- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07580378
Exploration of Acceptability of Alcohol Interventions
A Mixed-methods Study Exploring the Acceptability of Psychosocial Interventions and Social Determinants of Engagement With an NHS-led Alcohol Care Service.
Study Overview
Status
Detailed Description
The study will initially consists of a qualitative element assessing the acceptability of psychosocial interventions from the ITEP Manual, delivered by clinical staff, utilising a tailored version of the evidence-based, generic theoretical framework of acceptability questionnaire (Sekhon et al., 2022). This meets the ontological epistemology of a qualitative approach, based upon by its' focus on elicitation of subjective experience, perceptions and effort, in relation to the acceptability of delivering psychosocial interventions (Tombs and Strange, 2024). Assessing this is of particularly importance, as whilst the ITEP Manual has a strong evidence base for successful behaviour change, measures of acceptability regarding delivery are less well evidenced and have been postulated to influence clinicians' readiness to initiate behaviour change conversations, prospectively affecting patient outcomes (Bull et al., 2021).
The study will also investigate the correlation between demographic variables and engagement with a North West England, NHS-led, alcohol care service, amongst the patient population. Measures of interest will be based on existing, routinely captured data, including alcohol consumption (Audit-C/ AUDIT scores), and demographic variables of age, gender and socioeconomic status. Engagement can be defined in this case, as patient contact with the service, which might lead to referral to treatment and onward referral (although these latter variables are outside the scope of the current study). The social determinants of health are known to contribute to poorer outcomes, hence identification of those not engaging with such services, offers new opportunities to improve population health (Fraser et al., 2022; Hiam, 2025). Indeed, this philosophy aligns with the NHS 10-year plan which acknowledges the intolerable and detrimental health outcomes of polarised groups in UK society, with clear objectives set out to tackle inequalities in both access and outcomes (NHS, 2025).
It is anticipated that this study will contribute to our understanding of the importance of measuring the acceptability of delivering health behaviour interventions, amongst NHS clinical staff, delivering evidence-based psychosocial interventions. It is also anticipated the study will distinguish which social determinants of health, correlate to engagement with an NHS-based alcohol care service. It offers new opportunities to reflect on, and review current strategies for delivering on objectives, around ameliorating social inequalities within socially deprived areas (NHS, 2025). It may also highlight a need for more research to evaluate prospective improvement opportunities to reduce health inequalities, for those patient groups who are not engaging with such services.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michelle Stephens, Trust Sponsor
- Phone Number: UK: 07976 152397
- Email: research.sponsorship@elht.nhs.uk
Study Contact Backup
- Name: Aleksandra (Ola) Metryka, Chief Investigator
- Phone Number: 07977267956
- Email: research.sponsorship@elht.nhs.uk
Study Locations
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Lancashire
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Burnley, Lancashire, United Kingdom, BB102pq
- Burnley General Teaching Hospital
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Contact:
- Phone Number: 07977297281
- Email: christopher.gray@elht.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Part 1: The participants for part 1 will be identified by the former service lead, who still works in the Trust. A list of all the clinical staff who worked in the alcohol care service will be provided to the Chief Investigator, in order to facilitate contact, with prospective participants.
Part 2: Patients who had contact with the East Lancashire NHS-Health Trust alcohol-care service, between September 2023 and December 2024 (but who have not opted-out of their data being utilised for research purposes).
Description
Inclusion Criteria:
- Clinical staff who worked in the ELHT alcohol care service, and received training in the delivery of psychosocial interventions using the ITEP Manual, and who are still employed by ELHT in other roles (following de-commissioning of the alcohol care service).
- Patient data under part 2 of the study, who have not opted to have their data removed, in accordance with the NHS MESH, opt out scheme.
Exclusion Criteria:
- Clinical staff who worked in the ELHT alcohol care service, but who no longer work for the trust, or are retired.
- Clinical staff who did not receive training in the delivery of psychosocial interventions.
- Any patient data under part 2 of the study, who have opted to have their data removed for use, under the NHS MESH protocols.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Clinical ataff who delivered psychosocial interventions and staff who engaged with the service
The participants for part 1 will be identified by the former service lead, who still works in the Trust. A list of all the clinical staff who worked in the alcohol care service will be provided to the Chief Investigator, in order to facilitate contact, with prospective participants. This will be done via email correspondence on Trust computers, to work-based email addresses, to ensure that all correspondence within the study, is protected by Trust IT security. Part 2: The data pertaining to the patient contacts between September 2023 and December 2024, will be screened by the NHS England MESH team to determine if any patients have opted out of sharing their data for research purposes. Once confirmed, the residual data between September 2023 and December 2024 will then be reviewed for inclusion in the data analysis. That is, given that data is captured from a single-time point, for each data set (i.e. there is no intervention follow-up data to compare against). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acceptability of delivering psychosocial interventions & social determinants of access to an NHS-led Alcohol-Care service.
Time Frame: Anticipated to be no longer than 3 months
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Directed Content Analysis (DCA) will be used to analyse data from the outputs of the TFA-based questionnaire regarding the acceptability of interventions (Hsieh et al., 2005; Sekhon., et al, 2022). Descriptive statistics will be used to describe the current patient contact data from patients who engaged with the service during September 2023 and December 2024. |
Anticipated to be no longer than 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christopher Gray, Chief Investigator, East Lancashire NHS-Health Trust
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DEV116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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