The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore
Phase: NA
Conditions: Type2 Diabetes
Sponsor: National University of Singapore

DSRB Reference Number <2017/01191>, Version <1>, Dated <06-03-2018> 
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STUDY PROTOCOL 
 
 
PROTOCOL TITLE: 
The Impact of Collaborative Care Model in the Management of Primary Care Patients with 
Type 2 Diabetes Mellitus in Singapore 
 
PROTOCOL NUMBER: 2017 / 01191 
 
PROTOCOL VERSION:  Version 1 
PROTOCOL DATE:  
6 March 2018 
 
PRINCIPAL INVESTIGATOR:  
Ms. Tan Wei Yan Cheryl, BSc (Pharm) (Hons), CGP 
• Senior Pharmacist, National Healthcare Group Pharmacy 
 
SITE PRINCIPAL INVESTIGATOR:  
Dr. Tsou Yu Kei Keith, MBBCh, MMed (FM), MCFP(S), FCFP(S) 
• Director, Clinical Services, National University Polyclinics 
 
CO-INVESTIGATORS:  
Dr. Lee Yu-Chia Joyce, PharmD, BCPS, BCACP 
• Associate Professor in Clinical Pharmacy, Department of Pharmacy, Faculty of 
Science, National University of Singapore 
Mr. Lum Zheng Kang, BSc (Pharm) (Hons) 
• Research Assistant, Department of Pharmacy, Faculty of Science, National 
University of Singapore 
Ms. Xu Yingqi, BSc (Pharm) (Hons), MSc 
• PhD Candidate, Department of Pharmacy, Faculty of Science, National University of 
Singapore 
Mr. Khairul Dzakirin Bin Rusli, BSc (Hons), DipNurs, RN, EMT-B 
• Research Assistant, Department of Pharmacy, Faculty of Science, National University 
of Singapore 
 
STUDY SITE: 
National University Polyclinics (Bukit Batok, Choa Chu Kang, Pioneer, Jurong) 
O F F I C I AL  U S E  O N L Y  
Doc Name : Study Protocol 
Doc Number : 1 
Doc Version : 1 
Date : 6 Mar 2018 

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Background and Rationale:  
In Singapore, the prevalence of diabetes mellitus (DM) was approximately 12.8% in 20141 and 
the prevalence was projected to rise to 22.7% in 2035.2 In 2015, the International Diabetes 
Federation (IDF) reported that Singapore has the second highest proportion of diabetic patients 
among developed nations.1 In 2010, the total economic cost for working-age diabetic patients 
in Singapore was USD 787 million, and it was projected to rise to USD 1867 million in 2050.3 
The incidence of DM increases with age, and this is of particular concern because Singapore 
is one of Asia's fastest aging populations.4,5 As such, DM is becoming an increasingly important 
health issue that needs to be addressed with urgency. 
 
Uncontrolled DM is associated with significant microvascular complications such as 
retinopathy, nephropathy and neuropathy; it can also result in macrovascular complications 
such as stroke and myocardial infarction.6 DM is considered a coronary heart disease risk 
equivalent, and its contribution to cardiovascular diseases (CVD) increases patient morbidity 
and mortality by as much as 60% in Singapore.7,8 Studies have shown that the prognosis for 
subjects with DM without prior CVD was worse than that for non-diabetic subjects with prior 
CVD.9,10 Therefore, in order to prevent and reduce the occurrence of short-term and long-term 
macrovascular and microvascular complications, a holistic management of DM should include 
close monitoring of patient’s blood pressure (BP) and lipid profile in addition to good glycaemic 
control. 
 
The management of DM and its associated co-morbidities can be complex, and often requires 
multiple medications along with strict lifestyle modifications.11,12 Since chronic diseases are life-
long and without cure, strict and continuous lifestyle modifications can be exhausting; and for 
most patients, pharmacotherapy becomes the mainstay of chronic disease management. 
However, with time, pill burden may increase, and medication adherence and drug interactions 
can become a problem for many patients with chronic diseases.13,14 In addition, limited 
physician-patient contact can result in suboptimal care as different aspects of DM care such as 
extraction of subjective data from a thorough interview with the patients, monitoring of objective 
data trends, drug optimization, medication tolerability, lifestyle modifications and accuracy in 
the use of medications and auxiliary devices cannot be addressed.13,15 Such situations may 
give rise to not only therapeutic failure but also potential drug-related adverse events or drug-
drug interactions, which can increase the risk of drug-related mortality and morbidity.11  
 
