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

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ClinicalTrials.gov Identifier: NCT01678118
Recruitment Status : Active, not recruiting
First Posted : September 3, 2012
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
Sophie Davis School of Biomedical Education at The City College of New York
NYU Langone Health
Ralph Lauren Center for Cancer Care and Prevention
Heritage Health Center, New York
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Minority Smokers Behavioral: Patient Navigator

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care
Actual Study Start Date : April 2011
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. patient navigation (TPN) feasibility [ Time Frame: 1 year ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678118


Locations
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United States, New York
Heritage Health Center
New York, New York, United States, 10031
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Sophie Davis School of Biomedical Education at The City College of New York
NYU Langone Health
Ralph Lauren Center for Cancer Care and Prevention
Heritage Health Center, New York
Investigators
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Principal Investigator: Jamie Ostroff, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01678118    
Other Study ID Numbers: 11-028
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Patient Navigation
Tobacco dependent
smoking
Cessation
11-028