H. Pylori Infection
Conditions
Keywords
H. pylori, H. pylori infection
Brief summary
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.
Interventions
OTHERTest-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
OTHERUsual 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* self identifies as Chinese American * is an outpatient aged 21 years and older (adult) * plans to continue to live in the region during the next 12 months; * is willing to be randomized to either treatment or control groups * has a confirmed diagnosis of H. pylori infection by at least one of the following methods: C-urea breath test, histology, rapid urease test or bacterial culture, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test.
Exclusion criteria
* advanced chronic disease that would not allow the patient to complete follow-up or attend visits; * allergy to any of the study drugs; * pregnancy or currently breastfeeding * taking antibiotics or bismuth salts within 2 weeks before the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Eradication of H. Pylori (ITT) | Up to Month 3-Post Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months | Baseline, Month 6 | 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. |
| Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6 | Baseline, 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. |
| Change in Stomach Cancer Knowledge Between Baseline and 6-months | Baseline, Month 6 | 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) |
| Number of Participants With Eradication of H. Pylori (Clinically Confirmed) | Up to Month 3-Post Treatment | Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR. |
| Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months | Baseline, Month 6 | 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. |
| Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months | Baseline, Month 6 | 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. |
| Change in H. Pylori Knowledge Between Baseline and 6-months | Baseline, Month 6 | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 67 |
| 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. | 64 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 4 |
Baseline characteristics
| Characteristic | Health Systems-level Intervention | Total | CHW-led Patient Navigation Program |
|---|---|---|---|
| Age, Continuous | 44 years | 43.5 years | 42 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 131 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 67 Participants | 131 Participants | 64 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 67 participants | 131 participants | 64 participants |
| Sex: Female, Male Female | 36 Participants | 70 Participants | 34 Participants |
| Sex: Female, Male Male | 31 Participants | 61 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 68 |
| other Total, other adverse events | 0 / 67 | 0 / 68 |
| serious Total, serious adverse events | 0 / 67 | 0 / 68 |
Outcome results
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.
Time frame: Up to Month 3-Post Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Systems-level Intervention | Number of Participants With Eradication of H. Pylori (ITT) | 49 Participants |
| CHW-led Patient Navigation Program | Number of Participants With Eradication of H. Pylori (ITT) | 54 Participants |
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)
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-level Intervention | Change in H. Pylori Knowledge Between Baseline and 6-months | 1.03 score on a scale | Standard Deviation 2 |
| CHW-led Patient Navigation Program | Change in H. Pylori Knowledge Between Baseline and 6-months | 2.56 score on a scale | Standard Deviation 2.5 |
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.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-level Intervention | Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6 | 0.58 score on a scale | Standard Deviation 2.69 |
| CHW-led Patient Navigation Program | Change in Medication Adherence Report Scale (MARS-5) Score From Baseline to Month 6 | 0.77 score on a scale | Standard Deviation 2.95 |
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.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-level Intervention | Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months | 5 score on a scale | Standard Deviation 13.59 |
| CHW-led Patient Navigation Program | Change in Ottawa Decision Self-Efficacy Scale Score From Baseline to 6 Months | 5.7 score on a scale | Standard Deviation 11.77 |
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.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-level Intervention | Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months | 0.69 T-score | Standard Deviation 6.84 |
| CHW-led Patient Navigation Program | Change in PROMIS Global Mental Health T-Score Between Baseline and 6-months | 3.13 T-score | Standard Deviation 6.07 |
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.
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-level Intervention | Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months | -1.1 T-score | Standard Deviation 2.71 |
| CHW-led Patient Navigation Program | Change in PROMIS Global Physical Health T-Score Between Baseline and 6-months | 1.27 T-score | Standard Deviation 8.27 |
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)
Time frame: Baseline, Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Systems-level Intervention | Change in Stomach Cancer Knowledge Between Baseline and 6-months | 1.58 score on a scale | Standard Deviation 2.25 |
| CHW-led Patient Navigation Program | Change in Stomach Cancer Knowledge Between Baseline and 6-months | 3.25 score on a scale | Standard Deviation 2.9 |
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.
Time frame: Up to Month 3-Post Treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Health Systems-level Intervention | Number of Participants With Eradication of H. Pylori (Clinically Confirmed) | 49 Participants |
| CHW-led Patient Navigation Program | Number of Participants With Eradication of H. Pylori (Clinically Confirmed) | 54 Participants |