Studies conducted in different countries have shown that due to the complex nature of the 
chronic disease state, a collaborative care model can be a more effective approach in managing 
patients with DM.11,14-16 In addition to physicians, such a collaborative effort often includes 
clinical pharmacists, nurses, dietitians and/or social workers. Care carried out by these experts 
in different aspects of DM has been found to yield positive treatment outcomes for 
patients.13,16,17 
   
In countries such as Singapore, Jordan, the United States, and Canada, the collaborative care 
model has been shown to optimize therapeutic outcomes of patients with DM as evidenced by 
improvements in surrogate markers such as HbA1c, BP, LDL and TG (Table 1).18-21 These 
studies had a follow-up period ranging from 3 to 9 months. Although the degree or level of 
improvements vary across countries, the collaborative care model has shown to improve clinical 
outcomes of patients with DM.  
 

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Table 1. Improvements in Surrogate Markers from Collaborative Care Model 
Author 
(year) 
Study 
Design 
Country 
Clinical Outcomes 
Comments 
HbA1c   
(%) 
SBP       
(mm Hg) 
LDL 
(mmol/L) 
TG 
(mmol/L) 
Siaw 
MYL et 
al. 
(2017)18 
Randomis
ed 
controlled 
trial 
Singapore 
INT: -
0.3% at 
3-month 
and -
0.5% at 
6-month 
No 
significant 
changes 
over 6 
months 
No 
significant 
changes 
over 6 
months 
No 
significant 
changes 
over 6 
months 
Treatment 
satisfaction and 
distress were also 
assessed (better 
outcome in INT). INT 
also shown to 
significantly reduce 
direct medical costs 
as compared to UC. 
Jarab AS 
et al. 
(2012)19 
Randomiz
ed 
controlled 
trial 
Jordan 
INT: -
0.8; UC: 
+0.1  
INT: -5.8; 
UC: +1.1 
INT: -0.6; 
UC: No 
change 
INT: -0.5; 
UC: +0.2 
Medication 
adherence and self-
care techniques also 
improved in INT. 
Scott DM 
et al. 
(206)20 
Randomis
ed 
controlled 
trial 
United 
States of 
America 
INT: -
1.7; UC: 
-0.9 
INT: -3.4; 
UC: +2.1 
INT: -0.5; 
UC: -0.2 
NIL 
Quality of life was 
assessed using 
DQOL; some 
components favour 
INT but total scores 
were not significantly 
different between INT 
and UC.  
Katherine 
IT et al. 
(2005)21 
Randomis
ed 
controlled 
trial 
Canada 
INT: -
0.29; 
UC: 
+0.72 
INT: -2.0; 
UC: +7.0 
INT: -7.7; 
UC: +1.6 
INT: 
+40.6; 
UC: -0.9 
DQLCLTQ and SF-36 
were assessed. 
DQLCLTQ domains 
such as global role 
functioning, diabetes 
impact, health 
distress, and social 
stigma were 
significantly improved 
in INT. 
Abbreviations: INT, intervention; UC, usual care.  
 
In addition, positive humanistic outcomes were also illustrated in studies that looked at the 
effectiveness of collaborative care in terms of patient quality of life and medication adherence. 
In one study, it was shown that there was a statistically significant increase in mean ± standard 
deviation WB-Q12 scores (well-being) in the intervention group (21.9 ± 6.8 to 23.4 ± 6.8, 
p=0.04) but no change among controls at follow-up.13 Furthermore, the total mean ± SD BMQ 
score (beliefs about medications and medication adherence) dropped from 3.89 ± 1.78 to 2.74 
± 1.39 in the intervention group and increased from 2.81 ± 1.15 to 3.90 ± 1.45 (p<.001) for the 
control group.13 
 
Lastly, a collaborative care approach has demonstrated a reduction in overall health care costs 
for patients with DM.22 One study found that collaborative care was associated with a 62% 
decrease in the annual cost of treatment ($107,939.99 vs. $41,106.30 [U.S.]).22 Furthermore, 
after accounting for the additional cost of glucose monitoring ($30,604), there was still 34% 
annual savings for patients.22 
 

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Currently in Singapore, the effectiveness of the collaborative care model has only been 
evaluated prospectively for a duration of 6 months. The long-term impact of this care approach 
on the clinical, humanistic and economic outcomes have yet to be elucidated. 
 
In summary, due to the complex nature and multifactorial causes of chronic diseases, 
healthcare systems around the globe face many challenges as they work to deliver effective 
chronic disease management. Evidence has shown that health care can be delivered more 
effectively and efficiently through a multidisciplinary team approach, in which providers are 
supported by experts from different disciplines, and as a result are better equipped with the 
necessary resources and knowledge to manage their patients’ chronic diseases.18-21 With a 
diverse group of healthcare professionals on board, the healthcare team can ensure that their 
patients’ treatment goals are attained in the short-term and maintained in the long-term.  
 
