Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality Improvement Strategy in India: The C-QIP Trial.

BACKGROUND: Quality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India. METHODS: The C-QIP is a clinic-based, open randomized trial of a multicomponent intervention vs usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained nonphysician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (ie, dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines. RESULTS: We recruited 410 socio-demographically diverse patients with CVD from 4 hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure. CONCLUSION: This study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings. TRIAL REGISTRATION: Clinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659.

Assessment of Studies of Quality Improvement Strategies to Enhance Outcomes in Patients With Cardiovascular Disease.

Importance: Clinical care quality improvement (QI) strategies are critical to prevent and control cardiovascular disease (CVD). However, there is limited evidence regarding which components of the health system-, clinician-, and patient-based QI strategies contribute to their impact on CVD. Objectives: To identify, map, and organize evidence on the effectiveness and implementation of cardiovascular QI strategies that seek to improve outcomes in patients with CVD. Evidence Review: Eight electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Library, ProQuest, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform) were searched for studies published between January 1, 2009, and October 25, 2019. Eligible study designs included randomized trials and preintervention and postintervention evaluations. Descriptive findings of included studies were reported using several frameworks to map the intervention components stratified by target population, setting, outcomes, and overall results. Findings: From 8066 screened titles and abstracts, 456 unique studies with 150 148 unique patients (38.1% women and 61.9% men; mean [SD] age, 64.6 [7.1] years) were identified, including 427 randomized trials, 21 quasi-randomized studies, and 8 preintervention and postintervention studies. Of 336 studies from 45 countries that were classified, 255 (75.9%) were from high-income countries; 68 (20.2%), upper-middle-income countries; 13 (3.9%), lower-middle-income countries; and 0, low-income countries, with diverse clinical settings and target patient populations (post-myocardial infarction, stroke, heart failure). Patient support (311 studies), information communication technology (ICT) for health (78 studies), community support (18 studies), supervision (15 studies), and high-intensity training (14 studies) were the most commonly evaluated QI strategies. Other strategies were group problem-solving (7 studies), printed information (5 studies), strengthening infrastructure (4 studies), and financial incentives (3 studies). Patient support, ICT for health, training, and community support were strategies that had been evaluated the most for clinical end points and showed modest associations with several clinical outcomes. The other strategies did not have outcome-driven evaluations reported. Group problem-solving was associated with improved patient self-care and quality of life. Strengthening infrastructure was associated with improved treatment satisfaction. Printed information and financial incentives showed no meaningful effect. Conclusions and Relevance: This systematic review found that substantial variations exist in the types, effectiveness, and implementation of QI strategies for patients with CVD. A comprehensive map of QI strategies created by this study would be useful for researchers to identify where new knowledge is needed to improve cardiovascular outcomes. Outcome-driven evaluations and long-term studies are needed, particularly in low-income settings, to better understand the effects of QI strategies on prevention and control of CVD.