A Randomised Controlled Trial to Compare MedBook Portal and Standard Care in Medication Reconciliation at Transitions of Care From Hospital Discharge to Primary Healthcare Settings
Phase: NA
Conditions: Medication Reconciliation
Sponsor: Ministry of Health, Malaysia

1 
NMRR-22-02409-ODX 
NCT06517160 
 
 
 
 
 
            23 November 2022 
STUDY PROTOCOL & STATISTICAL ANALYSIS PLAN 
OFFICIAL TITLE 
A Randomised Controlled Trial to Compare MedBook Portal and Standard Care in Medication 
Reconciliation at Transitions of Care from Hospital Discharge to Primary Healthcare Settings 
 

2 
TABLE OF CONTENTS 
 
 
Page 
RESEARCH TITLE 
1 
TABLE OF CONTENTS 
2 
LIST OF TABLES 
5 
LIST OF FIGURES 
6 
LIST OF ABBREVIATIONS 
7 
CHAPTER 1 INTRODUCTION 
8 
1.1 
Study Background 
8 
1.2 
Problem Statement 
8 
1.3 
Research Question 
10 
1.4 
Objectives 
10 
1.5 
Study Hypotheses 
11 
1.6 
Conceptual Framework 
14 
1.7 
Significance of Research 
15 
1.8 
Chapter Summary 
16 
CHAPTER 2 METHODOLOGY 
17 
2.1 
Study Design 
17 
2.2 
Operational Definition of Terms 
17 
2.2.1 Medication Discrepancies 
17 

3 
2.2.2 Intentional Medication Discrepancy 
17 
2.2.3 Unintentional Medication Discrepancy 
17 
2.2.4 Types of Medication Discrepancies 
18 
2.3 
Study Population 
24 
2.4 
Study Sample and Locations 
24 
2.4.1 Inclusion criteria 
25 
2.4.2 Exclusion criteria 
25 
2.4.3 Withdrawal criteria 
25 
2.5 
Sample Size Calculation 
26 
2.6 
Study Duration 
27 
2.7 
Data and Instruments 
28 
2.7.1 Data Collection Form 
28 
2.7.2 MedBook Portal 
28 
2.7.3 MedBook Portal Notice 
30 
2.8 
Recruitment 
31 
2.9 
Medication Reconciliation Upon Hospital Discharge 
31 
2.10 
Randomisation and blinding 
31 
2.11 
Intervention Group 
32 
2.12 
Control Group 
33 
2.13 
Data Collection 
33 
2.14 
Outcomes 
37 

4 
2.15 
Data Analysis 
38 
2.16 
Chapter Summary 
39 
CHAPTER 3 GANTT CHART 
40 
3.1 
Gantt Chart 
40 
REFERENCES 
42 
APPENDICES 
44 
 

5 
LIST OF TABLES 
 
 
Page 
Table 1.1: 
Study Hypotheses 
12 
Table 2.1:  Description And Example Of Each Type Of Medication Discrepancy 
Identified During Medication Reconciliation At Hospital Discharge 
19 
Table 2.2:  Description And Example Of Each Type Of Medication Discrepancy 
Identified During Medication Reconciliation At The First Follow-Up At 
Health Clinics After Discharge From The Hospital 
21 
Table 2.3: 
Public Major Hospitals and Health Clinics Involved in this Study 
24 
Table 2.4:  Sample Size Allocation Of Each Hospitals 
27 
Table 2.5: 
Schedule of Enrolment, Interventions and Assessments 
35 
Table 3.1: 
Gantt Chart 
41 
 

6 
LIST OF FIGURES 
Page 
Figure 1.1:  Conceptual Framework 
14 
Figure 2.1: Example of medication discrepancies detected during medication 
reconciliation 
23 
Figure 2.2:  MedBook Portal in smartphone version 
29 
Figure 2.3:  MedBook Portal in computer version 
30 
Figure 2.4: MedBook Portal Notice 
30 
Figure 2.5: Study Flow Chart 
36 
 

7 
LIST OF ABBREVIATIONS 
 
 
BD 
Twice Daily 
HC 
Health Clinic 
MR 
Modified Release 
PRN 
When necessary 
OD 
Once Daily 
TDS 
Three times a day 
 
 
 
 
UNIMAS 
Universiti Malaysia Sarawak 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

8 
CHAPTER 1  
 
 
INTRODUCTION 
1.1 
Study Background 
The complex processes and human interactions involved in transitions of care between 
different healthcare settings harbour a great risk of medication errors, particularly among 
patients with multiple comorbidities and complex medication regimens. Medication 
reconciliation is thus one of the key strategies to improve medication safety across transitions 
of care. It is the formal process of creating the accurate and complete list of medications 
through the partnership between healthcare providers and patients at all interfaces of cares to 
reduce potential medication errors and patient harm (1). 
The four steps involved in medication reconciliation are: (1) verification: obtain the current 
medication list; (2) clarification: check the medication dosages; (3) reconciliation: compare 
and document newly prescribed and previous medications and (4) transmission: communicate 
the updated and verified medication list to the next healthcare provider (1). These processes 
involve multiple stakeholders (doctors, nurses, pharmacists, and patients) and all parties are 
interdependent and accounted to improve transitional care medication safety. 
1.2 
Problem Statement  
Numerous studies showed that medication discrepancies and errors are prevalent during 
admission and discharge (2, 3). Reconciliation of patient’s past medications upon admission 
has been an established routine for more than a decade among clinical pharmacists, especially 
in the general medical wards at tertiary healthcare institutions in Malaysia. Nonetheless, 
medication reconciliation upon and after hospital discharge has not been implemented in a 

