An update on the CHAMP-Path Study (Nov 2013).

1. CHAMP-Path Study
Updates
November 2013

2. CHAMP-Path Study Flowchart
(Last Update: 28 Nov 2013)
Enrollment
Assessed for Eligibility (n=405)
Missed (n=146)
Excluded (n=195)
Not meeting inclusion criteria (n=129)
Refused to participate (n=44)
Other reasons (n=22)
Analysis
Follow-up
Allocation
Randomized (n=210)
Allocated to Pathway Care (n=100)
Received Pathway Care (n=95)
Did not receive Pathway Care (n=5)
Misclassification (n=5)
Allocated to Usual Care (n=110)
Received Usual Care (n=100)
Did not receive Usual Care (n=10)
Misclassification (n=10)
Lost to Follow-up (n=19)
Misdiagnosis (n=9)
Transferred to CCU/ICU (n=5)
Re-enrollment (n=4)
Enrolled & discharged same day (n=1)
Lost to Follow-up (n=21)
Misdiagnosis (n=8)
Transferred to CCU/ICU (n=6)
Transferred to other specialty (n=1)
Re-enrollment (n=6)
Discontinued Pathway Care (n=4)
Patient died (n=2)
Discharged against medical advice (n=2)
Discontinued Usual Care (n=4)
Patient died (n=1)
Discharged against medical advice (n=3)
Analyzed (n= )
Excluded from analysis (n= )
Analyzed (n= )
Excluded from analysis (n= )

3. CHAMP-Path Study
STATUS
RECRUITING
Total Enrolled
Target Sample Size
210 504
Thank You for Your Support! 

4. THE CHAMP-PATH STUDY
Enrollment Status
ENROLLED
TARGET
SAMPLE SIZE
Community Acquired Pneumonia
53
166
Heart Failure
49
90
Acute Kidney Injury
35
30
Asthma
29
90
DVT/PE
41
128
PATHWAY

5. CHAMP-Path Study
Presentation Abstracts
KAIMRC 4th Annual Scientific Forum
12-13 November 2013, Riyadh

6. Abstract Presentation #1
Updates on CHAMP-Path:
Collaborative Healthcare Professionals Approach in
Monitoring of Patient Centered Outcomes through
Pathways: Pragmatic RCTs

7. 4th Annual Scientific Forum
“Research Day”
Abstract’s title
Names of authors
Department
Presenting Author
Title of the Presenting
Author
Updates on CHAMP-Path : Collaborative Healthcare
Professionals Approach in Monitoring of Patient
Centered Outcomes through Pathways : Pragmatic
RCTs
Ismail S, Alaifan T,AlWithenani R, Ahmed A, Hafez
J, Rashwan A, Matar E, Byelveld F, Carolus V,
Scudder B, Yusuf O, Khalil M, Abdrabuh L, Abbas S,
Karsou S, Zahrani Z,Gasim A, Elder K, Buhairi A,
Baseer M,Thomson J, AlMadani D, Siddiqui M,
Qureshi M,Melody O, Sawadi A, Shahrani K,
AlHamdan H, and Quadri K.H.M
Collaborative health care professionals
Dr. Sherine Ismail
Clinical Pharmacist ,Pharm.D , BCPS,
Teaching Assistant, Principles and Practice of
Clinical Research 2013, Harvard Medical School.
Contact information of
Email:
esmailss@ngha.med.sa
Presenting author
Phone:
02624000
Ext:
22863 or 22861
Pager:
1732
Mobile no:
0548967266
Abstract: Grant-Recipient of: King Abdullah International
Medical Research Center (RC10/134 J); CHAMPPath ClinicalTrials.gov: NCT01561885
Should not exceed 300 words

