HypertensionNCT06557005
Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
A study testing Facilitated Transition to Primary Care in people with Hypertension and Diabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the >30% of pregnant people who have or are at risk for these conditions. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertension, Diabetes, Postpartum
- What is being tested?
- Facilitated Transition to Primary Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to 23 May 2028
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)
- Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age
- If postpartum, has a neonate that is currently living at the time of enrollment
- Has one or more of the following conditions listed in the "Problem List," "Medical History," or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):
- Chronic or essential hypertension
- Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)
Show all 14Show fewer
- Type 1 or 2 diabetes (i.e., pre-existing diabetes)
- Gestational diabetes
- Class II Obesity (pre-pregnancy body mass index ≥35 kg/m2; or if pre-pregnancy body mass index is not known, a first trimester BMI of ≥35 kg/m2)
- Depression or anxiety disorder
- Has a primary care clinician listed in the patient's medical record
- Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities
- Able to read/speak English or Spanish language
- Is age ≥18 years old
Who cannot join
- Any individual not meeting all inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions
The lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the >30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.
Read the detailed description
Over 30% of pregnant people have at least one chronic medical condition, and 20% have certain prenatal conditions (e.g., pregnancy-related hypertension, gestational diabetes) that increase the risk of chronic disease later in life. While patients with these conditions are typically highly engaged in prenatal care, they encounter a "postpartum cliff" in health system support after delivery; many receive no postpartum primary care at all despite having ongoing medical needs. At a time of increased stress, sleep deprivation, and competing demands, they must navigate administrative burdens in accessing primary care, often without scheduling assistance or any formal handoff between their obstetric and primary care clinician (PCP). These burdens may lead to avoided or delayed postpartum primary care, exacerbating health inequities that existed prenatally even for those fortunate enough to have a PCP. Given the many benefits of primary care, this lack of obstetric-to-primary care coordination represents a missed opportunity to increase primary care engagement and manage chronic conditions earlier in life. The primary objective is to increase postpartum primary care engagement, quality, and experience by strengthening obstetric-to-primary care coordination using a behavioral economics-informed intervention. The intervention, integrated into routine inpatient postpartum care, includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. Using a robust randomized controlled trial of 1,320 participants that is built off of the team's pilot study, the proposed study will: (Aim 1) measure the intervention's impact on postpartum primary care visit completion, sustained engagement, and disparities in these outcomes; (Aim 2) measure the intervention's impact on high-value primary care service use; and (Aim 3) measure the intervention's impact on patient experience. The study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice and will provide insight into postpartum patients' health care experiences. By targeting a vulnerable population at a time of great need and opportunity, postpartum-to-primary care coordination has the potential to catalyze sustained primary care engagement throughout life and improve long-term health.
- Conditions
- Hypertension, Diabetes, Postpartum, Pregnancy, Anxiety, Depression
- Being tested
- Facilitated Transition to Primary Care
- Keywords
- Postpartum Care, Primary Care, Care Transitions, Chronic Disease
- Medical subject headings
- Hypertension, Diabetes Mellitus, Anxiety Disorders, Depression, Obesity, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated Transition to Primary CareOther
The intervention includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Routine Care | No intervention | Routine postpartum care |
| Facilitated Transition Group | Active comparator | The intervention is integrated into routine inpatient postpartum care and includes the following components: default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. Receives: Other: Facilitated Transition to Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of a primary care visit
Observation of a visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Measured: 155 days after date of delivery
Receipt of condition-specific recommended health screening and counseling by a primary care practitioner
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record.
For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record.
For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record. "
Measured: 155 days after date of delivery
Self-report of having a known, reliable primary care practitioner
The outcome is the Self-report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant).
Measured: 155 days after date of delivery
Self-report of mental health
Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared.
Measured: 155 days after date of delivery
Secondary outcomes (41)
Completion of an annual exam with a primary care practitioner
Observation of an annual exam or health care maintenance visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Measured: 155 days after date of delivery
Self-report of completion of a primary care visit
Self-report of a visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology) for any reason.
Measured: 155 days after date of delivery
Self-report of an annual exam with a primary care practitioner
Self-report of an annual exam or health care maintenance visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Measured: 155 days after date of delivery
Completion of a primary care visit
Observation of a visit with a primary care practitioner for any reason.
Measured: 365 days after date of delivery
Self-report of completion of a primary care visit
Self-report of a visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology) for any reason.
Measured: 365 days after date of delivery
Completion of an annual exam with a primary care practitioner
Observation of an annual exam or health care maintenance visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Measured: 365 days after date of delivery
Self-report of an annual exam with a primary care practitioner
Self-report of an annual exam or health care maintenance visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Measured: 365 days after date of delivery
Repeated primary care practitioner engagement
Observation of two or more primary care practitioner visits for any reason.
Measured: 365 days after date of delivery
Self-report of repeated primary care practitioner engagement
Self-report of two or more primary care practitioner visits for any reason.
Measured: 365 days after date of delivery
Extent of primary care practitioner engagement
Number of primary care practitioner visits for any reason.
Measured: 365 days after date of delivery
Self-report of extent of primary care practitioner engagement
Self-report of the number of primary care practitioner visits for any reason.
Measured: 365 days after date of delivery
Completion of a primary care visit
Observation of a visit with a primary care practitioner for any reason.
Measured: 548 days after date of delivery
Completion of an annual exam with a primary care practitioner
Observation of an annual exam or health care maintenance visit with a primary care practitioner.
Measured: 548 days after date of delivery
Repeated primary care practitioner engagement
Observation of two or more primary care practitioner visits for any reason.
Measured: 548 days after date of delivery
Extent of primary care practitioner engagement
Number of primary care practitioner visits for any reason.
Measured: 548 days after date of delivery
Self-report of receipt of condition-specific recommended health screening and counseling by a primary care practitioner
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as reported by the participant.
For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) as reported by the participant.
For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as reported by the participant.
Measured: 155 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner
For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record.
Measured: 155 days after date of delivery
Receipt of recommended screening for gestational condition by primary care practitioner
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record.
For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record."
Measured: 155 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner
For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record.
Measured: 365 days after date of delivery
Receipt of recommended screening for gestational condition by primary care practitioner
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record.
For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record.
Measured: 365 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner
For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record.
Measured: 548 days after date of delivery
Receipt of recommended screening for gestational condition by primary care practitioner
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record.
For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record.
Measured: 548 days after date of delivery
Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner
For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as reported by the participant.
Measured: 365 days after date of delivery
Self-report of receipt of recommended screening for gestational condition by primary care practitioner
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as reported by the participant.
For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) as reported by the participant. "
Measured: 365 days after date of delivery
Self-report of having a known, reliable primary care practitioner
Participant report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant).
Measured: 365 days after date of delivery
Urgent or emergent care use
Emergency department or urgent care visit for any reason as documented in the electronic health record.
Measured: 155 days after date of delivery
Self-report of urgent or emergent care use
Emergency department or urgent care visit for any reason as documented as reported by the participant.
Measured: 155 days after date of delivery
Urgent or emergent care use
Emergency department or urgent care visit for any reason as documented in the electronic health record.
Measured: 365 days after date of delivery
Self-report of urgent or emergent care use
Emergency department or urgent care visit for any reason as reported by the participant.
Measured: 365 days after date of delivery
Self-report of mental health
Edinburgh Perinatal Depression Scale score as reported by the participant.
Measured: 365 days after date of delivery
Urgent or emergent care use
Emergency department or urgent care visit for any reason as documented in the electronic health record.
Measured: 584 days after date of delivery
Interpregnancy interval
Defined as the time (in days) from date of delivery until subsequent date of conception.
Measured: 365 days after date of delivery
Interpregnancy interval
Defined as the time (in days) from date of delivery until subsequent date of conception.
Measured: 584 days after date of delivery
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
Observation of a prescription for or provider documentation noting the use of a medication for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder in the electronic health record.
Measured: 155 days
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
Observation of a prescription for or provider documentation noting the use of a medication for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder in the electronic health record.
Measured: 365 days
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
Observation of a prescription for or provider documentation noting the use of a medication for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder in the electronic health record.