9 
structured process, potentially putting patients at risk of medication errors during transitions of 
care from hospital to the primary healthcare setting. 
Very often, local healthcare providers find it difficult to retrieve previous medical records as 
the healthcare information system has not been integrated across the healthcare facilities in 
Malaysia. This problem gets worse when patients do not compile and keep their discharge 
summary properly when they are discharged and followed up at the primary health clinics. 
Tracing the record is either involving a lengthy process or to no avail due to vague information 
provided by the patient or caregiver. The referred facility could have continued with the 
previous medications without knowing the patient’s latest disease state. Thus, scattered sources 
of medication information among different levels of care and lack of integrated computerised 
healthcare information system pose a great challenge to ensure medication safety. Besides the 
above barriers, some other potential predictive factors associated with medication errors were 
patient characteristics, clinical conditions, number of medications, specific pharmacological 
agents, length of hospital stay and inexperienced prescribers (4). 
To the best of our knowledge, there has been no study conducted in Malaysia, that aims to 
reduce the medication errors when patients were discharged from a tertiary or secondary 
hospital to primary health clinic. Past studies conducted in western countries provided limited 
generalizable evidence on the efficacy of their interventions in dealing with the problem in 
local context due to different healthcare delivery system and practices (5, 6). In addition, 
relevant studies conducted in Malaysia merely explore the prevalence and factors contributing 
to the problem and the perception of stakeholders on the feasibility of implementing medication 
reconciliation program upon hospital discharge (7, 8). Hence, this warrants the development of 
an effective measure to overcome the problem. Apart from exploring the prevalence and 
predictors of medication discrepancies upon discharge, an innovative intervention that aims to 

10 
reduce the medication discrepancies upon transition of care will also be introduced and 
implemented at the major divisions in Sarawak as our first move. 
1.3 
Research Question 
The research question of the current study is “is MedBook Portal effective in reducing 
medication discrepancies upon transition of care from hospitals to primary health clinics?”. 
1.4 
Objectives 
In general, this study aims to assess the prevalence of medication discrepancies in the first 
prescription upon transition of care from hospitals to primary health clinics, comparing 
MedBook Portal to standard care.  
In specific, this study aimed: 
i. 
To assess the prevalence of medication discrepancies in the first prescription 
upon transition of care from hospitals to primary health clinics, comparing 
MedBook Portal to standard care.  
ii. 
To determine the prevalence of the type of medication discrepancies in the first 
prescription upon transition of care from hospitals to primary health clinics. 
iii. 
To determine the prevalence of the type of medication discrepancies in 
discharge prescription.  
iv. 
To identify the predictors associated with medication discrepancies in the first 
prescription upon transition of care from hospitals to primary health clinics. 
v. 
To identify the predictors associated with medication discrepancies in discharge 
prescription. 
 
 

11 
1.5 
Study Hypotheses 
The study hypotheses are formulated based on the study specific objectives. For the first 
specific objective, the hypothesis is about the impact of MedBook Portal on the prevalence of 
medication discrepancies in the first prescription upon transition of care from hospitals to 
primary health clinics.  
In terms of the second and third objectives, the hypotheses are based on the previous study 
conducted the hypotheses are based on the previous study conducted by Law and Chong (2017) 
in Malaysia. This study reported 49% of the discharge prescription were found to have a least 
one medication discrepancies (8).  
For the fourth and fifth specific objectives, there are five variables are included as the secondary 
outcome of the study, namely age of patient, number of comorbidities, number of medications, 
type of medication (ATC categorization), and experience of prescriber (category of prescriber). 
All the five secondary outcomes are hypothesized to be the predictors of medication 
discrepancies. The hypotheses are tabulated in Table 1.1.  
 
 
 
 
 
 
 

12 
Table 1.1: Study Hypotheses 
Specific objective 1: To assess the prevalence of medication discrepancies in the first 
prescription upon transition of care from hospitals to primary health clinics, comparing 
MedBook Portal to standard care. 
H1a 
There will be a significant difference of medication discrepancies rates between 
the intervention group and the control group after the intervention. The estimated 
difference of the medication discrepancies rates is 15%, with intervention group 
having lower medication discrepancies rates than control group. 
Specific objective 2: To determine the prevalence of the type of medication discrepancies 
in the first prescription upon transition of care from hospitals to primary health clinics. 
H2a 
The prevalence of each type of medication discrepancy ranges from 5 – 60%, 
with Drug omission as the most common medication discrepancy in the first 
prescription upon transition of care from hospitals to primary health clinics. 
Specific objective 3: To determine the prevalence of the type of medication discrepancies 
in discharge prescription. 
H3a 
The prevalence of each type of medication discrepancy ranges from 5 – 60%, 
with Drug omission as the most common medication discrepancy in discharge 
prescription. 
Specific objective 4:  To identify the predictors associated with medication discrepancies 
in the first prescription upon transition of care from hospitals to primary health clinics. 
H4a 
There is a significant association between age of patient, number of 
comorbidities, number of medications, type of medication (ATC categorization), 
experienced of prescriber (category of prescriber) and medication discrepancy in 
the first prescription upon transition of care from hospitals to primary health 
clinics. 
 
 

13 
continued 
Specific objective 5:  To identify the predictors associated with medication discrepancies 
in discharge prescriptions. 
H5a 
There is a significant association between age of patient, number of 
comorbidities, number of medications, type of medication (ATC categorization), 
experience of prescriber (category of prescriber) and medication discrepancy in 
discharge prescription. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

14 
1.6 
Conceptual Framework 
The conceptual framework of the study is based on the rationale and design of the “Multicenter 
Medication Reconciliation Quality Improvement Study” (MARQUIS) (9). Bidirectional 
medication information transfer across settings via electronic health records shall ease the 
medication reconciliation process. Subsequently, a reduction in medication discrepancy will 
be the outcome of the study. In addition, predictors correlated with medication discrepancies 
might impact the prevalence of medication discrepancies. Figure 1.1 depicts the conceptual 
framework of the study.  
 