Specific Aims and Objectives  
The purpose of this study is to determine the effectiveness of the collaborative care model in 
Singapore in which clinical pharmacists, nurses and dietitians are active participants who 
collaborate with physicians in caring for patients with type 2 DM. Since type 2 DM is a 
cardiovascular risk equivalent, co-morbidities such as hypertension (HTN) and dyslipidaemia 
(DLP) will also be evaluated to assess the holistic care provided for our patients afflicted with 
these top chronic diseases in Singapore.   
 
Specifically, this study aims to evaluate the long-term effectiveness and sustainability of an 
integrated collaborative care model comprising of a healthcare team (physician, clinical 
pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model 
(physician-centred care) mainly in the following outcomes (Table 2). 
 
Table 2. Outcome Measures for Proposed Study 
Types of Outcomes 
Descriptions 
Clinical 
• 
Glycated haemoglobin (HbA1c), systolic blood pressure (SBP), low density 
lipoprotein (LDL), total cholesterol, high density lipoprotein (HDL) and fasting 
triglyceride (TG) levels 
• 
Incidence of minor and major hypoglycaemia 
• 
DM-related clinical visit and hospitalization 
Humanistic 
• 
Health-related quality of life 
• 
Self-care management 
• 
Diabetes-related distress 
Economic 
• 
Cost effectiveness 
• 
Productivity 
 
The central hypothesis of this study is that patients with type 2 DM under the collaborative care 
model will have greater improvements in the clinical, humanistic and economic outcomes 
assessed than those under conventional care.  
 
Data collection period: 
12 March 2018 to 12 March 2020 
 

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Study Design and Methodology:  
Study Design and Setting 
This proposed project is a prospective, randomized controlled study to be conducted over a 12-
month period. This multi-centre study will be conducted in Bukit Batok and Choa Chu Kang 
Polyclinics. 
 
Study Participants 
Patients aged ≥ 21 years with Type 2 DM (HbA1c > 7%) and polypharmacy (≥ 5 medications) 
will be eligible for this study. Patients with Type 1 DM or who are unable to communicate 
independently in English, Chinese or Malay will be excluded from this study.  
 
Procedures 
Eligible patients will be screened and identified by research assistants of this study. Upon 
agreeing to participate in the study and signing of the informed consent, the patients will be 
randomised to either the control or intervention group using a random number generator or an 
equivalent by the research assistants.  
 
Patients randomly assigned to the usual or conventional care arm may be subject to as needed 
referral to the nurses for soft skill-related DM counselling and dietitian for diet control, at the 
discretion of the physician. These patients may be seen by different physicians at each visit, 
and pharmacists will not be involved in drug optimization except for dispensing.  
 
Patients randomly assigned to the collaborative care arm will see a healthcare team comprising 
clinical pharmacists in addition to physicians, nurses and dietitians. The clinical interventions 
carried out by the clinical pharmacist include but are not limited to counselling patients about 
drug therapy, performing simple physical assessments, ordering pertinent follow-up visits and 
laboratory tests on behalf of the physicians, and initiating, titrating, and terminating medications 
per the NHG Hypertension, Diabetes, Lipids Clinic (HDL-C) Protocol and under the supervision 
of the physicians as appropriate. The supervision is usually in the endorsement of prescriptions 
prepared by clinical pharmacists. In addition, the clinical pharmacist will serve as a bridge 
between patients and physicians to increase communication, and patients will need to be seen 
by physicians at least every four months. As needed, referrals to nurses and dieticians will also 
be actively made by the clinical pharmacist and vice versa. The clinical pharmacist will schedule 
clinic appointments approximately every four to six weeks in the 12-month interventional period. 
If the patient’s DM is well-controlled, i.e. with stable improvements in clinical measures, the 
clinical pharmacist may replace one or two clinic visits with telephone counselling at his/her 
discretion. All clinical pharmacists are board-certified pharmacotherapy specialists and/or 
board-certified ambulatory care pharmacist, and they have undergone the 3-month internal 
rotational endocrinology training held at Tan Tock Seng Hospital, comprising preceptors who 
are endocrinologists, senior clinical pharmacists, diabetes nurse educators, dietitian, and 
podiatrist, similar to the previous study conducted.18 

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Data Collection:  
The types of outcome measures and period of assessment are summarized in Table 3 below. 
Patient demographics, past medical history, and current medication use for both control and 
intervention group will be collected at enrolment. Serum creatinine level will also be followed 
up at every 6-month period to ensure that any diabetic complications are not due to change in 
organ function over time. 
 
Table 3. Summary of Outcome Measures 
Outcomes 
Parameters 
Time Period 
1. Clinical outcomes 
Treatment goal 
Baseline* 
6-month 
12-month 
1.1 HbA1c  
≤ 7% 
√ 
√ 
√  
1.2 SBP 
< 130 mm Hg 
√ 
√ 
√  
1.3 LDL 
< 2.6 mmol/L 
√ 
√  
√  
1.4 HDL 
≥ 1.0 mmol/L 
√ 
√  
√  
1.5 Total cholesterol 
< 5.2 mmol/L 
√ 
√  
√  
1.6 TG 
< 2.3 mmol/L 
√ 
√  
√  
1.7 Self-reported incidence of minor 
and major hypoglycaemia 
N/A 
√ 
√  
√  
1.8 DM-related clinic visit and 
hospitalization 
N/A 
- 
√  
√  
2.  Humanistic outcomes 
Measurement 
instrument 
Baseline* 
6-month 
12-month 
2.1 Health-related quality of life 
EQ-5D-5L, ADDQoL23  
√ 
√  
√  
2.2 Self-care management 
SDSCA24 
√ 
√  
√  
2.3 Diabetes-related distress 
PAID25 
√ 
√  
√ 
3. Economic outcomes 
Type of costs  
Baseline* 
6-month 
12-month 
3.1 Costs 
Direct costs 
- 
√ 
√ 
3.2 Productivity 
Indirect costs (WPAI-GH) 
- 
√ 
√ 
√: to be measured 
*Baseline refers to any time within the past 6 months prior to recruitment 
Abbreviations: HbA1c, glycated haemoglobin; SBP, systolic blood pressure; LDL, low-density lipoprotein; HDL, 
high-density lipoprotein; TG, triglyceride; DM, diabetes mellitus; EQ-5D-5L, EuroQoL 5-dimension 5-level; 
ADDQoL, Audit of Diabetes-Dependent Quality of Life; SDSCA, Summary of Self Care Activities; PAID, Problem 
Areas in Diabetes; WPAI-GH, Work Productivity Activity Impairment-Global Health. 
 
Clinical Outcomes  
The main clinical parameters to be collected include HbA1c, SBP, total cholesterol, LDL, HDL, 
and TG.  These short-term surrogate markers are predictive of the development of long-term 
DM-related complications. In addition, total cholesterol and other lipid parameters allow for 
estimation of cardiovascular risk. While several laboratory measures of glycemic levels are 
available, HbA1c will be used in this study as it is a recommended and reliable index of mean 
glycemic control over three months. Other outcome measures include: 1) incidence of minor 
and major hypoglycemia reported by patients, 2) frequency of DM-related clinic visits (by 
physician, pharmacist, nurses, dietitians) as indicated on patients’ appointment card and 
hospitalizations. Minor hypoglycemic events are defined as blood glucose of < 4.0 mmol/L or 
signs and symptoms with known precipitating causes such as irregular eating habits, increased 
daily activity or other attributes that can be modified. The minor hypoglycemic event should 
allow the patient to recover quickly with or without the ingestion of fast-acting glucose. Major 
hypoglycemic events are defined as any hypoglycemic symptoms, regardless of frequency, 
which require help from another person. The clinical information and laboratory values will be 
collected from the clinical databases available at the study sites, patient case notes, and patient 
self-reported questionnaires at baseline, at 6- and 12-month during the study period. Baseline 

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laboratory values will be collected at enrolment. If values are not available at enrolment, the 
most recent value available within the 6 months preceding enrolment will be recorded.   
 
Humanistic Outcomes   
Health-related quality of life (HRQoL) will be assessed using Research Assistant-administered 
questionnaires at baseline and as close to the 6-month and 12-month follow-ups as possible. 
The HRQoL measures will include a generic measure, EQ-5D-5L, and a DM-specific measure, 
the Audit of Diabetes Dependent Quality of Life (ADDQoL), and Problem Areas in Diabetes 
(PAID). Self-care management capabilities of patients will be assessed by the Summary of 
Diabetes Self-Care Activities Measure (SDSCA).  
 
Economic Outcomes 
The economic evaluation will be conducted from an institutional perspective. Direct healthcare 
costs will be estimated over 12 months. The direct costs will include physicians’ consultation 
fees, laboratory and procedures, medication costs, DM-related hospitalization, and DM-related 
A&E visits. 
 
