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Original Research |

Effectiveness of a Multicomponent Quality Improvement Strategy to Improve Achievement of Diabetes Care Goals: A Randomized, Controlled TrialMulticomponent Quality Improvement Strategy to Improve Diabetes Care Goals

Mohammed K. Ali, MBChB, MSc, MBA; Kavita Singh, MSc; Dimple Kondal, PhD; Raji Devarajan, MSc; Shivani A. Patel, MPH, PhD; Roopa Shivashankar, MD; Vamadevan S. Ajay, MPH, PhD; A.G. Unnikrishnan, MD, DM; V. Usha Menon, PhD; Premlata K. Varthakavi, MD, DNB; Vijay Viswanathan, MD, PhD; Mala Dharmalingam, MD, DM; Ganapati Bantwal, MD, DM; Rakesh Kumar Sahay, MD, DM; Muhammad Qamar Masood, MBBS; Rajesh Khadgawat, MD, DM; Ankush Desai, MD, DM; Bipin Sethi, MD, DM; Dorairaj Prabhakaran, MD, DM; K.M. Venkat Narayan, MD; Nikhil Tandon, MD, PhD, on behalf of the CARRS Trial Group*
[+] Article, Author, and Disclosure Information

This article was published at www.annals.org on 12 July 2016.

* Members of the CARRS Trial Group are listed in the Appendix.


From the Rollins School of Public Health, Emory University, Atlanta, Georgia; All India Institute of Medical Sciences, New Delhi, India; Public Health Foundation of India, Gurgaon, India; Chellaram Diabetes Institute, Pune, India; Amrita Institute of Medical Sciences, Kochi, India; Topiwala National Medical College & BYL Nair Charity Hospital, Mumbai, India; M.V. Hospital for Diabetes and Diabetes Research Centre, Chennai, India; Bangalore Endocrinology & Diabetes Research Centre and St. John's Medical College and Hospital, Bangalore, India; Osmania General Hospital and CARE Hospital, Hyderabad, India; Aga Khan University, Karachi, Pakistan; and Goa Medical College, Bambolim, India.

Disclaimer: The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health or the ASCEND (Asian Collaboration for Excellence in Non-Communicable Disease Prevention and Control) Research Network.

Acknowledgment: The members of the Writing Group and Steering Committee of the CARRS trial thank all of the participants and the contributors listed in the Appendix.

Financial Support: The CARRS trial was funded in part by the National Heart, Lung, and Blood Institute, National Institutes of Health, U.S. Department of Health and Human Services, under contract HHSN268200900026C, and by UnitedHealth Group, Minneapolis, Minnesota. Several members of the research team at the Public Health Foundation of India and Emory University were supported by the Fogarty International Clinical Research Scholars and Fellows program through grant 5R24TW007988 from the National Institutes of Health, Fogarty International Center through Vanderbilt University, Emory Global Health Institute, and D43 NCDs in India Training Program through award 1D43HD05249 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and Fogarty International Center. Ms. Singh is supported by the Fogarty International Center, National Institutes of Health, under award D43TW008332 (ASCEND Research Network).

Disclosures: Dr. Ali reports consulting fees from Novo Nordisk outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOf InterestForms.do?msNum=M15-2807.

Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.

Reproducible Research Statement:Study protocol, statistical code, and data set: Available at www.coecarrs.org/coe/jsp/carrsUpdate.jsp.

Requests for Single Reprints: Nikhil Tandon, MD, PhD, Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, Biotechnology Block, 3rd Floor, Room #312, Ansari Nagar, New Delhi 110 029, India; e-mail, nikhil_tandon@hotmail.com.

Current Author Addresses: Dr. Ali: Emory University, Rollins School of Public Health, 1518 Clifton Road, Room CNR 7041, Atlanta, GA 30322.

Ms. Singh and Drs. Khadgawat and Tandon: Department of Endocrinology & Metabolism, All India Institute of Medical Sciences, Biotechnology Block, 3rd Floor, Ansari Nagar, New Delhi 110 029, India.

Drs. Kondal, Shivashankar, and Ajay and Ms. Devarajan: Center of Excellence, Center for cArdio-metabolic Risk Reduction in South Asia, Public Health Foundation of India, 4th Floor, Plot No. 47, Sector 44, Institutional Area, Gurgaon 122 002, Haryana, India.

