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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG034532 | U.S. NIH Grant/Contract | View source | |
| P30AG064190 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Bureau of Economic Research, Inc. | OTHER |
| Massachusetts Institute of Technology | OTHER |
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Chronic health conditions affect most older adults. Preventative medicine and risk management strategies, especially when applied earlier in life, are essential to altering the trajectory of a disease and ultimately improving health outcomes. Primary care providers (PCP) often provide most of these services, though younger adults are the least likely to receive primary care. This project leverages a period of high engagement and health activation during an individual's life (pregnancy) to nudge her toward use of primary care after the pregnancy episode. This randomized controlled trial will test the hypothesis that a behavioral science-informed intervention, incorporating defaults and salience, can increase the rates of PCP follow-up within 4 months following a delivery for individual with hypertension, diabetes, obesity. If successful, this intervention could serve as a scalable solution to increase primary care use and preventative health services in a population that currently has low rates of engagement and utilization of these services.
Individuals will be randomized with equal probability into either a treatment or control arm. The intervention combines several features designed to target reasons for low take-up of primary care among postpartum individuals. This project will leverage the potential value of defaults/opt-out, salient information, and reminders to encourage use of primary care. Individuals in both the intervention and control arms will receive information via the study institution's patient portal toward the end of the pregnancy regarding the importance and benefits of primary care in the postpartum year. This information will be similar to, but reinforcing, the information they would receive from their obstetrician about following up with their primary care physician. In addition to this initial message, individuals in the treatment arm will receive the following intervention components, developed based on recent evidence regarding behavioral science approaches to activating health behaviors:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Routine postpartum care | |
| Facilitated Transition | Experimental | Behavioral science informed interventions to assist in the transition from postpartum to primary care providers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Default appointment scheduling | Behavioral | Default primary care appointment scheduling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Primary Care Provider Visit Attendance | Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health) | 4 months after the patient's estimated date of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Primary Care Provider Visit Attendance | Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health) | 12 months after the patient's estimated date of delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Clapp, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Jessica L Cohen, PhD | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42090155 | Derived | Gangaram A, Ganguli I, Ray A, Liang P, Bald C, Clapp MA, Cohen JL. Postpartum Primary Care Engagement and Acute Care Use: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2610798. doi: 10.1001/jamanetworkopen.2026.10798. | |
| 40117132 | Derived | Delgado A, Liang P, Bender T, Ray A, James KE, Ganguli I, Cohen JL, Clapp MA. Primary Care Utilization Within 1 Year After a Facilitated Postpartum-to-Primary Care Transition. Obstet Gynecol. 2025 Apr 1;145(4):409-416. doi: 10.1097/AOG.0000000000005848. Epub 2025 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Routine postpartum care |
| FG001 | Facilitated Transition | Behavioral science informed interventions to assist in the transition from postpartum to primary care providers Default appointment scheduling: Default primary care appointment scheduling Targeted messaging: Patient-specific messages about the importance of postpartum care transition Nudge Reminders: Primary care appointment reminders |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients receiving care at 6 outpatient clinics affiliated with a single hospital in Eastern Massachusetts
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Routine postpartum care |
| BG001 | Facilitated Transition | Behavioral science informed interventions to assist in the transition from postpartum to primary care providers Default appointment scheduling: Default primary care appointment scheduling Targeted messaging: Patient-specific messages about the importance of postpartum care transition Nudge Reminders: Primary care appointment reminders |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Primary Care Provider Visit Attendance | Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health) | Posted | Count of Participants | Participants | 4 months after the patient's estimated date of delivery |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Routine postpartum care | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Clapp, MD | Massachusetts General Hospital | 617-724-2000 | mark.clapp@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 2, 2023 | Aug 9, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D046110 | Hypertension, Pregnancy-Induced |
| D003920 | Diabetes Mellitus |
| D016640 | Diabetes, Gestational |
| D009765 | Obesity |
