| Primary | 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. | See Participant Flow Section. The screening rate was 100% in that we were able to review all potentially eligible participants as defined here. | Posted | | Count of Participants | | Participants | | Screening phase (Up to 1 week prior to enrollment) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Primary | Enrollment Rate (Feasibility) | The study team will track the proportion of eligible women approached for enrollment who enroll in the study. | 22 patients were confirmed eligible of which 13 were consented. | Posted | | Count of Participants | | Participants | | Screening phase (Up to one week prior to enrollment) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Primary | 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. | See also Participant Flow Section | Posted | | Number | | people | | Screening phase (Up to 1 week prior to enrollment) | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. | | OG001 | People Who Declined Participation | This outcome involves people who declined to participate in this study |
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| Primary | Retention Rate (Feasibility) | The study team will track the proportion of enrolled participants who complete the intervention and the study assessments. | We counted the participants who completed all study data assessments. | Posted | | Count of Participants | | Participants | | Enrollment through six months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Primary | Number of Completed Assessments (Feasibility) | The study team will track the proportion of the baseline, 3-month, and 6-month assessments that are completed. | | Posted | | Number | | Completed assessments | | Enrollment through six months | Possible assessments | Possible assessments | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Primary | 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. | Though this was a pre-specified outcome, it was not properly defined prior to starting the pilot. Because this pilot approached intervention testing by delivering different components of the intervention to different individuals, we were unable to clarify the denominator for this measure. Data was not collected for this outcome measure due to a change in intervention delivery. Data for this outcome will not be collected or reported in the future. | Posted | | | | | | Enrollment through six months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Primary | 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. | Data for this outcome measure was not collected. Motivational interviewing was planned to be recorded using the OnePass validated tool. This was a feasibility outcome measure which has since been determined to be not feasible because of unanticipated difficulty identifying appropriate conversations to record for analysis. The overall study status has been updated to 'Terminated' to reflect this absence of data. Data will not be collected or reported in the future. | Posted | | | | | | Enrollment through six months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Error | units on a scale | | Baseline and 3 months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Secondary | 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. | 7 participants provided complete data on this measure. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | visits | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | percentage | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Arm | This intervention will combine care coordination and motivational interviewing strategies. Care 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. |
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