Program Design Hypertension Chat Bot Pilot Study With the Primary Care Service Line
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
A 2-arm randomized pilot trial aimed at evaluating the effectiveness of a 6-month remote monitoring program for the management of hypertension (HTN). 300 eligible patients will be randomized in a 1:1 ratio into two recruitment arms: A) Control (usual care), or B) Remote monitoring via automated messaging program. The target population are patients at the Penn Family Medicine University City and Westtown primary care practices with baseline poor blood pressure control as indicated by two blood pressures greater than 140/90 within the past twelve month including the most recent measurement and on at least one anti-hypertensive agent.
详细描述
STUDY DESIGN:
Pragmatic, non-blinded, randomized controlled trial.
Randomization and enrollment:
- Randomization will be at the patient level (stratified/balanced randomization by PCP)
- Enrollment will take place over short time period based off of lists of eligible patients pulled from the EMR
- Lists of eligible patients sent to PCPs with opportunity to opt patients out. Patients will be contacted via text followed by phone call to introduce them to the program.
We expect recruitment to take approximately 1 month to reach a target sample size of 300. The program itself will be 6 months from the date of randomization. Total study duration should be approximately 7 months. Data analyses will take an additional 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) Two blood pressures > 140/90 within the past 12 months, including the most recent measurement AND 2) On at least one anti-hypertensive agent AND 3) On HTN registry AND 4)On PCSL registry 5) Are active patients at the Penn Family Medicine University City, Penn Presby and Westtown practices
排除标准
- •Any patients meeting the following criteria are excluded from the study:
- •On a PCSK9 inhibitor medication
- •Pregnant or currently breastfeeding
- •Have a significant disability or markedly shortened life expectancy (metastatic cancer, on hospice, ESRD, dementia, end stage renal failure, congestive heart failure)
- •Not fluent in English
研究组 & 干预措施
Intervention
Patients assigned to intervention arm will a text message notifying them of enrollment, be mailed a BP cuff and receive a recruitment phone call if nonresponsive to text. If the patient does not opt out, the research coordinator will mail a blood pressure cuff and proper measurement instructions and start their remote monitoring program in the Way to Health platform. Intervention arm participants will also receive usual care. Usual care for hypertension is as needed determined by the clinical expertise of the primary care provider and can include regular follow-up visits (in person or virtual), home blood pressure readings, titration of medications during visits or via telephone, referral to specialty care (e.g., Nephrology or Cardiology), blood tests or imaging studies.
干预措施: HTN Chat bot (Behavioral)
Control
Patients in the usual care arm will not be contacted by study staff at the start of the pilot, they will not receive a blood pressure cuff, and they will not receive any text messaging or any component of the program. They will eventually be contacted by study staff to schedule the 6 month BP check. Usual care for hypertension is as needed determined by the clinical expertise of the primary care provider and can include regular follow-up visits (in person or virtual), home blood pressure readings, titration of medications during visits or via telephone, referral to specialty care (e.g., Nephrology or Cardiology), blood tests or imaging studies.
结局指标
主要结局
Systolic Blood Pressure
时间窗: six months
change in systolic blood pressure from baseline to 6 month visit
次要结局
- Diastolic Blood Pressure(six months)