| D003866 | Depressive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Targeted messaging | Behavioral | Patient-specific messages about the importance of postpartum care transition |
|
| Nudge Reminders | Behavioral | Primary care appointment reminders |
|
| Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health) | Health care maintenance visit appointment with the patient's assigned primary care provider | 4 months after the patient's estimated date of delivery |
| Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health) | Health care maintenance visit appointment with the patient's assigned primary care provider | 12 months after the patient's estimated date of delivery |
| Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment | Any visit to a urgent care or emergency room visit | 4 months after the patient's estimated date of delivery |
| Rate of Visit Unscheduled Health Care Visit/Encounter | Any visit to a urgent care or emergency room visit | 12 months after the patient's estimated date of delivery |
| Rate of Contraception Plan Documented by the Time of Outcome Assessment | Contraception plan documented by any provider after delivery | 4 months after the patient's estimated date of delivery |
| Rate of Long-acting Contraception Use at Time of Outcome Assessment | Long-acting contraception use (implant, intrauterine device) | 4 months after the patient's estimated date of delivery |
| Rate of Long-acting Contraception Use | Long-acting contraception use (implant, intrauterine device) | 12 months after the patient's estimated date of delivery |
| Rate of Contraception Plan Documented | Contraception plan documented by any provider after delivery | 12 months after the patient's estimated date of delivery |
| Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes | Postpartum diabetes screening among those diagnosed with gestational diabetes | 4 months after the patient's estimated date of delivery |
| Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes | Postpartum diabetes screening among those diagnosed with gestational diabetes | 12 months after the patient's estimated date of delivery |
| Rate of Weight Counseling Documented in the Health Record Among Those With Obesity | Weight counseling documentation among those with obesity | 4 months after the patient's estimated date of delivery |
| Rate of Weight Counseling Documented in the Health Record Among Those With Obesity | Weight counseling documentation among those with obesity | 12 months after the patient's estimated date of delivery |
| Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension | Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension | 4 months after the patient's estimated date of delivery |
| Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension | Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension | 12 months after the patient's estimated date of delivery |
| Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders | Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders | 4 months after the patient's estimated date of delivery |
| Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders | Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders | 12 months after the patient's estimated date of delivery |
| Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders | New or continued antidepressant prescription use | 4 months after the patient's estimated date of delivery |
| Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders | New or continued antidepressant prescription use | 12 months after the patient's estimated date of delivery |
| Rate of Antihypertensive Use Among Individuals With Hypertension | New or continued antihypertensive medication use among individuals with hypertension | 4 months after the patient's estimated date of delivery |
| Rate of Antihypertensive Use Among Individuals With Hypertension | New or continued antihypertensive medication use among individuals with hypertension | 12 months after the patient's estimated date of delivery |
| Rate of Medication Use for Glycemic Control Among Individuals With Diabetes | New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes | 4 months after the patient's estimated date of delivery |
| Rate of Medication Use for Glycemic Control Among Individuals With Diabetes | New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes | 12 months after the patient's estimated date of delivery |
| Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes | Laboratory glucose screening test among individuals with or at risk for diabetes | 4 months after the patient's estimated date of delivery |
| Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes | Laboratory glucose screening test among individuals with or at risk for diabetes | 12 months after the patient's estimated date of delivery |
| Rate of Patient-reported Primary Care Visit Attendance | Primary care provider visit attendance per patient report | 4 months after the patient's estimated date of delivery |
| Rate of Patient-reported Primary Care Visit Attendance | Primary care provider visit attendance per patient report | 12 months after the patient's estimated date of delivery |
| 39012630 | Derived | Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen JL. Postpartum Primary Care Engagement Using Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422500. doi: 10.1001/jamanetworkopen.2024.22500. |
