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Grant Number: R03 HS13042
RFA/PA: PAR01-040 - Small Research Grant Program (replace 96-028/ addendum)
PI Name: BOROFF, ERIKA
Project Title: Tailored Nicotine Replacement Therapy for Outpatients
Abstract:
TITLE: TAILORED NICOTINE REPLACEMENT THERAPY FOR OUTPATIENTS
This project will test the feasibility of a physician and nurse run smoking cessation program which uses trans-dermal nicotine replacement therapy tailored to match pre-cessation serum cotinine levels. Findings from the proposed pilot study will provide essential information for submission of an RO1 proposal for a randomized clinical trial. The specific aims of the proposed pilot are to obtain estimates of die: 1) accessibility and availability of subjects in a general internal medicine practice; 2) refusal rates and selection issues; 3) ease of adjusting patch doses based on a protocol; 4) ease of administration of counseling sessions and questionnaires; 5) side effect profile of medications; 6) rates of adherence; 7) relationship between percent nicotine repletion and cessation rates; 8) identify all variables to be included in a proposal for a randomized controlled trial; 9) develop a database management system. Methodology: 1. Study Design - A 6-month, prospective, double blinded and randomized pilot study. 2. Subject Recruitment - 30 adults (15 intervention; 15 usual care) followed by internists at the Cleveland Clinic Foundation, who are currently smoking more than 15 cigarettes per day over the past 6 months, who respond to an advertisement, will be screened for readiness to change per the Transtheoretical model of Prochaska and DiClemente. Patients in the preparation phase will be invited to a screening visit for a physical exam, ECG and exhaled CO (carbon monoxide) level. 3. Intervention - Patients in the intervention group will have nicotine patch doses adjusted based on serum cotinine levels, whereas usual care patients will receive patch doses based on a standard protocol, regardless of cotinine levels. All patients will receive person-to -person counseling and telephone support by a nurse. 4. Outcomes Measurements-1) accessibility and availability of subjects in a general internal medicine practice; 2) refusal rates and selection issues; 3) ease of adjusting patch doses based on a protocol; 4) ease of administration of counseling sessions and questionnaires; 5) side effect profile of medications; 6) rates of adherence; 7) relationship between percent nicotine repletion and cessation rates (which will be confirmed by serum cotinine and exhaled CO). In addition, questionnaires will be used to assess quality of life and incidence of depressive symptoms at study's beginning and end. Significance: Tobacco use has been implicated as the leading avoidable cause of morbidity and mortality in the Unites States. In addition to deleterious effects on the individual's health, smoking incurs large societal costs as well. This pilot study will provide invaluable information on the feasibility of implementing a physician and nurse run smoking cessation intervention, applicable to general internal medicine practices, tailoring nicotine replacement therapy to varying levels of nicotine dependence.
Fiscal Year: 2002
Department: HARVARD PILGRIM HEALTH CARE, INC.
Project Start: 09/30/2002
Project End: 09/29/2004
IRG: HQER
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