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Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial.

ABSTRACT: Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will investigate whether or not proactive telephone support for smoking cessation, delivered through the National Health Service (NHS) Smoking Helpline is more effective or cost-effective than reactive support. It will also investigate whether or not providing nicotine replacement therapy (NRT), in addition to telephone counselling, has an adjunctive impact on smoking cessation rates and whether or not this is cost effective.This will be a parallel group, factorial design RCT, conducted through the English national NHS Smoking Helpline which is run from headquarters in Glasgow. Participants will be smokers who call the helpline from any location in England and who wish to stop smoking. If 644 participants are recruited to four equally-sized trial groups (total sample size = 2576), the trial will have 90% power for detecting a treatment effect (Odds Ratio) of 1.5 for each of the two interventions: i) proactive versus reactive support and ii) the offer of NRT versus no offer. The primary outcome measure for the study is self-reported, prolonged abstinence from smoking for at least six months following an agreed quit date. A concurrent health economic evaluation will investigate the cost effectiveness of the two interventions when delivered via a telephone helpline.The PORTSSS trial will provide high quality evidence to determine the most appropriate kind of counselling which should be provided via the NHS Smoking Helpline and also whether or not an additional offer of cost-free NRT is effective and cost effective for smoking cessation.

SUBMITTER: Coleman T

PROVIDER: S-EPMC2679731 | biostudies-literature | 2009 Apr

REPOSITORIES: biostudies-literature

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Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial.

Coleman Tim T McEwen Andy A Bauld Linda L Ferguson Janet J Lorgelly Paula P Lewis Sarah S

Trials 20090428

<h4>Background</h4>Telephone quit lines are accessible to many smokers and are used to engage motivated smokers to make quit attempts. Smoking cessation counselling provided via telephone can either be reactive (i.e. primarily involving the provision of evidence-based information), or proactive (i.e. primarily involving repeated, sequenced calls from and interaction with trained cessation counsellors). Some studies have found proactive telephone counselling more effective and this trial will inv ...[more]

PMID: 19400961

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Project description:ObjectiveTo assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.DesignRandomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen living in disadvantaged areas initiating breast feeding.MethodsEligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.Main outcome measuresPrimary outcomeany breast feeding at 6-8 weeks assessed by a telephone call from a researcher blind to group allocation.Secondary outcomesexclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.ResultsThere was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6-8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6-8 weeks; costs were sensitive to service organisation.ConclusionsProactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.Trial registration numberISRCTN27207603. The study protocol and final report are available on request.

Project description:ObjectiveTo assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.DesignParticipatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen initiating breast feeding and living in disadvantaged areas.MethodsQuantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.Main outcome measuresQuantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.ResultsA median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff-team-woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.ConclusionsImplementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.Trial registrationISRCTN27207603. The study protocol and final report is available on request.

Project description:BACKGROUND:Although breast milk has numerous benefits for infants' development, with greater effects in those born preterm (at < 37 gestational weeks), mothers of preterm infants have shorter breastfeeding duration than mothers of term infants. One of the explanations proposed is the difficulties in the transition from a Neonatal Intensive Care Unit (NICU) to the home environment. A person-centred proactive telephone support intervention after discharge from NICU is expected to promote mothers' sense of trust in their own capacity and thereby facilitate breastfeeding. METHODS/DESIGN:A multicentre randomized controlled trial has been designed to evaluate the effectiveness and cost-effectiveness of person-centred proactive telephone support on breastfeeding outcomes for mothers of preterm infants. Participating mothers will be randomized to either an intervention group or control group. In the intervention group person-centred proactive telephone support will be provided, in which the support team phones the mother daily for up to 14 days after hospital discharge. In the control group, mothers are offered a person-centred reactive support where mothers can phone the breastfeeding support team up to day 14 after hospital discharge. The intervention group will also be offered the same reactive telephone support as the control group. A stratified block randomization will be used; group allocation will be by high or low socioeconomic status and by NICU. Recruitment will be performed continuously until 1116 mothers (I: 558 C: 558) have been included. PRIMARY OUTCOME:proportion of mothers exclusively breastfeeding at eight weeks after discharge. SECONDARY OUTCOMES:proportion of breastfeeding (exclusive, partial, none and method of feeding), mothers satisfaction with breastfeeding, attachment, stress and quality of life in mothers/partners at eight weeks after hospital discharge and at six months postnatal age. Data will be collected by researchers blind to group allocation for the primary outcome. A qualitative evaluation of experiences of receiving/providing the intervention will also be undertaken with mothers and staff. DISCUSSION:This paper presents the rationale, study design and protocol for a RCT providing person-centred proactive telephone support to mothers of preterm infants. Furthermore, with a health economic evaluation, the cost-effectiveness of the intervention will be assessed.

Dataset Information

Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial.

Publications

Protocol for the Proactive Or Reactive Telephone Smoking CeSsation Support (PORTSSS) trial.

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