Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Ali MK

PROVIDER: S-EPMC6561084 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Publications

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

Ali Mohammed K MK Singh Kavita K Kondal Dimple D Devarajan Raji R Patel Shivani A SA Shivashankar Roopa R Ajay Vamadevan S VS Unnikrishnan A G AG Menon V Usha VU Varthakavi Premlata K PK Viswanathan Vijay V Dharmalingam Mala M Bantwal Ganapati G Sahay Rakesh Kumar RK Masood Muhammad Qamar MQ Khadgawat Rajesh R Desai Ankush A Sethi Bipin B Prabhakaran Dorairaj D Narayan K M Venkat KM Tandon Nikhil N

Annals of internal medicine 20160712 6

<h4>Background</h4>Achievement of diabetes care goals is suboptimal globally. Diabetes-focused quality improvement (QI) is effective but remains untested in South Asia.<h4>Objective</h4>To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes.<h4>Design</h4>Parallel, open-label, pragmatic randomized, controlled trial. (ClinicalTrials.gov: NCT01212328).<h4>Setting</h4>Diabetes clinics in India and Pakistan.<h4> ...[more]

PMID: 27398874

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Project description:BackgroundDiabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial.Methods and findingsThis parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dL) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c <7% plus BP <130/80 mm Hg and/or LDL-cholesterol <100 mg/dL) and first macrovascular endpoints (nonfatal myocardial infarction, nonfatal stroke, death, revascularization [angioplasty or coronary artery bypass graft]), which were co-primary outcomes. We also examined secondary outcomes, namely, single risk factor control, first microvascular endpoints (retinopathy, nephropathy, neuropathy), and composite first macrovascular plus microvascular events (which also included amputation and all-cause mortality) by treatment group and whether QI strategy implementation was continued over 6.5 years. At 6.5 years, assessment data were available for 854 participants (74.5%; n = 417 [intervention]; n = 437 [usual care]). In terms of sociodemographic and clinical characteristics, participants in the intervention and usual care groups were similar and participants at sites that continued were no different to participants at sites that discontinued intervention implementation. Patients in the intervention arm were more likely to exhibit sustained multiple risk factor control than usual care (relative risk: 1.77; 95% confidence interval [CI], 1.45, 2.16), p < 0.001. Cumulatively, there were 233 (40.5%) first microvascular and macrovascular events in intervention and 274 (48.0%) in usual care patients (absolute risk reduction: 7.5% [95% CI: -13.2, -1.7], p = 0.01; hazard ratio [HR] = 0.72 [95% CI: 0.61, 0.86]), p < 0.001. Patients in the intervention arm experienced lower incidence of first microvascular endpoints (HR = 0.68 [95% CI: 0.56, 0.83), p < 0.001, but there was no evidence of between-group differences in first macrovascular events. Beneficial effects on microvascular and composite vascular outcomes were observed in sites that continued, but not sites that discontinued the intervention.ConclusionsIn urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes.Trial registrationClinicalTrials.gov NCT01212328.

Project description:BackgroundEconomic dimensions of implementing quality improvement for diabetes care are understudied worldwide. We describe the economic evaluation protocol within a randomised controlled trial that tested a multi-component quality improvement (QI) strategy for individuals with poorly-controlled type 2 diabetes in South Asia.Methods/designThis economic evaluation of the Centre for Cardiometabolic Risk Reduction in South Asia (CARRS) randomised trial involved 1146 people with poorly-controlled type 2 diabetes receiving care at 10 diverse diabetes clinics across India and Pakistan. The economic evaluation comprises both a within-trial cost-effectiveness analysis (mean 2.5 years follow up) and a microsimulation model-based cost-utility analysis (life-time horizon). Effectiveness measures include multiple risk factor control (achieving HbA1c < 7% and blood pressure < 130/80 mmHg and/or LDL-cholesterol< 100 mg/dl), and patient reported outcomes including quality adjusted life years (QALYs) measured by EQ-5D-3 L, hospitalizations, and diabetes related complications at the trial end. Cost measures include direct medical and non-medical costs relevant to outpatient care (consultation fee, medicines, laboratory tests, supplies, food, and escort/accompanying person costs, transport) and inpatient care (hospitalization, transport, and accompanying person costs) of the intervention compared to usual diabetes care. Patient, healthcare system, and societal perspectives will be applied for costing. Both cost and health effects will be discounted at 3% per year for within trial cost-effectiveness analysis over 2.5 years and decision modelling analysis over a lifetime horizon. Outcomes will be reported as the incremental cost-effectiveness ratios (ICER) to achieve multiple risk factor control, avoid diabetes-related complications, or QALYs gained against varying levels of willingness to pay threshold values. Sensitivity analyses will be performed to assess uncertainties around ICER estimates by varying costs (95% CIs) across public vs. private settings and using conservative estimates of effect size (95% CIs) for multiple risk factor control. Costs will be reported in US$ 2018.DiscussionWe hypothesize that the additional upfront costs of delivering the intervention will be counterbalanced by improvements in clinical outcomes and patient-reported outcomes, thereby rendering this multi-component QI intervention cost-effective in resource constrained South Asian settings.Trial registrationClinicalTrials.gov: NCT01212328.

