Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care

Patient navigators have been shown to assist people seeking cancer screening and other medical services. The purpose of this study is to see whether a patient navigator can link smokers to available community resources shown to help smokers quit smoking.

Study Overview

• Status: Completed
• Conditions: Minority Smokers
• Intervention / Treatment: Behavioral: Patient Navigator

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States
      • Ralph Lauren Center for Cancer Care and Prevention
    • New York, New York, United States, 10031
      • Heritage Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will also be recruited from Heritage Health Center, located at 1727 Amsterdam Ave, which serves a large proportion to low income, minority patients in Harlem, New York. Also, from the Ralph Lauren Center for Cancer Care and Cancer Prevention (RLCCCP), a community based Center for the prevention, diagnosis, and treatment of cancer located at 1919 Madison Avenue.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Self-reported current daily smoker, as verified with a portable alveolar carbon monoxide (CO) analyzer (24 hour point prevalence); CO levels ≥ 8 ppm.
• English and/or Spanish-speaking
• Referred to the navigation program by their primary care clinician
• At baseline, participants report at least thinking about quitting (i.e., Contemplation or Preparation stages of readiness to quit).

Exclusion Criteria:

• Serious, untreated psychiatric illness (e.g., schizophrenia,) or active substance abuse likely to preclude adherence to the protocol

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

minority smokers; A single arm ABA design will be used to pilot a tobacco-focused patient navigation (TPN) intervention for low income, minority smokers.

Behavioral: Patient Navigator; The pt navigator will phone (email, text, or other preferred method of contact) pts prior to the date of previously set individual goals (e.g. going to an appt, getting their cessation medications filled, etc) as a reminder & to discuss barriers such as finances, transportation or ambivalent motivation. In this manner, pts receive navigation services tailored to their individual needs & barriers. Once pts are connected with a cessation service (defined as either using cessation medication or at least 1 contact with a Quitline or community-based cessation counselor)or provider-prescribed cessation medication usage, continues the navigation intervention will be considered complete. W/I the 3 month engagement period, pts will receive up to 6 contacts from the Pt Navigator following referral from primary care provider. Consistent with recommended pt navigation practice, the navigator will provide feedback to primary care provider regarding cessation services that the pts are receiving.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient navigation (TPN) feasibility	To evaluate the study's potential in terms of its reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of the intervention, tobacco-dependent patients will be asked to complete an intake interview and a telephone follow-up interview (at 3 to 6 months post-intervention).	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: NYU Langone Health; Ralph Lauren Center for Cancer Care and Prevention; Sophie Davis School of Biomedical Education at The City College of New York; Heritage Health Center, New York

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2011
• Primary Completion (Actual): July 20, 2021
• Study Completion (Actual): July 20, 2021

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Patient Navigation; smoking; Cessation; Tobacco dependent; 11-028
• Other Study ID Numbers: 11-028 (ROCTR)