We conducted a pilot randomised controlled trial (the PHaCT study), including a process evaluation to assess the acceptability of a housing-led Critical Time Intervention (CTI) for prison leavers and the use of a trial design. This paper presents the process evaluation findings.

To explore the acceptability of both the intervention and the trial design to participants and those delivering the intervention, and to assess whether the intervention was delivered with fidelity.

A process evaluation following Medical Research Council guidelines. Data collection included semi-structured interviews with participants and CTI caseworkers and observations of intervention delivery. A thematic analysis of interviews and observations was conducted to understand the intervention’s implementation and contextual factors as well as the trial process acceptability.

Participants for the pilot trial were recruited from three prisons in England and Wales where the intervention was being delivered.

While 28 out of 34 trial participants consented to interviews, only one was completed. Seven caseworkers were interviewed.

A housing-led CTI to support people leaving prison at risk of homelessness, involving phased, time-limited support from caseworkers, starting prerelease and continuing postrelease, to help secure stable housing and build independence, without directly providing housing.

The intervention’s acceptability was primarily reflected through the positive feedback and success stories shared by CTI caseworkers, as well as observational data indicating high acceptance among service users. The trial design’s acceptability was challenged by concerns about randomisation and equipoise, with staff viewing randomisation as unethical due to limited support for vulnerable populations. The fidelity to the CTI intervention housing-led approach was adhered to as best as possible; stable housing was prioritised for service users before addressing other needs. Despite these efforts, both sites encountered significant challenges due to limited housing availability and complex systems for securing social housing, particularly for single men leaving prison.

This wider study faced significant challenges which impacted the process evaluation. Despite these issues, the evaluation provides important insights into the challenges of conducting trials on interventions for people leaving prison. The challenges experienced should inform future study designs with similar populations and in similar settings.

ISRCTN46969988.

To determine whether a full-scale randomised control trial (RCT) assessing the efficacy and cost-effectiveness of a housing led Critical Time Intervention (CTI) is feasible and acceptable.

Pilot parallel two-arm individual level RCT, including process evaluation and embedded exploratory health economic evaluation.

Four prisons for men across England and Wales, UK.

Men leaving prison at risk of homelessness and intervention delivery staff.

CTI has four components: (1) pre-engagement phase: assessing the needs of the client and implementing a plan pre-discharge; (2) transition to community: forming relationships and goal setting; (3) try out: encouraging problem-solving and managing practical issues and (4) transfer of care: developing long-term goals and transferring responsibilities to community providers.

Progression criteria: recruitment, retention, acceptability of the processes (CTI and trial method) and fidelity of intervention delivery. We also assessed the completeness of primary, secondary and exploratory outcome measures and estimated intervention costs.

The recruitment progression criterion was met, with 92% (34/37) of approached individuals consenting to participate (target: 50%). However, the overall recruitment target of 80 was not achieved, and retention was low, only 18% (6/34) provided follow-up data, well below the 60% threshold. Retention was hindered by systemic challenges, including changes to prison release policies and reduced probation support. While the CTI model was acceptable to staff and service users, the trial design, particularly randomisation, was not. Intervention fidelity met the progression criteria. Baseline data collection for health economics and resource use was feasible, and intervention costs were estimated.

This pilot trial identified significant challenges to conducting a full-scale RCT of CTI in this context, particularly around retention, trial acceptability and systemic instability. While CTI remains a promising model, a traditional RCT design may not be viable in this setting without substantial structural and ethical adaptations.

ISRCTN46969988.

To integrate the quantitative and qualitative data collected as part of the PEACH (Procalcitonin: Evaluation of Antibiotic use in COVID-19 Hospitalised patients) study, which evaluated whether procalcitonin (PCT) testing should be used to guide antibiotic prescribing and safely reduce antibiotic use among patients admitted to acute UK National Health Service (NHS) hospitals.

Triangulation to integrate quantitative and qualitative data.

Four data sources in 148 NHS hospitals in England and Wales including data from 6089 patients.

A triangulation protocol was used to integrate three quantitative data sources (survey, organisation-level data and patient-level data: data sources 1, 2 and 3) and one qualitative data source (clinician interviews: data source 4) collected as part of the PEACH study. Analysis of data sources initially took place independently, and then, key findings for each data source were added to a matrix. A series of interactive discussion meetings took place with quantitative, qualitative and clinical researchers, together with patient and public involvement (PPI) representatives, to group the key findings and produce seven statements relating to the study objectives. Each statement and the key findings related to that statement were considered alongside an assessment of whether there was agreement, partial agreement, dissonance or silence across all four data sources (convergence coding). The matrix was then interpreted to produce a narrative for each statement.

To explore whether PCT testing safely reduced antibiotic use during the first wave of the COVID-19 pandemic.

Seven statements were produced relating to the PEACH study objective. There was agreement across all four data sources for our first key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. The second statement was related to this key statement, ‘During the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing safely reduced antibiotic prescribing’. Partial agreement was found between data sources 3 (quantitative patient-level data) and 4 (qualitative clinician interviews). There were no data regarding safety from data sources 1 or 2 (quantitative survey and organisational-level data) to contribute to this statement. For statements three and four, ‘PCT was not used as a central factor influencing antibiotic prescribing’, and ‘PCT testing reduced antibiotic prescribing in the emergency department (ED)/acute medical unit (AMU),’ there was agreement between data source 2 (organisational-level data) and data source 4 (interviews with clinicians). The remaining two data sources (survey and patient-level data) contributed no data on this statement. For statement five, ‘PCT testing reduced antibiotic prescribing in the intensive care unit (ICU)’, there was disagreement between data sources 2 and 3 (organisational-level data and patient-level data) and data source 4 (clinician interviews). Data source 1 (survey) did not provide data on this statement. We therefore assigned dissonance to this statement. For statement six, ‘There were many barriers to implementing PCT testing during the first wave of COVID-19’, there was partial agreement between data source 1 (survey) and data source 4 (clinician interviews) and no data provided by the two remaining data sources (organisational-level data and patient-level data). For statement seven, ‘Local PCT guidelines/protocols were perceived to be valuable’, only data source 4 (clinician interviews) provided data. The clinicians expressed that guidelines were valuable, but as there was no data from the other three data sources, we assigned silence to this statement.

There was agreement between all four data sources on our key finding ‘during the first wave of the pandemic (01/02/2020-30/06/2020), PCT testing reduced antibiotic prescribing’. Data, methodological and investigator triangulation, and a transparent triangulation protocol give validity to this finding.

ISRCTN66682918.