Clinical trial NCT06337799: Use of Allied-health Professionals to Improve Treatment of Disease
Official title: Use of Non-physician Allied-health Professionals to Recruit (and Follow) Research Participants, Sustain Engagement, and Improve and Diagnose Treatment of Diseases by Facilitating Transitions of Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preeclampsia
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.

Participants will:

Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months.

Detailed description: After consent, a research pharmacist will virtually monitor the participant's blood pressure until the 12-month follow up visit. The research pharmacists will have access to the participant's electronic medical records to monitor and document medications and clinic blood pressures for analysis . Participants will be asked to measure and return 14 blood pressure measurements (2x per day for 7 days) using our text messaging platform. They will be allowed to choose the times that they are sent reminders to measure their blood pressure. If a participant has blood pressure values sufficient for a hypertension diagnosis, the pharmacist will communicate via electronic medical record with the participant's primary care team. If they do not have a primary care provider, the pharmacist will facilitate finding one. The pharmacist will continue monitoring the participant and making recommendations to the primary care team through the electronic medical record to quickly adjust therapy to improve blood pressure control. The pharmacists will typically contact the participants (via participant's choice of phone, text, or email) every 2-3 weeks while their hypertension is uncontrolled. Once under control, the pharmacist will continue to contact the participant at least every 2 months to support adherence and reassess control.

Eligibility criteria: Inclusion Criteria:

* Biological mothers delivering at UIHC or attending a well-child visit for an infant between 1 month and 9 months
* Preeclampsia during pregnancy
* Preceived prenatal care at UIHC
* Owns a smartphone

Exclusion Criteria:

* Arm circumference greater than 17 inches
* Prisoner status
* Unable to provide own written informed consent

Primary outcomes:
measure: Number of Subjects at Risk for Hypertension
timeFrame: Through study completion, an average of 12 months
measure: Number of Subjects Exposed to a Screening Clinic
timeFrame: Through study completion, an average of 12 months
measure: Number of Subjects Screened at a Screening Clinic
timeFrame: Through study completion, an average of 12 months
measure: Number of Subjects Followed-Up by the Research Pharmacist
timeFrame: Through study completion, an average of 12 months
measure: Number of Subjects Diagnosed with Hypertension
timeFrame: Through study completion, an average of 12 months
measure: Number of Subjects Treated for Hypertension, if Diagnosed
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Philip M Polgreen, MD
role: PRINCIPAL_INVESTIGATOR
References: