Pregnancy RelatedACHIEVENCT06002165
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
A study testing ACHIEVE Multi-component Implementation Strategy in people with Pregnancy Related and Hypertension, run by University of North Carolina, Chapel Hill at 8 sites in United States.
Trial summary
The goal of this clinical trial is to test an approach to improve care for pregnant and post-partum patients with high blood pressure. The study participants are providers and staff in prenatal care clinics, and the condition of interest is severe hypertension. The research questions are: 1. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Pregnancy Related, Hypertension
- What is being tested?
- ACHIEVE Multi-component Implementation Strategy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,677 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Oct 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sites/Facilities Enrolling Participants
- The prenatal care clinics being recruited must meet all of the following inclusion criteria:
- Physical location of the clinic is in Orange, Alamance, Durham, or Wake County
- The clinic patient population includes ≥ 50 births per year
- The clinic uses an electronic health record system
- Additionally, the clinic's patient population must meet one or more of the following inclusion criteria:
Show all 20Show fewer
- ≥ 50% uninsured or insured by Medicaid
- ≥ 20% Black / African American
- ≥ 20% rural residents
- Clinic Participants
- Participants will include volunteers within the following categories:
- Implementation Team b. Care Team c. Medical Support Personnel
- Patients (Patient Education Cohort)
- Gave birth up to six months prior to the data collection timepoint
- Received at least two or more prenatal care visits from the participating clinic
- At least one of the two prenatal care visits must occur between 20- and 34-weeks gestation
- Patients: (Timely Delivery of Care Cohort)
- >20 weeks pregnant or up to six weeks post-partum in the 12 months prior to the data collection timepoint
- Had at least one documented episode of severe hypertension (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher) during a visit encounter with a participating clinic
- Individual pregnant or postpartum people should have all episodes included if they present with severe range blood pressures more than once on different days
Who cannot join
- Sites/Facilities Enrolling Participants
- Clinics that were part of the Pilot Phase of this study
- Clinics that had recently completed a similar quality improvement project focused on severe hypertension
- Implementation Team
- Provider cannot be a Medical Resident
- Care Team
Show all 12Show fewer
- Provider cannot be a Medical Resident
- Medical Support Personnel
- None
- Patients (Patient Education Cohort)
- None
- Patients (Timely Delivery of Care Cohort) a. None
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites
Cone Health
Burlington, North Carolina, 27215
Alamance County Health Department
Burlington, North Carolina, 27217
Piedmont Health Services
Chapel Hill, North Carolina, 27514
Unified Women's Healthcare of the Carolinas
Chapel Hill, North Carolina, 27514
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27516
Duke University Health System
Durham, North Carolina, 27710
Orange County Health Department
Hillsborough, North Carolina, 27278
WakeMed
Raleigh, North Carolina, 27610
About this study
Official title: Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle: ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension Through Implementation, Engagement, and Valuing Everyone)
The goal of this clinical trial is to test an approach to improve care for pregnant and post-partum patients with high blood pressure. The study participants are providers and staff in prenatal care clinics, and the condition of interest is severe hypertension. The research questions are:
- Does the ACHIEVE intervention increase the quality and accuracy of measuring patient blood pressure?
- Does the ACHIEVE intervention increase the documentation of delivery of patient education on hypertension?
- Does the ACHIEVE intervention result in better recognition and treatment of severe hypertension during practice sessions (simulations)?
- Does the ACHIEVE intervention result in better recognition and treatment of severe hypertension for patients who come to the clinic?
Participants from outpatient prenatal care clinics in North Carolina will work with an ACHIEVE Nurse Coordinator who will deliver training, coaching, simulations, and educational materials. Three groups of clinics will be phased into Active Implementation every six months. The study team will examine data collected before, during, and after the intervention to see if the results show improvement.