8. Introduction:
Patient Centeredness refers to healthcare that establishes partnership among healthcare practitioners,
patients, and their families. Previous studies have shown that mixed methodologies (quantitative and
qualitative) lead to better assessment of patient centeredness. No previous studies have been
reported in Saudi Arabia employing a similar methodology to measure patient-centered care. The
aim of this study was to explore the experience and satisfaction of patients admitted to medical
wards within NGHA-WR.
Methods:
In June and July 2013, thirty-five internal medicine patients, discharged after 3 or more days were
eligible to participate after verbal consent. Trained unit assistants interviewed patients using the
modified, validated CHAMP-Path questionnaire [Cronbach's Alpha = 0.91], containing 47 items
addressing patient satisfaction about services such as nutrition, health education, physician, nursing
and pharmaceutical care. Two focus group discussions (FGD) were conducted on 7 additional
patients. Data was analyzed with descriptive statistics using SPSS.
Results:
Nearly all patients were satisfied with both physician and nursing care. About half (45.7%) were not
informed about the expected length of stay. Less than half (15, 42.0%) and 20(57.2%) were not
satisfied with the comfort of the hospital, and the quality of food, respectively. However 31(88.7%)
were satisfied with the cleanliness of the ward. Medication reconciliation and discharge counseling
were received by 22(62.9%), and 19 (54.3%), respectively. A total of 27(77.1%) received nutritional
counseling, 13(37.1%) health education, and 10(28.6%) were referred to social services. Fifty-seven
percent reported moderate to complete pain relief. FGD reports revealed that male patients had a
positive experience with nurses, while females did not. Unsuitable food timings and long waiting
periods at emergency were also reported.
Discussion:
Despite several positives we believe the challenges identified in our study are a valid and reliable
representation of patients’ values and preferences, offering opportunities for further improvement in
quality of care.

9. Ismail S, Alaifan T, AlWithenani R, Ahmed A, Hafez J, Rashwan A, Matar E, Byelveld F, Carolus V, Scudder B, Yusuf
O, Khalil M, Abdrabuh L, Abbas S, Karsou S, Zahrani Z, Gasim A, Elder K, Buhairi A, Baseer M, Thomson J,
AlMadani D, Siddiqui M, Qureshi M, Melody O, AlSawadi A , Shahrani K, ALHamdan H and Quadri K.H.M
Department : Collaborative Health Care Professionals and Department of Medicine (NGHA-Jeddah)
Updates on CHAMP-Path : Collaborative Health Care Professionals Approach in Monitoring of Patient Centered
Outcomes through Pathways : Pragmatic RCTs
Methodology :
CHAMP-Path studies are pragmatic, parallel, single blinded , randomized controlled trials. A Collaborative
health care professionals of various departments ( Physicians, Pharmaceutical care, Nursing, Quality
improvement, Dietitians, social works and patient educators ) designed evidence based clinical pathways.
A pilot study was conducted from March 2012 to October 2012 and the study is currently on going.
Practicing physicians in clinical teaching unit in general internal medicine wards were randomized to usual
care (UC) or pathway care (PC) with only the PC arm having access to the clinical pathways.
Patient randomization was computer-generated through permuted blocks at 1:1 ratio with unequal size
blocks (4 and 6 ). Allocation concealment was done using opaque sealed envelopes distributed through
emergency pharmacy.
Eligibility criteria was age ≥ 14 yrs, hemodynamic stability, and pathway-specific inclusion and exclusion
criteria. Residents were responsible for screening and enrolling patient after obtaining an informed
consent. Patients are blinded to the allocated arm.
The intervention is clinical pathways integrated into Computerized Prescriber Order Entry (CPOE) preset
orders compared to usual care. The primary outcome is the reduction in LOS by two days. The secondary
outcomes are patient centered outcomes assessed through patient satisfaction questionnaire ,
determinants of LOS, and 30 day re-admission.
Statistical analysis :
The primary outcome will be reported as mean LOS SD , 95% CI, p-value . Unpaired two-tailed student Ttest will be used to test for significance among UC and PC. Chi-square test will be used to assess 30 days
readmission rates and Regression analysis for determinants of LOS. Descriptive statistics for patient
centered outcomes. (The SPSS statistical software will be used for data analysis).
A sample size of 504 patients was calculated for all medical diagnoses (AKI: 30, VTE: 128, Asthma: 90,
heart failure: 90, CAP: 166) to provide an 80% power with a level of significance of 5% and accounting for
10%-20% attrition rate.
Trial Profile CHAMP-Path clinical trials
Assessed for eligibility (363 patients)
Enrollment
Allocation
Grant-Recipient of: King Abdullah International Medical Research Center (RC10/134 J); CHAMP-Path
ClinicalTrials.gov; number, NCT01561885.)
Follow up
A Clinical pathway is an evidence-based integrated plan of care within a pre-defined time frame by
multidisciplinary health care professionals. Usual care is the current practice within the Department of
Medicine. There is a paucity of data and conflicting evidence about the utility of clinical pathways in actual
practice. CHAMP-Path trials are designed to determine if collaborative, clinical pathway care (PC) versus
usual care (UC) in a Joint Commission International (JCI) accredited facility will decrease the length of stay
(LOS) across multiple medical diagnoses over 2 years. These 5 medical diagnoses are: Acute kidney Injury
(AKI), Venous Thromboembolism (VTE), Asthma, Heart failure (HF) , and Community Acquired Pneumonia
(CAP). We aim to report an update on the ongoing trials.
Results :
Analysis
Introduction:
Randomized (186 patients)
Pathway Care (91 patients)
• (87) Patients received PC
• (4) Patients did not receive PC (Misclassification)
(18) patients Lost follow up : (Reasons)
(8) Misdiagnosis
(5)Transferred to CCU/ICU
(4) Re-Enrollment
(1) Enrolled & discharged same day
(4) Discontinued intervention : (Reasons)
(2 ) Died
(2) Discharged against medical advice
ITT Analysis (n) = Not yet
Excluded (177)
(113) Not meeting Inclusion Criteria
(42) Refused to participate
(22) Other reasons
Usual Care (95 patients)
• (85) Patients received UC
• (10) Patients did not receive UC (Misclassification)
(20 ) patients Lost follow up : (Reasons)
(8) Misdiagnosis
(6) Transferred to CCU/ICU
(6) Re-Enrollment
(4 ) Discontinued intervention: (Reasons )
(3) Discharged against medical advice
(1) Patient Died
ITT Analysis (n) = Not yet
To date, 186 patients have been enrolled from March 2012 till September 2013 (almost 1/3 of the estimated sample
size). AKI is almost achieving target sample as (29/30 ) patients enrolled while Asthma (26/90) , VTE (36/128) , CAP
(46/ 166) and HF (46/90).
Discussion:
CHAMP-Path pragmatic RCTs are recruiting patients at present, however many challenges of real life setting affect the
enrollment rate . Misdiagnosis occurs frequently in CAP pathway .The challenges of rotating residents in medicine
services, requires continuous education and organization for computerized pathway care access among teams. On the
other hand, CHAMP-Path RCTs represent the effectiveness of clinical pathways in real life settings. In addition, the
various clinical pathways initiated in this a JCI accredited facility, provide opportunities for addressing patient
centeredness and improving the flow of patients in the medical wards, through the reduction of LOS.
Conclusion : We propose that CHAMP-Path Pragmatic RCTs are pioneering studies in attempting to demonstrate
whether integrated, patient-centered clinical pathways are truly effective in real life settings and in improving patient important clinical outcomes. It is anticipated that 2 more years would be required to complete these trials.

