Asthma and Pest Control Study: Demonstrating Return-on-Investment for In-Home Pest Control for Children With Persistent Asthma

NCT02700542 | Completed DMC

• 1 other identifier: 13-097
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 2

Brief Summary

The New York City Department of Health and Mental Hygiene and Montefiore Medical Center, with the Fund for Public Health of New York (FPHNY), DOHMH's fiscal agent, are partnering on a study to evaluate the feasibility, health outcomes and return-on-investment of a single, integrated pest management (IPM) intervention for Bronx, Harlem, and Northern Manhattan children aged 5 to 12 with persistent asthma who are living in homes with pests. By demonstrating cost effectiveness, this study could provide the basis for health insurance coverage of an IPM visit embedded in clinical treatment plans for high-risk asthma patients living with pests. Asthma is the most common childhood disease in New York City, and both prevalence and hospitalization rates are highest in high-poverty neighborhoods. The greatest individual and community-level factor associated with asthma disparities is varying exposure to triggers in the home, most notably cockroaches and mice. Asthma health care costs are significant, and prevention efforts to reduce triggers could result in improved outcomes and significant cost savings. Unlike traditional pest control, which relies on pesticides, IPM eliminates pests and prevents re-infestation by addressing housing conditions conducive to pests and with safe, targeted use of pesticides. This project targets low-income children with the potential to significantly improve their health and well-being. A total of 400 families - 400+ children which includes screened and recruited siblings - will be recruited on to the study. The study is designed to evaluate an inexpensive and scalable environmental intervention for asthma that can be replicated in other New York City neighborhoods and incorporated into any urban healthcare setting in New York State and nationwide.

Conditions

Asthma

Keywords

asthma; pest management

Outcome Measures

Primary Outcomes (18)

• Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 6 months

  Baseline to 6-months

• Change from baseline in costs of urgent care (unscheduled ambulatory) visits at 6 months

  Baseline to 6-Months

• Change from 6-months in counts of urgent care (unscheduled ambulatory) visits at 12 months

  6 months and 12 months

• Change from 6-months in costs of urgent care (unscheduled ambulatory) visits at 12 months

  6 months and 12 months

• Change from baseline in counts of urgent care (unscheduled ambulatory) visits at 12 months

  Baseline and 12 months

• Change from baseline in costs urgent care (unscheduled ambulatory) visits at 12 months

  Baseline and 12 months

• Change from baseline in counts of Emergency Department visits at 6 months

  Baseline to 6 months

• Change from baseline in costs of Emergency Department visits at 6 months

  Baseline to 6 months

• Change from 6-months in counts of Emergency Department visits at 12 months

  6 month to 12 month

• Change from 6-months in costs of Emergency Department visits at 12 months

  6 month to 12 month

• Change from baseline in counts of Emergency Department visits at 12 months

  Baseline to 12 months

• Change from baseline in costs of Emergency Department visits at 12 months

  Baseline to 12 months

• Change from baseline in counts of hospitalizations at 6 months

  Baseline to 6 months

• Change from baseline in costs of hospitalizations at 6 months

  Baseline to 6 months

• Change from 6 months in counts of hospitalizations at 12 months

  6 months to 12 months

• Change from 6 months in costs of hospitalizations at 12 months

  6 months to 12 months

• Change from baseline in counts of hospitalizations at 12 months

  Baseline to 12 months

• Change from baseline in costs of hospitalizations at 12 months

  Baseline to 12 months

Secondary Outcomes (9)

• Change from baseline in number of symptom days per 2-weeks (Participant Reported Outcome) at 6 months

  Baseline to 6 months

• Change from 6 months in number of symptom days per 2-weeks (participant Reported Outcome) at 12 months

  6 months to 12 months

• Change from baseline in number of symptom days per 2-weeks (participant reported outcome) at 12 months

  Baseline to 12 months

• Change from Baseline in the Number of Days Child Missed School (Participant Reported Outcome) at 6 months

  Baseline to 6 months

• Change from 6 Months in the Number of Days Child Missed School (Participant Reported Outcome) at 12 months

  6 months to 12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants randomly assigned to the intervention group will receive the Integrated Pest Management (IPM) treatment 2-4 weeks of completion of the baseline assessment.The IPM protocol for this research will focus on pest control in the bathrooms and kitchen and will include an assessment of the pest problem, thorough cleaning, patching of small holes, identification and referral of any necessary large repairs, and targeted application of safe pesticides as needed. In cases of severe infestation, a second treatment visit might be required in the home. In addition to the intervention, the family will be provided with basic information about good pest-control practices, such as appropriate food storage, and be given a set of food storage containers.

Other: Integrated Pest Management

Control

PLACEBO COMPARATOR

Participants randomly assigned to the control group will be offered the equivalent intervention, information, and food storage containers after completion of their 12-month assessment.

Other: Integrated Pest Management

Interventions

Integrated Pest Management OTHER

One-time, in-home, pest intervention for children with persistent asthma living in homes with parent-reported cockroach and/or mouse infestation.

Control; Intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Current residence in the Bronx, Harlem and Northern Manhattan with no plans to move within the recruitment period (3 months) outside the Bronx, Harlem or Northern Manhattan
• a. Families with plans to move within the recruitment period to another location in the Bronx, Harlem, or Northern Manhattan will be placed on list to be called at the end of the recruitment period to reassess eligibility at that time, if the sample size has not yet been achieved.
• Age: 5-12 years
• Persistent asthma or currently prescribed inhaled corticosteroids/other prevention medication
• Persistent asthma (including mild, moderate or severe), according to National Heart Lung and Blood Institute (NHLBI) criteria:
• i. Experiencing symptoms more than 2 days per week in past month ii. Awaking at night due to symptoms more than 2 times per month iii. Use of SABA meds (i.e., albuterol) for symptom control (not prevention) more than 2 days per week in past month iv. Any interference with daily activity v. Having exacerbations requiring oral systemic corticosteroids 2 or more time per year
• Any past-year urgent care visits for asthma:
• ED visits
• Hospitalizations
• Parent-reported pest infestation - cockroaches or mice - in the home
• Have a working phone
• Caregiver primary language of English or Spanish

You may not qualify if:

• Child living in foster care
• Current residence in shelter or other similar temporary accommodation in the Bronx, Harlem, or Northern Manhattan

Sponsors & Collaborators

• New York City Department of Health and Mental Hygiene: lead
• Montefiore Medical Center: collaborator
• Healthfirst: collaborator
• Affinity Health Plan: collaborator

Study Sites (2)

New York City Department of Health and Mental Hygiene

New York, New York, 10013, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Daniel Kass, MSPH

  NYC Department of Health and Mental Hygiene

  PRINCIPAL INVESTIGATOR

• Marina Reznik, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: March 7, 2016
• Study Start: May 21, 2014
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 17, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)