- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00816036
Improving the Delivery of Smoking Cessation Guidelines in Hospitalized Veterans
6 april 2015 uppdaterad av: US Department of Veterans Affairs
The primary objective of this study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers.
If proven effective, the proposed intervention will provide a practical strategy to enhance the adoption and implementation of recommended smoking cessation procedures in VA hospitals, and will demonstrate the utility of quitlines in preventing relapse in hospitalized smokers once they leave the hospital.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Although the majority of hospitalized VA smokers receive some form of cessation counseling during hospitalization, few receive outpatient cessation counseling and/or pharmacotherapy following discharge, which are key factors associated with long-term cessation.
The primary objective of this research study is to determine whether a nurse-initiated intervention, which couples brief inpatient counseling and proactive telephone counseling by a centralized tobacco quitline, improves 6-month cessation rates in hospitalized VA smokers.
Co-primary aims are to determine whether the intervention improves the prescription of recommended pharmacotherapy for smoking cessation and the referral of patients for telephone counseling (or other outpatient cessation counseling).
We will perform a quasi-experimental before-after trial in hospitalized patients, aged 18 or older, who smoke at least one cigarette per day on average.
After a 6-month baseline period, we will implement the intervention and enroll a separate cohort of patients over the subsequent 6 months.
The intervention will include: 1) nurse training in delivery of bedside cessation counseling, 2) use of CPRS-based practice tools (to streamline nursing assessment and documentation, to facilitate prescription of pharmacotherapy), 3) computerized referral of motivated inpatients for proactive telephone counseling, and 4) use of nursing peer leaders to provide coaching and performance feedback to ward nurses.
Enrolled patients will be contacted by telephone at 3 and 6 months to assess 7-day point prevalence abstinence and prolonged abstinence (with biochemical confirmation of self-reported quitters at 6 months).
We will identify barriers and facilitators to implementation by using clinician focus groups, and will assess attitudes of staff nurses toward cessation counseling by questionnaire.
We will also conduct semi-structured interviews in a subsample of patients and nurses to assess perceptions of the intervention, and will use content analysis to interpret the data.
Studietyp
Interventionell
Inskrivning (Faktisk)
898
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Colorado
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Denver, Colorado, Förenta staterna, 80220
- VA Eastern Colorado Health Care System, Denver, CO
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Iowa
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Iowa City, Iowa, Förenta staterna, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
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-
Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
- Minneapolis VA Health Care System, Minneapolis, MN
-
-
Nebraska
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Omaha, Nebraska, Förenta staterna, 68105-1873
- VA Medical Center, Omaha
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Patients: The study sample will include general medical inpatients, aged 18 or older, who smoke at least one cigarette per day on average, regardless of their willingness to quit smoking. To increase applicability of study results, the goal is to enroll patients with characteristics that reflect the full range and distribution of patients observed in clinical practice. Current smokers transferred from intensive care units (or other monitored beds) to a general medical ward will be eligible.
- Nurses: The study sample will include staff nurses who are assigned to a general medicine inpatient unit at one of the participating sites.
Exclusion Criteria:
- Hospitalization for less than 18 hours (e.g., patients admitted for overnight observation);
- Acute medical decomposition (e.g., acute respiratory failure requiring intubation, cardiac arrest, septic shock);
- Altered mental status;
- Unstable psychiatric disorder (e.g., acute psychosis);
- Dementia;
- Communication barrier (unable to speak English, hard of hearing, aphasic);
- Pregnancy;
- Terminal illness (<12 month life expectancy);
- No access to a phone or the absence of a permanent address;
- Admitted for treatment of substance abuse.
No patient will be included unless they are able to provide informed consent and agree to be contacted by telephone during follow-up (to assess smoking status).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Arm 1
Baseline Period
|
|
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Experimentell: Arm 2
Intervention Period
|
1. Enhanced academic detailing of staff nurses (face-to-face training, feedback on group performance, and periodic check-ins with both nurse managers and peer leaders); 2. Adaptation of the computerized information system (modified nursing admission database that includes pertinent questions about smoking, computerized "quick orders" for smoking cessation medications), 3) Patient self-management support (self-help materials, fax referral of motivated patients to state quit line), and 4) nursing peer leaders on each study unit.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
7-day Point-prevalence Smoking Abstinence (6-month)
Tidsram: 6 months post enrollment
|
This is the number of patients who reported not have smoked cigarettes over the 7 days prior to the 6-month follow-up interview.
|
6 months post enrollment
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Referrals to Quitline
Tidsram: Assessed within 72 hours of hospital discharge
|
Assessed within 72 hours of hospital discharge
|
|
Prescription of Recommended Pharmacotherapy for Smoking Cessation
Tidsram: Assessed within 72 hours of hospital discharge
|
Assessed within 72 hours of hospital discharge
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: David A. Katz, MD MSc, Iowa City VA Health Care System, Iowa City, IA
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Katz DA, Holman J, Johnson S, Hillis SL, Ono S, Stewart K, Paez M, Fu S, Grant K, Buchanan L, Prochazka A, Battaglia C, Titler M, Vander Weg MW. Implementing smoking cessation guidelines for hospitalized veterans: effects on nurse attitudes and performance. J Gen Intern Med. 2013 Nov;28(11):1420-9. doi: 10.1007/s11606-013-2464-7. Epub 2013 May 7.
- Kamath AS, Vaughan Sarrazin M, Vander Weg MW, Cai X, Cullen J, Katz DA. Hospital costs associated with smoking in veterans undergoing general surgery. J Am Coll Surg. 2012 Jun;214(6):901-8.e1. doi: 10.1016/j.jamcollsurg.2012.01.056. Epub 2012 Apr 11.
- Katz D, Vander Weg M, Fu S, Prochazka A, Grant K, Buchanan L, Tinkelman D, Reisinger HS, Brooks J, Hillis SL, Joseph A, Titler M. A before-after implementation trial of smoking cessation guidelines in hospitalized veterans. Implement Sci. 2009 Sep 10;4:58. doi: 10.1186/1748-5908-4-58.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2009
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
29 december 2008
Först inskickad som uppfyllde QC-kriterierna
30 december 2008
Första postat (Uppskatta)
31 december 2008
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 april 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 april 2015
Senast verifierad
1 april 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- IIR 07-113
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .