Preterm BirthNCT05120843
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
A study testing Care coordination and motivational interviewing in people with Preterm Birth and Health Care Utilization, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Health Care Utilization, Tobacco Use
- What is being tested?
- Care coordination and motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2022to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Less than 45 years old
- History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
- Intention to seek pediatric care at one of two pediatric primary care sites
- Medicaid insurance
Who cannot join
- History of sterilization procedure.
- Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
- Limited English proficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Feasibility Testing of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.
Read the detailed description
Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within two weeks of birth. Investigators will assess feasibility, adoption, reach, and fidelity of the intervention and of study data collections strategies. The intervention protocol will be revised to reflect these assessments.
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, Depression, Weight, Birth
- Being tested
- Care coordination and motivational interviewing
- Keywords
- Preconception care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing
- Medical subject headings
- Premature Birth, Patient Acceptance of Health Care, Tobacco Use, Contraception Behavior, Depression, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care coordination and motivational interviewingBehavioural
Interventionist will engage participants in care planning, health education, health care navigation, screening for unmet health needs or social needs, and motivational interviewing. The final intervention is expected to be six months in duration. However during this single-arm open testing phase, some participants may receive only key components of the intervention in order to assess feasibility, reach, adoption, and fidelity of those components.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Other | This intervention will combine care coordination and motivational interviewing strategies. Receives: Behavioral: Care coordination and motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening Rate (Feasibility)
The study team will compare the number of potentially eligible participants to those who are screened for eligibility. The number screened will be defined as the number of people whose are reviewed to approach for enrollment. The number of potentially eligible participants will be considered the number of women with preterm births with Medicaid insurance.
Measured: Screening phase (Up to 1 week prior to enrollment)
Enrollment Rate (Feasibility)
The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
Measured: Screening phase (Up to one week prior to enrollment)
Reasons for Non-participation (Acceptability)
For women who decline enrollment we will ask them, if they are willing, to provide reasons for non-participation and potential study modifications that might have encouraged them to participate. Responses will be tabulated and reviewed for potential themes.
Measured: Screening phase (Up to 1 week prior to enrollment)
Retention Rate (Feasibility)
The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.
Measured: Enrollment through six months
Number of Completed Assessments (Feasibility)
The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.
Measured: Enrollment through six months
Care Coordination Fidelity (Feasibility)
We will assess the proportion of intervention components completed, including interventionist completion of screening tools, as well as other tasks outlined in the care plan, including focused education, navigation, and addressing barriers to care, screening.
Measured: Enrollment through six months
Motivational Interviewing (MI) Fidelity (Feasibility)
OnePass is a validated tool used to evaluate MI practice and assess fidelity based on review of a single session, using 23 items to assess MI components.61 This tool yields a global score while also identifying specific areas for additional practice and training. Scores range from 1 - 7 with 5 considered a minimum for competence. Interventionists will complete at least one OnePass within a month of starting MI sessions with participants.
Measured: Enrollment through six months
Secondary outcomes (4)
Change in Autonomy Support
Autonomy support will be measured with the short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.
Measured: Baseline and 3 months
Change in Autonomous Motivation
Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90) with a higher score indicating higher emotion regulation strategy.
Measured: Baseline and 6 months
Count of Preventive Care Visits
This will include postpartum visits, visits for contraceptive management, routine preventive care visits, and visits to follow-up on complications of pregnancy (secondary prevention). Visits will be abstracted from the health record and from interventionist records.
Measured: 6 months
Proportion of Recommended Care Completed
This Outcome Measure reports the average percentage of the recommended care plan completed among participants. Recommended care will be abstracted from a care plan completed within the first two weeks after enrollment. Completed care will be abstracted from the health record and from interventionist records.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start3 Feb 2022
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Why it stopped: This study was terminated once we had collected sufficient information to proceed with the subsequent pilot trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120843
- Sponsor's protocol ID
- 20-017871
- Other IDs
- 1K23HD102560
- Status last verified
- Jan 2026
- First submitted
- 13 Sep 2021
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Testing of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
- ClinicalTrials.gov ID
- NCT05120843
- Acronym / sponsor ID
- 20-017871
- Conditions
- Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, Depression, Weight, Birth
- Keywords
- Preconception care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated once we had collected sufficient information to proceed with the subsequent pilot trial.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.
Detailed description
Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within two weeks of birth. Investigators will assess feasibility, adoption, reach, and fidelity of the intervention and of study data collections strategies. The intervention protocol will be revised to reflect these assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Other | Behavioral: Care coordination and motivational interviewingThis intervention will combine care coordination and motivational interviewing strategies. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Female
- Less than 45 years old
- History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
- Intention to seek pediatric care at one of two pediatric primary care sites
- Medicaid insurance
Key exclusion criteria (3 listed)
- History of sterilization procedure.
- Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
- Limited English proficiency
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 |
|---|---|---|
| Care coordination and motivational interviewingInterventionist will engage participants in care planning, health education, health care navigation, screening for unmet health needs or social needs, and motivational interviewing. The final intervention is expected to be six months in duration. However during this single-arm open testing phase, some participants may receive only key components of the intervention in order to assess feasibility, reach, adoption, and fidelity of those components. | Behavioural | Intervention Arm |
Primary outcome
Screening Rate (Feasibility)
Time frame: Screening phase (Up to 1 week prior to enrollment)
The study team will compare the number of potentially eligible participants to those who are screened for eligibility. The number screened will be defined as the number of people whose are reviewed to approach for enrollment. The number of potentially eligible participants will be considered the number of women with preterm births with Medicaid insurance.
Enrollment Rate (Feasibility)
Time frame: Screening phase (Up to one week prior to enrollment)
The study team will track the proportion of eligible women approached for enrollment who enroll in the study.
Reasons for Non-participation (Acceptability)
Time frame: Screening phase (Up to 1 week prior to enrollment)
For women who decline enrollment we will ask them, if they are willing, to provide reasons for non-participation and potential study modifications that might have encouraged them to participate. Responses will be tabulated and reviewed for potential themes.
Retention Rate (Feasibility)
Time frame: Enrollment through six months
The study team will track the proportion of enrolled participants who complete the intervention and the study assessments.
Number of Completed Assessments (Feasibility)
Time frame: Enrollment through six months
The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed.
Care Coordination Fidelity (Feasibility)
Time frame: Enrollment through six months
We will assess the proportion of intervention components completed, including interventionist completion of screening tools, as well as other tasks outlined in the care plan, including focused education, navigation, and addressing barriers to care, screening.
Motivational Interviewing (MI) Fidelity (Feasibility)
Time frame: Enrollment through six months
OnePass is a validated tool used to evaluate MI practice and assess fidelity based on review of a single session, using 23 items to assess MI components.61 This tool yields a global score while also identifying specific areas for additional practice and training. Scores range from 1 - 7 with 5 considered a minimum for competence. Interventionists will complete at least one OnePass within a month of starting MI sessions with participants.
4 secondary outcomes
Change in Autonomy Support
Time frame: Baseline and 3 months
Change in Autonomous Motivation
Time frame: Baseline and 6 months
Count of Preventive Care Visits
Time frame: 6 months
Proportion of Recommended Care Completed
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care coordination and motivational interviewing in people with Preterm Birth and Health Care Utilization, run by Children's Hospital of Philadelphia 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 5 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: stopped early, as of the sponsor's last update on 27 Jan 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?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Screening Rate (Feasibility) (time frame: Screening phase (Up to 1 week prior to enrollment)). The study lists 7 primary outcomes in all. 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 27 Jan 2026.