Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare (MIND-THE-GAP)

9 mars 2017 uppdaterad av: Royal College of Surgeons, Ireland

Medical Student INtervention to Promote Effective Nicotine Dependence and Tobacco HEalthcare: GrAduate Entry Programme (MIND-THE-GAP) Feasibility Randomised Trial

Background: Smoking counselling during hospitalisation with post-discharge follow-up increases quitting. However, provision of cessation care for hospitalised patients is suboptimal. Students are potentially an untapped resource for providing cessation advice, but no studies have investigated this.

Aim: To determine if medical students can encourage motivation to stop smoking (MTSS; primary outcome) in hospitalised smokers .

Design: 2-arm RCT Setting: RCSI (www.rcsi.ie) and Connolly Hospital (www.hse.ie/eng/services/list/3/hospitals/Connolly/).

Participants: Inpatient smokers. Intervention and procedures: 60 graduate medical students will receive standardised motivational interviewing training in the provision of cessation advice. Each student will be randomly assigned to counsel ~1-3 smokers each, including an individual in-hospital, face-to-face session and post-discharge phone counselling. Training and implementation will cover Sept-2015-May-2016. Smokers will be randomised to 'usual care' (n~90), or intervention (n~90, student-delivered motivational interviewing). A researcher will enable recruitment and follow-up, and conduct a qualitative evaluation of programme participants.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

67

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Irland
      • Dublin, Irland
        • Connolly Hospital Blanchardstown

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:

  • All identified inpatient smokers at Connolly Hospital.

Exclusion Criteria:

  • Advised by ward manager that patient is too unwell or cognitively impaired, or otherwise unsuitable;
  • Death during hospitalisation;
  • Receiving palliative care;
  • Under 18 years of age;
  • To be transferred to another hospital;
  • Not English speaking;
  • Refusal to participate;
  • Inpatient in psychiatric ward

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention
Motivational interviewing The medical student will deliver a 15 minute consultation with the patient. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, educate the patient about effective behavioral and pharmacological cessation strategies, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy. Patients who elect to receive this consult with have a coloured sticker placed by the medical student on the medical chart requesting a consultation.
Beteende: Motivational interviewing

The medical student will deliver a brief (approximately 15 minute) consultation with the patient that is based on principles of social cognitive theory and motivational interviewing. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy (via a chart sticker).

Each student will counsel 1-3 smokers each over the 8-month academic period, with student training and intervention staggered over this time. Students will also re-contact the smoker at 1-week post-discharge via telephone or personal follow-up, to provide further support.
Inget ingripande: Usual care
This group will not receive student contact, but may be counselled by the smoking cessation officer or other Connolly staff as per normal procedures.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Motivation to Stop Smoking Scale (MTSS)
Tidsram: Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Repeated measures: MTSS scores at baseline, 1-week, 3- and 6-month follow-up.
Change in motivation to quit
Tidsram: Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.
If, on a scale of 1 to 10, 1 is not at all motivated to give up smoking and 10 is 100% motivated to give up, what number would you give yourself at the moment?
Repeated measures: single item scores at baseline, 1-week, 3- and 6-month follow-up.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients who receive a prescription for a cessation medication at the time of discharge
Tidsram: By discharge, an average of 5-10 days post-admission
The proportion of patients who receive a prescription for a cessation medication at the time of discharge, assessed via medical chart audit;
By discharge, an average of 5-10 days post-admission
proportion of patients who report any use of a prescribed or over-the-counter cessation medication
Tidsram: at 3- and 6-months discharge
the proportion of patients who report any use of a prescribed or over-the-counter cessation medication, of an approved cessation pharmacotherapy, including nicotine patch, gum, lozenge, inhaler, mouth spray, Champix, or Zyban at 1- and 6-months discharge
at 3- and 6-months discharge
proportion of attending physicians who prescribe cessation medication during the hospitalisation
Tidsram: During hospitalisation (baseline)
the proportion of attending physicians who prescribe cessation medication during the hospitalisation (to be obtained by medical chart audit);
During hospitalisation (baseline)
7-day point prevalent abstinence rates
Tidsram: 3- and 6-months
7-day point prevalent abstinence rates assessed at both 3- and 6-months by self-report
3- and 6-months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Perceived student efficacy
Tidsram: 3- and 6-months
Single items survey: How helpful was the support that you received from the medical student?" [not at all, a little bit, somewhat, quite a bit, or very much]?"
3- and 6-months
Perceived student knowledge
Tidsram: 3- and 6-months
Single item survey: How knowledgeable was the medical student about quitting smoking? [not at all, a little bit, somewhat, quite a bit, or very much]
3- and 6-months
Quit attempts
Tidsram: 3- and 6-months

Three questionnaire items:

  1. In the past one/six months, have you quit smoking? Yes/No
  2. If no, in the past one/six months have you attempted to quit smoking? Yes/No
  3. If yes, how many times have you tried to quit in the past three/six months? ______
3- and 6-months
Professional advice
Tidsram: 3- and 6 months
One questionnaire item: In the past 3/6 months since your hospital admission, did a doctor or health professional discuss ways of giving up smoking with you?
3- and 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Royal College of Surgeons, Ireland

Samarbetspartners

Connolly Hospital Blanchardstown
University of Memphis
Health Service Executive, Ireland

Utredare

  • Studierektor: Seamus Sreenan, RCSI and Connolly Hospital
  • Studierektor: Liam Cormican, RCSI and Connolly Hospital
  • Studierektor: Ken Ward, University of Memphis
  • Studierektor: Lisa Mellon, PhD, RCSI
  • Studierektor: Ronan Conroy, RCSI
  • Studierektor: Anne Hickey, PhD, RCSI
  • Studierektor: Sinead Stynes, Connolly Hospital
  • Huvudutredare: Frank Doyle, PhD, RCSI
  • Studierektor: GEP IC1, RCSI students

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

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 (Faktisk)

1 november 2015

Primärt slutförande (Faktisk)

1 december 2016

Avslutad studie (Faktisk)

1 december 2016

Studieregistreringsdatum

Först inskickad

3 november 2015

Först inskickad som uppfyllde QC-kriterierna

9 november 2015

Första postat (Uppskatta)

10 november 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 mars 2017

Senast verifierad

1 april 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • REC1126

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 .

Kliniska prövningar på Motivational interviewing

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Lithuania

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera