Emergency Department-Initiated Team-Based Care for Severe Hypertension

Browse trials for

• Hypertension 6,114
• Emergencies 1,328

Keywords

• Emergency Department
• Team-Based Care
• Remote Patient Monitoring
• Clinical Pharmacist
• Community Health Worker
• Blood Pressure Control
• Severe Hypertension

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 700 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.

Study arms

• Experimental
  Team-Based Care

  Participants receive protocol-directed, guideline-concordant outpatient hypertension care initiated from the ED. A study physician or clinical pharmacist reviews eligibility, medications, allergies, comorbidities, laboratory values, and pregnancy status when applicable and sends an antihypertensive prescription during the ED visit or within 24 hours after discharge when clinically appropriate. Participants receive a validated cellular home blood pressure monitor and perform home monitoring through month 6. Clinical pharmacists conduct an initial virtual visit within 7-14 days and approximately monthly visits through month 6, adjusting medications based on blood pressure, symptoms, adherence, and laboratory results. Community health worker/patient navigator support addresses medication access, appointments, primary care linkage, transportation, insurance, social needs, and monitoring barriers.

  Other: Emergency Department-Initiated Team-Based Care

• Active comparator
  Usual Care

  Participants receive standard ED evaluation, discharge instructions, prescriptions if independently ordered by treating clinicians, and outpatient follow-up recommendations. Hypertension management by primary care or specialty clinicians occurs at clinician and participant discretion. The study does not provide protocolized pharmacist medication management or study remote patient monitoring during the first 6 months. Clinically indicated care is not withheld. Research contacts and outcome assessments are performed, and assistance addressing care-access barriers is available as described in the protocol.

  Other: Usual Care

Interventions

• OtherEmergency Department-Initiated Team-Based Care

  A multicomponent care-delivery strategy that combines prompt guideline-based antihypertensive prescribing, remote blood pressure monitoring, clinical pharmacist-led virtual medication management, and community health worker/patient navigator support during the 6-month active intervention period.

  Also known as: Team-Based Care, TBC

• OtherUsual Care

  Standard ED discharge care and outpatient hypertension follow-up at clinician and participant discretion, without protocolized study pharmacist medication management or study remote monitoring during the first 6 months.

  Also known as: Standard Care

Primary outcomes

1. Mean systolic blood pressure at 6 months

   Systolic blood pressure in mm Hg measured in person by trained outcome assessors masked to treatment assignment, using a validated automated device and a standardized seated measurement protocol. The mean of prespecified valid readings will define the 6-month value.

   Time frame: 6 months after randomization

Secondary outcomes

1. Proportion of participants with blood pressure below 130/80 mm Hg

   Proportion of participants whose standardized in-person research blood pressure is systolic blood pressure below 130 mm Hg and diastolic blood pressure below 80 mm Hg at each specified visit.

   Time frame: 6 and 12 months after randomization

2. Mean diastolic blood pressure

   Diastolic blood pressure in mm Hg measured during the standardized in-person research blood pressure assessment.

   Time frame: 6 and 12 months after randomization

3. Mean arterial pressure

   Mean arterial pressure in mm Hg calculated from standardized in-person research blood pressure measurements using the prespecified Statistical Analysis Plan method.

   Time frame: 6 and 12 months after randomization

4. Mean systolic blood pressure at 12 months

   Systolic blood pressure in mm Hg measured in person using the same validated device model, cuff-sizing procedures, positioning requirements, and averaging rules used for the baseline and 6-month assessments.

   Time frame: 12 months after randomization

5. Proportional change in systolic blood pressure from baseline

   Participant-level proportional change in standardized systolic blood pressure from the baseline research value to each specified follow-up visit.

   Time frame: 6 and 12 months after randomization

6. Proportional change in mean arterial pressure from baseline

   Participant-level proportional change in mean arterial pressure from baseline to each specified follow-up visit.

   Time frame: 6 and 12 months after randomization

7. Number of all-cause emergency department encounters

   Count of all-cause ED encounters identified through participant report, electronic health records, health information exchange data, and billing or encounter data.

   Time frame: From randomization through 12 months

8. Number of hypertension-related emergency department encounters

   Count of ED encounters classified as hypertension related using prespecified definitions in the Statistical Analysis Plan and endpoint adjudication materials.

