Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients

Acute Coronary Syndrome Clinical Trial

— ACS QUIK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256657
• Other study ID #: ACS QUIK
• Secondary ID: 1K99HL107749-01A
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21374
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presenting with Acute Coronary Syndrome

Exclusion Criteria:

• Below the Age of 18

• Patient without Acute Coronary Syndrome

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Behavioral:
• Quality Improvement Toolkit
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.

Locations

Country	Name	City	State
India	Government Medical College Alappuzha	Alappuzha	Kerala
India	Samaritan Hospital	Aluva	Kerala
India	Little Flower Hospital & Research Center	Angamaly	Kerala
India	Baby Memorial Hospital	Calicut	Kerala
India	Government Medical College Kozhikode	Calicut	Kerala
India	Metro International Cardiac Centre	Calicut	Kerala
India	Sree Narayana Institute of Medical Sciences	Chalakka	Kerala
India	Rajah Charitable Medical Trust	Chavakkad	Kerala
India	KVM Hospital	Cherthala	Kerala
India	PVS Memorial Hospital	Cochin	Kerala
India	Sukapuram Hospital	Edapal	Kerala
India	Irinjalakuda Co-operative Hospital Limited	Irinjalakuda	Kerala
India	Lal Memorial Hospital	Irinjalakuda	Kerala
India	Kannur Medical College Super Specialty Hospital	Kannur	Kerala
India	Koyili Hospital	Kannur	Kerala
India	Pariyaram Medical College Hospital	Kannur	Kerala
India	St. Martin De Porres Hospital	Kannur	Kerala
India	Amrita Institute of Medical Sciences & Research Center	Kochi	Kerala
India	Indira Ghandi Co-operative Hospital	Kochi	Kerala
India	Lakshmi Hospital	Kochi	Kerala
India	Lisie Hospital	Kochi	Kerala
India	Lourdes Hospital	Kochi	Kerala
India	Malankara Orthodox Syrian Church Medical College Hospital	Kolenchery	Kerala
India	AA Rahim Memorial District Hospital	Kollam	Kerala
India	Bishop Benziger Hospital	Kollam	Kerala
India	Dr. K. Damodaran Memoral Hospital	Kollam	Kerala
India	Holy Cross Hospital	Kollam	Kerala
India	Travancore Medical College	Kollam	Kerala
India	St. Joseph's Hospital	Kothamangalam	Kerala
India	Malabar Institute of Medical Sciences	Kottakkal	Kerala
India	Bharath Cardiovascular Institute	Kottayam	Kerala
India	Caritas Hospital	Kottayam	Kerala
India	Government Medical College Kottayam	Kottayam	Kerala
India	S.H. Medical Centre Hospital	Kottayam	Kerala
India	KMCT Medical College	Kozhikode	Kerala
India	C.H. Memorial Hospital	Malappuram	Kerala
India	Lakshmi Hospital	Palakkad	Kerala
India	Palakkad Government District Hospital	Palakkad	Kerala
India	Thangam Hospital	Palakkad	Kerala
India	EMS Memorial Hospital	Perintalmanna	Kerala
India	Ramdas Clinic & Nursing Home	Perintalmanna	Kerala
India	Tellicherry Cooperative Hospital	Thalassery	Kerala
India	Ananthapuri Hospital and Research Institute	Thiruvananthapuram	Kerala
India	Medical College Thiruvananthapuram	Thiruvananthapuram	Kerala
India	Noorul Islam Institute of Medical Science & Research Foundation	Thiruvananthapuram	Kerala
India	SK Hospital	Thiruvananthapuram	Kerala
India	Sree Chitra Institute for Medical Sciences and Technology	Thiruvananthapuram	Kerala
India	Sree Gokulam Medical College & Research Foundation	Thiruvananthapuram	Kerala
India	St. Mary's Hospital	Thodupuzha	Kerala
India	Amala Institute of Medical Sciences	Thrissur	Kerala
India	Aswini Hospital	Thrissur	Kerala
India	Daya General Hospital & Specialty Surgery Centre	Thrissur	Kerala
India	Elite Mission Hospital	Thrissur	Kerala
India	Government Medical College Thrissur	Thrissur	Kerala
India	Jubilee Mission Medical College & Research Institute	Thrissur	Kerala
India	Modern Hospital	Thrissur	Kerala
India	Mother Hospital Limited	Thrissur	Kerala
India	Santhi Nursing Home	Thrissur	Kerala
India	St. James Hospital	Thrissur	Kerala
India	WestFort Hi-Tech Hospital Limited	Thrissur	Kerala
India	Pushpagiri Institute of Medical Sciences and Research Centre	Tiruvalla	Kerala
India	Kerala Institute of Medical Sciences	Trivandrum	Kerala
India	PRS Hospital	Trivandrum	Kerala

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

India, 

References & Publications (2)

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) — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	In-Hospital Medication Rates	Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital medication prescription rates.	30 Days
Secondary	Discharge Medication Rates	Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.	30 Days
Secondary	Discharge Advice Relative to Healthy Lifestyles	Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge advice relative to healthy lifestyles.	30 Days
Secondary	In-Hospital and 30-Day Expanded MACE	Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital and 30-day expanded MACE.	30 Days
Secondary	Concordance with locally-defined performance measures and in-hospital and 30-day MACE	To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.	30 Days
Secondary	Health Related Quality of Life	To evaluate health related quality of life in post-ACS patients (30-days) using a translated and validated version of the Seattle Angina Questionnaire (SAQ).	30 Days
Secondary	Impoverishing Effects of an ACS Event	To evaluate individual- and household-level impoverishing effects of an ACS event in the context of the recent implementation of a national government insurance program for families below the poverty line.	30 Days