Number of Subjects to be enrolled: 
A 12-month study conducted in the United States of America involving the collaborative care 
model reported an effect size of 0.4.20 With an allocation ratio of 1:1 into the intervention or 
control arms, approximately 125 patients are needed in each arm, to obtain a statistical power 
of 80% (two-sided Type I error rate = 0.05) and after taking into account a 20% dropout rate. 
As such, 250 patients will be needed to assess the effectiveness of a collaborative care model 
versus the usual model of care in the polyclinics. 
 
Data source: 
Clinical data will be collected from patient electronic case notes, prescription records accessed 
from CPSS2 and iPharm and investigation results from the electronic laboratory module in 
CPSS2. Humanistic data and incidence of hypoglycaemia will be elucidated through 
participant’s self-reported questionnaires. Cost data will be obtained from the respective 
institution financial databases. 
 
Data Analysis:      
Descriptive analyses will be performed on all variables. The differences in the improvement of 
clinical and patient-reported outcomes will be examined between the two groups using the 
Student’s t test or Wilcoxon rank-sum test as appropriate. Categorical data between the two 
study groups will be analyzed using the Chi-square test for independence or Fisher’s exact test 
when expected cell size is less than 5. Pearson’s product-moment correlation will be used to 
examine correlations between continuous variables such as HbA1c and HRQoL scores. 
Baseline factors that are significant in the bivariate analysis will be included in a multiple linear 
regression model to investigate the unique impact of the intervention on and the unique 
association of individual factors with each outcome score while adjusting for other covariates. 
The level of Type I error rate will be set at P < 0.05.   
 
The sum of the costs incurred will be compared between the two groups using the Wilcoxon 
rank-sum test as the cost data are not expected to be normally distributed. General linear 
models with a log-link to the gamma distribution will be used to conduct multivariate analysis of 
costs between the groups. Gamma distributions are well suited for cost data since it a right-

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skewed distribution. A cost-effectiveness analysis will be performed in which the effectiveness 
is defined by reduction in HbA1c between baseline and the 12-month follow-up. The 
incremental cost-effectiveness ratio will be calculated in which the difference in total costs 
between two groups is divided by the difference in the reduction in HbA1c between the two 
groups. Sensitivity analysis will be conducted to evaluate the influence of uncertainties in the 
variables and assumptions employed on the analysis results.  
 
Data Entry and Storage:  
All research-related electronic data collected will be de-identified, coded and entered in 
Microsoft Excel spreadsheet that will be password-protected and will be stored together with 
research-related paper documents in the investigators office at the National University of 
Singapore Department of Pharmacy, Faculty of Science. All patient information will be kept 
strictly confidential, following the policies of the study institution(s) involved. For hardcopy data, 
they will be stored in designated locked cabinet(s) or room(s) that are accessible to authorized 
study personnel only. For electronic data, they will be stored on in a secured computer that is 
password-protected. The databases will not contain subject identifiers and the data linking 
subject identifiers and the subject identification codes will be stored separately. These 
documents will be retained for a minimum of three years after study completion or as per 
institutional policies. 
 
Confidentiality of Data and patient Records: 
Investigators in this study will have access to all research-related data on a need-to-know basis 
or as per institutional policies. Collaborators in this study will only have access to research-
related data that has been coded and has no patient related identifier. Only the principal 
investigators and co-investigators or collaborators will have access to the data in the excel 
spreadsheet. There will not be any sharing or releasing of raw data to any other persons. 
 
Publication:  
The principal investigators and co-investigators/collaborators are entitled to full de-identified 
data access and to publish the study findings as appropriate.  
 
Patients Reimbursement: 
Upon completion of the baseline questionnaires, the participant will be given a glucometer and 
a maximum of 4 bottles (each bottle with 50 units) of test strips and lancets. If the participant 
completes the questionnaires at the 6-month time point, he / she will be reimbursed with $20.00 
in cash or equivalent. If the participant completes the questionnaires at the 12-month time-point, 
he / she will be reimbursed with $30.00 in cash or equivalent. 
 
Selected References: 
 
1. 
International Diabetes Federation. IDF Diabetes Atlas (7th Edition). 2015. 
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Png ME, Yoong J, Phan TP, et al. Current and future economic burden of diabetes 
among working-age adults in Asia: conservative estimates for Singapore from 2010-
2050. BMC Public Health. 2016; 16:153. 
4. 
Kirkman MS, Briscoe VJ, Clark N, et al. Diabetes in older adults. Diabetes Care. 2012; 
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