Measured: 584 days
Contraception use
The use of any form of contraception as documented in the electronic health record
Measured: 155 days
Contraception use
The use of any form of contraception as documented in the electronic health record
Measured: 365 days
Contraception use
The use of any form of contraception as documented in the electronic health record
Measured: 584 days
Self-report of contraception
Self-report of using contraception or discussing family planning/contraception
Measured: 155 days
Self-report of contraception
Self-report of using contraception or discussing family planning/contraception
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start23 May 2025
- Primary completion23 May 2027 (estimated)
- Study completion23 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Responsible party
- Principal investigator, Mark Clapp, MD MPH, Massachusetts General Hospital
- Investigators
- Mark A Clapp, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557005
- Sponsor's protocol ID
- 2024P002210
- Other IDs
- R01HS030245-01
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets generated for this analysis will be preserved and shared publicly after planned primary and secondary analyses are completed by the research team or at the end of the award, whichever occurs last. Data will be preserved for at least 5 years after public posting to ensure outside investigators can access and use this information for related research. Study metadata, code, and a deidentified data set that includes all collected trial data will be publicly available, without restricted access, on the Harvard Dataverse Repository.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions
- ClinicalTrials.gov ID
- NCT06557005
- Acronym / sponsor ID
- 2024P002210
- Conditions
- Hypertension, Diabetes, Postpartum, Pregnancy, Anxiety, Depression
- Keywords
- Postpartum Care, Primary Care, Care Transitions, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 23 May 2027 (estimated)
- Study completion
- 23 May 2028 (estimated)
- First posted
- 16 Aug 2024 (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 lack of postpartum primary care coordination is a missed opportunity to increase primary care engagement and manage chronic conditions early in life, especially for the >30% of pregnant people who have or are at risk for these conditions. This study aims to increase postpartum primary care engagement, quality, and experience by strengthening postpartum transitions to primary care using a behavioral economics-informed, multi-component intervention integrated into usual inpatient postpartum care. Using a randomized controlled trial and repeated outcome assessments through administrative and survey data, this study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice, potentially catalyzing sustained primary care engagement throughout life.
Detailed description
Over 30% of pregnant people have at least one chronic medical condition, and 20% have certain prenatal conditions (e.g., pregnancy-related hypertension, gestational diabetes) that increase the risk of chronic disease later in life. While patients with these conditions are typically highly engaged in prenatal care, they encounter a "postpartum cliff" in health system support after delivery; many receive no postpartum primary care at all despite having ongoing medical needs. At a time of increased stress, sleep deprivation, and competing demands, they must navigate administrative burdens in accessing primary care, often without scheduling assistance or any formal handoff between their obstetric and primary care clinician (PCP). These burdens may lead to avoided or delayed postpartum primary care, exacerbating health inequities that existed prenatally even for those fortunate enough to have a PCP. Given the many benefits of primary care, this lack of obstetric-to-primary care coordination represents a missed opportunity to increase primary care engagement and manage chronic conditions earlier in life. The primary objective is to increase postpartum primary care engagement, quality, and experience by strengthening obstetric-to-primary care coordination using a behavioral economics-informed intervention. The intervention, integrated into routine inpatient postpartum care, includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. Using a robust randomized controlled trial of 1,320 participants that is built off of the team's pilot study, the proposed study will: (Aim 1) measure the intervention's impact on postpartum primary care visit completion, sustained engagement, and disparities in these outcomes; (Aim 2) measure the intervention's impact on high-value primary care service use; and (Aim 3) measure the intervention's impact on patient experience. The study will generate rigorous, actionable evidence to ensure primary care coordination becomes standard postpartum care practice and will provide insight into postpartum patients' health care experiences. By targeting a vulnerable population at a time of great need and opportunity, postpartum-to-primary care coordination has the potential to catalyze sustained primary care engagement throughout life and improve long-term health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Care | No intervention | –Routine postpartum care |
| Facilitated Transition Group | Active comparator | Other: Facilitated Transition to Primary CareThe intervention is integrated into routine inpatient postpartum care and includes the following components: default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Receiving obstetric care at an MGH-affiliated obstetrics practice (except for the MGH HOPE Clinic, which has a unique care model that provides prenatal and postnatal care for individuals with substance use disorder, including the provision of primary care through 2+ years postpartum)
- Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age
- If postpartum, has a neonate that is currently living at the time of enrollment
- Has one or more of the following conditions listed in the "Problem List," "Medical History," or clinical notes during prenatal, intrapartum, or postpartum encounters in the EHR (or in the case of BMI, the patient's anthropometric measurements):
- Has a primary care clinician listed in the patient's medical record
Key exclusion criteria (1 listed)
- Any individual not meeting all inclusion criteria
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 |
|---|---|---|
| Facilitated Transition to Primary CareThe intervention includes default PCP visit scheduling, tailored nudge messages to patients, ongoing care recommendations sent to the PCP, and a summary of recommendations after pregnancy given to the patient. | Other | Facilitated Transition Group |
Primary outcome
Completion of a primary care visit
Time frame: 155 days after date of delivery
Observation of a visit with a primary care practitioner (defined as physicians and advanced practice clinicians affiliated with the following medical specialties: internal medicine, family medicine, pediatrics and adolescent medicine, and gynecology).
