Preventing Relapse to Smoking Among Prisoners After Release

Smoking Clinical Trial

— PROSPER  

Official title:

Preventing Relapse to Smoking Among Prisoners After Release: Developing and Piloting a Complex Health Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04271371
• Other study ID #: 254028
• Status: Completed
• Start date: August 8, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: February 2024
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria 2. Release prisoner cohort

• All participants are aged 18 or over (no upper age limit)

• Are currently residing in one of the three study sites (HMPs Nottingham, Ranby and Sudbury)

• Male (women will not be held at any of the study sites)

• Have a provisional release date within the next 2 months.

• Are capable of understanding and consenting to the study.

• Remand and sentenced prisoners.

• Who report that they are a current smoker and/or a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.

3. Reception prisoner cross-sectional

• All participants are aged 18 or over (no upper age limit)

• Are currently residing in the open prison study site (HMP Sudbury)

• Male (women will not be held at any of the study sites)

• Have been in the open prison more than two weeks but for less than 3 months.

• Have been transferred from a closed prison.

• Are capable of understanding and consenting to the study.

• Sentenced prisoners.

• Who report that they were a current smoker prior to entering prison (smoked up to 7 days before entering prison), and/or were in prison (and still on the same sentence) and a current smoker prior to the smoke-free prison policy.

Exclusion criteria 2. Release prisoner cohort

• Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.

• Non-smokers.

• Being deported post release.

• Been in prison for less than four weeks.

3. Reception prisoner cross-sectional

• Present a serious risk of harm to the researchers, highlighted in PNOMIS records or by a member of staff.

• Been in prison for less than 2 weeks.

• Non-smokers.

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Recurrence
• Smoking
• Smoking Reduction

Intervention

Other:
• Not yet developed
A prototype intervention will be developed over Phase 1 & 2 and piloted in Phase 3 of this study.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham, School of Medicine	Nottingham	Please Select

Sponsors (5)

Lead Sponsor	Collaborator
University of Nottingham	Cancer Research UK, Her Majesty's Prison and Probation Service (HMPPS), Plymouth University Peninsula Schools of Medicine & Dentistry (PUPSMD), Public Health England

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop and pilot test the feasibility and acceptability of an intervention to help prevent prisoners relapse to smoking after release.	Smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported.	3 years
Secondary	To document prisoners smoking history to date and levels of nicotine addiction.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	To document the support provided to manage nicotine addiction during imprisonment and in the periods immediately before and after release.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	The impact of smoke-free prison policy on prisoners smoking behaviours.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	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).	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	To establish the extent to which prisoners relapse to smoking after transfer to an open prison where smoking is permitted in designated areas.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	To obtain views on triggers to smoking after release (and transfer to an open prison) and how relapse might be prevented.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	For those prisoners who return to smoking after release, at what point do they resume smoking (in days).	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	After release do prisoners use cessation pharmacotherapy, electronic cigarettes or NHS SSS support, or any other means of preventing relapse.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	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.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	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.	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	Review of methods of recruitment in prison and community follow-up (to feed into future pilot intervention study).	Phase 1 (Scoping stakeholder interviews/Release prisoner cohort/Reception prisoner cross-sectional)	1 year
Secondary	To develop, design, and refine an intervention to prevent smoking relapse after release with input from fellow academics, stakeholders and PPI groups.	Phase 2 (Intervention development)	1 year
Secondary	To develop logic models to map the problem and the prototype intervention.	Phase 2 (Intervention development)	1 year
Secondary	To assess any barriers and facilitators to the developed intervention.	Phase 3 (Intervention pilot & Intervention process evaluation)	1 year
Secondary	To explore any unintended consequences as a result of the intervention.	Phase 3 (Intervention pilot & Intervention process evaluation)	1 year
Secondary	To identify aspects of the intervention and delivery that could be improved.	Phase 3 (Intervention pilot & Intervention process evaluation)	1 year
Secondary	Explore smoking abstinence rates at 1 week, 1 month and 3 months post release, self-reported and CO validated.	Phase 3 (Intervention pilot & Intervention process evaluation)	1 year
Secondary	Explore impact of the intervention on self-reported health, housing, reconviction rates, use of illicit substances in prisoner's post- release.	Phase 3 (Intervention pilot & Intervention process evaluation)	1 year