Preventing Relapse to Smoking Among Prisoners After Release

Completed

• Conditions: Electronic Cigarette Use; Smoking; Smoking Reduction
• Interventions: Other: Not yet developed

• Registration Number: NCT04271371
• Lead Sponsor: University of Nottingham

Brief Summary

Prisoners experience huge health inequalities, and their exceptionally high smoking prevalence (five times the national average) contributes significantly to their high mortality. Since the introduction of smoke-free polices across Her Majesty's Prison and Probation Service (HMPPS) in England and Wales, prisoners are now obliged to abstain from smoking while held in prison. This represents a unique opportunity to promote lifelong cessation in this highly disadvantaged and marginalised group. However, evidence suggests most prisoners intend to resume smoking as soon as possible after release. A systematic review of prison smoke-free polices worldwide concluded that there was a need for new research to identify effective strategies to reduce relapse in these individuals.

Detailed Description

The primary objective of this study will be to develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release. The study will work in accordance with the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The Preventing Relapse tO Smoking among PrisonErs after Release (PROSPER) study consists of three key Phases:

1. Document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release; establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release; and obtain views on how relapse might be prevented.

2. Drawing on current literature and findings from Phase 1, develop and design an prototype intervention to prevent smoking relapse after release.

3. To pilot the designed prototype intervention and conduct a process evaluation to inform the development of further work in this area.

The research will be carried out in three prisons in the East Midlands. The main duties will include recruitment of participants (HMPPS staff members and prisoners), data collection, data analysis, assist with intervention development and refining related intervention materials/resources, co-facilitate Patient and Public Involvement (PPI) groups, contribute to the ethical application for the pilot intervention, and preparation of manuscripts for peer-review publication.

Study Timeline

• Study Start: 2019-08-08
• Study First Submitted: 2019-09-06
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-17
• Primary Completion: 2023-05-01
• Study Completion: 2023-12-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prototype intervention	Not yet developed	To be developed through Phase 1 and 2

Primary Outcome Measures

Name	Time	Method
To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.	3 years	Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.

Secondary Outcome Measures

Name	Time	Method
To document prisoners smoking history to date and levels of nicotine addiction.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
The impact of smoke-free prison policy on prisoners smoking behaviours.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
To establish the extent to which prisoners intentionally resume or unintentionally relapse to smoking after release (and does their intended behaviour pre-release predict post-release behaviour).	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
To obtain views on triggers to smoking after release (and transfer to an open prison) and how relapse might be prevented.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
After release do prisoners use cessation pharmacotherapy, electronic cigarettes or NHS SSS support, or any other means of preventing relapse.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Record and examine other potential predictors (as outlined in the international literature) of relapse to smoking after release from smoke-free prisons, e.g other negative health behaviours.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
To develop, design, and refine an intervention to prevent smoking relapse after release with input from fellow academics, stakeholders and PPI groups.	1 year	Phase 2 (Intervention development)
For those prisoners who return to smoking after release, at what point do they resume smoking (in days).	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
For those prisoners who do return to smoking after release, do they smoke less, the same or more as they previously smoked before entering prison/and or before the prison service went smoke-free.	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
Review of methods of recruitment in prison and community follow-up (to feed into future pilot intervention study).	1 year	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)
To identify aspects of the intervention and delivery that could be improved.	1 year	Phase 3 (Intervention pilot \& Intervention process evaluation)
Explore smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported and CO validated.	1 year	Phase 3 (Intervention pilot \& Intervention process evaluation)
Explore impact of the intervention on self-reported health, housing, reconviction rates, use of illicit substances in prisoner's post- release.	1 year	Phase 3 (Intervention pilot \& Intervention process evaluation)
To develop logic models to map the problem and the prototype intervention.	1 year	Phase 2 (Intervention development)
To assess any barriers and facilitators to the developed intervention.	1 year	Phase 3 (Intervention pilot \& Intervention process evaluation)
To explore any unintended consequences as a result of the intervention.	1 year	Phase 3 (Intervention pilot \& Intervention process evaluation)

Trial Locations

Locations (1)

University of Nottingham, School of Medicine; 🇬🇧 Nottingham, Please Select, United Kingdom