 
 
 
 
 
 
 
 
 
 
Prevalence 
of 
Medication 
Discrepancy 
Medication 
Reconciliation 
Predictors  
• Age of patient 
• Number of comorbidities 
• Number of medications 
• Type of medications 
• Category of prescriber 
MedBook 
Portal 
Figure 1.1:  
Conceptual Framework 

15 
1.7 
Significance of Research 
Proper documentation in hospital discharge summary is essential to ensure continuity of care 
as patient is involved in multiple care transitions. At hospital discharge, reconciliation is done 
by checking pre-admission medication list and inpatient medication chart prior to the 
finalisation of the discharge medication list. Pharmacists serve as the last row of defence to 
ensure the accuracy of the prescribed medications, couple with discharge counselling to 
enhance medication understanding and adherence. 
In Sarawak, every patient who undergoes medical follow-up at a primary public healthcare 
setting possesses a personal medical record which will be presented to the doctor during health 
clinic follow-up and upon hospital admission. Nonetheless, the information upon hospital 
discharge and clinic follow-up at the secondary or tertiary healthcare setting are not 
incorporated in the same personal medical record. The discharge summary is provided in 
separate copies, and the record of clinic follow-up at secondary or tertiary healthcare settings 
is kept at the clinic. Due to the scattered information, the redundancy of medications with the 
same or different dosing regimens from various clinics follows up across primary to tertiary 
healthcare settings is a common issue. Subsequently, this has created confusion and dilemma 
for the patients as to which regimen to follow, deprived their rights to a holistic treatment 
approach and jeopardized their health condition. 
Recognising the missing part in the healthcare system, enhanced focus on medication 
reconciliation upon and after hospital discharge could bridge the gap to promote medication 
and patient safety. By implementing the medication reconciliation upon hospital discharge by 
pharmacists based in the wards, coupling with patient education and discharge medication plan 
communication, and followed with the introduction of a medication portal to the prescriber 
upon discharge which eventually serve as a compilation of personal medication records. 

16 
Subsequently, during clinic follow-up, medication reconciliation and updating of the patient 
medication list in the medication portal will be carried out by the pharmacist in the primary 
healthcare setting.  
In a nutshell, this study may greatly benefit the patients through anticipated medication 
discrepancies reduction via an innovative intervention. Besides, this intervention is also 
deemed easy to implement, thus enhancing the duplications and generalizability of the 
intervention to the healthcare facilities in Malaysia. 
1.8 
Chapter Summary 
Medication reconciliation is one of the key strategies to improve medication safety across 
transitions of care. Local healthcare providers find it difficult to retrieve previous medical 
records as the healthcare information system has not been integrated across the healthcare 
facilities in Malaysia. Thus, an electronic health record that aims to reduce medication 
discrepancies upon transition of care will be introduced. The study’s findings are essential to 
healthcare professionals in implementing electronic health records. Due to the limited 
resources at healthcare facilities, healthcare professionals shall prioritise the patients that need 
medication reconciliation. 
 
 
 
 
 
 

17 
CHAPTER 2  
 
METHODOLOGY 
2.1 
Study Design 
Given the nature of the research question, a randomised controlled trial is developed to compare 
the prevalence of medication discrepancies in the first prescription upon transition of care from 
hospitals to primary health clinics between MedBook Portal and standard care. This study is a 
prospective and multicentre randomised controlled trial with a 1:1 allocation ratio to two 
groups, namely the intervention group and the control group. MedBook portal is a webpage 
that enables sharing of patient medication profile among healthcare facilities under the Ministry 
of Health.  
2.2 
Operational Definition of Terms 
2.2.1 Medication Discrepancies 
Medication discrepancy is defined as any variation or difference in medication regimen 
identified when comparing an old medication list and the newly prescribed medications. 
2.2.2 Intentional Medication Discrepancy 
Intentional medication discrepancy is defined as a justified discrepancy by a change in the 
patient’s clinical condition. 
2.2.3 Unintentional Medication Discrepancy 
Unintentional medication discrepancy is defined as unjustified discrepancy after checking with 
prescriber. It is a medication error, specifically prescribing error.  
 

18 
2.2.4 Types of Medication Discrepancies 
Medication discrepancy is classified into:  
i. 
Discrepant dose 
ii. 
Discrepant frequency 
iii. 
Polypharmacy 
iv. 
Drug Omission  
v. 
Drug Addition  
vi. 
Inappropriate drug 
Table 2.1 lists the description and example of each type of medication discrepancy identified 
during medication reconciliation at hospital discharge. Table 2.2 lists the description and 
example of each type of medication discrepancy identified during medication reconciliation at 
the first follow-up at health clinics after discharge from the hospital. Figure 2.1 illustrates the 
example of medication discrepancies detected during medication reconciliation at hospital 
discharge and the first follow up at the health clinic. 
 
 
 
 
 
 
 
 
 
 
 

19 
Table 2.1:  
Description And Example Of Each Type Of Medication Discrepancy 
Identified During Medication Reconciliation At Hospital Discharge 
Type of 
Medication 
Discrepancy 
Description 
Example 
Discrepant 
dose 
A different dosage of a medication 
is prescribed in the discharge 
prescription compared to the old 
medication list in the medication 
history assessment form and 
inpatient medication charts.  
A 
patient 
was 
treated 
with 
Atorvastatin 20mg before admission 
and during admission; however, the 
patient 
was 
discharged 
with 
Atorvastatin 40mg.   
Discrepant 
frequency 
A 
different 
frequency 
of 
medication prescribed in the 
discharge prescription compared 
to the old medication list in the 
medication history assessment 
form and inpatient medication 
chart. 
A 
patient 
was 
treated 
with 
Metoprolol 
50mg 
OD 
before 
admission. In the ward, the patient 
has been given Metoprolol 50mg 
BD and has been discharged with 
Metoprolol 50mg BD. 
Polypharmacy Multiple agents from the same 
therapeutic class. 
Metoprolol 
is 
listed 
in 
the 
medication history assessment form. 
In the ward, Metoprolol is stopped, 
and the patient is started with 
Bisoprolol.  During discharge, 
metoprolol is restarted and given 
together with Bisoprolol. 
 
