Contraceptive Usage, Depression, Health Care Utilization, Preterm Birth, Tobacco Use, Weight, Birth
Conditions
Keywords
Preconception care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing
Brief 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.
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.
Interventions
BEHAVIORALCare coordination and motivational interviewing
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.
Sponsors
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female 2. Less than 45 years old 3. 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) 4. Intention to seek pediatric care at one of two pediatric primary care sites 5. Medicaid insurance
Exclusion criteria
1. History of sterilization procedure. 2. Plan to move away from the area or transfer pediatric primary care within six months of enrollment. 3. Limited English proficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening Rate (Feasibility) | 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) | 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) | 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) | 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) | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Autonomy Support | Baseline and 3 months | 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. |
| Change in Autonomous Motivation | Baseline and 6 months | 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. |
| Count of Preventive Care Visits | 6 months | 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. |
| Proportion of Recommended Care Completed | 6 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
We have included a Table for the screening and enrollment phase of the study because a major goal of the study was to assess feasibility of screening and enrollment procedures, as well as reasons for non-participation. This table, and the numbers included in this table, support calculation of Outcomes 1 - 3. In addition they provide important information about feasibility that are relevant to other research in this area.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 29.4 years STANDARD_DEVIATION 5.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gestational age at delivery | 33.2 weeks STANDARD_DEVIATION 3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
None listed