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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43MD019206-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Two arm study, intervention and control, to explore the impact of an online training program to help community health workers (CHWs) conduct effective outreach to support postpartum mothers, particularly those at higher risk for complications.
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the MOMS Postpartum course and explore the following research question: To what extent does exposure to the MOMS Postpartum course increase CHWs' knowledge, skills, attitudes/beliefs, self-efficacy, and intentions to provide support to postpartum mothers?
MOMS Postpartum course is set in context of imperative need of assisting postpartum mothers in the U.S. and working with CHWs after pregnancy to have better maternal outcomes, particularly among high-risk mothers. Researchers worked with subject matter experts, CHWs, and the intended audience to ensure the MOMS Postpartum course reflects the specific needs of postpartum mothers; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for CHWs to conduct outreach with high-risk postpartum mothers. MOMS Postpartum course will provide an effective, low-cost, evidence-based, professional development curriculum to train CHWs to provide support to postpartum mothers and fill a gap in care.
The Principal Investigator (PI), with input from the subject matter experts and CHWs, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDHRC Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to CHWs via electronic notifications and flyers. Evaluation partners include CHW Association of Rochester, Center for Health Innovation, and other CHW organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, CHWs will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to MOMS Postpartum course and will complete an online posttest survey after completing the online modules. The control group participants will not be exposed to the MOMS Postpartum course and will complete a posttest one week after completing the pretest. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from Alchemer into an encrypted Excel file and import the raw data into STATA. The investigators will match the pretest and posttest responses using the random assigned identifiers and conduct analyses to test for the effect of MOMS Postpartum course exposure on changes in CHWs' knowledge, skills, attitudes/beliefs, perceived self-efficacy, and intentions to conduct outreach to postpartum mothers.
The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to MOMS Postpartum course and increased knowledge among the intervention group in comparison to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment: MOMS Postpartum course | Experimental | Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy. |
|
| Control | No Intervention | Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOMS Postpartum Course | Other | Online professional development training for CHWs on outreach and support for high-risk postpartum mothers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge Pretest Score | Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge. | Pretest (Baseline) |
| Knowledge Posttest Score | Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge. | Posttest (1 week after baseline) |
| Skills Pretest Score | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers | Pretest (Baseline) |
| Skills Posttest Score | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posttest (1 week after baseline) |
| Self-efficacy Pretest Score | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) to measure CHWs' beliefs that they can effectively support postpartum mothers | Pretest (Baseline) |
| Self-efficacy Posttest Score |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction at Posttest | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, to measure CHWs' satisfaction with the course, interactive experiences, and offline resources and measure the extent to which CHWs would recommend the course | Posttest (1 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knowledge Scores From Pretest to Posttest | At both pretest and posttest, we asked all participants the same multiple choice knowledge questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons, which we will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We will average these composite scores across all participants for both groups to create mean scores. We then subtracted pretest scores from posttest scores and will average these changes for all participants. Positive scores mean a gain in knowledge and a higher scores mean higher gains from baseline to posttest. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dexter L Cooper, MPH | KDH Research & Communication | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KDH Research & Communication | Atlanta | Georgia | 30309 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment: MOMS Postpartum Course | Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy. MOMS Postpartum Course: Online professional development training for CHWs on outreach and support for high-risk postpartum mothers |
| FG001 | Control | Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment: MOMS Postpartum Course | Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy. MOMS Postpartum Course: Online professional development training for CHWs on outreach and support for high-risk postpartum mothers |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Knowledge Pretest Score | Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge. | One participant excluded for missing data | Posted | Mean | Standard Deviation | score on a scale | Pretest (Baseline) |
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment: MOMS Postpartum Course | Community health workers (CHWs) in the treatment group will complete the MOMS Postpartum course online training program. They will engage with the training materials, apply learned concepts, and complete pretest and posttest assessments to measure changes in their knowledge, skills, attitudes, intentions and self-efficacy. MOMS Postpartum Course: Online professional development training for CHWs on outreach and support for high-risk postpartum mothers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen D. Holtz, PhD | KDH Research & Communication | 4043958711 | kholtz@kdhrc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2025 | Mar 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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Community health workers will be randomly assigned to either the treatment group, which will complete the MOMS Postpartum course, or the control group, which will not receive the training during the study period. Both groups will complete pretest and posttest assessments.
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Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, to measure CHWs' beliefs that they can effectively support postpartum mothers
| Posttest (1 week after baseline) |
| Attitudes Pretest Score | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers | Pretest (Baseline) |
| Attitudes Posttest Score | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posttest (1 week after baseline) |
| Intentions Pretest Score | Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers | Pretest (Baseline) |
| Intentions Posttest Score | Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posttest (1 week after baseline) |
| From pretest to posttest (1 week) |
| Change in Skills Scores From Pretest to Posttest | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in skills and higher scores mean higher gains from baseline to posttest. | From pretest to posttest (1 week) |
| Change in Self-Efficacy Scores From Pretest to Posttest | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum women. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and average these changes for all participants. Positive scores mean a gain in self-efficacy and higher scores mean higher gains from baseline to posttest. | From pretest to posttest (1 week) |
| Change in Attitudes Scores From Pretest to Posttest | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in attitudes and higher scores mean higher gains from baseline to posttest. | From pretest to posttest (1 week) |
| Change in Intention Scores From Pretest to Posttest | Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers. We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups. We then subtracted pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in intentions and higher scores mean higher gains from baseline to posttest. | From pretest to posttest (1 week) |
| BG001 | Control | Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Years of CHW experience | Mean | Standard Deviation | years |
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| Highest education | Number | participants |
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| Hours of CHW training in the last 12 months | Count of Participants | Participants |
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| CHW certification | Count of Participants | Participants |
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| Volunteer or paid position | Count of Participants | Participants |
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| OG001 | Control | Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. |
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| Primary | Knowledge Posttest Score | Multiple-choice questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons. The score is reported on a scale of 0 to 100, calculated as the percentage of correctly answered questions. Higher scores indicate greater knowledge. | One participant excluded for missing data | Posted | Mean | Standard Deviation | score on a scale | Posttest (1 week after baseline) |
|
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| Primary | Skills Pretest Score | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Pretest (Baseline) |
|
|
|
|
| Primary | Skills Posttest Score | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Posttest (1 week after baseline) |
|
|
|
|
| Primary | Self-efficacy Pretest Score | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) to measure CHWs' beliefs that they can effectively support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Pretest (Baseline) |
|
|
|
|
| Primary | Self-efficacy Posttest Score | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, to measure CHWs' beliefs that they can effectively support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Posttest (1 week after baseline) |
|
|
|
|
| Primary | Attitudes Pretest Score | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Pretest (Baseline) |
|
|
|
|
| Primary | Attitudes Posttest Score | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Posttest (1 week after baseline) |
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| Primary | Intentions Pretest Score | Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Pretest (Baseline) |
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| Primary | Intentions Posttest Score | Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers | Posted | Mean | Standard Deviation | score on a scale | Posttest (1 week after baseline) |
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| Secondary | Satisfaction at Posttest | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, to measure CHWs' satisfaction with the course, interactive experiences, and offline resources and measure the extent to which CHWs would recommend the course | Posted | Mean | Standard Deviation | score on a scale | Posttest (1 weeks after baseline) |
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| Other Pre-specified | Change in Knowledge Scores From Pretest to Posttest | At both pretest and posttest, we asked all participants the same multiple choice knowledge questions on content related to postpartum care, self-care practices, and needs of postpartum mothers based on information from the MOMS Postpartum course lessons, which we will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 meant a participant got zero questions correct while a score of 100 meant a participant got all questions correct. We will average these composite scores across all participants for both groups to create mean scores. We then subtracted pretest scores from posttest scores and will average these changes for all participants. Positive scores mean a gain in knowledge and a higher scores mean higher gains from baseline to posttest. | One participant excluded for missing data | Posted | Mean | Standard Deviation | score on a scale | From pretest to posttest (1 week) |
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| Other Pre-specified | Change in Skills Scores From Pretest to Posttest | Likert scale ranging from 1 (no experience) to 10 (extensive experience), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum mothers. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in skills and higher scores mean higher gains from baseline to posttest. | Posted | Mean | Standard Deviation | score on a scale | From pretest to posttest (1 week) |
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| Other Pre-specified | Change in Self-Efficacy Scores From Pretest to Posttest | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree), with a higher score being a better outcome, on conducting education and outreach to postpartum mothers and how to support postpartum women. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and average these changes for all participants. Positive scores mean a gain in self-efficacy and higher scores mean higher gains from baseline to posttest. | Posted | Mean | Standard Deviation | score on a scale | From pretest to posttest (1 week) |
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| Other Pre-specified | Change in Attitudes Scores From Pretest to Posttest | Likert scale ranging from 1 (strongly disagree) to 10 (strongly agree) on attitudes conducting education and outreach to postpartum mothers and how to support postpartum mothers. We will average ratings from each question to create an average composite rating for each participant, then average these composite scores for both groups. We will then subtract pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in attitudes and higher scores mean higher gains from baseline to posttest. | Posted | Mean | Standard Deviation | score on a scale | From pretest to posttest (1 week) |
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| Other Pre-specified | Change in Intention Scores From Pretest to Posttest | Likert scale ranging from 1 (extremely unlikely) to 10 (extremely likely) on intentions conducting education and outreach to postpartum mothers and how to support postpartum mothers. We averaged ratings from each question to create an average composite rating for each participant, then averaged these composite scores for both groups. We then subtracted pretest scores from posttest scores and averaged these changes for all participants. Positive scores mean a gain in intentions and higher scores mean higher gains from baseline to posttest. | Posted | Mean | Standard Deviation | score on a scale | From pretest to posttest (1 week) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control | Community health workers (CHWs) in the control group will not receive access to the MOMS Postpartum course training during the study period. Their will continue their usual work without the additional training while also completing pretest and posttest assessments to allow for comparison with the treatment group. | 0 | 0 | 0 | 0 | 0 | 0 |
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