- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00865553
Computer-Assisted Stop-Smoking Program in Helping Doctors Counsel Patients Who Smoke Cigarettes
Clinical Testing of a Decision Support System for Tobacco Use Treatment
RATIONALE: A computer-assisted stop-smoking program may help doctors counsel patients who smoke and may help increase the number of patients who stop smoking.
PURPOSE: This phase II trial is studying how well a computer-assisted stop-smoking program works in helping doctors counsel patients who smoke cigarettes.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
OBJECTIVES:
- Test the hypothesis that the clinical decision support system will improve the rate at which physicians assist their patients with smoking cessation by providing information and recommendations on smoking cessation resources.
- Assess whether exposure to information and recommendations facilitated by the smoking cessation-personal digital assistant (SC-PDA) will increase the rate at which patients make at least 1 attempt to quit smoking in the month following the physician visit.
- Assess whether exposure to information and recommendations facilitated by the SC-PDA will increase the reported use of counseling and pharmacotherapy during those attempts over that observed with a smoking status identification system alone.
- Evaluate the acceptance of the SC-PDA into the workflow of ambulatory care clinics.
OUTLINE: In weeks 1-12, physicians have access to a smoking status identification system (SSID) that reminds the physician the smoking status of the patient they are evaluating. In weeks 6-12, physicians have access to a computerized smoking cessation clinical decision support system using a hand-held personal digital assistant (SC-PDA) that they can use in the exam room with their patients who smoke. The SC-PDA system assists physicians in recommending and prescribing approved pharmacotherapy; facilitates referral of patients to local counseling resources; prints a tailored handout for a patient listing specific recommendations, instructions, and cessation resources; and generates the necessary documentation to support billing for this intervention.
Patients who visit their physician in weeks 2-6 or weeks 8-12 complete a survey after their clinic visit and undergo a telephone interview 1 month later. Physicians undergo interviews and focus groups are conducted with clinic staff in weeks 12-16.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Vermont
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Burlington, Vermont, Forenede Stater, 05405-0110
- Rekruttering
- Vermont Cancer Center at University of Vermont
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Kontakt:
- Clinical Trials Office - Vermont Cancer Center at University o
- Telefonnummer: 802-656-2178
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Current smoker, defined as self-reported smoking most days or every day (patient)
- Seeks care at a participating Fletcher Allen Health Care primary care clinic (patient)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Physician adherence to the United States Public Health Service's Tobacco Use and Dependence Treatment guideline (USPHS Guideline) as measured by the patient exit survey
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Patient perception of physician as measured by the patient exit survey and telephone interview
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Prevalence of smoking and associated variables as measured by the patient exit survey
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Patient interaction with the smoking cessation-personal digital assistant (SC-PDA) as measured by the patient exit survey and telephone interview
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Patient report of physician SC-PDA use as measured by the patient exit survey and telephone interview
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Aggregate data on accessing SC-PDA screens by each physician as measured by the SC-PDA server log
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Generation of patient handouts as measured by the SC-PDA server log, clinic staff focus groups, and telephone interview
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Physician self-reported use of SC-PDA as measured by physician interview
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Physician opinion on perceived value and barriers to use as measured by physician interview
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Clinic staff opinion on the effect of SC-PDA on clinic workflow as measured by clinic staff focus groups
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Theodore W. Marcy, MD, MPH, University of Vermont
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000629824
- VCC-08186
- IRB#00000486
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