| 38633772 | Derived | Clapp MA, Ray A, Liang P, James KE, Ganguli I, Cohen J. Increasing Postpartum Primary Care Engagement through Default Scheduling and Tailored Messaging: A Randomized Clinical Trial. medRxiv [Preprint]. 2024 May 1:2024.01.21.24301585. doi: 10.1101/2024.01.21.24301585. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Rate of Primary Care Provider Visit Attendance | Any visit with 1) a primary care provider (e.g., internal medicine, family medicine, pediatrics, gynecology) and 2) receipt of "annual" or "health care maintenance" services OR disease-specific management (diabetes, hypertension, obesity, mental health) | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health) | Health care maintenance visit appointment with the patient's assigned primary care provider | Posted | Count of Participants | Participants | 4 months after the patient's estimated date of delivery |
|
|
|
| Secondary | Rate of Visit With a Patient's Assigned Primary Care Provider for Receipt of "Annual" or "Health Care Maintenance" Services OR Disease-specific Management (Diabetes, Hypertension, Obesity, Mental Health) | Health care maintenance visit appointment with the patient's assigned primary care provider | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Visit Unscheduled Health Care Visit/Encounter by the Time of Outcome Assessment | Any visit to a urgent care or emergency room visit | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Visit Unscheduled Health Care Visit/Encounter | Any visit to a urgent care or emergency room visit | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Contraception Plan Documented by the Time of Outcome Assessment | Contraception plan documented by any provider after delivery | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Long-acting Contraception Use at Time of Outcome Assessment | Long-acting contraception use (implant, intrauterine device) | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Long-acting Contraception Use | Long-acting contraception use (implant, intrauterine device) | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Contraception Plan Documented | Contraception plan documented by any provider after delivery | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes | Postpartum diabetes screening among those diagnosed with gestational diabetes | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Pregestational Diabetes Screening Among Individuals With Gestational Diabetes | Postpartum diabetes screening among those diagnosed with gestational diabetes | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Weight Counseling Documented in the Health Record Among Those With Obesity | Weight counseling documentation among those with obesity | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Weight Counseling Documented in the Health Record Among Those With Obesity | Weight counseling documentation among those with obesity | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension | Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Blood Pressure Measurement Documented in the Health Record Among Those With or at Risk for Hypertension | Blood pressure documented in the EHR among those diagnosed within chronic or pregnancy-related hypertension | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders | Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Mental Health Service Referral or Use Among Individuals With Mood or Anxiety Disorders | Clinical support services (e.g., social work, psychiatry, therapy) for individuals with mood or anxiety disorders | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders | New or continued antidepressant prescription use | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Antidepressant Use Among Individuals With Mood or Anxiety Disorders | New or continued antidepressant prescription use | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Antihypertensive Use Among Individuals With Hypertension | New or continued antihypertensive medication use among individuals with hypertension | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Antihypertensive Use Among Individuals With Hypertension | New or continued antihypertensive medication use among individuals with hypertension | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Medication Use for Glycemic Control Among Individuals With Diabetes | New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Medication Use for Glycemic Control Among Individuals With Diabetes | New or continued oral or subcutaneous diabetes medication use control among individuals with diabetes | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes | Laboratory glucose screening test among individuals with or at risk for diabetes | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Assessment of Glycemic Control Among Individuals With or at Risk for Diabetes | Laboratory glucose screening test among individuals with or at risk for diabetes | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Patient-reported Primary Care Visit Attendance | Primary care provider visit attendance per patient report | Not Posted | 4 months after the patient's estimated date of delivery | Participants |
| Secondary | Rate of Patient-reported Primary Care Visit Attendance | Primary care provider visit attendance per patient report | Not Posted | 12 months after the patient's estimated date of delivery | Participants |
| 173 |
| 0 |
| 173 |
| 0 |
| 173 |
| EG001 | Facilitated Transition | Behavioral science informed interventions to assist in the transition from postpartum to primary care providers Default appointment scheduling: Default primary care appointment scheduling Targeted messaging: Patient-specific messages about the importance of postpartum care transition Nudge Reminders: Primary care appointment reminders | 0 | 180 | 0 | 180 | 0 | 180 |
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| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |