- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Vermont
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Burlington, Vermont, Vereinigte Staaten, 05405-0110
- Rekrutierung
- 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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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
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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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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Theodore W. Marcy, MD, MPH, University of Vermont
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CDR0000629824
- VCC-08186
- IRB#00000486
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