10. Abstract Presentation #2
Measuring patient centeredness using the CHAMPPath validated questionnaire & focus group
discussions: A pilot study

11. 4th Annual Scientific Forum
“R
esearch Day”
Abstract’s title
Names of authors
Department
Presenting Author
Title of the Presenting Author
Measuring patient centeredness using the CHAMP-Path
validated questionnaire & focus group discussions: A pilot
study
Jane Thomson, Doha AlMadani, Oyindamola Yusuf, Maryam
Khalil, Muhammad Siddiqui, Bonnie Scudder, Arlene Rashwan,
Eman Matar, Majed Farahat, Mohammad Alghamdi, Suzan
Kashaan, Wafaa Bataweel, Sherine Ismail, Jani Hafez, Zeyad
Zahrani, and Quadri KHM
Nursing (Medicine & Surgery), NGHA-WR and Champ-Path collaborators
Ms. Jane Thomson
Director Clinical Nursing: Medicine & Surgery, NGHA-WR
Email:
thomsonja@ngha.med.sa
Phone:
(02) 624-0000
Ext:
24840
Pager:
4840
Mobile no:
Abstract: Grant-Recipient of King Abdullah International Medical Research
Center (RC10/134 J); Registered on ClinicalTrials.gov
(NCT01561885).
Should not exceed 300 words
Contact information of
Presenting author

12. Introduction:
Patient Centeredness refers to healthcare that establishes partnership among healthcare practitioners,
patients, and their families. Previous studies have shown that mixed methodologies (quantitative and
qualitative) lead to better assessment of patient centeredness. No previous studies have been reported in
Saudi Arabia employing a similar methodology to measure patient-centered care. The aim of this study was
to explore the experience and satisfaction of patients admitted to medical wards within NGHA-WR.
Methods:
In June and July 2013, thirty-five internal medicine patients, discharged after 3 or more days were eligible
to participate after verbal consent. Trained unit assistants interviewed patients using the modified, validated
CHAMP-Path questionnaire [Cronbach's Alpha = 0.91], containing 47 items addressing patient satisfaction
about services such as nutrition, health education, physician, nursing and pharmaceutical care. Two focus
group discussions (FGD) were conducted on 7 additional patients. Data was analyzed with descriptive
statistics using SPSS.
Results:
Nearly all patients were satisfied with both physician and nursing care. About half (45.7%) were not
informed about the expected length of stay. Less than half (15, 42.0%) and 20(57.2%) were not satisfied
with the comfort of the hospital, and the quality of food, respectively. However 31(88.7%) were satisfied
with the cleanliness of the ward. Medication reconciliation and discharge counseling were received by
22(62.9%), and 19 (54.3%), respectively. A total of 27(77.1%) received nutritional counseling, 13(37.1%)
health education, and 10(28.6%) were referred to social services. Fifty-seven percent reported moderate to
complete pain relief. FGD reports revealed that male patients had a positive experience with nurses, while
females did not. Unsuitable food timings and long waiting periods at emergency were also reported.
Discussion:
Despite several positives we believe the challenges identified in our study are a valid and reliable
representation of patients’ values and preferences, offering opportunities for further improvement in quality
of care.