 
 
 

20 
Table 2.1 continued 
Drug 
Omission 
Medication is not prescribed in the 
discharge prescription but is listed 
in 
the 
medication 
history 
assessment form and inpatient 
medication chart. 
Metoprolol 
is 
listed 
in 
the 
medication history assessment form. 
However, Metoprolol is stopped in 
the ward and the patient is 
discharged without Metoprolol. 
Drug 
Addition 
Medication is prescribed in the 
discharge prescription but not 
listed in the medication history 
assessment form and inpatient 
medication chart. 
A patient has been discharged with 
Gliclazide 
MR. 
However, 
Gliclazide MR is not listed in the 
medication history assessment form 
or inpatient medication chart. 
Inappropriate 
Drug 
Any medication discrepancies that 
do not fit into any of the 
previously mentioned categories, 
such as a medication that no 
longer needed but is reordered in 
new prescription; a different 
formulation of the same item is 
prescribed. 
Example 1: 
A patient had diarrhoea in the ward 
and was given oral Loperamide 2mg 
TDS or PRN. However, Loperamide 
2mg TDS was written on the 
discharge prescription when the 
patient no longer had diarrhoea. 
Example 2:   
A patient has been discharged with 
Chloramphenicol 
ear 
drops. 
However, the patient has an eye 
infection and was treated with 
Chloramphenicol eye drops in the 
ward. 
 

21 
Table 2.2:  
Description And Example Of Each Type Of Medication Discrepancy 
Identified During Medication Reconciliation At The First Follow-Up At Health 
Clinics After Discharge From The Hospital 
Type of 
Medication 
Discrepancy 
Description 
Example 
Discrepant 
dose 
A different dosage of a medication 
is 
prescribed 
in 
the 
new 
prescription compared to the 
discharge prescription. 
A patient has been discharged with 
Losartan 100mg. However, the new 
prescription on the first visit to the 
health clinic is Losartan 50mg. 
Discrepant 
frequency 
A 
different 
frequency 
of 
medication prescribed in the new 
prescription compared to the 
discharge prescription. 
A patient has been discharged with 
Frusemide 40mg BD. However, 
only Frusemide 40mg OD is 
prescribed in the new prescription 
on the first visit to the health clinic. 
Polypharmacy Multiple agents from the same 
therapeutic class. 
Mefenamic acid and Diclofenac are 
prescribed concurrently.   
Drug 
Omission 
Medication is not prescribed in the 
new prescription but is listed in 
the discharge prescription. 
A patient was discharged with 
Metoprolol, 
Losartan, 
and 
Metformin. 
However, 
only 
Metoprolol and Metformin are 
prescribed in the new prescription 
on the first visit to the health clinic. 
 
 
 
 
 

22 
Table 2.2 continued 
Drug 
Addition 
Medication is prescribed in the 
new prescription but not listed in 
the discharge prescription. 
On the first visit to the health clinic, 
the patient is prescribed with 
Metoprolol, 
Losartan 
and 
Metformin. 
However, 
only 
Metoprolol and Metformin are listed 
in the discharge medication list.  
Inappropriate 
Drug 
Any medication discrepancies that 
do not fit into any of the 
previously mentioned categories, 
such as a medication that no 
longer needed but is reordered in 
new prescription; a different 
formulation of the same item is 
prescribed. 
Example 1: 
A patient has been discharged with 
Budesonide inhaler. However, the 
patient 
was 
prescribed 
with 
Budesonide nasal spray. 
Example 2:  
A patient has been discharged with 
Gliclazide 
120mg 
MR 
OD. 
However, the patient was prescribed 
with Gliclazide 120mg OD in the 
new prescription on the first visit to 
health clinic. 
 
 
 
 
 
 

23 
Medication History Assessment 
Form (CP1) 
 
Inpatient Medication Chart 
T. Metoprolol 50mg BD 
T. Gliclazide MR 60mg OD 
T. Atorvastatin 20mg ON 
T. Pantoprazole 40mg OD 
T. Aspirin 75mg OD 
T. Losartan 100mg OD 
T. Gliclazide MR 60mg OD 
T. Atorvastatin 40mg ON 
IV. Pantoprazole 40mg OD 
T. Loperamide l/l TDS 
T. Neurobion l/l OD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2.1: Example of medication discrepancies detected during medication reconciliation 
Discharge Prescription 
T. Losartan 50mg BD 
T. Gliclazide 60mg OD 
T. Atorvastatin 40mg ON 
T. Loperamide I/I TDS 
T. Cardiprin 100mg OD 
T. Neurobion l/l OD 
T. Mecobalamin 500mcg TDS 
Medication Discrepancy Identified 
Drug 
Type 
Justification 
T. Losartan 50mg BD  
T. Losartan 50mg BD  
T. Gliclazide 60mg OD 
T. Loperamide I/I TDS  
T. Cardiprin 100mg OD  
T. Mecobalamin 500mcg TDS  
T. Metoprolol 50mg BD 
T. Pantoprazole 40mg OD  
T. Aspirin 75mg OD 
Unintentional Discrepant Dose  
Unintentional Discrepant Frequency 
Unintentional inappropriate Drug  
Unintentional inappropriate Drug  
Intentional Drug Addition 
Unintentional Polypharmacy 
Intentional Drug Omission 
Unintentional Drug Omission 
Intentional Drug Omission 
Should be 100mg  
Should be OD 
Should be Gliclazide MR 
Patient no longer diarrhea 
From Aspirin to Cardiprin 
Neurobion was prescribed 
No longer indicated 
Should be continued 
No longer indicated 
RECONCILIED Discharge 
Prescription 
T. Losartan 100mg OD 
T. Gliclazide MR 60mg OD 
T. Atorvastatin 40mg ON 
T. Cardiprin 100mg OD 
T. Neurobion l/l OD 
T. Pantoprazole 40mg OD 
First Prescription at Clinic 
T. Metoprolol 100mg BD 
T. Gliclazide MR 90mg OD 
T. Atorvastatin 20mg ON 
T. Pantoprazole 40mg OD 
T. Aspirin 75mg OD 
T. Paracetamol 1g PRN 
Medication Discrepancy Identified 
Drug 
Type 
Justification 
T. Metoprolol 100mg BD  
T. Gliclazide MR 90mg OD 
T. Atorvastatin 20mg ON 
T. Aspirin 75mg OD 
T. Paracetamol 1g PRN  
T. Losartan 100mg OD 
T. Cardiprin 100mg OD  
T. Neurobion l/l OD 
Unintentional Drug Addition 
Intentional Discrepant Dose 
Unintentional Discrepant Dose 
Unintentional Drug Addition  
Intentional Drug Addition 
Unintentional Drug Omission 
Unintentional Drug Omission 
Unintentional Drug Omission 
No longer indicated 
Increased dose 
Should be 40mg 
No longer indicated 
Indicated 
Should be continued 
Change from Aspirin to Cardiprin 
Should be continued 
Reconciliation at  
Hospital Discharge 
At Hospital  
Reconciliation at  
Health Clinic 
At Health Clinic 

24 
2.3 
Study Population 
The targeted population is the adult patients in Sarawak who are discharged from the public 
tertiary hospitals and referred to the public primary health clinics.  These patients will continue 
to be treated at the selected public primary health clinics. 
2.4 
Study Sample and Locations 
This study will be conducted in four public tertiary hospitals and ten public primary health 
clinics. The four public hospitals that cater for the patients from southern, central, and northern 
zones in Sarawak are selected. Those are Sarawak General Hospital (southern zone), Sibu 
Hospital, Sarikei Hospital (middle zone) and Miri Hospital (northern zone).  
During this study, ten public primary health clinics which are located nearby to the four selected 
hospitals are chosen to follow up the participants who will be discharged and referred to these 
clinics. The healthcare facilities involved in this study are presented in Table 2.3. All patients 
who fulfil the selection criteria mentioned later will be invited to participate in the study.  
Table 2.3: 
Public Major Hospitals and Health Clinics Involved in this Study 
Public Major Hospitals 
Public Primary Health Clinics 
Sarawak General Hospital 
Batu Kawa HC, Kota Sentosa HC, Kota Samarahan HC 
Sibu Hospital 
Jalan Oya HC, Lanang HC, Sibu Jaya HC 
Miri Hospital 
Miri HC, Tudan HC 
Sarikei Hospital 
Sarikei HC, Bintangor HC 
 
 
 
 
 
 

25 
2.4.1 Inclusion criteria 
Patients who fulfil the following criteria will be invited to participate in the study: 
i. 
Adult patients aged 18 years and above in general medical wards who had any 
of the following comorbidities: (1) 
cardiovascular related diseases, e.g.: 
hypertension, acute coronary syndrome, heart failure, stroke, atrial fibrillation; 
(2) endocrine related diseases, e.g.: diabetes, thyroid disorders; (3) renal 
related diseases, e.g.: chronic kidney disease, end stage renal failure; (4) 
respiratory related diseases, e.g.: asthma, chronic obstructive pulmonary 
disease. 
ii. 
Patients who are referred to the selected primary health clinics after hospital 
discharge. 
iii. 
Patients with home-based medical card. 
2.4.2 Exclusion criteria 
Patients discharged during public holidays or weekends will be excluded from this study. 
2.4.3 Withdrawal criteria 
Patients readmitted to hospitals before the first review at the health clinic shall be withdrawn 
from the study. Patients can choose to withdraw at any time. Withdrawn patients will not be 
replaced. 
 
 
 
 

26 
2.5 
Sample Size Calculation 
This study aims to compare the prevalence of medication discrepancies in the first prescription 
upon transition of care from hospitals to primary health clinics between MedBook Portal and 
standard care. Hence, a two-tailed z-test of proportion between two groups with 80% power 
and a 5% of level significance will be used (10). The prevalence of medication discrepancies 
upon discharge reported in a previous study is 49% (8). We estimate the reduction of 
medication discrepancies via implementation of MedBook is 15%. Thus, a sample size of 322 
subjects, 161 subjects in each group, is sufficient to detect a clinically importance difference 
of 15% between groups. However, with the estimation of a 20% loss to follow up, a total of 
386 subjects will be recruited. 
In addition, this study also aims to ascertain the prevalence of medication discrepancies and 
type of medication discrepancies in discharge prescription and in the first prescription upon 
transition of care from hospitals to primary health clinics. Sample size is calculated by using 
the following formula (11):  
n =  
where n = sample size,  
Z = Z statistic for a level of confidence,  
P = expected prevalence or proportion 
d = precision 
 
 
Z2P(1-P) 
d2 

27 
By determining the Z = 1.96 for 95% CI and d = 0.05, the minimum sample size is 384. Based 
on the above sample size calculation, a total of 386 patients will be recruited. The sample size 
allocation for each hospital is determined on a pro-rata basis based on the total bed numbers in 
general medical wards and Bed Occupancy Rate (Table 2.4). 
Table 2.4:  
Sample Size Allocation Of Each Hospitals 
Public Major 
Hospitals 
Wards 
Total 
Bed 
Numbers 
Bed 
Occupancy 
Rate (%) 
Sample 
Size 
Allocation 
Sarawak General 
Hospital 
Male General Ward 
48 
114.4 
144 
Female General Ward 
48 
102.0 
Sibu Hospital 
Male General Ward 1  
36 
62.2 
106 
Male General Ward 2 
36 
73.4 
Female General Ward 
32 
83.5 
Miri Hospital 
Male General Ward 
29 
114.1 
72 
Female General Ward 
30 
62.8 
Sarikei Hospital 
Male General Ward 
35 
82.4 
64 
Female General Ward 
35 
50.2 
Total 
- 
329 
- 
386 
 
