Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-09 @ 1:58 AM
Study NCT ID:
NCT06557005
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-05-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of a primary care visit', 'timeFrame': '155 days after date of delivery', 'description': '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).'}, {'measure': 'Receipt of condition-specific recommended health screening and counseling by a primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': '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.\n\nFor 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.\n\nFor 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. "'}, {'measure': 'Self-report of having a known, reliable primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': "The outcome is the Self-report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant)."}, {'measure': 'Self-report of mental health', 'timeFrame': '155 days after date of delivery', 'description': 'Edinburgh Perinatal Depression Scale will be administered and the total EPDS score compared.'}], 'secondaryOutcomes': [{'measure': 'Completion of an annual exam with a primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': '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).'}, {'measure': 'Self-report of completion of a primary care visit', 'timeFrame': '155 days after date of delivery', 'description': '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.'}, {'measure': 'Self-report of an annual exam with a primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': '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).'}, {'measure': 'Completion of a primary care visit', 'timeFrame': '365 days after date of delivery', 'description': 'Observation of a visit with a primary care practitioner for any reason.'}, {'measure': 'Self-report of completion of a primary care visit', 'timeFrame': '365 days after date of delivery', 'description': '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.'}, {'measure': 'Completion of an annual exam with a primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': '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).'}, {'measure': 'Self-report of an annual exam with a primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': '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).'}, {'measure': 'Repeated primary care practitioner engagement', 'timeFrame': '365 days after date of delivery', 'description': 'Observation of two or more primary care practitioner visits for any reason.'}, {'measure': 'Self-report of repeated primary care practitioner engagement', 'timeFrame': '365 days after date of delivery', 'description': 'Self-report of two or more primary care practitioner visits for any reason.'}, {'measure': 'Extent of primary care practitioner engagement', 'timeFrame': '365 days after date of delivery', 'description': 'Number of primary care practitioner visits for any reason.'}, {'measure': 'Self-report of extent of primary care practitioner engagement', 'timeFrame': '365 days after date of delivery', 'description': 'Self-report of the number of primary care practitioner visits for any reason.'}, {'measure': 'Completion of a primary care visit', 'timeFrame': '548 days after date of delivery', 'description': 'Observation of a visit with a primary care practitioner for any reason.'}, {'measure': 'Completion of an annual exam with a primary care practitioner', 'timeFrame': '548 days after date of delivery', 'description': 'Observation of an annual exam or health care maintenance visit with a primary care practitioner.'}, {'measure': 'Repeated primary care practitioner engagement', 'timeFrame': '548 days after date of delivery', 'description': 'Observation of two or more primary care practitioner visits for any reason.'}, {'measure': 'Extent of primary care practitioner engagement', 'timeFrame': '548 days after date of delivery', 'description': 'Number of primary care practitioner visits for any reason.'}, {'measure': 'Self-report of receipt of condition-specific recommended health screening and counseling by a primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': 'For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as reported by the participant.\n\nFor 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.\n\nFor 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.'}, {'measure': 'Receipt of recommended screening and counseling for chronic condition by primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': '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.'}, {'measure': 'Receipt of recommended screening for gestational condition by primary care practitioner', 'timeFrame': '155 days after date of delivery', 'description': '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.\n\nFor 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."'}, {'measure': 'Receipt of recommended screening and counseling for chronic condition by primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': '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.'}, {'measure': 'Receipt of recommended screening for gestational condition by primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': '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.\n\nFor 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.'}, {'measure': 'Receipt of recommended screening and counseling for chronic condition by primary care practitioner', 'timeFrame': '548 days after date of delivery', 'description': '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.'}, {'measure': 'Receipt of recommended screening for gestational condition by primary care practitioner', 'timeFrame': '548 days after date of delivery', 'description': '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.\n\nFor 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.'}, {'measure': 'Self-report of receipt of recommended screening and counseling for chronic condition by primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': '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.'}, {'measure': 'Self-report of receipt of recommended screening for gestational condition by primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': 'For individuals with gestational hypertensive disorders, appropriate management is defined as blood pressure screening by a primary care practitioner as reported by the participant.\n\nFor 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. "'}, {'measure': 'Self-report of having a known, reliable primary care practitioner', 'timeFrame': '365 days after date of delivery', 'description': "Participant report of having a known, reliable primary care practitioner (doctor, nurse practitioner, or physician's assistant)."}, {'measure': 'Urgent or emergent care use', 'timeFrame': '155 days after date of delivery', 'description': 'Emergency department or urgent care visit for any reason as documented in the electronic health record.'}, {'measure': 'Self-report of urgent or emergent care use', 'timeFrame': '155 days after date of delivery', 'description': 'Emergency department or urgent care visit for any reason as documented as reported by the participant.'}, {'measure': 'Urgent or emergent care use', 'timeFrame': '365 days after date of delivery', 'description': 'Emergency department or urgent care visit for any reason as documented in the electronic health record.'}, {'measure': 'Self-report of urgent or emergent care use', 'timeFrame': '365 days after date of delivery', 'description': 'Emergency department or urgent care visit for any reason as reported by the participant.'}, {'measure': 'Self-report of mental health', 'timeFrame': '365 days after date of delivery', 'description': 'Edinburgh Perinatal Depression Scale score as reported by the participant.'}, {'measure': 'Urgent or emergent care use', 'timeFrame': '584 days after date of delivery', 'description': 'Emergency department or urgent care visit for any reason as documented in the electronic health record.'}, {'measure': 'Interpregnancy interval', 'timeFrame': '365 days after date of delivery', 'description': 'Defined as the time (in days) from date of delivery until subsequent date of conception.'}, {'measure': 'Interpregnancy interval', 'timeFrame': '584 days after date of delivery', 'description': 'Defined as the time (in days) from date of delivery until subsequent date of conception.'}, {'measure': 'Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder', 'timeFrame': '155 days', 'description': '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.'}, {'measure': 'Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder', 'timeFrame': '365 days', 'description': '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.'}, {'measure': 'Prescription or documentation of medication use for the treatment of a pre-existing or newly diagnosed mood or anxiety disorder', 'timeFrame': '584 days', 'description': '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.'}, {'measure': 'Contraception use', 'timeFrame': '155 days', 'description': 'The use of any form of contraception as documented in the electronic health record'}, {'measure': 'Contraception use', 'timeFrame': '365 days', 'description': 'The use of any form of contraception as documented in the electronic health record'}, {'measure': 'Contraception use', 'timeFrame': '584 days', 'description': 'The use of any form of contraception as documented in the electronic health record'}, {'measure': 'Self-report of contraception', 'timeFrame': '155 days', 'description': 'Self-report of using contraception or discussing family planning/contraception'}, {'measure': 'Self-report of contraception', 'timeFrame': '365 days', 'description': 'Self-report of using contraception or discussing family planning/contraception'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum Care', 'Primary Care', 'Care Transitions', 'Chronic Disease'], 'conditions': ['Hypertension', 'Diabetes', 'Postpartum', 'Pregnancy', 'Anxiety', 'Depression', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 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)\n* Pregnant with a live fetus or delivered a live-born neonate ≥24 weeks of gestation, based on the clinical estimate of gestational age\n* If postpartum, has a neonate that is currently living at the time of enrollment\n* 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):\n\n * Chronic or essential hypertension\n * Hypertensive disorders related to pregnancy (e.g., pre-eclampsia)\n * Type 1 or 2 diabetes (i.e., pre-existing diabetes)\n * Gestational diabetes\n * 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)\n * Depression or anxiety disorder\n* Has a primary care clinician listed in the patient\'s medical record\n* Has access to or agrees to be enrolled in the electronic health record patient portal and consents to be contacted via these modalities\n* Able to read/speak English or Spanish language\n* Is age ≥18 years old\n\nExclusion Criteria\n\n• Any individual not meeting all inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06557005', 'briefTitle': 'Facilitated Transitions From Postpartum to Primary Care Coordination for People With Chronic Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Bridges to Primary Care: Transforming Postpartum Primary Care Coordination for People With Chronic Conditions', 'orgStudyIdInfo': {'id': '2024P002210'}, 'secondaryIdInfos': [{'id': 'R01HS030245-01', 'link': 'https://reporter.nih.gov/quickSearch/R01HS030245-01', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Routine Care', 'description': 'Routine postpartum care'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Facilitated Transition Group', 'description': '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.', 'interventionNames': ['Other: Facilitated Transition to Primary Care']}], 'interventions': [{'name': 'Facilitated Transition to Primary Care', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Facilitated Transition Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Mark A Clapp, MD, MPH', 'role': 'CONTACT', 'email': 'mark.clapp@mgh.harvard.edu', 'phone': '617-726-2000'}], 'overallOfficials': [{'name': 'Mark A Clapp, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'url': 'https://dataverse.harvard.edu/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data and materials will be available after planned primary and secondary analyses are completed by the research team or at the end of the award, whichever occurs last (expected 08/2029). Data will be available and accessible for at least 5 years after posting.', 'ipdSharing': 'YES', 'description': '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.\n\nStudy 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.', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician Investigator', 'investigatorFullName': 'Mark Clapp, MD MPH', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}