Home Blood Pressure Monitoring Intervention for Self-Management of High Blood Pressure Among Alaska Native People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- Provider-level: frequency of antihypertensive medication adjustments
研究概览
简要总结
"Blood Pressure: Improving Control among Alaska Native People" (BP-ICAN) that targets blood pressure control among Alaska Native and American Indian (AN/AI) people diagnosed with hypertension. Participants will include adults with a diagnosis of hypertension who have not achieved blood pressure control. Primary Care Center (PCC) provider teams and associated panels of Alaska Native or American Indian (ANAI) adults will be randomized into the control or intervention arm. The investigators will recruit up to 10 ANAI adults per PCC provider for a total of 324 participants. Intervention participants will receive a home blood pressure monitor (HBPM), upload personal home blood pressure values into a data mall, and be encouraged to communicate with providers and pharmacists about HBPM results using an online electronic health record application, telephone, or other existing clinical processes. HBPM measurements for each intervention arm participant will be provided to provider teams and integrated pharmacists. Control participants will receive care as usual. Data will be collected over a 12 month period. Participants will meet with investigators at time of consent (baseline), and 3, 6, and 12 months after baseline. At each visit, participants will have blood pressure measured using 3 methods (aneroid sphygmomanometer, automated Omron upper arm cuff device, and automated Omron wrist cuff device), complete surveys, and have height, weight, and arm circumference measured. In-person measures are omitted during the pandemic and only one method of blood pressure measurement is used (upper arm cuff device). Clinical and service utilization information will be electronically queried with participant consent. The investigators will examine whether participants in the intervention arm have better blood pressure control at the end of the 12 month period than participants in the control arm.
详细描述
Background:
Cardiovascular disease (CVD) and stroke have become leading causes of mortality among ANAI people, who experience CVD disparities in incidence, risk factors, and mortality, especially for stroke, compared to the general population. From 1994-2003 stroke mortality in ANAIs was at least 25% higher than for Whites in Alaska. Over the same period, stroke mortality for ANAIs under age 45 increased 400%, but declined in Whites. In addition, the decline in age-adjusted CVD mortality observed in recent decades within the general population does not extend to ANAIs. Controlling hypertension is a pillar of prevention for CVD and stroke.
Although ANAIs were formerly thought to have a very low prevalence of stroke and CVD, more reliable newer data indicate high levels of hypertension and associated mortality. A recent systematic review of 141 publications on hypertension in ANAI people documented a significant increase in recorded prevalence over the past 3 decades, as well as a significantly higher prevalence in ANAI adults than in reference populations, usually White. Aggregated data from the Behavioral Risk Factor Surveillance System (BRFSS) also show a higher prevalence of self-reported hypertension in ANAIs than in non-Hispanic Whites (27% vs. 22%). The National Health Interview Survey found a similar disparity of 35% vs 26% in ANAIs vs. Whites. As in non-Hispanic Whites, 61% of ANAIs with hypertension were taking anti-hypertensive medication. In a previous study, an investigator on the present proposal examined the health records of 524 ANAI elders, finding that 23% had undiagnosed hypertension, and 38% had diagnosed hypertension. Of those with diagnoses, 81% were taking medication, 37% had well-controlled blood pressure (BP), and lifestyle counseling was rare.
Ongoing management of high BP often requires healthcare providers to initiate or intensify therapy in response to uncontrolled high BP. A recent review concluded that the patient/provider relationship, patient/provider communication, and patient-centered decision making were essential to appropriate decisions on medication change. Another study using electronic health record (EHR) data on military veterans found that ~60% of patients with hypertension had poorly controlled systolic BP, yet less than half of clinicians made medication changes after a computer-generated notification.
Improving BP control requires the involvement not only of individuals but of healthcare systems and social environments. Communications must extend care to patients "where patients are" outside the clinic; facilitate BP self-management; and minimize barriers to care AN/AIs face in healthcare access. Across Alaska, 60% of residents are medically underserved, and in 75% of Alaskan communities, regardless of residents' race, comprehensive healthcare services are accessible only by air or water. Even in urban areas, health disparities among AN/AIs persist, and access to care is affected by factors such as lack of transportation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •At least one visit to SCF providers or Community Health Aides within the previous year
- •Alaska Native or American Indian
- •At least 18 years old
- •Meet one of the following two conditions:
- •I. Hypertension diagnosis and 1 systolic blood pressure (SBP) >= 140 mmHg in past 24 months in EHR, AND
- •SBP >= 140 mmHg at research visit or from the mean of BP measures during the home screening period, OR
- •SBP 130-139 mmHg at research visit or from the mean of BP measures during the home screening period plus at least one comorbid condition as stated in American Heart Association guidelines (cardiovascular disease, heart failure, stroke, atrial fibrillation, chronic kidney disease, kidney transplant, or diabetes) II. No hypertension diagnosis but 1 SBP >= 140 mmHg in past 18 months in EHR, AND
- •SBP >=140mmHg at research visit or from the mean of BP measures during the home screening period, OR
- •SBP 130-139 mmHg at research visit or from the mean of BP measures during the home screening period plus at least one comorbid condition as stated in AHA guidelines (cardiovascular disease, heart failure, stroke, atrial fibrillation, chronic kidney disease, kidney transplant, or diabetes)
- •Ability to provide informed consent
- •Willingness and ability to use a HBPM
- •Willingness to complete the necessary data collection procedures, including transmission of BP measurements and permission for study staff to access EHR and/or PHR data.
- •Exclusion criteria:
- •Does not meet inclusion criteria
排除标准
- 未提供
结局指标
主要结局
Provider-level: frequency of antihypertensive medication adjustments
时间窗: 3 months, 6 months, and 12 months
Examine number of medication adjustments (new prescription or change in dose of antihypertensive medications) between participants in the intervention group compared to the control group.
Individual-level: within-person change in systolic blood pressure
时间窗: 12 months
Examine change in systolic blood pressure (mmHg) between participants in the intervention group compared to the control group.
System-level: change in systolic blood pressure for all patients with hypertension
时间窗: 12 months
Examine change in systolic blood pressure (mmHg) between all patients whose providers are in the intervention group (receiving automated alerts about high blood pressure and pharmacist support), compared to patients whose providers are in the control group (do not receive alerts and pharmacist support).
次要结局
未报告次要终点
研究者
Denise Dillard
Director of Research
Southcentral Foundation