2.6 
Study Duration 
This study is estimated to be conducted over 6 months, expecting to commence in August 2023. 
 

28 
2.7 
Data and Instruments 
2.7.1 Data Collection Form 
Medication discrepancies detected will be categorised according to the following groupings, 
discrepant dose, discrepant frequency, polypharmacy, drug omission, drug addition and 
inappropriate drug. Other data that will be collected include age, gender, number of 
medications, type of medication based on Anatomical Therapeutic Chemical (ATC) 
categorisation in Drug Formulary Ministry of Health Malaysia, comorbidities, and category of 
prescriber.  
There are two electronic data collection forms using Google Form for data entry. The first data 
collection form (Appendix A) is administered by pharmacist at hospital before allocation. The 
second data collection form (Appendix B) is to be administered by pharmacist at the health 
clinic. 
2.7.2 MedBook Portal 
MedBook portal (https://aplikasi.jknsarawak.moh.gov.my/medbook) is a webpage that enable 
sharing of patient medication records among healthcare facilities under Ministry of Health. 
Sarawak State Health Department owned and managed this portal. All the information is kept 
under their server. Doctors in the Health Clinics and Study Pharmacists will be given access to 
this portal whereby each of the healthcare providers shall log in using their Identification 
Number and the password created by them. Doctor shall log in to MedBook Portal to check on 
discharge medication list when reviewing the patient at health clinic. MedBook Portal can be 
accessed both using a smartphone or a computer. The design of MedBook Portal in the 
smartphone version is shown in Figure 2.2. The design of MedBook Portal in the computer 
version is shown in Figure 2.3.  

29 
During the discharge process, the study pharmacist at hospital will upload the discharge 
prescription to MedBook Portal for both the control group and intervention group. When 
uploading the discharge prescription, the study pharmacist shall select the radio button 
‘intervention’ for patients in the intervention group. MedBook Portal allows doctors at health 
clinics to view the prescription under the intervention group only. Whereas pharmacists at 
health clinics can view all the prescriptions in both groups. This setting is done based on the 
user role in MedBook Portal. The purpose of the setting is to ease the study pharmacist at the 
health clinic to compare the discharge prescription in MedBook Portal and the first prescription 
at the health clinic to identify medication discrepancies in both groups. 
 
Figure 2.2:  
MedBook Portal in smartphone version 
 

30 
 
Figure 2.3:  
MedBook Portal in computer version 
 
2.7.3 MedBook Portal Notice 
A MedBook Portal Notice will be placed in front of the patient’s home-based medical card. 
Only patients in the intervention group are given MedBook Portal Notice. Hence, the doctors 
and pharmacists at health clinics can identify the recruited patients in the intervention group. 
The layout of the MedBook Portal Notice is shown in Figure 2.4. 
 
 
 
 
 
 
 
Figure 2.4: 
MedBook Portal Notice 

31 
2.8 
Recruitment 
In this study, patients who are decided to be discharged from the selected hospital and fulfilled 
the inclusion criteria will be recruited. The patients will be given a full explanation regarding 
the study according to the patient information sheet before enrolment. Subsequently, patients 
will be requested to provide written informed consent (Appendix C) if they agree to participate 
in the study. 
2.9 
Medication Reconciliation Upon Hospital Discharge 
Medications in the discharge prescription will be considered as the primary source of reference 
for discharge reconciliation, as this is the list of medications that the pharmacy will refer to for 
medication preparation and eventually will be given to the patients upon discharge. Study 
pharmacists will conduct discharge medication reconciliation before randomization. Discharge 
medication reconciliation will be carried out by comparing the medications in the discharge 
prescription against the medications in the medication history assessment form (pre-admission 
medications) and inpatient medication charts (medications started during admission) to detect 
medication discrepancies before discharge medications preparation. If any differences are 
detected, study pharmacists will confirm with the doctor to decide intentional or unintentional 
medication discrepancies-any amendment to be documented on the discharge prescription. 
2.10 
Randomisation and blinding 
The recruited patients will be randomised to the intervention and control groups in a 1: 1 ratio 
before discharge. Randomisation will be conducted using the online program available at 
http://www.graphpad.com/quickcalcs/index.cfm (12). A research coordinator will be 
appointed to administer the randomisation and inform the study pharmacist to deliver the 
intervention according to the assigned group. The research coordinator has no contact with 
patients, study pharmacists and doctors.  In addition, the research coordinator will manage the 

32 
patient list with their code and group assignment. Subsequently, the research coordinator will 
send the patient list to the principal investigator to remind the patient of the follow-up date at 
the health clinic. Due to the nature of the intervention, patients, doctors, and study pharmacists 
are not blinded. 
2.11 
Intervention Group 
MedBook Portal Notice will be attached in front of the patient’s home-based medical card for 
the doctors and pharmacists at health clinics to identify the recruited patients. This appointment 
would be their first follow-up at health clinics after discharge from the hospital.  
During the doctor’s review of the patient in the intervention group, the doctor shall log in to 
the MedBook Portal to check on the discharge medication list and review the case based on the 
previous medical record in the home-based medical card and the discharge note if the patient 
hand over it to the doctors in their first review. Then, the doctor will conduct medication 
reconciliation by comparing the list of medications in the discharge prescription against the 
new prescription prepared.  
Study pharmacists at the health clinics are required to screen patients’ home-based medical 
cards presented to the pharmacy upon collecting medications. Once the pharmacists at health 
clinics identify the recruited patients via the MedBook Portal Notice, the pharmacist shall log 
in to the MedBook Portal to check the discharge medication list. The pharmacist shall conduct 
medication reconciliation by comparing the new prescription received against the discharge 
medication list in the portal. Intervention is to be carried out by the study pharmacists through 
confirmation with the doctor to determine the intentional or unintentional medication 
discrepancies. 

33 
2.12 
Control Group 
Patients will receive the standard care in which doctors review patients based on the previous 
medical record in the home-based medical card and discharge note if the patient hands it to the 
doctors in their first review. Doctors cannot retrieve a patient’s discharge medication list from 
MedBook Portal. No MedBook Portal Notice is attached to the patient’s home-based medical 
card.  
The principal investigator will provide a patient list in the control group to the study pharmacist 
at the health clinic. By knowing their appointment date, the study pharmacist shall search for 
the first prescription upon transitioning care from the hospital to the primary health clinic. 
Subsequently, the study pharmacist shall compare the discharge prescription in MedBook 
Portal with the first prescription to identify medication discrepancies. If any differences are 
detected, study pharmacists will confirm with the doctor to decide intentional or unintentional 
medication discrepancies. However, the study pharmacist might not be able to retrieve the first 
prescription immediately on the appointment date as there is no MedBook Portal Notice 
attached. As a result, the study pharmacist can only check with the prescriber on the 
discrepancy at a later time.  
2.13 
Data Collection 
The prevalence of medication discrepancies during discharge is collected through medication 
reconciliation by the study pharmacist at the hospital using the electronic data collection form. 
In addition, the type of medication discrepancies and predictors associated with medication 
discrepancies will be collected simultaneously using the first data collection form (Appendix 
A) by the study pharmacist at a hospital before allocation.  
To compare the prevalence of medication discrepancies in the first prescription upon transition 
of care from hospitals to primary health clinics between the MedBook Portal and standard care, 

34 
data collection on the number of medication discrepancies will be carried out during the first 
follow-up at the health clinic after the hospital discharge. A pharmacist will administer the 
second data collection form (Appendix B) at the health clinic. 
Throughout the study, there is only one follow-up visit at the health clinic, the first after hospital 
discharge. However, the time frame between the discharge date and the appointment date for 
the first follow-up at the health clinic varies from days to weeks depending on the duration 
determined by the hospital. Thus, the expected duration of subject participation would range 
from one week to two months.  
To reduce loss to follow-up, the study pharmacist shall contact the patient via WhatsApp or 
phone call to remind the patient of the follow-up date at the health clinic. The schedule of 
enrolment, interventions and assessments of the study are presented in Table 2.5. The study 
flow chart is illustrated in Figure 2.5. 
 
 

35 
Table 2.5: Schedule of Enrolment, Interventions and Assessments 
Timepoint 
Study Period 
Enrolment 
Allocation 
Post-
allocation 
Close-out 
-t1 
0 
1st Primary 
Health Clinic 
Follow Up 
 
ENROLMENT: 
 
 
 
 
Eligibility screen 
X 
 
 
 
Participant 
Information Sheet  
X 
 
 
 
Informed consent 
X 
 
 
 
Allocation 
 
X 
 
 
INTERVENTIONS: 
 
 
 
 
MedBook Portal 
 
X 
X 
 
ASSESSMENTS: 
 
 
 
 
Prevalence of 
medication 
discrepancies 
X 
 
X 
 
Predictors of 
medication 
discrepancies 
X 
 
X 
 
 
 
 
 
 

36 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2.5: 
Study Flow Chart 
 
At Hospital 
At Health Clinic
Patient information 
sheet & informed 
consent 
Control Group 
Intervention Group 
Data entry 
1st follow up at health clinic 
Data entry 
Doctors 
• Review patients based on their home-based 
medical card and discharge. (Standard care) 
Doctors 
• Review patients based on their home-based 
medical card and discharge. (Standard care) 
• Compare the discharge prescription in MedBook 
Portal against the new prescription. 
Pharmacists 
• Receive the home-based medical card and new 
prescription, and reconcile them using medication 
list in home-based medical card. (Standard care) 
• Search for the new prescription based on the 
control group‘s patient list and the given 
appointment date. 
• Compare the discharge prescription in the 
MedBook Portal against the new prescription at a 
later time. For any discrepancies, check with the 
doctor on the intention. 
Pharmacists 
• Receive the home-based medical card and new 
prescription, and reconcile them using medication 
list in home-based medical card. (Standard care) 
• Compare the discharge prescription in the 
MedBook Portal against the new prescription. For 
any discrepancies, check with the doctor on the 
intention. 
 
Assess discharge patient’s eligibility 
Conduct medication reconciliation upon discharge  
Randomise 
• Patient were given discharge note. (Standard care) 
• Discharge prescriptions are uploaded into 
MedBook Portal by hospital pharmacist and can 
be retrieved by pharmacists at health clinic. 
 
 
 
• Patient were given discharge note. (Standard care) 
• Discharge prescriptions are uploaded into 
MedBook Portal by hospital pharmacist and can 
be retrieved by doctors & pharmacists at health 
clinic. 
• MedBook Portal Notice in front of the patient 
home-based medical card. 
Excluded 

37 
2.14 
Outcomes 
The primary outcome of the study is the percentage of prescriptions with medication 
discrepancies in the first prescription during the first follow-up visit at the primary health clinic 
after hospital discharge. A comparison of the prevalence of prescriptions with medication 
discrepancies in the intervention group and the control group will be conducted.  
The secondary outcome of the study is the percentage of prescriptions with medication 
discrepancies in the discharge prescription. This is measured before the intervention. In 
addition, the type of medication discrepancies and predictors associated with medication 
discrepancies in discharge prescriptions and the first prescriptions upon transitioning care from 
hospitals to primary health clinics will be collected. Predictors associated with medication 
discrepancies will be analysed using multiple logistic regression. 
 
 

38 
2.15 
Data Analysis 
All data will be analysed using The jamovi project (2022) (Version 2.3). Descriptive statistics 
(frequency and percentage; mean and standard deviation) will be used to describe the socio-
demographic characteristics of the participants. 
Categorical variables, expressed as numbers and percentages, are compared by the Chi-square 
test. Continuous variables will be tested for normality using One-Sample Kolmogorov-
Smirnov Test and compared using independent t-test for normally distributed data and the 
Mann-Whitney U test for non-normally distributed data. Data with normal distribution are 
reported as mean (standard deviation, SD), while non-normally distributed variables are 
reported as median (interquartile range, IQR).  
The predictors associated with medication discrepancies will first be analysed using univariable 
logistic regression. The variables with p-value <0.1 by univariable analysis will be included in 
the multivariable logistic regression model. All statistical tests are two-tailed and p<0.05 is set 
to be statistically significant.  
 
