MH-Rx Study: Comprehensive and Multi-Level Medication Therapy Management and Non-Medical Health Related Needs Targeted Intervention Model for Maternal Health Outcomes. (Baby on Board: Check-in on You, Your Medication, & Your Blood Pressure)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Change in mean systolic blood pressure
研究概览
简要总结
This randomized controlled trial will evaluate whether adding Community Health Worker (CHW)/Social Worker (SW)-led support for non-medical health related needs (NMHRN) and clinician-led Medication Therapy Management (MTM) to remote blood pressure monitoring improves outcomes for pregnant women with chronic hypertension or gestational hypertension (i.e high blood pressure that was present before pregnancy or developed during pregnancy).
All participants will monitor their blood pressure at home, use the TSU MH Rx app, and complete assessments related to social needs, depression, anxiety, pregnancy care experiences, and satisfaction. Only participants in the intervention group will receive targeted virtual social needs support and virtual regular MTM sessions focused on medications, self-care, adherence, and risk reduction. The study will assess blood pressure and maternal outcomes, feasibility, and participant satisfaction with the combined intervention.
详细描述
This randomized controlled trial will evaluate the effectiveness of combining Community Health Worker (CHW)/Social Worker (SW)-led non-medical health related needs (NMHRN) intervention + Clinician-Led Medication Therapy Management (MTM) with remote blood pressure (BP) monitoring among pregnant women with chronic hypertension or gestational hypertension (i.e high blood pressure that was present before pregnancy or developed during pregnancy).
All participants will receive a TelliHealth BP01 remote blood pressure monitoring kit and access to the TSU MH Rx app. They will complete self-led BP checks at least three times weekly until 14 weeks postpartum, with automated text/app alerts for abnormal readings. All participants will also complete self-administered assessments at specified time points: the modified PREPARE NMHRN survey, PHQ-9 depression survey, and GAD-7 anxiety survey at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum; the PCPC-US prenatal experience survey at 32-36 weeks; and the PCMC-US intrapartum experience and participant satisfaction surveys at 10-14 weeks postpartum. Abnormal NMHRN, PHQ-9, and GAD-7 results will trigger electronic alerts and appropriate resources, while GAD-7 and PHQ-9 scores will be reviewed using a tiered management plan. Any PHQ-9 question 9 (suicidal ideation) score ≥1 will prompt same-business-day contact, provision of 988 Suicide and Crisis Lifeline information, and recommendation for immediate PCP/OBGYN follow-up.
Only intervention-arm subjects will receive virtual CHW/SW-led tailored social needs support sessions at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum, along with clinician-led medication therapy management (MTM) at randomization and every 4 weeks (±14 days). Virtual MTM includes medication reconciliation and assessment, review of labs and dosing, maternal self-care education, adherence counseling, and risk reduction. All intervention participants will receive CHW/SW check-ins; those without identified social needs will receive general support rather than tailored social needs services.
The study will assess BP outcomes, maternal outcomes as well as the overall feasibility and patient satisfaction with the CHW/SW-led NMHRN + Clinician-Led MTM intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, pregnant ≤34 weeks
- •Pregnancy Status: Pregnant, up to 34 weeks of gestation. Able to provide medical confirmation of pregnancy
- •Age 18-45
- •Diagnosis of chronic hypertension or Gestational Hypertension ( i.e: high blood pressure that was present before pregnancy or developed during pregnancy).
- •Currently taking ≥1 medication
- •Smartphone user
- •Able to speak and read English
- •Ability to participate in self-led surveys and perform remote blood pressure monitoring
排除标准
- •Inability to Provide Legal Consent: Individuals who cannot legally consent to participate in the research study will be excluded.
- •Availability Constraints: Individuals who are unavailable or unable to commit to the required study sessions and self-led surveys throughout the duration of their pregnancy and the 14-week postpartum follow-up period.
- •Language Barrier: Individuals who do not speak and read English.
- •Inability or Unwillingness to Provide Required Information: Individuals who are unable or unwilling to provide reliable contact information (phone, email, or address for app/text-based study communications), basic medical history needed to verify eligibility, or medical confirmation of pregnancy and gestational age (e.g., discharge summary, progress note, MyChart note, or signed medical release).
研究组 & 干预措施
CHW/SW-led NMHRN + Clinician-Led Medication Therapy Management (MTM)
Subjects in the experimental arm (intervention group) will receive virtual Clinician-Led Medication Therapy Management (MTM) at randomization (weeks 0-2) and then every 4 weeks (±14 days) until 14 weeks postpartum. MTM includes medication reconciliation, assessment, maternal self-care education, review of labs, dosing recommendations, and guidance to improve adherence and reduce adverse maternal/neonatal outcomes. They will also receive virtual CHW/SW-led targeted non-medical health related needs (NMHRN) support at randomization, 32-36 weeks gestation, and 10-14 weeks postpartum. All participants in the intervention arm will receive CHW/SW check-ins at each of these three points; those without identified social needs will receive general check-ins rather than targeted interventions.
干预措施: Community Health Worker (CHW)/Social Worker (SW)-led non-medical health related needs (NMHRN) intervention + Clinician-Led Medication Therapy Management (MTM) with remote blood pressure monitoring (Behavioral)
Active Comparator (Control group)
Participants randomized to Active comparator arm (Control group) will receive standard prenatal and postpartum care as provided by their healthcare providers. Participants will not receive the Community Health Worker/Social Worker-led non-medical health-related needs intervention, or the clinician-led Medication Therapy Management through the study. Study assessments and outcome data will be collected according to the study schedule.
干预措施: Active Comparator (Control group) (Behavioral)
结局指标
主要结局
Change in mean systolic blood pressure
时间窗: From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks)
The primary clinical endpoint is the change in mean Systolic Blood Pressure (SBP) compared between the intervention and control groups. To be eligible in the primary analysis, participants must contribute to a minimum of 3 weeks of blood pressure data.
次要结局
- Recruitment rates(From start of recruitment through completion of enrollment (up to 27 months))
- Retention Rate(From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks))
- Technical Reliability of the 4G Blood Pressure Monitoring Device, TSU MH-Rx App, and Text Alerts(Survey at study completion or 10-14 weeks postpartum; technical support tickets from randomization through 10-14 weeks postpartum (up to 54 weeks))
- Participant Satisfaction with study participation(Study completion or 10-14 weeks postpartum)
- Scores and Follow-up Interventions from Self-Administered Non-Medical Health Related Needs evaluation (modified Prepare survey)(Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum)
- Scores and Follow-up Interventions from Self-Administered Anxiety symptom survey (Generalized Anxiety Disorder 7-Item Scale, GAD-7)(Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum)
- Scores and Follow-up Interventions from Self-Administered Depressive symptom survey (Patient Health Questionnaire-9, PHQ-9)(Randomization (weeks 0-2 of enrollment), 32-36 weeks' gestation, and 10-14 weeks postpartum)
- Scores and Follow-up Interventions from Self-Administered assessment of prenatal care experience (26-Item Person-Centered Prenatal Care Scale, United States: PCPC-US)(At 32-36 weeks' gestation)
- Scores and Follow-up Interventions from Self-Administered assessment of intrapartum care experience (35-Item Person-Centered Maternity Care Scale, United States: PCMC-US)(At 10-14 weeks postpartum)
- Blood Pressure Readings and Interventions(From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks))
- Duration and Type of MTM and CHW/SW Related Activities(From randomization through study completion or 10-14 weeks postpartum (up to 54 weeks))