Dr. Patel: Emory University, Rollins School of Public Health, 1518 Clifton Road, CNR 6th Floor, Atlanta, GA 30322.

Dr. Unnikrishnan: Chellaram Diabetes Institute, Lalani Quantum, Pune-Bangalore National Highway 4, Bavdhan (Budruk), Pune, Maharashtra 411 021, India.

Dr. Menon: Department of Endocrinology & Diabetes, Amrita Institute of Medical Sciences, AIMS Ponekkara PO, Kochi 682 041, Kerala, India.

Dr. Varthakavi: Department of Endocrinology, Topiwala National Medical College & BYL Nair Charity Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai 400 008, Maharashtra, India.

Dr. Vishwanathan: M.V. Hospital for Diabetes and Diabetes Research Centre, No. 4, West Madha Church Street, Royapuram, Chennai 600 013, Tamil Nadu, India.

Dr. Dharmalingam: Bangalore Endocrinology & Diabetes Research Centre, #35, 5th Cross, Malleswaram Circle, Bangalore 560 003, Karantaka, India.

Dr. Bantwal: St. John's Medical College and Hospital, Department of Endocrinology, Sarjapur Road, Koramangala, Bangalore 560 034, Karantaka, India.

Dr. Sahay: Osmania General Hospital, Department of Endocrinology, 2nd Floor, Golden Jubilee Block, Afzalgunj, Hyderabad 500 012, Telangana, India.

Dr. Masood: Department of Medicine, Section of Endocrinology and Diabetes, Aga Khan University, Stadium Road, Karachi 74800, Pakistan.

Dr. Desai: Goa Medical College, Endocrine Unit, Department of Medicine, Bambolim, Goa 403 202, India.

Dr. Sethi: Department of Endocrinology, CARE Hospital, Road No. 1, Banjara Hills, Hyderabad 500 034, Telangana, India.

Dr. Prabhakaran: Centre for Control of Chronic Conditions, Public Health Foundation of India, 4th Floor, Plot No. 47, Sector 44, Institutional Area, Gurgaon 122 002, Haryana, India.

Dr. Narayan: Emory University, Rollins School of Public Health, 1518 Clifton Road, Room CNR 7049, Atlanta, GA 30322.

Author Contributions: Conception and design: M.K. Ali, D. Prabhakaran, K.M.V. Narayan, N. Tandon.

Analysis and interpretation of the data: M.K. Ali, K. Singh, D. Kondal, R. Devarajan, S.A. Patel, D. Prabhakaran, K.M.V. Narayan, N. Tandon.

Drafting of the article: M.K. Ali, K. Singh, R. Devarajan.

Critical revision of the article for important intellectual content: M.K. Ali, K. Singh, R. Devarajan, R. Shivashankar, A.G. Unnikrishnan, P.K. Varthakavi, V. Vishwanathan, M. Dharmalingam, R.K. Sahay, M.Q. Masood, D. Prabhakaran, K.M.V. Narayan, N. Tandon.

Final approval of the article: M.K. Ali, K. Singh, D. Kondal, R. Devarajan, S.A. Patel, R. Shivashankar, V.S. Ajay, A.G. Unnikrishnan, V.U. Menon, P.K. Varthakavi, V. Vishwanathan, M. Dharmalingam, G. Bantwal, R.K. Sahay, M.Q. Masood, R. Khadgawat, A. Desai, B. Sethi, D. Prabhakaran, K.M.V. Narayan, N. Tandon.

Provision of study materials or patients: A.G. Unnikrishnan, V.U. Menon, P.K. Varthakavi, V. Vishwanathan, M. Dharmalingam, R.K. Sahay, G. Bantwal, M.Q. Masood, R. Khadgawat, A. Desai, B. Sethi, N. Tandon.

Statistical expertise: D. Kondal, S.A. Patel, K.M.V. Narayan.

Obtaining of funding: M.K. Ali, V.S. Ajay, D. Prabhakaran, K.M.V. Narayan, N. Tandon.

Administrative, technical, or logistic support: K. Singh, R. Devarajan, R. Shivashankar, V.S. Ajay, P.K. Varthakavi, V. Vishwanathan, M. Dharmalingam, R.K. Sahay, D. Prabhakaran, K.M.V. Narayan, N. Tandon.