Read the detailed description
New or worsening high blood pressure in pregnancy can develop into a disease called preeclampsia. If left untreated, preeclampsia may turn into eclampsia. Eclampsia occurs when a pregnant person has a seizure or a stroke, which can lead to lifelong health problems, or even death. In 2018, 14% of pregnant people who gave birth in North Carolina experienced high blood pressure. Rural, low-income, and women of color are at greatest risk for complications of high blood pressure in pregnancy and postpartum. These same individuals also face challenges in accessing care. To improve maternal health outcomes for these patients, the Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN bundle) which includes five areas of focus: (1) Readiness of clinics to change practices (2) Recognition of high blood pressure (3) Response to patients with high blood pressure during pregnancy or postpartum; 4) Reporting/Systems Learning to track data related to clinic changes and (5) Respectful Care to ensure equity and respect in care of patients. Initially released in 2015, The HTN bundle has been used by hospitals to improve recognition and treatment of high blood pressure in birthing people. The ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension through Implementation, Engagement, and Valuing Everyone) Initiative was developed to support outpatient clinics in providing more effective care to pregnant individuals with high blood pressure. Adapting this bundle for community clinics providing pregnancy care has the potential to reach more birthing people outside the hospital setting who are most vulnerable to complications.
In the initial phase of ACHIEVE, the study team partnered with three rural Piedmont Health Services (PHS) clinics that serve mostly White and Latinx patients. The inpatient HTN bundle was adapted to fit their setting and re-named the Outpatient Hypertension (O-HTN) bundle. Additionally, a coalition was established to engage patients, clinic providers/staff, and the broader community to: (a) understand factors influencing maternal health including economic stability, education, health care access, and community context, (b) assess what makes it easier or harder to implement the O-HTN bundle in community outpatient clinic settings, (c) adapt the O-HTN bundle to fit those settings and populations, and (d) select and tailor changes to clinic practices using continuous cycles of learning, measuring and adapting to be the most effective and sustainable for the organization. Building on this formative work, the goal of the clinical trial is to determine the impact of four implementation strategies (training, coaching, facilitation, educational materials) in up to 20 outpatient clinics in central North Carolina. Usual clinic care for severe hypertension will be compared to the care provided after a practice has 12 months of implementation support from the ACHIEVE Nurse Coordinator. ACHIEVE partners include healthcare leadership, clinic providers and staff, community-based organizations, and individuals with lived experience who will work together on this project. If the project succeeds in improving care, the ACHIEVE model will be shared across the state and nationally to support healthier birthing people and communities.
- Conditions
- Pregnancy Related, Hypertension
- Being tested
- Usual Care, ACHIEVE Multi-component Implementation Strategy
- Keywords
- Hypertension, Pregnancy Related, Practice Guidelines, Prenatal Care, Quality Improvement, Implementation Science
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareBehavioural
All clinics in North Carolina Perinatal Region IV have access to Severe HTN Bundle resources on the AIM website (https://saferbirth.org/psbs/severe-hypertension-in-pregnancy) and the locally adapted Outpatient HTN Bundle resources on the North Carolina Perinatal Region IV Provider Support Network website (https://www.mombaby.org/outpatient-bundle-for-severe-hypertension/). At baseline, the clinical leadership of all enrolled sites will receive direct communication via email that describes and provides links to the available resources. This will constitute "usual care."
ACHIEVE Multi-component Implementation StrategyBehavioural
The intervention is comprised of four implementation strategies: facilitation/coaching, training, simulation, and delivering educational materials. The ACHIEVE study team, primarily the Nurse Coordinator, will engage teams within each clinic to participate in quality improvement activities utilizing these four strategies. The Nurse Coordinator will train the providers/staff on the O-HTN bundle components, facilitate corresponding office systems and workflow changes, and conduct simulations of patients with severe hypertension so care teams can practice the steps involved in recognizing and responding to episodes of severe hypertension in a timely manner.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | Placebo comparator | The Usual Care Arm is comprised of the clinics that are not yet receiving the intervention. All clinics participating in the study are in the Usual Care Arm until they begin the Active Implementation phase. Receives: Behavioral: Usual Care |
| Active Implementation Arm | Active comparator | The Active Implementation Arm is comprised of the clinics that have started to receive the intervention, which is the ACHIEVE multi-component implementation strategy delivered by the Nurse Coordinators. All clinics (divided into 3 Cohorts) move from the Usual Care Arm into the Active Implementation Arm in sequential order (six months apart). Receives: Behavioral: ACHIEVE Multi-component Implementation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized percentage of achieving the highest possible score for blood pressure measurement technique
Derived from an 11-item observation checklist with a maximum score of 11 points per observation (sample: all Medical Support Personnel who are trained to measure blood pressure for prenatal patients). The construct is fidelity to blood pressure measurement technique; a higher score represents an improvement in fidelity; the range for the checklist is 0-11 which will be translated into a normalized percentage from 0-100.