13. Name: Jane Thomson, Doha AlMadani, Oyindamola Yusuf, Maryam Khalil, Muhammad Siddiqui, Bonnie Scudder, Arlene Rashwan,
Eman Matar, Francis Byleveld, Virginia Carolus, Majed Farahat, Mohammad Alghamdi, Suzan Kashaan, Wafaa Bataweel, Sherine Ismail,
Jani Hafez, Zeyad Zahrani, and Quadri KHM
Department: Nursing (Medicine & Surgery) with Collaborative Healthcare Professionals, NGHA-WR
Measuring Patient Centeredness Using the CHAMP-Path Validated Questionnaire
& Focus Group Discussions: A Pilot Study
INTRODUCTION
RESULTS
“I was in ER for more than 10
hours……waiting on a chair. I’d
rather go to a bad hospital
than to go through this ER.”
METHODOLOGY
“I was supposed to be
discharged in the morning.
But I left in the night
…..I don’t know why.”
The tables below show the highest and lowest rated items for the CHAMP-Path
patient satisfaction questionnaire, as well as the services not received by the
majority of respondents.
Images
In June and July 2013, thirty-five internal medicine patients,
discharged after three or more days, were eligible to
participate. Trained ward unit assistants interviewed patients
using the modified, validated CHAMP-Path patient satisfaction
questionnaire [Cronbach's Alpha = 0.91], a 47-item instrument
with a five-point scale used to rate satisfaction with the quality
of services provided by six departments (Physician, Nursing,
Pharmacy, Nutrition, Health Education, and Social Services).
Data was analyzed with descriptive statistics using SPSS.
DISCUSSION
“They forgot to bring me
food, I was given no tea or
milk with breakfast, food was
cold, I would like a food
menu”
Two focus group discussions (FGD) were conducted from each
gender. One group of four male patients and another group of
three female patients.
“I know I had allergies to this
medicine….nobody listened.”
LOWEST
“I feel this hospital
has a sense of
commitment.”
HIGHEST
Patient Centeredness refers to healthcare that establishes a
partnership among healthcare practitioners, patients, and
their families. There is a worldwide drive to understand the
best way to measure people’s expectations and satisfaction
with healthcare. Previous studies have shown that mixed
methodologies (quantitative and qualitative) lead to better
assessment of patient centeredness.
The aim of this study is to measure, understand, and act on
the experience of patients and their families admitted to
medical wards within NGHA-WR.
“Different doctor,
Different diagnosis, Different
treatment plan…. who to talk to?”
“What I need most is more mercy,
more kindness and more humanity
from all staff”
“I’m worried about giving the right
care to my uncle after discharge…
I only received training once.”
This pilot study showed that the responses received from the patient
satisfaction questionnaire were reflective of the themes derived from the focus
group discussions (FGD). Thus, both the quantitative and qualitative results
were complementary to each other. However, the FGD probed deeper into the
thoughts, feelings, and experience of the patients. The FGD was a newly
introduced methodology, which our patient population received favorably.
The results highlight perceived gaps within the healthcare services provided,
such as health education and social services.
Recommendations from this pilot may include setting up a task force to
improve Food, Fluid and Nutritional Care for patients; and to improve overall
inter-disciplinary teamwork.
In conclusion, this pilot study demonstrated the feasibility of this mixed
methodology for measuring patient centeredness, thus we intend to move
forward to conduct the study on a larger scale.

14. Abstract Presentation #3
A pragmatic RCT comparing pathway-based versus
usual care in Acute Kidney Injury (AKI) –
CHAMP-Path Study

15. 4th Annual Scientific Forum
“R
esearch Day”
Abstract’s title
Names of authors
Department
Presenting Author
Title of the Presenting Author
Contact information of
Presenting author
A pragmatic RCT comparing pathway-based versus usual care in
Acute Kidney Injury (AKI) – CHAMP-Path Study
Quadri KHM, Sherine Ismail, Zuhair Abunijem, Abdullah AlMalki,
Mohammed Balla, Mohammed Qureshi, Rehan Qureshi, Jani Hafez,
Maryam Khalil, Thamer Alaifan, Atta Rehman, Oyindamola Yusuf,
Garry Mackenzie, Omar Taleb, Abdulhameed Gasim, Zeyad
Zahrani, Sulaiman Karsou
Medicine
Quadri KHM
Chairman, Department of Medicine
Email:
QuadriMU@ngha.med.sa
Phone:
(012) 624-0000
Ext:
21665
Pager:
2099
Mobile no:
0563228917
Abstract: CHAMP-Path Study: Grant-R
ecipient of King Abdullah International
Medical R
esearch Center (R 10/ 134/ J); R
C
egistered on
ClinicalTrials.gov (NCT01561885)
Should not exceed 300 words

