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

This study is currently recruiting participants.
Verified April 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
Sophie Davis School of Biomedical Education at The City College of New York
New York University School of Medicine
Ralph Lauren Center for Cancer Care and Prevention
Heritage Health Center, New York
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01678118
First received: August 30, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes

August 30, 2012
April 10, 2013
April 2011
April 2016   (final data collection date for primary outcome measure)
patient navigation (TPN) feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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).
patient navigation (TPN) feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 months post-intervention).
Complete list of historical versions of study NCT01678118 on ClinicalTrials.gov Archive Site
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Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care
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.
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Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

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.
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.
minority smokers
A single arm ABA design will be used to pilot a tobacco-focused patient navigation (TPN) intervention for low income, minority smokers.
Intervention: Behavioral: Patient Navigator
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jamie Ostroff, PhD 646-888-0041
Contact: Jack Burkhalter, PhD 646-888-0040
United States
 
NCT01678118
11-028
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • Sophie Davis School of Biomedical Education at The City College of New York
  • New York University School of Medicine
  • Ralph Lauren Center for Cancer Care and Prevention
  • Heritage Health Center, New York
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP