Maternal Health Assessment in Pediatric Care

NCT ID: NCT07294573

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2026-07-31

Brief Summary

The major goal of this study is to develop and pilot M-HARP (Maternal Health Assessment and Referral Integrated into Pediatric Care). M-HARP will adapt a successful US-based health screening and referral protocol to fit the needs of new mothers at Clínica de Familia La Romana, Dominican Republic.

Detailed Description

The major goal of this project is to improve the access and utilization of primary healthcare of women in the postpartum period at Clínica de Familia La Romana (CFLR), by designing and piloting M-HARP. Additionally, by applying best practices in implementation science, our study will provide data that can be utilized in other settings. First, the investigators will develop strategies for integrating M-HARP into CFLR through stakeholder engagement. Second, we will pilot M-HARP at CFLR by recruiting postpartum women during their child's pediatric well child visit and measure implementation outcomes guided by the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework.

Aim 1: Develop strategies and processes for establishing M-HARP into CFLR. In Aim 1 the investigators will conduct two in-person advisory meetings, each held at CFLR. One meeting will be with mothers that receive their obstetric care and/or bring their children to CFLR for pediatric care. A second meeting advisory meeting clinicians at CFLR- obstetricians, pediatricians, family planning providers, family medicine and internal medicine. In each meeting we will review the M-HARP questionnaire, the draft protocol and conduct a patient journey mapping exercise. These meetings will be audio recorded and transcribed so the meetings can be reviewed later. Results from these meetings are solely recommendations for M-HARP protocol optimization and will not be published. Therefore, the advisory board members are not research participants.

Aim 2: Pilot M-HARP:

The pilot will enroll participants into two separate groups- the standard of care (SOC) group or M-HARP receipt group. All participants are mothers that will be recruited and enrolled while accompanying their infant to a pediatric visit at CFLR. Potential participants will be recruited after their child has been placed in the clinical exam room. In standard practice, the nurse or medical assistant from CFLR will intake the child (record vital signs and review immunization history). Then the family will wait in the exam room for the pediatrician. At this time the research assistant will approach the mother and assess interest in participating in the study. If the mother is interested, the research assistant will explain the study and assess the mother's eligibility. If mother agrees to participate, consent will be explained and signed. This will all occur in the exam room, which is a private space.

In phase 1, the investigators will enroll SOC, who will complete a questionnaire on demographics and medical history but will not have the M-HARP questionnaire reviewed by the pediatrician. Phase 2 will consist of M-HARP recipient group enrollment. During Phase 2, participants will also fill out a questionnaire on demographics and medical history but will also be given the M-HARP questionnaire. The M-HARP questionnaire will gather information on healthcare visits since delivery, desire for contraception, PHQ-2 depression screening, and desire for referral. The M-HARP questionnaire will be subsequently reviewed by the pediatrician. If the participants meet the criteria, they will be referred to the appropriate primary care service within the CFLR clinic. CFLR provides many different care services including primary care, obstetrics and gynecology, family planning and psychological care. Follow-up for SOCs and M-HARP recipients will occur 2-3 months after enrollment. All participants will be contacted to complete a survey (online or over the phone), which will be a repeat of the M-HARP questionnaire that assesses use of primary care and/or family planning services. At this time, study team members will review Clinical de Familia's medical records to evaluate if participants had scheduled or attended clinical visits. After the follow-up survey, we will conduct interviews with 15 participants in the M-HARP recipient group. The interview will assess the participants' experience in M-HARP, its acceptability, feasibility, and integration into pediatric care at CFLR. Participant information will be de-identified during data analysis and contact information will only be accessible to research staff to ensure confidentiality. Lastly, to ensure that all participants have the same access to health resources, after the follow-up survey the SOC participants will be provided with the same referrals that were offered to the M-HARP recipient group after the initial questionnaire, but their health care use data will not be tracked after that time.

Conditions

Postpartum Care; Primary Care; Mental Health; Family Planning; Care Coordination

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

M-HARP recipient

Participants will complete a brief health questionnaire and will be referred to clinical care if indicated.

Group Type: EXPERIMENTAL

referral

Intervention Type: BEHAVIORAL

Participants in the intervention arm will be given the "M-HARP questionnaire." The M-HARP questionnaire will gather information on healthcare visits since delivery, desire for contraception, depression screening, and desire for referral. The M-HARP questionnaire will be subsequently reviewed by the pediatrician. If the participants meet the criteria, they will be referred to the appropriate clinical service, including primary care, obstetrics and gynecology, family planning and psychological care.

Interventions

referral

Participants in the intervention arm will be given the "M-HARP questionnaire." The M-HARP questionnaire will gather information on healthcare visits since delivery, desire for contraception, depression screening, and desire for referral. The M-HARP questionnaire will be subsequently reviewed by the pediatrician. If the participants meet the criteria, they will be referred to the appropriate clinical service, including primary care, obstetrics and gynecology, family planning and psychological care.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Women attending pediatric visits at Clínica de Familia La Romana during the study period
• Women in postpartum period, with children up to 6 months of age ≥18 years

Exclusion Criteria

• Pregnant with another child, since they will be triaged to prenatal care rather than postpartum primary care
• Unwilling and unable to consent
• Women who do not speak Spanish or Creole.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Clínica de Familia La Romana, Dominican Republic

UNKNOWN

Sponsor Role: collaborator

John James Parker

OTHER

Sponsor Role: lead

Responsible Party

John James Parker

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Clínica De Familia

La Romana, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

1001PC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU00224392

Identifier Type: -

Identifier Source: org_study_id