Project description:In the U.S., where the prevalence of type 2 diabetes has reached epidemic proportions, many patients with this disease are treated by primary care physicians in community-based systems, including accountable care organisations (ACOs). To address gaps in the quality of diabetes care, national quality measures have been established, including patient-centered measures adopted by the Centers for Medicare and Medicaid Services for its Shared Savings Program for ACOs. From a patient-centered perspective, high-quality diabetes care depends on effective communication between clinicians and patients, along with patient education and counseling about medications and lifestyle. We designed and implemented a quality improvement (QI) program for 30 primary care physicians treating patients with type 2 diabetes in three structurally similar but geographically diverse ACOs. Retrospective chart audits were conducted before (n = 300) and after (n = 300) each physician participated in accredited continuing medical education (CME) courses that focused on QI strategies. Randomly selected charts were audited to measurably assess essential interventions for improved outcomes in type 2 diabetes including the physicians' documentation of patient counseling and assessment of side effects, and patients' medication adherence status and changes in hemoglobin A1C (A1C) and body mass index (BMI). Paced educational interventions included a private performance improvement Internet live course conducted for each physician, small-group Internet live courses involving peer discussion, and a set of enduring materials, which were also multi-accredited for all clinicians in the physician's practice. Continual improvement cycles were guided by analysis of the baseline chart audits, quantitative survey data, and qualitative feedback offered by participants. To extend the benefit of the education, the enduring materials were offered to the interprofessional team of clinicians throughout the U.S. who did not participate in the QI program. For brevity, this article presents outcomes of the 30 primary care physicians. Baseline to post-education improvements were observed for percentages of charts with documented assessment of medication side effects (+11%) and counseling about medication risks/benefits (+28%), medication adherence (+13%), and lifestyle modifications (+8%). Improvements were also observed for documented adherence to diabetes medications (+24%) and first-to-last visit changes in A1C (-0.16%) and BMI (-2.1). The findings indicate a positive influence of QI education on primary care physicians' performance of patient-centered quality measures and patient outcomes.

Project description:Studies on inflammatory bowel disease (IBD) have reported suboptimal approaches to patient care. In the United States, the findings have motivated leading gastroenterology organizations to call for initiatives that support clinicians in aligning their practices with quality measures for IBD and priorities of the National Quality Strategy (NQS). We designed and implemented a quality improvement (QI) education program on ulcerative colitis in which patient charts were audited for 30 gastroenterologists before (n = 300 charts) and after (n = 290 charts) they participated in QI-focused educational activities. Charts were audited for nine measures, selected for their alignment with four NQS priorities: making care safer, ensuring patient engagement, promoting communication, and promoting effective treatment practices. Four of the measures, including guideline-directed vaccinations and assessments of disease type and activity, were part of the CMS Physician Quality Reporting System (PQRS). The other five measures involved counseling patients on various topics in ulcerative colitis management, documentation of side effects, assessment of adherence status, and simplification of dosing. The gastroenterologists also completed baseline and post-education surveys designed to assess qualitative outcomes. One of the educational interventions was a private audit feedback session conducted for each gastroenterologist. The sessions were designed to support participants in identifying measures reflecting suboptimal care quality and developing action plans for improvement. In continuous improvement cycles, follow-up interventions included QI tools and educational monographs. Across the nine chart variables, post-education improvements ranged from 0% to 48%, with a mean improvement of 15.9%. Survey findings revealed improvements in self-reported understanding of quality measures and intentions to apply them to practice, and lower rates of perceived significant barriers to high-quality care. The findings indicate the potential for QI education to support gastroenterologists in improving their performance on key measures of care quality for patients with ulcerative colitis.

Dataset Information

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

Background

Objective

Design

Setting

Patients

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

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

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