Utilizing Pediatric Primary Care Connections to Advance Reproductive Health

Johns Hopkins University

Status: Enrolling

Conditions: Contraceptive Use

Treatments: Other: Contraceptive need survey; Other: Conecta Familia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07064837

1K23HD110615-01A1 (U.S. NIH Grant/Contract)

IRB00389763

Details and patient eligibility

About

The purpose of this study is to understand in what ways the pediatrician's office can support women's family planning by screening for contraceptive needs at each well child visit over the first 12 months of the child's life. Part one of the study will be working with families and clinic-based social needs navigators around where and how the screening process will be integrated into an existing pediatric workflow. Part two of the study will include (a) surveying mothers of 12-15 month olds about contraceptive use experience to get a baseline followed by (b) implementing the screening process into pediatrics and measuring how well the screener is able to identify unmet contraceptive needs and how people are or are not using the screening process. This will occur over approximately 12 months. Part (b) includes enrolling families who have a contraceptive need case and following the case in the child's medical record. At the end of the 12 month intervention the investigators will (c) invite some families to participant in an interview about the experience with the contraceptive need screener. Part three will be focus group feedback from clinicians and staff about the contraceptive need screening process. Part four will be key informant interviews with community stakeholders on the expansion of this screener.

Full description

The investigators propose to design and test a Spanish-language maternal contraceptive needs screening and care coordination intervention within primary care pediatrics called Conecta. The investigator's goal is to determine if this intervention can reduce unmet contraceptive need among Latina immigrant mothers. The aims of this study are:

Aim 1: To refine Conecta, a stakeholder-informed Spanish language contraceptive needs screening and care coordination intervention for implementation with existing pediatric social needs navigation, Hopkins Community Connection (HCC). The investigators will translate workflow observations into process maps and present and discuss the process maps with stakeholders who will visually assess the stakeholder's role and interaction in the workflow. Stakeholders will focus feedback on specific, practical ways that contraceptive needs screening and care coordination support would be valuable. This feedback will help the investigators build Conecta from the existing scaffolding of the HCC structure.

Aim 2: To conduct a Hybrid Type 1 implementation-effectiveness pilot of Conecta and evaluate 1) Conecta's effectiveness in reducing unmet contraceptive need, and 2) Conecta's

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

There are four study populations categorized in this study:

• Staff of the Baltimore Medical Systems (BMS) medical practice, which includes clinicians (i.e. M.D., D.O., N.P.), medical assistants, nurses, receptionists;
• Hopkins Community Connection Resource Advocates (i.e. staff) based at the BMS;
• Community health care providers including clinicians, case managers, social workers, and nurses

Eligible BMS patients comprised of the following subpopulations:

1. Latinas with a 12 month old child who is a BMS patient;
2. Latinas with an infant 0-1 month old who is a BMS patient.

Eligibility criteria by population:

Historical control group inclusion criteria are:

• individuals who identify as Latina AND foreign-born, AND
• communication preference is Spanish AND
• 22 years or older (any parent 21 years or younger is almost always also one of the investigator's patients) AND
• are the biological parent of a 12 month old child who is a BMS patient.

Intervention cohort inclusion criteria are:

• individuals who identify as Latina AND foreign-born, AND
• communication preference is Spanish AND
• 22 years or older AND
• are the biological parent of a < 1 month old who is a BMS patient.

Participant inclusion criteria for Both:

• BMS staff OR Hopkins Community Connection Advocate staff AND
• age 18 years or older.

Participant inclusion criteria for semi-structured interviews:

• Member of intervention cohort group AND child
• has completed 12 months of life AND
• has completed contraceptive need survey.

Participant inclusion criteria for key informant interviews:

• staff member from one of 5 local health care clinics including Baltimore City Department of Health, Planned Parenthood, Women, Infants, and Children, and two federally qualified health centers AND
• direct interaction with Spanish speaking individuals AND
• age 18 years or older.

Exclusion Criteria:

Individuals with bilateral tubal ligation (permanent contraception) at time of recruitment

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Contraceptive need screener 'Conecta'

Experimental group

Description:

The Conecta intervention is a Spanish language contraceptive need screening and referral process that includes a screener and referral to social needs navigation bundled with developmental screener in 0-12 month old pediatric well visit for written completion by the mother of the patient

Treatment:

Other: Conecta Familia

Other: Contraceptive need survey

Historical control group

Placebo Comparator group

Description:

One time survey of contraceptive use and need experience among mothers of 12-15 month olds. Recruitment will occur prior to intervention with a sample of individuals who will be comparable to those who will participate in intervention.

Treatment:

Other: Contraceptive need survey