Pregnancy RelatedNCT04261894
The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
A study testing OPTIMIZE in people with Pregnancy Related, run by Northwestern University at 1 site in United States.
Trial summary
This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- OPTIMIZE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 15 to 45 years
- Self-identified as Black/African American
- Pregnant or recently gave birth (less than 6 months post-delivery)
- English speaking
Who cannot join
- Cognitive impairment
- Incarceration
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
ACCESS Community Health Network
Chicago, Illinois, 60609
About this study
This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care.
Read the detailed description
African American women and their infants experience profound perinatal health disparities. The purpose of this study is to develop and evaluate the OPTIMIZE intervention, which is an integrated and comprehensive perinatal care checklist with patient navigation support, using a Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial among 600 African American women (15-45 years of age and 1st-2nd trimester of pregnancy) recruited from approximately 20 clinics affiliated with two Chicago area community health center networks that are the largest providers of perinatal care for low-income African American women in Chicago. Clinic sites will be randomized 1:1 to standard perinatal care (control arm) or standard perinatal care plus the OPTIMIZE checklist with Patient Navigation support starting from the initial prenatal visit and up through 12-weeks postpartum (intervention arm).
The study will test the central hypothesis that African American women in the OPTIMIZE intervention group will have received a greater proportion of recommended perinatal care components (prenatal care content, postpartum care content, and social determinants of health content) consistent with American College of Obstetricians and Gynecologists guidelines than African American women in the standard care group.
- Conditions
- Pregnancy Related
- Being tested
- OPTIMIZE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMIZEBehavioural
The study intervention is implementation of the OPTIMIZE perinatal care checklist with patient navigation support. The checklist will contain perinatal care components to be assessed for each participant. Specifically, the checklist will be built into the electronic health record as a secure digital record of: (1) the participant's adherence to the recommended prenatal and postpartum visit schedule, (2) the completion of procedures and processes in a participant's prenatal and postpartum standard care plan, and (3) the completion of processes to address social determinants of health, along with completion of referrals to appropriate support resources. The OPTIMIZE checklist will also include records of patient navigation review, engagement, and tracking of barrier status and resolution
| Study group | Role | What they receive |
|---|---|---|
| OPTIMIZE | Experimental | This arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support. Receives: Behavioral: OPTIMIZE |
| Standard Care | No intervention | This arm includes provision of standard perinatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Perinatal Care Components
The primary outcome will be a composite proportion of perinatal care components across three domains, including prenatal care, postpartum care, and social determinants of health content compared between the intervention and control arms.
Measured: Baseline through 6 months postpartum
Secondary outcomes (6)
Rate of breastfeeding
Measured by patient report of feedings per day and week
Measured: 6 weeks, 3 months, and 6 months postpartum
Rate of depressive symptoms
Proportion of women with postpartum depression as measured by Patient Health Questionnaire-9
Measured: Baseline through 6 months postpartum
Rate of postpartum contraception uptake and adherence
Proportion of women receiving and maintaining contraception
Measured: Up to 6 months postpartum
Rate of influenza vaccine uptake
Proportion of women receiving influenza vaccine
Measured: Up to 6 months postpartum
Rate of Tetanus, Diphtheria, Pertussis vaccine uptake
Proportion of women receiving Tetanus, Diphtheria, Pertussis vaccine
Measured: Up to 6 months postpartum
Rate of human papillomavirus vaccine
Proportion of women receiving human papillomavirus vaccine
Measured: Up to 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start23 Jun 2021
- Primary completion31 Mar 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Simon, Northwestern University
- Investigators
- Melissa A Simon, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261894
- Sponsor's protocol ID
- SP0052930
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care
- ClinicalTrials.gov ID
- NCT04261894
- Acronym / sponsor ID
- SP0052930
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 23 Jun 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 10 Feb 2020 (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.
This study will develop and test an intervention, called OPTIMIZE, which includes the use of a perinatal checklist by clinic staff and provision of patient navigation support to African American pregnant women. Half of the clinics in the study will be assigned to the OPTIMIZE intervention and half will administer standard care.
Detailed description
African American women and their infants experience profound perinatal health disparities. The purpose of this study is to develop and evaluate the OPTIMIZE intervention, which is an integrated and comprehensive perinatal care checklist with patient navigation support, using a Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial among 600 African American women (15-45 years of age and 1st-2nd trimester of pregnancy) recruited from approximately 20 clinics affiliated with two Chicago area community health center networks that are the largest providers of perinatal care for low-income African American women in Chicago. Clinic sites will be randomized 1:1 to standard perinatal care (control arm) or standard perinatal care plus the OPTIMIZE checklist with Patient Navigation support starting from the initial prenatal visit and up through 12-weeks postpartum (intervention arm).
The study will test the central hypothesis that African American women in the OPTIMIZE intervention group will have received a greater proportion of recommended perinatal care components (prenatal care content, postpartum care content, and social determinants of health content) consistent with American College of Obstetricians and Gynecologists guidelines than African American women in the standard care group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Hybrid Type I Cluster Randomized Effectiveness-Implementation Pragmatic Trial
| Arm | Type | Receives |
|---|---|---|
| OPTIMIZE | Experimental | Behavioral: OPTIMIZEThis arm includes implementation of the OPTIMIZE perinatal care checklist with patient navigation support. |
| Standard Care | No intervention | –This arm includes provision of standard perinatal care. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 15 to 45 years
- Self-identified as Black/African American
- Pregnant or recently gave birth (less than 6 months post-delivery)
- English speaking
Key exclusion criteria (3 listed)
- Cognitive impairment
- Incarceration
- Adults unable to consent
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 |
|---|---|---|
| OPTIMIZEThe study intervention is implementation of the OPTIMIZE perinatal care checklist with patient navigation support. The checklist will contain perinatal care components to be assessed for each participant. Specifically, the checklist will be built into the electronic health record as a secure digital record of: (1) the participant's adherence to the recommended prenatal and postpartum visit schedule, (2) the completion of procedures and processes in a participant's prenatal and postpartum standard care plan, and (3) the completion of processes to address social determinants of health, along with completion of referrals to appropriate support resources. The OPTIMIZE checklist will also include records of patient navigation review, engagement, and tracking of barrier status and resolution | Behavioural | OPTIMIZE |
Primary outcome
Receipt of Perinatal Care Components
Time frame: Baseline through 6 months postpartum
The primary outcome will be a composite proportion of perinatal care components across three domains, including prenatal care, postpartum care, and social determinants of health content compared between the intervention and control arms.
6 secondary outcomes
Rate of breastfeeding
Time frame: 6 weeks, 3 months, and 6 months postpartum
Rate of depressive symptoms
Time frame: Baseline through 6 months postpartum
Rate of postpartum contraception uptake and adherence
Time frame: Up to 6 months postpartum
Rate of influenza vaccine uptake
Time frame: Up to 6 months postpartum
Rate of Tetanus, Diphtheria, Pertussis vaccine uptake
Time frame: Up to 6 months postpartum
Rate of human papillomavirus vaccine
Time frame: Up to 6 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Melissa A Simon, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMIZE in people with Pregnancy Related, run by Northwestern University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 13 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Perinatal Care Components (time frame: Baseline through 6 months postpartum). 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 Apr 2026.