Wellmann Irmgardt Alicia, Ayala Luis Fernando, Valley Taryn M, Irazola Vilma, Huffman Mark D, Heisler Michele, Rohloff Peter, Donis Rocío, Palacios Eduardo, Ramírez-Zea Manuel, Flood David
INCAP Research Center for Prevention of Chronic Diseases, Institute of Nutrition of Central America and Panama, Guatemala City, Guatemala.
Department of Anthropology, University of Wisconsin-Madison, Madison, USA.
Glob Heart. 2025 Jan 31;20(1):9. doi: 10.5334/gh.1397. eCollection 2025.
The World Health Organization HEARTS Technical Package is a widely implemented global initiative to improve the primary care management of cardiovascular disease risk factors. The study's objective is to report outcomes from a pilot implementation trial of integrated hypertension and diabetes management based on the HEARTS model in Guatemala.
We conducted a single-arm pilot implementation trial over six months from October 2023 to May 2024 in 11 Guatemalan Ministry of Health primary care facilities in two districts. The pilot evaluated a package of five HEARTS-aligned implementation strategies to improve the pharmacological treatment of hypertension and diabetes. The primary outcomes were feasibility and acceptability, measured through 20 structured interviews with Ministry of Health employees and by examining enrolment and retention data. Secondary outcomes included a suite of implementation and clinical outcomes, including treatment rates. When baseline data were available, we analyzed secondary outcomes as the net change from baseline or using an interrupted time series approach.
The study enrolled 964 patients, of whom 58.8% had hypertension only, 30.4% had diabetes only, and 10.8% had both conditions. Surveys on feasibility and acceptability among Ministry of Health staff had a median score of 5.0 (IQR: 5.0 to 5.0) and 5.0 (IQR range: 4.8 to 5.0), respectively, exceeding the prespecified benchmark of ≥3.5. Both districts achieved the prespecified benchmark of enrolling ≥25 hypertension patients and ≥25 diabetes patients. Only 36% of patients attended a follow-up visit within three months, lower than the prespecified benchmark of ≥75%. Monthly treatment rates during the pilot increased by 22.3 (95% CI: 16.2 to 28.4; P < 0.001) and 3.5 (95% CI: -1.6 to 8.7; P = 0.17) patients per month for hypertension and diabetes, respectively.
Implementation of an integrated hypertension and diabetes model based on HEARTS was generally feasible and acceptable in the Ministry of Health in Guatemala. Findings can refine national scale-up in Guatemala and inform HEARTS implementation projects in other settings.
世界卫生组织的HEARTS技术包是一项广泛实施的全球倡议，旨在改善心血管疾病危险因素的初级保健管理。本研究的目的是报告在危地马拉基于HEARTS模型进行的高血压和糖尿病综合管理试点实施试验的结果。
2023年10月至2024年5月，我们在危地马拉两个地区的11个危地马拉卫生部初级保健机构进行了为期六个月的单臂试点实施试验。该试点评估了一套五项与HEARTS一致的实施策略，以改善高血压和糖尿病的药物治疗。主要结果是可行性和可接受性，通过对卫生部员工进行20次结构化访谈以及检查登记和留存数据来衡量。次要结果包括一系列实施和临床结果，包括治疗率。当有基线数据时，我们将次要结果分析为与基线相比的净变化或使用中断时间序列方法。
该研究共纳入964例患者，其中58.8%仅患有高血压，30.4%仅患有糖尿病，10.8%同时患有这两种疾病。对卫生部工作人员进行的可行性和可接受性调查的中位数得分分别为5.0（四分位间距：5.0至5.0）和5.0（四分位间距范围：4.8至5.0），超过了预先设定的≥3.5的基准。两个地区都达到了预先设定的基准，即登记≥25例高血压患者和≥25例糖尿病患者。只有36%的患者在三个月内进行了随访，低于预先设定的≥75%的基准。试点期间，高血压和糖尿病患者每月的治疗率分别增加了22.3例（95%置信区间：16.2至28.4；P<0.001）和3.5例（95%置信区间：-1.6至8.7；P = 0.17）。
在危地马拉卫生部，基于HEARTS的高血压和糖尿病综合模型的实施总体上是可行的且可接受的。研究结果可完善危地马拉的全国推广，并为其他地区的HEARTS实施项目提供参考。