16. INTRODUCTION:
The CHAMP-Path AKI Trial is a pragmatic, parallel, single-blind RCT. The utility of AKI clinical pathways in
reducing length of stay (LOS) has not been reported. Therefore, we aim to study LOS in AKI comparing
pathway versus usual care as a part of the CHAMP-Path Trials.
METHODS:
Enrollment began in March 2012. Patients presenting to the emergency department, older than 14 years
with a serum creatinine increase of greater than1.5 times baseline (RIFLE Criteria), with AKI as the
admitting diagnosis with hemodynamic stability were eligible. Patients with CKD stages 4 or 5, transplants,
obstructive uropathy, glomerulonephritis, interstitial nephritis, and pregnancy were excluded. After informed
consent patients were randomized and blinded to receive either pathway or usual care.
The AKI pathway was developed by multidisciplinary health care professionals. Pathways were integrated
into a computerized prescriber order entry system (CPOE). General medicine physicians were randomized
to provide either usual or pathway care, with only the pathway arm having access to CPOE. Patients were
randomized via computer-generated sequence with allocation concealment by opaque sealed envelopes,
via emergency pharmacy.
Primary Outcome: a decrease in LOS by 2 days. Secondary outcomes: 30 day re-hospitalization rate,
determinants of (LOS), and in-hospital mortality. A sample size of 30 patients was estimated based on a
mean LOS of 5 ± 1.8 days, powered at 80% with an alpha of 5% and 20% attrition rate. Mean LOS ±SD,
95% CI, p-values using an intention-to-treat analysis will be reported. Regression analysis will be used to
identify determinants of LOS.
RESULTS:
To date, 27 of 81 patients screened were enrolled, with 12 allocated to pathway and 15 to usual care.
CONCLUSION:
The trial is expected to complete shortly, providing our first insight on AKI pathway effectiveness in
pragmatic settings. Our results are expected to influence future pathway utilization in NGHA.

17. Quadri KHM, Sherine Ismail, Zuhair Abunijem, Abdullah AlMalki, Mohammed Balla, Mohammed Qureshi,
Rehan Qureshi, Jani Hafez, Maryam Khalil, Thamer Alaifan, Atta Rehman, Oyindamola Yusuf, Garry Mackenzie,
Omar Taleb, Abdulhameed Gasim, Zeyad Zahrani, Sulaiman Karsou
Collaborative Healthcare Professionals with the Department of Medicine, King Abdulaziz Medical City, Jeddah
A Pragmatic RCT Comparing Pathway-based versus Usual Care in
Acute Kidney Injury (AKI) – CHAMP-Path Study
Introduction
Results
The CHAMP-Path AKI Trial is a pragmatic, parallel, single-blind RCT which began enrollment in March 2012. The
utility of AKI clinical pathways in reducing length of stay has not been reported. Therefore, we aim to study the
length of stay (LOS) in AKI, comparing pathway versus usual care as a part of the CHAMP-Path Trials
(NCT 01561885, ClincialTrials.gov). This is a description of the trial’s methodology and current status.
To date, 29 patients out of a target sample size of 30 patients have been enrolled, with 14 allocated to
pathway and 15 to usual care.
Methodology
The AKI pathway was developed by a team of multidisciplinary health care professionals. Pathways were
integrated into a computerized prescriber order entry system (CPOE).
General medicine physicians were randomized to provide
either usual or pathway care, with only the pathway arm
having access to the Pathways CPOE.
GIM Physicians &
Enrolled Patients
Randomization
Usual Care
(CTU1)
Pathway Care
(CTU2)
INCLUSION CRITERIA
EXCLUSION CRITERIA
Age > 14 years old
Pregnancy
Serum Creatinine > 50% baseline ICU patients
(RIFLE Criteria)
AKI is the principal diagnosis
Stage 4/5 Chronic Kidney Disease
Hemodynamic stability
Kidney allograft recipients
Screening & Enrollment:
AKI Eligibility Criteria for patients presenting to ER
 Written Informed Consent
Randomization via a computer-generated sequence,
allocation concealment, opaque sealed envelopes through ER Pharmacy.
 Patient Blinding
Obstructive Uropathy
Glomerulonephritis
Interstitial Nephritis
Primary Outcome
Secondary Outcome
Decrease in LOS by 2 days
30-day readmission rate, determinants of LOS, and in-hospital mortality
Sample Size
30 patients. (Estimation based on mean LOS of 5 1.8 days, powered at 80% with an
alpha of 5% and 20% attrition rate).
Mean LOS SD, 95% CI, p-values using an intention-to-treat analysis will be reported. Regression analysis will be
used to identify determinants of LOS.
Discussion
Our study represents one of the first attempts to report outcomes on Acute Kidney Injury and length of
hospitalization, exclusive of ICU settings. To our knowledge, this is the first randomized pragmatic trial
comparing AKI management in a pathway-guided format compared with Usual Care. A multi-factorial etiology
frequently makes it challenging to isolate the diagnosis of AKI from other principal causes of hospitalization,
accounting for the large number of patients failing to meet the inclusion criteria. We also excluded patients
with chronic kidney disease stages 4 & 5, as well as renal allograft recipients. The trial is expected to complete
shortly, providing our first insight on AKI pathway effectiveness in real-life settings. Our results are expected to
influence future pathway utilization in NGHA.