Collection and assembly of data: K. Singh, R. Devarajan, R. Shivashankar, A.G. Unnikrishnan, V.U. Menon, P.K. Varthakavi, V. Vishwanathan, M. Dharmalingam, R.K. Sahay, M.Q. Masood, R. Khadgawat, A. Desai, N. Tandon.


Ann Intern Med. 2016;165(6):399-408. doi:10.7326/M15-2807
© 2016 American College of Physicians
Text Size: A A A

Background: Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia.

Objective: To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes.

Design: Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328)

Setting: Diabetes clinics in India and Pakistan.

Patients: 1146 patients (575 in the intervention group and 571 in the usual care group) with type 2 diabetes and poor cardiometabolic profiles (glycated hemoglobin [HbA1c] level ≥8% plus systolic blood pressure [BP] ≥140 mm Hg and/or low-density lipoprotein cholesterol [LDLc] level ≥130 mg/dL).

Intervention: Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records.

Measurements: Proportions achieving HbA1c level less than 7% plus BP less than 130/80 mm Hg and/or LDLc level less than 100 mg/dL (primary outcome); mean risk factor reductions, health-related quality of life (HRQL), and treatment satisfaction (secondary outcomes).

Results: Baseline characteristics were similar between groups. Median diabetes duration was 7.0 years; 6.8% and 39.4% of participants had preexisting cardiovascular and microvascular disease, respectively; mean HbA1c level was 9.9%; mean BP was 143.3/81.7 mm Hg; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months, a greater percentage of intervention participants achieved the primary outcome (18.2% vs. 8.1%; relative risk, 2.24 [95% CI, 1.71 to 2.92]). Compared with usual care, intervention participants achieved larger reductions in HbA1c level (−0.50% [CI, −0.69% to −0.32%]), systolic BP (−4.04 mm Hg [CI, −5.85 to −2.22 mm Hg]), diastolic BP (−2.03 mm Hg [CI, −3.00 to −1.05 mm Hg]), and LDLc level (−7.86 mg/dL [CI, −10.90 to −4.81 mg/dL]) and reported higher HRQL and treatment satisfaction.

Limitation: Findings were confined to urban specialist diabetes clinics.

Conclusion: Multicomponent QI improves achievement of diabetes care goals, even in resource-challenged clinics.

Primary Funding Source: National Heart, Lung, and Blood Institute and UnitedHealth Group.

Figures

Grahic Jump Location
Appendix Figure 1.

Registration, randomization, and follow-up of study participants.

BP = blood pressure; HbA1c = glycated hemoglobin; LDLc = low-density lipoprotein cholesterol.

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Figure 1.

Control of risk factors during follow-up, by treatment group.

Overall RR was obtained via log-binomial models using generalized estimating equations. Estimates combined all nonmissing values collected at baseline, months 12 and 24, and the end of the study. Error bars indicate 95% CIs. Model terms included treatment, time, treatment-by-time interaction, baseline value, and site. BP = blood pressure; HbA1c = glycated hemoglobin; LDLc = low-density lipoprotein cholesterol; RR = relative risk.

* <70 mg/dL for participants with history of cardiovascular disease.

Grahic Jump Location
Grahic Jump Location
Appendix Figure 2.

Mean between-group changes in HbA1c level, SBP, DBP, and LDLc level during follow-up.

Overall mean differences were obtained via linear regression models using generalized estimating equations. Estimates combine all nonmissing values collected at baseline, months 12 and 24, and the end of the study. Error bars indicate 95% CIs. Model terms included treatment, time, treatment-by-time interaction, baseline value, and site. DBP = diastolic blood pressure; HbA1c = glycated hemoglobin; LDLc = low-density lipoprotein cholesterol; SBP = systolic blood pressure.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Primary outcome (achievement of multiple risk factor targets), by prespecified baseline subgroups.

Error bars indicate 95% CIs, and P values are for the test of homogeneity for each subgroup. BMI = body mass index; BP = blood pressure; CVD = cardiovascular disease; HbA1c = glycated hemoglobin; INR = Indian rupees; LDLc = low-density lipoprotein cholesterol; RR = relative risk; USD = U.S. dollars.

* Retinopathy, neuropathy, or renal failure.

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