Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients
ACS QUIK
Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
3 other identifiers
interventional
21,374
1 country
63
Brief Summary
The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Typical duration for not_applicable
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 17, 2018
August 1, 2018
2.1 years
October 1, 2014
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
30-Day Major Adverse Cardiovascular Events
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on 30-day major adverse cardiovascular events (MACE \[death, reinfarction stroke, or major bleeding\]) in patients admitted with acute coronary syndrome, adjusted for hospital, time, and step.
30 Days from Hospital Discharge
Secondary Outcomes (7)
In-Hospital Medication Rates
30 Days
Discharge Medication Rates
30 Days
Discharge Advice Relative to Healthy Lifestyles
30 Days
In-Hospital and 30-Day Expanded MACE
30 Days
Concordance with locally-defined performance measures and in-hospital and 30-day MACE
30 Days
- +2 more secondary outcomes
Study Arms (5)
Step 1: Toolkit Implemented in Month 4
EXPERIMENTALQuality Improvement Toolkit
Step 2: Toolkit Implemented in Month 8
EXPERIMENTALQuality Improvement Toolkit
Step 3: Toolkit Implemented in Month 12
EXPERIMENTALQuality Improvement Toolkit
Step 4: Toolkit Implemented in Month 16
EXPERIMENTALQuality Improvement Toolkit
Step 5: Toolkit Implemented in Month 20
EXPERIMENTALQuality Improvement Toolkit
Interventions
The quality improvement toolkit is comprised of standardized admission and discharge checklists, clinical pathways, an audit and feedback mechanism through electronic data capture, and a monthly report used in conjunction with root cause analysis meetings. Quality improvement toolkits are implemented by individual hospitals.
Eligibility Criteria
You may qualify if:
- Presenting with Acute Coronary Syndrome
You may not qualify if:
- Below the Age of 18
- Patient without Acute Coronary Syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Government Medical College Alappuzha
Alappuzha, Kerala, 688005, India
Samaritan Hospital
Aluva, Kerala, 683562, India
Little Flower Hospital & Research Center
Angamaly, Kerala, 683572, India
Baby Memorial Hospital
Calicut, Kerala, 673004, India
Government Medical College Kozhikode
Calicut, Kerala, 673008, India
Metro International Cardiac Centre
Calicut, Kerala, 673014, India
Sree Narayana Institute of Medical Sciences
Chalakka, Kerala, 683594, India
Rajah Charitable Medical Trust
Chāvakkād, Kerala, 680506, India
KVM Hospital
Cherthala, Kerala, 688524, India
Sukapuram Hospital
Edappāl, Kerala, 679576, India
Irinjalakuda Co-operative Hospital Limited
Irinjālakuda, Kerala, 680661, India
Lal Memorial Hospital
Irinjālakuda, Kerala, 680712, India
Koyili Hospital
Kannur, Kerala, 670004, India
St. Martin De Porres Hospital
Kannur, Kerala, 670301, India
Pariyaram Medical College Hospital
Kannur, Kerala, 670503, India
Kannur Medical College Super Specialty Hospital
Kannur, Kerala, 670612, India
Lourdes Hospital
Kochi, Kerala, 682012, India
Lakshmi Hospital
Kochi, Kerala, 682016, India
PVS Memorial Hospital
Kochi, Kerala, 682017, India
Lisie Hospital
Kochi, Kerala, 682018, India
Indira Ghandi Co-operative Hospital
Kochi, Kerala, 682020, India
Amrita Institute of Medical Sciences & Research Center
Kochi, Kerala, 682041, India
Malankara Orthodox Syrian Church Medical College Hospital
Kolenchery, Kerala, 682311, India
AA Rahim Memorial District Hospital
Kollam, Kerala, 691001, India
Bishop Benziger Hospital
Kollam, Kerala, 691001, India
Dr. K. Damodaran Memoral Hospital
Kollam, Kerala, 691001, India
Holy Cross Hospital
Kollam, Kerala, 691571, India
Travancore Medical College
Kollam, Kerala, 691589, India
Bharath Cardiovascular Institute
Kottayam, Kerala, 686001, India
S.H. Medical Centre Hospital
Kottayam, Kerala, 686001, India
Government Medical College Kottayam
Kottayam, Kerala, 686008, India
Caritas Hospital
Kottayam, Kerala, 686630, India
KMCT Medical College
Kozhikode, Kerala, 673602, India
St. Joseph's Hospital
Kōthamangalam, Kerala, 686691, India
Malabar Institute of Medical Sciences
Kōttakkal, Kerala, 676503, India
C.H. Memorial Hospital
Malappuram, Kerala, 676552, India
Palakkad Government District Hospital
Palakkad, Kerala, 678001, India
Thangam Hospital
Palakkad, Kerala, 678004, India
