Home » Trials » SLCTR/2019/039
A randomised control trial to evaluate the impact of a clinical pharmacist on optimizing the quality use of medicines according to the Acute Coronary Syndrome (ACS) secondary prevention guidelines and medication adherence following discharge in patients with ACS
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SLCTR Registration Number
SLCTR/2019/039
Date of Registration
The date of last modification
Oct 25, 2024
Trial Status
Scientific Title of Trial
A randomised control trial to evaluate the impact of a clinical pharmacist on optimizing the quality use of medicines according to the Acute Coronary Syndrome (ACS) secondary prevention guidelines and medication adherence following discharge in patients with ACS
Public Title of Trial
Assessment of the impact of a clinical pharmacist compared to standard care in improving quality use of medicines, patient adherence and reducing hospital readmissions in patients diagnosed with acute coronary syndrome
Disease or Health Condition(s) Studied
Acute Coronary Syndrome
Scientific Acronym
None
Public Acronym
None
Brief title
Impact of a clinical pharmacist in improving quality use of medicines, patient adherence and reducing hospital readmissions in patients diagnosed with ACS
Universal Trial Number
U1111-1241-1907
Any other number(s) assigned to the trial and issuing authority
2019/EC/26
What is the research question being addressed?
Does the intervention of a clinical pharmacist in patients with ACS improve quality use medicines, patient adherence and reduce hospital readmissions?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Applicable
Intervention(s) planned
The study will be conducted at the Medical wards of Teaching hospital Peradeniya. The patients will be randomized into control and intervention groups by block randomization method. There are four sections (A, B, C, D) in the medical wards at TH Peradeniya. Patients in the section A, B will be considered as the control group and patients in section C, D will be considered as the intervention group for the first three months of data collection. The sections will be swapped for the next three months. This method is planned to minimize the contamination of control groups by having intervention patients within the same section. The intervention will be delivered by the principle investigator, and a qualified pharmacist will assist the process. Interventions planned • Medication history will be recorded by the clinical pharmacist at the time of recruitment and it will be reconciled against the inward medication plan. • Patients medication adherence will be assessed at the time of recruitment by using a validated adherence assessment tool (Brief Medication Questionnaire). • Continuous medication review by the clinical pharmacist daily during the patients stay at the ward and discharge medication review at the time of discharge. BNF, AMH and ACS therapeutic guidelines will be used for the review. • Identification and resolution of medication related problems (Wrong drug choice, wrong dose, drug interactions etc.), • Discharge medication counselling with written information and labelled medicine by the clinical pharmacist. • Follow up after discharge at 1 month, 3 months and 6 months intervals by the clinical pharmacist at the medical clinic. • Hospital readmissions, changes to medications, adverse drug reactions will be checked during the respective period at each follow up and medication related issues will be resolved at the follow-ups. • At the end of the study period (6 months after follow up) patients medication adherence will be reassessed using the same tool to check the improvement.
Inclusion criteria
Male and female patients above 18 years of age who are diagnosed and managed as ACS by the medical team will be considered as the study population in this study
Exclusion criteria
Patients who refuse to participate Patients who are diagnosed with psychological disorders Patients who are younger than 18 years Patients who are pregnant
Primary outcome(s)
|
1.
1) Number of hospital readmissions due to acute coronary syndrome related issues during the study period |
[ At the end of the followup period (six months after discharge) ] |
|
2.
2) Changes in medication adherence. (Patients medication adherence will be compared between the time of recruitment and end of study at six months after discharge using a validated tool (Brief Medication Questionnaire) |
[] |
Secondary outcome(s)
|
1.
Number of Drug related problems |
[ At the end of the followup period (six months after discharge) ] |
|
2.
Number of adverse drug reactions during the study period |
[ At the end of the followup period (six months after discharge) ] |
|
3.
Cost effectiveness of clinical pharmacist intervention |
[ At the end of the followup period (six months after discharge) ] |
Target number/sample size
340 patients in the control arm and 340 patients in the intervention arm
Countries of recruitment
Sri Lanka
Anticipated start date
2019-11-12
Anticipated end date
2021-03-10
Date of first enrollment
2019-11-15
Date of study completion
2022-03-10
Recruitment status
Complete: follow up complete
Funding source
Self funded
Regulatory approvals
Status
Approved
Date of Approval
2019-07-05
Approval number
2019/EC/26
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Faculty of Medicine, University of Peradeniya, Peradeniya |
| Telephone: | 0812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
N. M. Y. Bagyawantha
Lecturer (Probationary)
Department of Pharmacy, Faculty of Allied Health Sciences, University of Peradeniya, Peradeniya
0812065792
0712179296
bagyawanthanmy@gmail.com
Contact Person for Public Queries
Dr A C M Fahim
Head
Department of Pharmacy, Faculty of Allied Health Sciences, University of Peradeniya, Peradeniya
0814479822
0777664285
fahim.cader@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Yes
Date of posting results
Date of study completion
2022-03-10
Final sample size
323
Date of first publication
Link to results
Brief summary of results
A total of 365 patients were enrolled in the study and most of them were older male (55%, mean age 62.68 years). Both groups showed poor baseline medication adherence and DRPs were detected successfully in both groups. Most (60%) of the suggestions provided by the clinical pharmacists to resolve DRPs and optimize medications were accepted by the treating team. The discharge medication appropriateness of the intervention group was significantly higher compared to that of control group (p<0.0001). Medication adherence at six-months post discharge was improved considerably in the intervention group (by 49.3%) compared to that of control group (by 18.8%)