Measured: Up to 48 months
Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.
Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 2 points per chart (sample: 25 charts per clinic randomly selected from all pregnant patients who delivered up to 6-months prior to the data collection timepoint). The construct is fidelity to the patient education protocol; a higher score represents an improvement in fidelity; the range for the score is 0-2 which will be translated into a normalized percentage from 0-100.
Measured: Up to 48 months
Secondary outcomes (2)
Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension
Derived from a 5-item checklist with a maximum score of 5 points per simulation (sample: all care teams in clinics that provide prenatal care.) The outcome measure will be assessed at the beginning, middle, and end of the Active Implementation phase. The construct is fidelity to recognition and response to simulated episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the checklist is 0-5 which will be translated into a normalized percentage from 0-100.
Measured: Up to 13 months
Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN
Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 4 points per episode (sample: all episodes of severe HTN among patients who were >20 weeks pregnant or up to six weeks postpartum and received prenatal care from a participating clinic in the 12 months prior to the data collection timepoint). The outcome measure will be assessed in the 12 months before, during, and after the Active Implementation phase. The construct is recognition and response to actual episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the score is 0-4 which will be translated into a normalized percentage of 0-100.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start4 Oct 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study design for the clinical trial component of the ACHIEVE initiative is a hybrid type III, multiple baseline design. Study team members will recruit and collect data from up to 20 outpatient clinics that serve pregnant patients. The clinic staff and providers will receive the intervention (a set of tailored implementation strategies) to increase their capacity to deliver timely care to patients with severe hypertension. The participating clinics will receive the intervention in three consecutive and overlapping cohorts. The first cohort, outpatient prenatal care clinics in Orange and Alamance Counties, will receive the intervention in Months 7-18 of the study. The second cohort, clinics in Durham County, will receive the intervention in Months 13-24, six months after Cohort 1 begins. The third cohort, clinics in Durham and Wake Counties, will receive the intervention in Months 19-30, twelve months after Cohort 1 begins.
- Masking
- None (open label)
- Enrolment
- 5,677 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University, University of California, San Diego, Westat
- Responsible party
- Sponsor
- Investigators
- Mary K Menard, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002165
- Sponsor's protocol ID
- 23-0968
- Other IDs
- OT2HL158287
- Acronym
- ACHIEVE
- Status last verified
- Nov 2026
- First submitted
- 15 Aug 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that will be generated from our project will contain PHI. Based on ethical considerations and the need to protect the confidentiality of participants, we expect to produce the following public-use data sets to be preserved and shared: * Data on fidelity to protocols for Blood Pressure Measurement (observations of medical support personnel) * Data on fidelity to protocols for Patient Education (retrospective chart audits) * Data on fidelity to protocols for Recognition and Response to Episodes of Severe Hypertension (observations of care teams during simulations) * Data on fidelity to protocols for Recognition and Response to Episodes of Severe Hypertension (retrospective chart audits) Data will be aggregated at the clinic level and reported for each measurement time period. Data will include fidelity to each element of the protocol and an overall score. Clinics will be de-identified.
Publications
Leeman J, Rohweder CL, Lin FC, Lightfoot AF, Costello JM, Farahi N, Harper K, Quist-Nelson J, Teal EN, Vu MB, Wheeler S, Menard MK. Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design. BMC Health Serv Res. 2024 Sep 30;24(1):1156. doi: 10.1186/s12913-024-11579-8.
PubMed 39350133
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle: ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension Through Implementation, Engagement, and Valuing Everyone)
- ClinicalTrials.gov ID
- NCT06002165
- Acronym / sponsor ID
- ACHIEVE / 23-0968
- Conditions
- Pregnancy Related, Hypertension
- Keywords
- Hypertension, Pregnancy Related, Practice Guidelines, Prenatal Care, Quality Improvement, Implementation Science
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,677 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Duke University, University of California, San Diego, Westat
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test an approach to improve care for pregnant and post-partum patients with high blood pressure. The study participants are providers and staff in prenatal care clinics, and the condition of interest is severe hypertension. The research questions are:
- Does the ACHIEVE intervention increase the quality and accuracy of measuring patient blood pressure?
