Post-Discharge Smoking Cessation Strategies: Helping HAND 4 (HH4)
3. maj 2022 opdateret af: Nancy A. Rigotti, Massachusetts General Hospital
Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers
This randomized controlled trial will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers admitted to 3 U.S. hospitals.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This multi-site randomized controlled trial (RCT) will compare the effectiveness of two models of post-discharge tobacco cessation treatment for adult smokers who are admitted to 3 large hospital systems in 3 U.S. regions (MA, PA, TN).
All patients will receive guideline-based tobacco cessation treatment delivered in hospital by each site's existing Tobacco Treatment Service that is directed by a study investigator.
Patients who plan to quit smoking after hospital discharge will be randomly assigned to 1 of 2 post-discharge tobacco treatment interventions and followed at 1, 3, and 6 months.
One arm uses bidirectional electronic referral (eReferral) to the state tobacco quitline.
The other arm, Personalized Tobacco Care Management (PTCM), combines proactive messages delivered by automated interactive voice response (IVR) phone calls, text messaging, and/or email with health coaching provided by a hospital-based tobacco counselor.
Both groups will receive at least 1 month of nicotine replacement therapy.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1416
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Vanderbilt University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Current cigarette smoker (>=1 cigarette in the week before admission and >=1 cigarette/day when smoking at a baseline rate in the month prior to admission)
- Admitted to a study hospital
- Seen by hospital smoking counselor during inpatient stay
- Plans to try to quit smoking after hospital discharge
Exclusion Criteria:
- Inability to give informed consent or participate in counseling due to serious cognitive or psychiatric disorder (e.g., dementia, psychosis)
- Life expectancy <12 months
- Medical instability
- No reliable telephone access or inability to use telephone
- Non-English speaking
- Pregnant, breastfeeding, to planning to become pregnant in the next 6 months.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Transitional Tobacco Care Management (TTCM)
TTCM will provide 8 weeks of nicotine replacement therapy at hospital discharge and proactive contacts over 3 months delivered by automated IVR call.
At each contact the patient is offered a return call from the hospital-based tobacco coach for counseling, medication advice, and coordination of care with the patient's outpatient health care team.
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PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice).
At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.
Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
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Aktiv komparator: eReferral to State Tobacco Quitline (QL)
Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient.
Quitline staff will contact patient to offer up to 5 proactive telephone calls from a tobacco coach.
Patient may also be eligible for NRT sample.
Feedback from the quitline will be sent back to the patient's medical chart.
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Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient.
Feedback from the Quitline will be included in the patient's medical chart.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tobacco Abstinence, Biochemically Confirmed
Tidsramme: 6 months after hospital discharge
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Participant self-report of no use of any tobacco product (cigarettes, cigars, little cigars, pipes, smokeless tobacco product) in the past 7 days AND either a saliva sample with a cotinine concentration <=10 ng/ml OR breath sample with a carbon monoxide concentration <=9 ppm.
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6 months after hospital discharge
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tobacco Abstinence, Self-report
Tidsramme: 1 month after hospital discharge
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Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
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1 month after hospital discharge
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Tobacco Abstinence, Self-report
Tidsramme: 3 months after hospital discharge
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Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
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3 months after hospital discharge
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Tobacco Abstinence, Self-report
Tidsramme: 6 months after hospital discharge
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Participant self-report of abstinence for the past 7 days from any tobacco product use (cigarettes, cigars, little cigars, pipes, smokeless tobacco product).
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6 months after hospital discharge
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Engagement in Cessation Treatment
Tidsramme: 1 month after hospital discharge
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Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at the 1 month post-discharge assessment.
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1 month after hospital discharge
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Engagement in Cessation Treatment
Tidsramme: 3 months after hospital discharge
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Number of participants who report currently using tobacco treatment (defined as cessation medication or cessation counseling) at 3 month post-discharge assessment
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3 months after hospital discharge
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Self-reported Continuous Tobacco Abstinence Since Hospital Discharge
Tidsramme: 6 months follow-up
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Number of participants who self-report having smoked no cigarettes and used no other tobacco products (cigars, little cigars, pipes, smokeless tobacco) since index hospital discharge
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6 months follow-up
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Hilary A Tindle, MD, MPH, Vanderbilt University Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Rigotti NA, Chang Y, Davis EM, Regan S, Levy DE, Ylioja T, Kelley JHK, Notier AE, Gilliam K, Douaihy AB, Singer DE, Tindle HA. Comparative Effectiveness of Postdischarge Smoking Cessation Interventions for Hospital Patients: The Helping HAND 4 Randomized Clinical Trial. JAMA Intern Med. 2022 Aug 1;182(8):814-824. doi: 10.1001/jamainternmed.2022.2300.
- Rigotti NA, Schnitzer K, Davis EM, Regan S, Chang Y, Kelley JHK, Notier AE, Gilliam K, Douaihy A, Levy DE, Singer DE, Tindle HA. Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial. Trials. 2020 Apr 16;21(1):336. doi: 10.1186/s13063-020-04257-7. Erratum In: Trials. 2020 May 4;21(1):375.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2018
Primær færdiggørelse (Faktiske)
17. november 2020
Studieafslutning (Faktiske)
17. november 2020
Datoer for studieregistrering
Først indsendt
18. juli 2018
Først indsendt, der opfyldte QC-kriterier
18. juli 2018
Først opslået (Faktiske)
27. juli 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017P000774/PHS
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