Clinical trial NCT02256657: Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients
Official title: Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-10-03
Enrollment: 21374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: This study is a cluster randomized, stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size to one of five cohorts. After a four-month baseline period, the quality improvement toolkit will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement the quality improvement toolkit at time points 8, 12, 16, and 20 months respectively, continuing the use of the toolkits from that time forward to the end of the study. The primary outcome is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be continuously collected and compared at one interim time point for safety and efficacy. Final analysis compares MACE rates before and after implementation of the quality improvement toolkits, accounting for cluster effects of hospital, cohort and time.

Eligibility criteria: Inclusion Criteria:

* Presenting with Acute Coronary Syndrome

Exclusion Criteria:

* Below the Age of 18
* Patient without Acute Coronary Syndrome

Primary outcomes:
measure: 30-Day Major Adverse Cardiovascular Events
timeFrame: 30 Days from Hospital Discharge
Secondary outcomes:
measure: In-Hospital Medication Rates
timeFrame: 30 Days
measure: Discharge Medication Rates
timeFrame: 30 Days
measure: Discharge Advice Relative to Healthy Lifestyles
timeFrame: 30 Days
measure: In-Hospital and 30-Day Expanded MACE
timeFrame: 30 Days
measure: Concordance with locally-defined performance measures and in-hospital and 30-day MACE
timeFrame: 30 Days
measure: Health Related Quality of Life
timeFrame: 30 Days
measure: Impoverishing Effects of an ACS Event
timeFrame: 30 Days
Other outcomes:
Locations:
city: Alappuzha
country: India
facility: Government Medical College Alappuzha
state: Kerala
city: Aluva
country: India
facility: Samaritan Hospital
state: Kerala
city: Angamaly
country: India
facility: Little Flower Hospital & Research Center
state: Kerala
city: Calicut
country: India
facility: Baby Memorial Hospital
state: Kerala
city: Calicut
country: India
facility: Government Medical College Kozhikode
state: Kerala
city: Calicut
country: India
facility: Metro International Cardiac Centre
state: Kerala
city: Chalakka
country: India
facility: Sree Narayana Institute of Medical Sciences
state: Kerala
city: Chavakkad
country: India
facility: Rajah Charitable Medical Trust
state: Kerala
city: Cherthala
country: India
facility: KVM Hospital
state: Kerala
city: Cochin
country: India
facility: PVS Memorial Hospital
state: Kerala
city: Edapal
country: India
facility: Sukapuram Hospital
state: Kerala
city: Irinjalakuda
country: India
facility: Irinjalakuda Co-operative Hospital Limited
state: Kerala
city: Irinjalakuda
country: India
facility: Lal Memorial Hospital
state: Kerala
city: Kannur
country: India
facility: Koyili Hospital
state: Kerala
city: Kannur
country: India
facility: St. Martin De Porres Hospital
state: Kerala
city: Kannur
country: India
facility: Pariyaram Medical College Hospital
state: Kerala
city: Kannur
country: India
facility: Kannur Medical College Super Specialty Hospital
state: Kerala
city: Kochi
country: India
facility: Lourdes Hospital
state: Kerala
city: Kochi
country: India
facility: Lakshmi Hospital
state: Kerala
city: Kochi
country: India
facility: Lisie Hospital
state: Kerala
city: Kochi
country: India
facility: Indira Ghandi Co-operative Hospital
state: Kerala
city: Kochi
country: India
facility: Amrita Institute of Medical Sciences & Research Center
state: Kerala
city: Kolenchery
country: India
facility: Malankara Orthodox Syrian Church Medical College Hospital
state: Kerala
city: Kollam
country: India
facility: AA Rahim Memorial District Hospital
state: Kerala
city: Kollam
country: India
facility: Bishop Benziger Hospital
state: Kerala
city: Kollam
country: India
facility: Dr. K. Damodaran Memoral Hospital
state: Kerala
city: Kollam
country: India
facility: Holy Cross Hospital
state: Kerala
city: Kollam
country: India
facility: Travancore Medical College
state: Kerala
city: Kothamangalam
country: India
facility: St. Joseph's Hospital
state: Kerala
city: Kottakkal
country: India
facility: Malabar Institute of Medical Sciences
state: Kerala
city: Kottayam
country: India
facility: Bharath Cardiovascular Institute
state: Kerala
city: Kottayam
country: India
facility: S.H. Medical Centre Hospital
state: Kerala
city: Kottayam
country: India
facility: Government Medical College Kottayam
state: Kerala
city: Kottayam
country: India
facility: Caritas Hospital
state: Kerala
city: Kozhikode
country: India
facility: KMCT Medical College
state: Kerala
city: Malappuram
country: India
facility: C.H. Memorial Hospital
state: Kerala
city: Palakkad
country: India
facility: Palakkad Government District Hospital
state: Kerala
city: Palakkad
country: India
facility: Thangam Hospital
state: Kerala
city: Palakkad
country: India
facility: Lakshmi Hospital
state: Kerala
city: Perintalmanna
country: India
facility: EMS Memorial Hospital
state: Kerala
city: Perintalmanna
country: India
facility: Ramdas Clinic & Nursing Home
state: Kerala
city: Thalassery
country: India
facility: Tellicherry Cooperative Hospital
state: Kerala
city: Thiruvananthapuram
country: India
facility: SK Hospital
state: Kerala
city: Thiruvananthapuram
country: India
facility: Medical College Thiruvananthapuram
state: Kerala
city: Thiruvananthapuram
country: India
facility: Sree Chitra Institute for Medical Sciences and Technology
state: Kerala
city: Thiruvananthapuram
country: India
facility: Ananthapuri Hospital and Research Institute
state: Kerala
city: Thiruvananthapuram
country: India
facility: Noorul Islam Institute of Medical Science & Research Foundation
state: Kerala
city: Thiruvananthapuram
country: India
facility: Sree Gokulam Medical College & Research Foundation
state: Kerala
city: Thodupuzha
country: India
facility: St. Mary's Hospital
state: Kerala
city: Thrissur
country: India
facility: Santhi Nursing Home
state: Kerala
city: Thrissur
country: India
facility: WestFort Hi-Tech Hospital Limited
state: Kerala
city: Thrissur
country: India
facility: Jubilee Mission Medical College & Research Institute
state: Kerala
city: Thrissur
country: India
facility: Elite Mission Hospital
state: Kerala
city: Thrissur
country: India
facility: Mother Hospital Limited
state: Kerala
city: Thrissur
country: India
facility: Aswini Hospital
state: Kerala
city: Thrissur
country: India
facility: Daya General Hospital & Specialty Surgery Centre
state: Kerala
city: Thrissur
country: India
facility: St. James Hospital
state: Kerala
city: Thrissur
country: India
facility: Amala Institute of Medical Sciences
state: Kerala
city: Thrissur
country: India
facility: Government Medical College Thrissur
state: Kerala
city: Thrissur
country: India
facility: Modern Hospital
state: Kerala
city: Tiruvalla
country: India
facility: Pushpagiri Institute of Medical Sciences and Research Centre
state: Kerala
city: Trivandrum
country: India
facility: PRS Hospital
state: Kerala
city: Trivandrum
country: India
facility: Kerala Institute of Medical Sciences
state: Kerala
Study officials:
affiliation: Northwestern University
name: Mark D Huffman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: WestFort Hi-Tech Hospital
name: PP Mohanan, MD, DM
role: STUDY_DIRECTOR
affiliation: Centre for Chronic Disease Control
name: Doirairaj Prabhakaran, MD, DM
role: STUDY_CHAIR
affiliation: Northwestern University
name: Donald Lloyd-Jones, MD, ScM
role: STUDY_CHAIR
References:
citation: 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.
citation: Huffman 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.
citation: Pei 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.
citation: Huffman 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.
citation: Singh 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.
citation: Sarma 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.