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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54MD000538 | 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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This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, > 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health systems-level intervention | Active Comparator | using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; |
|
| CHW-led patient navigation program | Active Comparator | a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test-and-treat EHR-CHW intervention | Other | a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Eradication of H. Pylori (ITT) | Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. Includes positive results for those with self-reported or missing results. | Up to Month 3-Post Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Eradication of H. Pylori (Clinically Confirmed) | Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. | Up to Month 3-Post Treatment |
| Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simona Kwon, DrPH,MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Systems-level Intervention | using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; Test-and-treat EHR-CHW intervention: a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies |
| FG001 | CHW-led Patient Navigation Program | a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability Usual care of EHR-only intervention: a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Systems-level Intervention | using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; Test-and-treat EHR-CHW intervention: a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants With Eradication of H. Pylori (ITT) | Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. Includes positive results for those with self-reported or missing results. | Posted | Count of Participants | Participants | Up to Month 3-Post Treatment |
|
6 Months
Systematic assessment through standard questionnaire
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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 | Health Systems-level Intervention | using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; Test-and-treat EHR-CHW intervention: a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yi-Ling Tan | NYU Langone Health | 646-501-3489 | yi-ling.tan@nyulangone.org |
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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 | May 9, 2023 | Jun 7, 2024 | Prot_SAP_000.pdf |
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| Usual care of EHR-only intervention | Other | a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. |
|
Participants completed the Ottawa Decision Self-Efficacy Scale, which assessed participants' confidence in making an informed choice, at baseline and 6-month follow-up. The scale consists of 11 questions on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The raw score is the sum of responses. The raw score is converted to a standardized total score that ranges from 0 to 100; higher total scores indicate greater decision self-efficacy. |
| Baseline, Month 6 |
| Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6 | Participants completed the MARS-5 self-assessment of medication adherence at baseline and 6-month follow-up. One item assessed unintentional non-adherence, while four items assessed intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Adherence is defined as a score of 25. | Baseline, Month 6 |
| Change in Stomach Cancer Knowledge Between Baseline and 6-months | Participants were asked about associations with the risk of getting stomach cancer (alcohol, spicy food, stress, family history, h. pylori infection, smoking, salty food, being physically inactive, pickled food, food high in sugar). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-10, 10=highest knowledge) | Baseline, Month 6 |
| Change in H. Pylori Knowledge Between Baseline and 6-months | Participants were asked about associations with h. pylori (blood, untreated/contaminated water, rats, mosquitoes, contaminated food, vomit, poor sanitation). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-7, 7=highest knowledge) | Baseline, Month 6 |
| Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months | Participants completed the PROMIS Global Physical Health Scale, which assessed participants' physical health, at baseline and 6-month follow-up. Four questions assessed global physical health. Three questions were administered using five-category response scales, and one item used a response scale of 0-10 that was recoded to five categories. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured. | Baseline, Month 6 |
| Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months | Participants completed the PROMIS Global Mental Health Scale, which assessed participants' mental health, at baseline and 6-month follow-up. Four questions assessed global mental health, and all were administered using five-category response scales. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured. | Baseline, Month 6 |
| CHW-led Patient Navigation Program |
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability Usual care of EHR-only intervention: a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability
Usual care of EHR-only intervention: a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.
|
|
| Secondary | Number of Participants With Eradication of H. Pylori (Clinically Confirmed) | Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. | Posted | Count of Participants | Participants | Up to Month 3-Post Treatment |
|
|
|
| Secondary | Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months | Participants completed the Ottawa Decision Self-Efficacy Scale, which assessed participants' confidence in making an informed choice, at baseline and 6-month follow-up. The scale consists of 11 questions on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The raw score is the sum of responses. The raw score is converted to a standardized total score that ranges from 0 to 100; higher total scores indicate greater decision self-efficacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
|
|
|
| Secondary | Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6 | Participants completed the MARS-5 self-assessment of medication adherence at baseline and 6-month follow-up. One item assessed unintentional non-adherence, while four items assessed intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Adherence is defined as a score of 25. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
|
|
|
| Secondary | Change in Stomach Cancer Knowledge Between Baseline and 6-months | Participants were asked about associations with the risk of getting stomach cancer (alcohol, spicy food, stress, family history, h. pylori infection, smoking, salty food, being physically inactive, pickled food, food high in sugar). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-10, 10=highest knowledge) | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
|
|
|
| Secondary | Change in H. Pylori Knowledge Between Baseline and 6-months | Participants were asked about associations with h. pylori (blood, untreated/contaminated water, rats, mosquitoes, contaminated food, vomit, poor sanitation). True or false was chosen. Variables were recoded to correct (1) and incorrect (0), and summed for a final score (0-7, 7=highest knowledge) | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 6 |
|
|
|
| Secondary | Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months | Participants completed the PROMIS Global Physical Health Scale, which assessed participants' physical health, at baseline and 6-month follow-up. Four questions assessed global physical health. Three questions were administered using five-category response scales, and one item used a response scale of 0-10 that was recoded to five categories. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured. | Posted | Mean | Standard Deviation | T-score | Baseline, Month 6 |
|
|
|
| Secondary | Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months | Participants completed the PROMIS Global Mental Health Scale, which assessed participants' mental health, at baseline and 6-month follow-up. Four questions assessed global mental health, and all were administered using five-category response scales. Responses are recoded into t-scores, which rescales the raw sum score into a standardized score from 0-100, with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the concept being measured. | Posted | Mean | Standard Deviation | T-score | Baseline, Month 6 |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | CHW-led Patient Navigation Program | a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability Usual care of EHR-only intervention: a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. | 0 | 68 | 0 | 68 | 0 | 68 |
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