove cap and/or shake MDI; failure to load device and/or inhale fast and deeply via device ) will be given a sum score of zero. For ethical reasons, such major errors will also be corrected in patients belonging to the control group. Good MDIs use technique: when patients respond to greater than or equal to seven the mean score of MDIs use technique (≥70%). Poor MDIs use technique: when patients respond to less than seven the mean score of MDIs use technique (< 70%).	6 month
change in Knowledge about disease and treatment	An updated version of the Knowledge of Asthma and Asthma Medicine questionnaire will be used to assess patients' knowledge of asthma and its treatment at the start of the intervention period and after the 6-month follow-up.	6 month
Number of Drug therapy problems reduced	Using the PCNE(Pharmaceutical Care Network Europe) Classification tool Version 6.2 from Pharmaceutical Care Network Europe (PCNE) drug therapy problems will be identified. The PCNE V 6.2 has four primary issue domains, eight primary cause domains, and five primary intervention domains. There are 37 grouped sub-domains for causes, 9 grouped sub-domains for problems, and 17 grouped sub-domains for effects.Pharmaceutical care evaluation will be carried out and any drug therapy problems will be addressed accordingly.	6 month
Change in Asthma Quality of life	Asthma-specific quality of life will be assessed at the start of the intervention period and after the 6-month follow-up period using the Standardized Asthma Quality of Life Questionnaire (AQLQ(S)).	6 month

Collaborators and Investigators

• Sponsor: University of Gondar
• Investigators: Principal Investigator: Eden A Mehari, Msc, University of Gondar

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: June 27, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Asthma; ASTHMA-PHAR; Clinical pharmacist led intervention
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ASTHMA-PHAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A deidentified analytical dataset will be posted in an open access repository upon study completion.
• IPD Sharing Time Frame: The time frame will start from the time when summary data are published or start 6 months after publication.
• IPD Sharing Access Criteria: PD and additional supporting data information will be shared through open-access journals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No