 

39 
2.16 
Chapter Summary 
This is a two-group randomised controlled trial conducted at four public tertiary hospitals and 
ten public primary health clinics in Sarawak, Malaysia. Adult patients in general medical wards 
who are discharged from the hospitals and referred to the selected primary health clinics will 
be recruited in the study. Eligible subjects will be randomised into intervention group and 
control group in a ratio of 1:1. During the first follow-up at the primary health clinic after 
discharge from hospital, doctors in the primary health clinics review the patients in the 
intervention group based on the discharge medication list in the MedBook Portal. Patients in 
the control group receive the standard care. Study pharmacists conduct medication 
reconciliation and identify medication discrepancies. 
The primary outcome of this study is the percentage of prescriptions with medication 
discrepancies in the first prescription during the first follow-up visit at the primary health clinic 
after hospital discharge. A comparison of the prevalence of prescriptions with medication 
discrepancies in the intervention group and the control group will be conducted. The secondary 
outcomes are the percentage of prescriptions with medication discrepancies in the discharge 
prescription, the type of medication discrepancies and predictors associated with medication 
discrepancies in discharge prescriptions and the first prescriptions upon transitioning care from 
hospitals to primary health clinics. All data will be analysed using The jamovi project (2022) 
(Version 2.3). All statistical tests are two-tailed and p<0.05 is set to be statistically significant. 
 
 
 

40 
CHAPTER 3   
 
 
GANTT CHART 
3.1 
Gantt Chart 
A Gantt Chart illustrates the duration of the task in the study and the sequencing of each 
activity. Proper planning for each activity is crucial to ensure the study is completed in the 
allocated time. The main activity of this study is depicted in Table 3.1.  
 
 

41 
Table 3.1: Gantt Chart 
Activities 
2022 
2023 
2024 
7 
8 
9 
10 
11 
12 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
Literature Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Proposal Write-Up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Site Meeting 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ethics submission & approval  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preparation of study materials 
& training 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Write Up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Submission for publication 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

42 
REFERENCES 
1. 
Medication Safety in Transitions of Care. Geneva: World Health Organization; 2019. 
Report No.: WHO/UHC/SDS/2019.9. 
2. 
Abu Farha R, Yousef A, Gharaibeh L, Alkhalaileh W, Mukattash T, Alefishat E. 
Medication discrepancies among hospitalized patients with hypertension: assessment of 
prevalence and risk factors. BMC Health Serv Res. 2021;21(1):1338. 
3. 
Cornu P, Steurbaut S, Leysen T, De Baere E, Ligneel C, Mets T, et al. Effect of 
medication reconciliation at hospital admission on medication discrepancies during 
hospitalization and at discharge for geriatric patients. Ann Pharmacother. 2012;46(4):484-94. 
4. 
Hias J, Van der Linden L, Spriet I, Vanbrabant P, Willems L, Tournoy J, et al. 
Predictors for unintentional medication reconciliation discrepancies in preadmission 
medication: a systematic review. Eur J Clin Pharmacol. 2017;73(11):1355-77. 
5. 
Farley TM, Shelsky C, Powell S, Farris KB, Carter BL. Effect of clinical pharmacist 
intervention on medication discrepancies following hospital discharge. Int J Clin Pharm. 
2014;36(2):430-7. 
6. 
Kripalani S, Roumie CL, Dalal AK, Cawthon C, Businger A, Eden SK, et al. Effect of 
a pharmacist intervention on clinically important medication errors after hospital discharge: a 
randomized trial. Ann Intern Med. 2012;157(1):1-10. 
7. 
Hassali MA, Al-Haddad M, Shafie AA, Tangiisuran B, Saleem F, Atif M, et al. 
Perceptions among general medical practitioners toward implementation of medication 
reconciliation program for patients discharged from hospitals in Penang, Malaysia. J Patient 
Saf. 2012;8(2):76-80. 

43 
8. 
Law BK, Chong CP. Prevalence and predictors of medication discrepancies upon 
discharge among adult patients: a prospective study from Malaysia. Journal of Asian 
Association of Schools of Pharmacy. 2017;6(1):1-9. 
9. 
Mueller SK, Kripalani S, Stein J, Kaboli P, Wetterneck TB, Salanitro AH, et al. A 
toolkit to disseminate best practices in inpatient medication reconciliation: multi-center 
medication reconciliation quality improvement study (MARQUIS). Jt Comm J Qual Patient 
Saf. 2013;39(8):371-82. 
10. 
Sakpal TV. Sample size estimation in clinical trial. Perspect Clin Res. 2010;1(2):67-9. 
11. 
Naing L, Winn T, Rusli BN. Practical Issues in Calculating the Sample Size for 
Prevalence Studies Archives of Orofacial Sciences. 2006;1:9-14. 
12. 
Suresh K. An overview of randomization techniques: An unbiased assessment of 
outcome in clinical research. J Hum Reprod Sci. 2011;4(1):8-11. 
 

44 
APPENDICES 
Appendix A: Data Collection Form to be administered by Pharmacist at Hospital 
(https://forms.gle/wZrjjTpgLtHM8cb59) 
 

45 
 

46 
 

47 
 

48 
 
 
 

49 
Appendix B: Data Collection Form to be administered by Pharmacist at Health Clinic 
(https://forms.gle/3wENridxTmN9WYV77) 
 

50 
 

51 
 

52 
 

53 
 

54 
 

55 
Appendix C: Study Participant Information Sheet and Informed Consent Form in English 
 

56 
 

57 
 

58