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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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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: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.

Project description:ImportanceMany patients with cancer who would benefit from psychosocial care do not receive it. Implementation strategies may favor the integration of psychosocial care into practice and improve patient outcomes.ObjectiveTo evaluate the effectiveness of the Humanization in Cancer Care (HuCare) Quality Improvement Strategy vs standard care as improvement of at least 1 of 2 domains (emotional or social function) of patient health-related quality of life at baseline and 3 months. A key secondary aim included investigation of the long-term effect.Design, setting, and participantsHuCare2 was a multicenter, incomplete, stepped-wedge cluster randomized clinical trial, conducted from May 30, 2016, to August 28, 2019, in three 5-center clusters of cancer centers representative of hospital size and geographic location in Italy. The study was divided into 5 equally spaced epochs. Implementation sequence was defined by a blinded statistician; the nature of the intervention precluded blinding for clinical staff. Participants included consecutive adult outpatients with newly diagnosed cancer of any type and stage starting medical cancer treatment.InterventionsThe HuCare Quality Improvement Strategy comprised (1) clinician communication training, (2) on-site visits for context analysis and problem-solving, and (3) implementation of 6 evidence-based recommendations.Main outcomes and measuresThe primary outcome was the difference between the means of changes of individual scores in emotional or social functions of health-related quality of life detected at baseline and 3-month follow-up (within each group) and during the postintervention epoch compared with control periods (between groups). Long-term effect of the intervention (at 12 months) was assessed as a secondary outcome. Intention-to-treat analysis was used.ResultsA total of 762 patients (475 [62.3%] women) were enrolled (400 HuCare Quality Improvement Strategy and 362 usual care); mean (SD) age was 61.4 (13.1) years. The HuCare Quality Improvement Strategy significantly improved emotional function during treatment (odds ratio [OR], 1.13; 95% CI, 1.04-1.22; P = .008) but not social function (OR, 0.99; 95% CI, 0.89-1.09; P = .80). Effect on emotional function persisted at 12 months (OR, 1.05; 95% CI, 1.00-1.10; P = .04).Conclusions and relevanceIn this trial, the HuCare Quality Improvement Strategy significantly improved the emotional function aspect of health-related quality of life during cancer treatment and at 12 months, indicating a change in clinician behavior and in ward organization. These findings support the need for strategies to introduce psychosocial care; however, more research is needed on factors that may maximize the effects.Trial registrationClinicalTrials.gov Identifier: NCT03008993.

Project description:In sub-Saharan African settings like the Democratic Republic of the Congo, high-quality care during childbirth and the immediate postpartum period is lacking in public facilities, necessitating multipronged interventions to improve care. We used a pre-post design to examine the effectiveness of a low-dose, high-frequency capacity-building and quality improvement (QI) intervention to improve care for women and newborns around the day of birth in 16 health facilities in Kinshasa, Democratic Republic of the Congo. Effectiveness was assessed based on changes in provider skills, key health indicators, and beneficiary satisfaction. To assess changes in the competency of the 188 providers participating in the intervention, we conducted objective structured clinical examinations on care for mothers and newborns on the day of birth, immediate postpartum family planning (PPFP) counseling and method provision, and postabortion care before and after implementation of training and at 6 and 12 months after training. Interrupted time series (ITS) analysis techniques were used to analyze routine health service data for changes in select maternal, newborn, and postpartum outcomes before and after the intervention. To assess changes in clients' perceptions of care, 2 rounds of telephone surveys were administered. Before the intervention, less than 2% of participating providers demonstrated competency in skills. Immediately after training, more than 80% demonstrated competency, and 70% retained competency after 12 months. ITS analyses show the risk of early neonatal death declined significantly by 9% (95% confidence interval [CI]=4%, 13%, P<.001), and likelihood of immediate PPFP uptake increased significantly by 72% (95% CI=53%, 92%, P<.001). Client satisfaction improved by 58% over the life of the project. These findings build on previous studies documenting the effectiveness of clinical capacity-building and QI approaches. If implemented at scale, this approach has the potential to substantively contribute to improving maternal and perinatal health in similar settings.

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

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

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