Scalability of a Home Health Navigator Program to Reduce Arsenic, Nitrate, and Lead in Private Well Water

Effectiveness and Scalability of a Home Health Navigator Program to Reduce Environmental Hazards

Approximately 34 million Americans rely on private wells to supply their drinking water. Private wells are excluded from the Safe Drinking Water Act. Consequently, people who use private wells have not benefited from pollution prevention activities mandated by this law. This is a public health concern because toxic chemicals such as arsenic, nitrate, and lead are frequently detected in drinking water provided by private wells at concentrations that exceed the Safe Drinking Water Act's maximum contaminant levels. Chronic exposure to toxics in drinking water increase the risk of several chronic diseases. Several states in the U.S. have implemented or are proposing legislative policies to require testing and treatment of private wells and it is critical that public health agencies offer a program to aid homeowners with adherence to these new policies. Subsequently, there is a need to determine if individual-level interventions would be more effective for promoting behaviors that would reduce, mitigate, or eliminate exposure to contaminated well water. Lay health care workers may be able to provide cost-effective counseling to promote environmental health decision making among homeowners that have contaminated wells. This study will involve a community efficacy trial that brings together university-based researchers, State and Local agencies, and Extension Services. The community efficacy trial will be implemented by community health navigators via the Extension service. Specifically, it will involve a randomized controlled trial in Oregon to test the acceptability, fidelity, scalability and efficacy of 2 different intervention arms to reduce harmful toxicant exposures through the adoption of appropriate well water treatment. Upon completion, it will will produce a private well safety intervention program that has been tested and modified through empirical research. By capturing the costs and retaining the most efficacious intervention components, our cooperative approach has a better chance of scalability into practice across multiple stakeholders (i.e. Extension services, state health agencies). This information has the potential to reduce health disparities in rural America that are related to a household's source of drinking water.

Study Overview

• Status: Active, not recruiting
• Conditions: Pollution; Exposure
• Intervention / Treatment: Behavioral: Community health worker

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97331
      • Oregon State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Participants are eligible for the study if they 1) Reside in Oregon; 2) Are a homeowner with a private well; 3) Use a private well as the primary source of drinking water; 4) Currently live in the home with the private well and intend to live in the home for at least 12 months from now; 5) Be at least 21 years old; and 6) Be able to complete a questionnaire in English or Spanish.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Usual practice; People will receive a free well water test kit that is delivered by mail and the results from this water test. They will also be mailed material that is provided by the Oregon Health Authority's Domestic Well Stewardship Program which is the Water Well Owner's Handbook(in English or Spanish) and contaminant guides.	Behavioral: Community health worker; A trained navigator (e.g. OSU Extension staff) will have 3 meetings with the participants in Arm 2. These meetings will be held in person, on the phone, or in zoom.
Experimental: Arm 2: Health navigator; People will receive a free well water test kit that is delivered by mail and the results from this water test. They will also be mailed material that is provided by the Oregon Health Authority's Domestic Well Stewardship Program which is the Water Well Owner's Handbook(in English or Spanish) and contaminant guides. In addition, a trained health navigator will meet with the homeowner three times to assist the homeowner's decision-making. Activities include: i) Interpreting results, ii) Improving health literacy and numeracy through teach-back moments, iii) Assessment of household risk for contaminants from well and septic, iv) Assessment of risk to family members, pets, livestock, etc v) Coaching to resolve ambivalence or lack of motivation and other barriers using elicit-provide-elicit motivational interviewing; vi) Assistance with decision-making and weighing financial options, and vii) Goal-setting and action plans.	Behavioral: Community health worker; A trained navigator (e.g. OSU Extension staff) will have 3 meetings with the participants in Arm 2. These meetings will be held in person, on the phone, or in zoom.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment implemented by homeowner that will reduce their exposure to arsenic, nitrate or lead in their drinking water	The homeowner has adopted behaviors that will be appropriate for reducing their exposure to arsenic, nitrate, and lead in their drinking water. This will be assessed based on the homeowners response on a survey delivered after 12 month. Appropriate treatment will be defined as the use of drinking water technology that removes the contaminant detected (e.g. reverse osmosis, distillation, arsenic removal filter, or removal of lead-based water fixtures) or switching to bottled water for drinking and cooking.	12 months
Clean water sample	A water sample that is collected from their home's kitchen faucet is tested by a certified laboratory and the contaminant of concern (arsenic, nitrate, or lead) is below its maximum contaminant level (arsenic < 10ug/L; nitrate <10mg/L, and lead <15 ug/L)	12 months
Well Stewardship Behaviors	This will be assessed based on questions in the homeowner survey which asks the participants what actions they take to test, treat, and maintain the water quality that is coming from their private well.	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	Water Environmental Literacy Level Scale - WELLS is a 6-item scale. The reference for this is: Irvin, V. L., Rohlman, D., Vaughan, A., Amantia, R., Berlin, C., & Kile, M. L. (2019). Development and Validation of an Environmental Health Literacy Assessment Screening Tool for Domestic Well Owners: The Water Environmental Literacy Level Scale (WELLS). International journal of environmental research and public health, 16(5), 881. doi:10.3390/ijerph16050881; Brief Health Literacy Screener (Chew Items) is a 3-item scale. The reference for this: Chew, L.D., Bradley, K.A., & Boyko, E.J. (2004). Brief questions to identify patients with inadequate health literacy. Family Medicine, 36(8): 588-594.	6 months and 12 months
Risk perception	This will be assessed our homeowner survey which includes a condensed form of the RANAS (Risk, Attitude, Norms, Ability, Self-Regulation) Scales published in Flannigan et al (2015) Dissemination of well water arsenic results to homeowners in Central Maine: influences on mitigation behavior and continued risks for exposure. Sci Total Environ, 505: 1282-90.	6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health history - Blood pressure	National Health and Nutrition Examination Survey (NHANES) questionnaires for Blood Pressure	6 months and 12 months
Health history - Diabetes	National Health and Nutrition Examination Survey (NHANES) questionnaires for Diabetes	6 months and 12 months
Health history - Cardiovascular	National Health and Nutrition Examination Survey (NHANES) questionnaires for cardiovascular	6 months and 12 months
Health history - Cancer	National Health and Nutrition Examination Survey (NHANES) questionnaires for cancer	6 months and 12 months
Health history - Reproductive Health	National Health and Nutrition Examination Survey (NHANES) questionnaires for reproductive health	6 months and 12 months
Health history - Anemia	National Health and Nutrition Examination Survey (NHANES) questionnaires for anemia	6 months and 12 months
Patient-Reported Quality of life	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale to assess health symptoms (pain, fatigue, mental health, physical health, social health and overall health	6 months and 12 months

Collaborators and Investigators

• Sponsor: Oregon State University
• Collaborators: National Institute of Environmental Health Sciences (NIEHS); Oregon Health Authority
• Investigators: Principal Investigator: Molly Kile, ScD, Oregon State University; Principal Investigator: Veronica Irvin, PhD, Oregon State University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: lead; health promotion; water treatment; drinking water; home environment; nitrate; environmental health; arsenic; environmental pollution; ground water; water wells; water pollutant; water pollution; water purification; chemical water pollution; underground water; water quality; environmental carcinogens; environmental exposure; environmental pollutant; toxic environmental substances
• Other Study ID Numbers: NIH # 5R01ES031669; R01ES031669 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No