18. Abstract Presentation #4
Overcoming the challenges of screening and recruitment
in a resident-driven pragmatic randomized trial–
The CHAMP-Path experience

19. 4th Annual Scientific Forum
“R
esearch Day”
Abstract’s title
Names of authors
Department
Presenting Author
Title of the Presenting Author
Contact information of
Presenting author
Overcoming the challenges of screening and recruitment in a
resident-driven pragmatic randomized trial– The CHAMP-Path
experience
Maryam Khalil, Thamer AlAifan, Raad AlWithenani, Akram Ahmad,
Reham Alharbi, Samah Nawawi, Reem Assebaiei, Osamah Hakami,
Abdullah AlSaeidi, Hadeel AlQurashi, Salwa Aidarous, Melody
Omana, Sherine Ismail, Oyindamola Yusuf, Jani Hafez, Zeyad
Zahrani, Gasim Abdulhameed, Sulaiman Karsou, and Quadri KHM
Medicine
Maryam Khalil
Research Assistant, KAIMRC (CHAMP-Path Study)
Email:
Maryam.research@gmail.com
Phone:
(012) 624-0000
Ext:
21298
Pager:
2436
Mobile no:
0508886840
Abstract: CHAMP-Path Study: Grant-R
ecipient of King Abdullah International
Medical R
esearch Center (R 10/ 134/ J); R
C
egistered on
ClinicalTrials.gov (NCT01561885)
Should not exceed 300 words

20. INTRODUCTION:
Successful patient recruitment in a clinical trial depends on motivation and participation. Studies have
reported that less than half of participating physicians screen patients, and that only 20% of eligible
patients are recruited. Pragmatic trials are particularly challenging in this respect. We report our
experience with patient recruitment and the strategies employed to improve resident participation in the
CHAMP-Path Study, a pragmatic, parallel, single-blind RCT designed to evaluate the effectiveness of
five clinical pathways in reducing length of stay (LOS).
METHODS:
In order to motivate residents to screen and recruit patients, we used the following strategies: making
daily reminder calls to residents on-duty in the ER during the night and day; awarding certificates of
appreciation periodically to the most supportive residents in recognition; and visibly updating the patient
enrollment counter promptly.
To address resident barriers in recruitment, we made the following efforts: revised the Arabic translation
of the Informed Consent and made it more patient-friendly; conducted Informed Consent workshops;
provided research books for capacity-building; designed a resident-friendly flowchart to clarify
recruitment procedures; and sponsored the most supportive residents to attend research conferences.
After employing these strategies we compared screening and enrollment rates between the pilot phase
and the main phase to date. Statistical analyses were performed using the chi-squared test for
proportions.
RESULTS:
Screening rate improved significantly from 58.6% in the pilot study to 79.5% in the main study
(p<0.0001). In addition recruitment rate also improved significantly from 38.8% in the pilot study to
55.1% (p=0.009) in the main study.
CONCLUSION:
By employing diverse strategies to motivate and empower participating residents, we have successfully
improved our patient screening and recruitment rates. Based on the current enhanced recruitment

21. Maryam Khalil, Thamer AlAifan, Raad AlWithenani, Akram Ahmad,
Reham AlHarbi, Samah Nawawi,
Reem Assebaiei, Osamah Hakami, Abdullah AlSaiedi, Hadeel AlQurashi, Salwa Aidarous, Melody Omana,
Sherine Ismail, Oyindamola Yusuf, Jani Hafez, Zeyad Zahrani, Gasim Abdulhameed, Sulaiman Karsou,
and KHM Quadri
Collaborative Healthcare Professionals with the Department of Medicine, King Abdulaziz Medical City, Jeddah
Overcoming the Challenges of Screening and Recruitment in a
Resident-Driven, Pragmatic, Randomized Trial – The CHAMP-Path Experience
INTRODUCTION
Successful patient recruitment in a clinical trial depends on the
motivation and support of participating physicians. Studies have
reported that less than 50% of participating physicians recruit patients,
and that only 20% of eligible patients are enrolled1. Pragmatic trials are
particularly challenging in this respect. We report our experience with
patient recruitment and the strategies employed to improve resident
participation in the CHAMP-Path Study, a pragmatic, parallel, singleblind RCT designed to evaluate the effectiveness of five clinical
pathways in reducing length of stay (LOS).
RESULTS
Less than 50% of
participating
physicians actually
recruit patients, and
often only 20% of
eligible patients are
enrolled.1
Both the screening rate and recruitment rate improved significantly, with a p-value of
< 0.0001 and 0.009 respectively.
METHODOLOGY
To motivate residents to participate, we:
 Made daily reminder and follow-up calls to residents
on-call in the ER to minimize forgetfulness;
 Awarded certificates of appreciation periodically to
the most supportive residents;
 Visibly updated the patient enrollment counter;
 Sponsored the most supportive and top recruiting
residents to attend clinical research conferences.
To address recruitment barriers, we:
 Made the Informed Consent form (Arabic version)
more patient-friendly
 Conducted Informed Consent workshops;
 Established a Research Library for capacity-building;
 Designed a flowchart to clarify recruitment procedures.
Statistical analysis:
Screening and enrollment rates were compared between
the pilot study and the main study. Chi-squared test for
proportions was used for statistical analysis.
DISCUSSION & CONCLUSION
Participating residents can be motivated to screen and recruit patients when diverse strategies are
used. To boost recruitment, we used a blend of motivation and support techniques. The reminder
calls and appreciation certificates were an attempt to build personal contact between the residents
and research team. Studies have shown that having regular and personal contact with participating
physicians is one of the effective strategies for influencing participation2. It has also been reported
that participating physicians gain motivation through the motivation of the research group2. Thus
we conducted workshops and established a research library – not only to breakdown recruitment
barriers – but to also cultivate an enthusiasm for clinical research. As a different approach to other
studies, we sponsored top recruiting residents to attend clinical research conferences, provided
Informed Consent workshops, and used an enrollment counter. With consistent effort, we hope to
witness further improvement. Based on the current enhanced recruitment rate, we expect to
complete the CHAMP-Path trials within the next two years.
References:
1de Wit NJ, Quartero AO, Zuithoff AP, Numans ME: Participation and successful patient recruitment in primary care. J Fam Pract 2001, 50:976
2 Fransen G, van Marrewijk C, Mujakovic S,et al. Pragmatic trials in primary care: methodological challenges and solutions demonstrated by the
DIAMOND study.BMC Med Res Methodol 2007;7(16).
CHAMP-Path Study:
Grant-Recipient of King Abdullah International Medical Research Center (RC 10/134/J); Registered on ClinicalTrials.gov (NCT01561885)

22. Acknowledgments
Department of Medicine
Department of Nursing-Ward 16, Ward 17, ER, Wards 3/4/20
Department of Pharmacy
Department of Quality Management
Department of Health Promotions
Department of Clinical Nutrition
Unit Assistants – Ward 16, Ward 17, ER, Wards 3/4/20
CHAMP-Path Team
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