Lakshmi Hospital
Palakkad, Kerala, 678013, India
EMS Memorial Hospital
Perintalmanna, Kerala, 679322, India
Ramdas Clinic & Nursing Home
Perintalmanna, Kerala, 679322, India
Tellicherry Cooperative Hospital
Thalassery, Kerala, 670101, India
SK Hospital
Thiruvananthapuram, Kerala, 695006, India
Medical College Thiruvananthapuram
Thiruvananthapuram, Kerala, 695011, India
Sree Chitra Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala, 695011, India
Ananthapuri Hospital and Research Institute
Thiruvananthapuram, Kerala, 695024, India
Noorul Islam Institute of Medical Science & Research Foundation
Thiruvananthapuram, Kerala, 695123, India
Sree Gokulam Medical College & Research Foundation
Thiruvananthapuram, Kerala, 695607, India
St. Mary's Hospital
Thodupuzha, Kerala, 685584, India
Santhi Nursing Home
Thrissur, Kerala, 679561, India
WestFort Hi-Tech Hospital Limited
Thrissur, Kerala, 680002, India
Jubilee Mission Medical College & Research Institute
Thrissur, Kerala, 680005, India
Elite Mission Hospital
Thrissur, Kerala, 680007, India
Mother Hospital Limited
Thrissur, Kerala, 680012, India
Aswini Hospital
Thrissur, Kerala, 680020, India
Daya General Hospital & Specialty Surgery Centre
Thrissur, Kerala, 680022, India
St. James Hospital
Thrissur, Kerala, 680307, India
Amala Institute of Medical Sciences
Thrissur, Kerala, 680555, India
Government Medical College Thrissur
Thrissur, Kerala, 680596, India
Modern Hospital
Thrissur, Kerala, 680664, India
Pushpagiri Institute of Medical Sciences and Research Centre
Tiruvalla, Kerala, 689101, India
PRS Hospital
Trivandrum, Kerala, 695002, India
Kerala Institute of Medical Sciences
Trivandrum, Kerala, 695029, India
Related Publications (6)
Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Lloyd-Jones DM, Prabhakaran D. Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. Am Heart J. 2017 Mar;185:154-160. doi: 10.1016/j.ahj.2016.10.026. Epub 2016 Dec 21.
PMID: 28267469BACKGROUNDHuffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Krishnan MN, Natesan S, Gopinath R, Viswanathan S, Stigi J, Joseph J, Chozhakkat S, Lloyd-Jones DM, Prabhakaran D; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):567-578. doi: 10.1001/jama.2017.21906.
PMID: 29450524RESULTPei J, Wang X, Xing Z, Chen P, Su W, Deng S, Hu X. Association between admission systolic blood pressure and major adverse cardiovascular events in patients with acute myocardial infarction. PLoS One. 2020 Jun 19;15(6):e0234935. doi: 10.1371/journal.pone.0234935. eCollection 2020.
PMID: 32559257DERIVEDHuffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Spertus JA, Chan PS, Natesan S, Abdullakutty J, Krishnan MN, Tp A, Renga S, Punnoose E, Unni G, Prabhakaran D, Lloyd-Jones DM; ACS QUIK Investigators. Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e004980. doi: 10.1161/CIRCOUTCOMES.118.004980.
PMID: 30755027DERIVEDSingh K, Devarajan R, Mohanan PP, Baldridge AS, Kondal D, Victorson DE, Karmali KN, Zhao L, Lloyd-Jones DM, Prabhakaran D, Goenka S, Huffman MD; ACS QUIK Investigators. Implementation and acceptability of a heart attack quality improvement intervention in India: a mixed methods analysis of the ACS QUIK trial. Implement Sci. 2019 Feb 6;14(1):12. doi: 10.1186/s13012-019-0857-7.
PMID: 30728053DERIVEDSarma S, Harikrishnan S, Baldridge AS, Devarajan R, Mehta A, Selvaraj S, Ali MK, Mohanan PP, Prabhakaran D, Huffman MD. Availability, Sales, and Affordability of Tobacco Cessation Medicines in Kerala, India. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004108. doi: 10.1161/CIRCOUTCOMES.117.004108.
PMID: 29150536DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Huffman, MD, MPH
Northwestern University
- STUDY DIRECTOR
PP Mohanan, MD, DM
WestFort Hi-Tech Hospital
- STUDY CHAIR
Doirairaj Prabhakaran, MD, DM
Centre for Chronic Disease Control
- STUDY CHAIR
Donald Lloyd-Jones, MD, ScM
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor in Preventive Medicine and Medicine-Cardiology
Study Record Dates
First Submitted
October 1, 2014
First Posted
October 3, 2014
Study Start
November 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
August 17, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data have been distributed to NHLBI BIOLINCC.
- Access Criteria
- Access to data will be managed through NLHBI BIOLINCC request process.
De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.