Receipt of condition-specific recommended health screening and counseling by a primary care practitioner
Time frame: 155 days after date of delivery
For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as documented in the electronic health record. For individuals with gestational diabetes, appropriate management is defined as observation of a postpartum glucose screening testing (e.g., GTT, HgbA1c) in the electronic health record. For individuals with chronic conditions, appropriate management is defined as receipt of both condition-specific screening (mood, weight, blood pressure and/or diabetes screening) and receipt of counseling, discussion of a management, and/or referral for or acknowledgment of subspecialist management for that condition by a primary care practitioner as documented in the electronic health record. "
Self-report of having a known, reliable primary care practitioner
Time frame: 155 days after date of delivery
The outcome is the Self-report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant).
Self-report of mental health
Time frame: 155 days after date of delivery
Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared.
41 secondary outcomes
Completion of an annual exam with a primary care practitioner
Time frame: 155 days after date of delivery
Self-report of completion of a primary care visit
Time frame: 155 days after date of delivery
Self-report of an annual exam with a primary care practitioner
Time frame: 155 days after date of delivery
Completion of a primary care visit
Time frame: 365 days after date of delivery
Self-report of completion of a primary care visit
Time frame: 365 days after date of delivery
Completion of an annual exam with a primary care practitioner
Time frame: 365 days after date of delivery
Self-report of an annual exam with a primary care practitioner
Time frame: 365 days after date of delivery
Repeated primary care practitioner engagement
Time frame: 365 days after date of delivery
Self-report of repeated primary care practitioner engagement
Time frame: 365 days after date of delivery
Extent of primary care practitioner engagement
Time frame: 365 days after date of delivery
Self-report of extent of primary care practitioner engagement
Time frame: 365 days after date of delivery
Completion of a primary care visit
Time frame: 548 days after date of delivery
Completion of an annual exam with a primary care practitioner
Time frame: 548 days after date of delivery
Repeated primary care practitioner engagement
Time frame: 548 days after date of delivery
Extent of primary care practitioner engagement
Time frame: 548 days after date of delivery
Self-report of receipt of condition-specific recommended health screening and counseling by a primary care practitioner
Time frame: 155 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner
Time frame: 155 days after date of delivery
Receipt of recommended screening for gestational condition by primary care practitioner
Time frame: 155 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner
Time frame: 365 days after date of delivery
Receipt of recommended screening for gestational condition by primary care practitioner
Time frame: 365 days after date of delivery
Receipt of recommended screening and counseling for chronic condition by primary care practitioner
Time frame: 548 days after date of delivery
Receipt of recommended screening for gestational condition by primary care practitioner
Time frame: 548 days after date of delivery
Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner
Time frame: 365 days after date of delivery
Self-report of receipt of recommended screening for gestational condition by primary care practitioner
Time frame: 365 days after date of delivery
Self-report of having a known, reliable primary care practitioner
Time frame: 365 days after date of delivery
Urgent or emergent care use
Time frame: 155 days after date of delivery
Self-report of urgent or emergent care use
Time frame: 155 days after date of delivery
Urgent or emergent care use
Time frame: 365 days after date of delivery
Self-report of urgent or emergent care use
Time frame: 365 days after date of delivery
Self-report of mental health
Time frame: 365 days after date of delivery
Urgent or emergent care use
Time frame: 584 days after date of delivery
Interpregnancy interval
Time frame: 365 days after date of delivery
Interpregnancy interval
Time frame: 584 days after date of delivery
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
Time frame: 155 days
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
Time frame: 365 days
Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder
Time frame: 584 days
Contraception use
Time frame: 155 days
Contraception use
Time frame: 365 days
Contraception use
Time frame: 584 days
Self-report of contraception
Time frame: 155 days
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 13 Jul 2026.
- Individual participant dataSharing planned: Yes. Data sets generated for this analysis will be preserved and shared publicly after planned primary and secondary analyses are completed by the research team or at the end of the award, whichever occurs last. Data will be preserved for at least 5 years after public posting to ensure outside investigators can access and use this information for related research. Study metadata, code, and a deidentified data set that includes all collected trial data will be publicly available, without restricted access, on the Harvard Dataverse Repository.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Mark A Clapp, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Transition to Primary Care in people with Hypertension and Diabetes, run by Massachusetts General Hospital at 1 site 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 14 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Contact Mark A Clapp, MD, MPH (617-726-2000, mark.clapp@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of a primary care visit (time frame: 155 days after date of delivery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.