- Does the ACHIEVE intervention increase the documentation of delivery of patient education on hypertension?
- Does the ACHIEVE intervention result in better recognition and treatment of severe hypertension during practice sessions (simulations)?
- Does the ACHIEVE intervention result in better recognition and treatment of severe hypertension for patients who come to the clinic?
Participants from outpatient prenatal care clinics in North Carolina will work with an ACHIEVE Nurse Coordinator who will deliver training, coaching, simulations, and educational materials. Three groups of clinics will be phased into Active Implementation every six months. The study team will examine data collected before, during, and after the intervention to see if the results show improvement.
Detailed description
New or worsening high blood pressure in pregnancy can develop into a disease called preeclampsia. If left untreated, preeclampsia may turn into eclampsia. Eclampsia occurs when a pregnant person has a seizure or a stroke, which can lead to lifelong health problems, or even death. In 2018, 14% of pregnant people who gave birth in North Carolina experienced high blood pressure. Rural, low-income, and women of color are at greatest risk for complications of high blood pressure in pregnancy and postpartum. These same individuals also face challenges in accessing care. To improve maternal health outcomes for these patients, the Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During Pregnancy and Postpartum Period Safety Bundle (HTN bundle) which includes five areas of focus: (1) Readiness of clinics to change practices (2) Recognition of high blood pressure (3) Response to patients with high blood pressure during pregnancy or postpartum; 4) Reporting/Systems Learning to track data related to clinic changes and (5) Respectful Care to ensure equity and respect in care of patients. Initially released in 2015, The HTN bundle has been used by hospitals to improve recognition and treatment of high blood pressure in birthing people. The ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension through Implementation, Engagement, and Valuing Everyone) Initiative was developed to support outpatient clinics in providing more effective care to pregnant individuals with high blood pressure. Adapting this bundle for community clinics providing pregnancy care has the potential to reach more birthing people outside the hospital setting who are most vulnerable to complications.
In the initial phase of ACHIEVE, the study team partnered with three rural Piedmont Health Services (PHS) clinics that serve mostly White and Latinx patients. The inpatient HTN bundle was adapted to fit their setting and re-named the Outpatient Hypertension (O-HTN) bundle. Additionally, a coalition was established to engage patients, clinic providers/staff, and the broader community to: (a) understand factors influencing maternal health including economic stability, education, health care access, and community context, (b) assess what makes it easier or harder to implement the O-HTN bundle in community outpatient clinic settings, (c) adapt the O-HTN bundle to fit those settings and populations, and (d) select and tailor changes to clinic practices using continuous cycles of learning, measuring and adapting to be the most effective and sustainable for the organization. Building on this formative work, the goal of the clinical trial is to determine the impact of four implementation strategies (training, coaching, facilitation, educational materials) in up to 20 outpatient clinics in central North Carolina. Usual clinic care for severe hypertension will be compared to the care provided after a practice has 12 months of implementation support from the ACHIEVE Nurse Coordinator. ACHIEVE partners include healthcare leadership, clinic providers and staff, community-based organizations, and individuals with lived experience who will work together on this project. If the project succeeds in improving care, the ACHIEVE model will be shared across the state and nationally to support healthier birthing people and communities.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design for the clinical trial component of the ACHIEVE initiative is a hybrid type III, multiple baseline design. Study team members will recruit and collect data from up to 20 outpatient clinics that serve pregnant patients. The clinic staff and providers will receive the intervention (a set of tailored implementation strategies) to increase their capacity to deliver timely care to patients with severe hypertension. The participating clinics will receive the intervention in three consecutive and overlapping cohorts. The first cohort, outpatient prenatal care clinics in Orange and Alamance Counties, will receive the intervention in Months 7-18 of the study. The second cohort, clinics in Durham County, will receive the intervention in Months 13-24, six months after Cohort 1 begins. The third cohort, clinics in Durham and Wake Counties, will receive the intervention in Months 19-30, twelve months after Cohort 1 begins.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | Placebo comparator | Behavioral: Usual CareThe Usual Care Arm is comprised of the clinics that are not yet receiving the intervention. All clinics participating in the study are in the Usual Care Arm until they begin the Active Implementation phase. |
| Active Implementation Arm | Active comparator | Behavioral: ACHIEVE Multi-component Implementation StrategyThe Active Implementation Arm is comprised of the clinics that have started to receive the intervention, which is the ACHIEVE multi-component implementation strategy delivered by the Nurse Coordinators. All clinics (divided into 3 Cohorts) move from the Usual Care Arm into the Active Implementation Arm in sequential order (six months apart). |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Sites/Facilities Enrolling Participants
- The prenatal care clinics being recruited must meet all of the following inclusion criteria:
- Additionally, the clinic's patient population must meet one or more of the following inclusion criteria:
- Clinic Participants
- Patients (Patient Education Cohort)
Key exclusion criteria (12 listed)
- Sites/Facilities Enrolling Participants
- Implementation Team
- Care Team
- Medical Support Personnel
- Patients (Patient Education Cohort)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareAll clinics in North Carolina Perinatal Region IV have access to Severe HTN Bundle resources on the AIM website (https://saferbirth.org/psbs/severe-hypertension-in-pregnancy) and the locally adapted Outpatient HTN Bundle resources on the North Carolina Perinatal Region IV Provider Support Network website (https://www.mombaby.org/outpatient-bundle-for-severe-hypertension/). At baseline, the clinical leadership of all enrolled sites will receive direct communication via email that describes and provides links to the available resources. This will constitute "usual care." | Behavioural | Usual Care Arm |
| ACHIEVE Multi-component Implementation StrategyThe intervention is comprised of four implementation strategies: facilitation/coaching, training, simulation, and delivering educational materials. The ACHIEVE study team, primarily the Nurse Coordinator, will engage teams within each clinic to participate in quality improvement activities utilizing these four strategies. The Nurse Coordinator will train the providers/staff on the O-HTN bundle components, facilitate corresponding office systems and workflow changes, and conduct simulations of patients with severe hypertension so care teams can practice the steps involved in recognizing and responding to episodes of severe hypertension in a timely manner. | Behavioural | Active Implementation Arm |
Primary outcome
Normalized percentage of achieving the highest possible score for blood pressure measurement technique
Time frame: Up to 48 months
Derived from an 11-item observation checklist with a maximum score of 11 points per observation (sample: all Medical Support Personnel who are trained to measure blood pressure for prenatal patients). The construct is fidelity to blood pressure measurement technique; a higher score represents an improvement in fidelity; the range for the checklist is 0-11 which will be translated into a normalized percentage from 0-100.
Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.
Time frame: Up to 48 months
Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 2 points per chart (sample: 25 charts per clinic randomly selected from all pregnant patients who delivered up to 6-months prior to the data collection timepoint). The construct is fidelity to the patient education protocol; a higher score represents an improvement in fidelity; the range for the score is 0-2 which will be translated into a normalized percentage from 0-100.
2 secondary outcomes
Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension
Time frame: Up to 13 months
Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 39350133Leeman J, Rohweder CL, Lin FC, Lightfoot AF, Costello JM, Farahi N, Harper K, Quist-Nelson J, Teal EN, Vu MB, Wheeler S, Menard MK. Community-engaged implementation of a safety bundle for pregnancy-related severe hypertension in the outpatient setting: protocol for a type 3 hybrid study with a multiple baseline design. BMC Health Serv Res. 2024 Sep 30;24(1):1156. doi: 10.1186/s12913-024-11579-8.
- Individual participant dataSharing planned: Yes. Data that will be generated from our project will contain PHI. Based on ethical considerations and the need to protect the confidentiality of participants, we expect to produce the following public-use data sets to be preserved and shared: * Data on fidelity to protocols for Blood Pressure Measurement (observations of medical support personnel) * Data on fidelity to protocols for Patient Education (retrospective chart audits) * Data on fidelity to protocols for Recognition and Response to Episodes of Severe Hypertension (observations of care teams during simulations) * Data on fidelity to protocols for Recognition and Response to Episodes of Severe Hypertension (retrospective chart audits) Data will be aggregated at the clinic level and reported for each measurement time period. Data will include fidelity to each element of the protocol and an overall score. Clinics will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary K Menard, MD, MPH principal investigator
University of North Carolina, Chapel Hill
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACHIEVE Multi-component Implementation Strategy in people with Pregnancy Related and Hypertension, run by University of North Carolina, Chapel Hill at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalized percentage of achieving the highest possible score for blood pressure measurement technique (time frame: Up to 48 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06002165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.