   Time frame: From randomization through 12 months

9. Number of all-cause hospitalizations

   Count of inpatient hospitalizations identified through participant report, electronic health records, health information exchange data, and billing or encounter data.

   Time frame: From randomization through 12 months

10. Time to first major adverse cardiovascular event

    Time to the first occurrence of acute heart failure or pulmonary edema requiring ED or hospital care, acute myocardial infarction or acute coronary syndrome, ischemic or hemorrhagic stroke, urgent coronary revascularization, or all-cause death. Potential events will undergo blinded physician adjudication.

    Time frame: From randomization through 12 months

11. Incidence of adverse events, serious adverse events, and adverse events of special interest

    Number and proportion of participants with adverse events, serious adverse events, and prespecified adverse events of special interest, including symptomatic hypotension, syncope or presyncope, falls, severe dizziness, acute kidney injury or clinically significant worsening of kidney function, electrolyte abnormalities, angioedema or allergic reaction, severe edema leading to medication change, medication error, pregnancy, and clinically important device malfunction.

    Time frame: From informed consent through 30 days after the final study contact, up to approximately 13 months

12. Change in 12-item Short Form Health Survey score

    Change in SF-12 physical and mental component summary scores from baseline to the 12-month assessment.

    Time frame: Baseline to 12 months after randomization

13. Medication adherence measured by the Adherence to Refills and Medications Scale

    ARMS total score and change from baseline, calculated according to the instrument scoring method. Lower scores generally indicate better adherence.

    Time frame: Baseline, 6 months, and 12 months after randomization

14. Change in estimated 10-year cardiovascular disease risk

    Change in the prespecified 10-year ASCVD and/or PREVENT risk estimate among participants with the variables required for calculation, using methods specified in the Statistical Analysis Plan.

    Time frame: Baseline to 12 months after randomization

15. Total healthcare utilization costs

    Total healthcare utilization costs derived from encounter, billing, reimbursement, and pharmacy data using the prespecified economic evaluation methods.

    Time frame: From randomization through 12 months

16. Quality-adjusted life-years

    Quality-adjusted life-years estimated from SF-12-derived health utility values and survival during follow-up, using methods specified in the health economic analysis plan.

    Time frame: From randomization through 12 months

17. Incremental cost-effectiveness ratio for team-based care versus usual care

    Incremental cost per quality-adjusted life-year gained for team-based care compared with usual care, with uncertainty estimated using prespecified health economic methods.

    Time frame: From randomization through 12 months

Other outcomes

1. Antihypertensive prescription completed within 24 hours of ED discharge

   Proportion of participants assigned to team-based care for whom a guideline-concordant antihypertensive prescription is completed during the ED visit or within 24 hours after discharge.

   Time frame: Within 24 hours after ED discharge

2. Remote blood pressure monitoring engagement

   Number of valid monitoring periods, completed measurement sessions, and transmitted blood pressure readings during the active intervention period.

   Time frame: From randomization through 6 months

3. Clinical pharmacist intervention exposure

   Number and timing of completed clinical pharmacist contacts and medication-management visits.

   Time frame: From randomization through 6 months

4. Antihypertensive medication intensification

   Number and type of antihypertensive medication initiations, dose increases, medication additions, or regimen consolidations documented during the active intervention period.

   Time frame: From randomization through 6 months

5. Community health worker or patient navigator contacts

   Number, timing, and documented purpose of community health worker or patient navigator contacts, including care linkage, medication access, insurance, transportation, technology, and other social needs.

   Time frame: From randomization through 12 months

6. Usual-care contamination and co-intervention exposure

   Occurrence of antihypertensive prescribing, single-pill combination therapy, pharmacist management, remote monitoring, or other team-based-care-like services received outside the assigned study intervention.

   Time frame: From randomization through 12 months

Individual participant data

Plan to share: Yes — De-identified individual participant data and associated metadata will be prepared for controlled-access sharing through ScHARe or another NIH-approved repository, consistent with the informed consent, institutional certification, the NIH Data Management and Sharing Plan, and applicable privacy protections.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: After completion of the primary analyses and publication of the primary results, for the period required by the NIH-approved Data Management and Sharing Plan.

Access criteria: Access will be provided through a controlled-access NIH-approved repository. Requests will be reviewed under the repository's access procedures and applicable institutional requirements and must be consistent with participant consent, institutional certification, and approved data-use terms.