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

NCT05395663 | Active Not Recruiting DMC

• 2 other identifiers: NIH # 5R01ES031669R01ES031669
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pollution; Exposure

Keywords

drinking water; arsenic; nitrate; lead; environmental pollution; ground water; home environment; water wells; health promotion; water pollutant; water pollution; water treatment; water purification; chemical water pollution; underground water; water quality; environmental carcinogens; environmental health; environmental exposure; environmental pollutant; toxic environmental substances

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Health literacy

  6 months and 12 months

• Risk perception

  6 months and 12 months

Other Outcomes (7)

• Health history - Blood pressure

  6 months and 12 months

• Health history - Diabetes

  6 months and 12 months

• Health history - Cardiovascular

  6 months and 12 months

Study Arms (2)

Arm 1: Usual practice

ACTIVE COMPARATOR

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

Arm 2: Health navigator

EXPERIMENTAL

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

Interventions

Community health worker BEHAVIORAL

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.

Arm 1: Usual practice; Arm 2: Health navigator

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oregon State University: lead
• Oregon Health Authority: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (1)

• Irvin VL, Kile ML, Lucas-Woodruff C, Cude C, Anderson L, Baylog K, Hovell MF, Choun S, Kaplan RM. An overview of the Be Well Home Health Navigator Program to reduce contaminants in well water: Design and methods. Contemp Clin Trials. 2024 May;140:107497. doi: 10.1016/j.cct.2024.107497. Epub 2024 Mar 11.

  PMID: 38471641 DERIVED

MeSH Terms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Molly Kile, ScD

  Oregon State University

  PRINCIPAL INVESTIGATOR

• Veronica Irvin, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The care providers are the OSU Extension Service agents serving as the navigators in the intervention arm and the Oregon Health Authority as the usual care arm. They will not know participants assigned to the other arms. Biostatistician will evaluate the effectiveness of the intervention without knowing the condition of the participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 27, 2022
• Study Start: June 16, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

US (1)