Patient-Centered Cancer Prevention In Chinese Americans

Not Applicable

Completed

Conditions: H. Pylori Infection

Interventions: Other: Test-and-treat EHR-CHW intervention
Other: Usual care of EHR-only intervention

Registration Number: NCT03340454

Lead Sponsor: NYU Langone Health

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 135

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health systems-level intervention	Test-and-treat EHR-CHW intervention	using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;
CHW-led patient navigation program	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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)
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 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.