iHOST (Improving Hospital Opioid Substitution Therapy): An intervention to improve care for people who use opioids in NHS hospitals
| ISRCTN | ISRCTN47320412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47320412 |
| IRAS number | 310856 |
| Secondary identifying numbers | CPMS 52950, NIHR133022, IRAS 310856 |
- Submission date
- 04/07/2022
- Registration date
- 11/07/2022
- Last edited
- 05/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
People who use illicit opioids (PWUO), such as heroin, are over-represented in urgent and emergency admissions. Late presentation with complications from injecting-related infections and injuries is common, yet retention in hospital care is low. This is a serious problem, associated with: reliance on ambulatory care, complex admissions, unplanned hospitalisation, discharge against medical advice (DAMA), readmission, surgical intervention and high NHS costs.
Our research, engagement with affected groups, and international evidence show that poor management of opioid substitution treatment (OST) in hospital emergency, acute admissions and high burden wards is a primary barrier to timely and effective care for PWUO. Experiences of OST delay or omission can cause severe physical and psychological distress and result in treatment interruption or DAMA to obtain illicit drugs. PWUO experiencing opioid withdrawal can be challenging to manage; improving their experience and feelings of safety in the hospital setting is beneficial for both patients and providers.
Aim: To optimise OST management in hospital settings to reduce delayed presentation, self-discharge and emergency readmission among PWUO.
Who can participate?
People who use opioids (PWUO): People who have a history of opioid use for non-medical reasons AND/OR are prescribed OST in a community setting for illicit opioid dependence; 18 years or over; assessed as capable to consent (not in debilitating withdrawal or intoxicated); presenting at A&E, an acute admissions ward or inpatient at one of the hospital sites OR a client at one of the linked drug treatment services.
Providers: healthcare staff involved in the prescribing, supply or administration of medicines to patients within A&E, acute admissions and high burden inpatient wards; staff at linked drug treatment services.
What does the study involve?
There are four phases to this study. Phase 1: Finalising the iHOST intervention; Phase 2: Testing iHOST (at University College London Hospital); Phase 3: Evaluating iHOST (at St James's University Hospital, Leeds and Royal Stoke University Hospital, Staffordshire); Phase 4: Developing iHOST resources and outputs.
Our primary outcomes will be measured through a difference-in-difference analysis of routinely collected clinical data at three iHOST evaluation sites, using comparative data from the national Hospital Episode Statistics (HES) database. A qualitative process evaluation, involving in-depth interviews and focus groups with patients and providers will assess iHOST acceptability and fidelity, clarify causal mechanisms, and identify contextual factors such as human resources and commissioning that might be associated with success.
Full methods details are available in section A13 of the IRAS form and in the project protocol.
What are the possible benefits and risks of participating?
Qualitative interview and focus group participants might not directly benefit from this research, but our aim is that this intervention will help improve hospital care for people who use drugs. This might be of benefit to patient and provider participants and/or their peers and colleagues in the future.
Being a participant in the study should not involve any physical or psychological harm. We recognize that talking about care seeking and possible experiences of stigma due to opioid use can be difficult for some and that the potential risk of pre-existing stigma and prejudice can be a barrier to research engagement by PWUO and staff. We mitigate this risk firstly, by engaging PWUO through our peer researchers. PI Harris has over 17 years’ experience in research with PWUO and Noctor is an experienced peer outreach worker. Both have strong track records of developing trusting research relationships with people from marginalised communities. Secondly, we will also use a peer model to engage staff: the ‘iHOST champion’. We are working closely with a research nurse in Phase 1 to develop this role description with the aim of promoting sustainability. Staff turn-over has here been identified as a risk. The voluntary nature of the training offer is a risk to uptake. The champion model is designed to promote engagement, which will be badged as contributing to continuing professional development and staff will receive a certificate from Exchange Supplies on completion to evidence CPD
Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
March 2022 to May 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Aubrey Ko
aubrey.ko@lshtm.ac.uk
Contact information
Scientific
Department of Public Health, Environments and Society
London School of Hygiene & Tropical Medicine
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
| Phone | +44 (0)20 7299 4806 |
|---|---|
| aubrey.ko@lshtm.ac.uk |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Improving Hospital Opioid Substitution Therapy (iHOST): implementation and assessment of an intervention to reduce late presentations, discharges against medical advice and repeat admissions among people who use opioids |
| Study acronym | iHOST |
| Study hypothesis | Does the iHOST toolkit reduce delays in OST prescription in two hospitals compared to historical local data, and does this lead to reduced DAMA and emergency readmission of PWUO compared to historical local rates and a national comparator cohort? |
| Ethics approval(s) | Approved 31/05/2022, London - Camden & Kings Cross Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +442071048276; camdenandkingscross.rec@hra.nhs.uk), ref: 22/LO/0370 |
| Condition | Addiction, substance dependence |
| Intervention | The iHOST toolkit comprises: 1. A ‘My Meds’ card. A prototype card has been developed with people who use opioids (PWUO). This provides information for hospital staff to prioritise and expedite medicines reconciliation, including blank fields for OST prescriber and pharmacy contacts. 2. A helpline for patients and providers run by the charity Release. 3. An online training module for staff in hospital Accident and Emergency (A&E,), acute admissions, and high burden hospital wards. 4. A ‘best practice’ hospital policy template. 5. An iHOST ‘champion’ to support sustainability post intervention. This is a four-phase study. Methods for each phase, including research participant involvement are outlined below: Phase 1 [months 1-8]: iHOST OPTIMISATION. Sites: UCLH, linked drug treatment services. A. Evidence review: We will conduct a systematic review of the literature to synthesise the evidence for interventions for managing the care of people who inject drugs in emergency outpatient or acute hospital inpatient settings. We have conducted a review of NHS policies for substance dependence management. This will be finalised for publication. B. iHOST toolkit optimisation. - We will conduct 2 workshops with PWUO and providers, 1 at each of two drug treatment services (Margarete Centre, Camden and Islington NHS Trust and Better Lives, Islington) to receive feedback on and finalise the My Meds card design and seek input into the Advocacy helpline concept (acceptability and content need). Participants: ~7 PWUO & 3 providers per workshop, n=~20. - We will conduct 1 workshop at UCLH to inform training module content and design. Participants: UCLH A&E, acute admissions, high burden wards, drug liaison; hospital pharmacy staff (n=~10). - We will conduct 1 additional workshop at Release Charity, as required, to finalise advocacy helpline content, delivery and methods of data generation. Participants: Release staff (n=4); PWUO (n=6); Hospital providers (n=4). - We will employ Delphi methods to develop and finalise the NHS hospital substance dependence management policy template. These comprise developing evidence statements for each section of the hospital policy template (derived from literature review and national clinical guidance) alongside ‘best practice’ examples from our policy review to be sent to a panel of experts (comprising the lead pharmacist for each UK drug treatment service, members of the Specialist Pharmacy Service, the UK clinical guidelines panel, lead clinicians and PPI representatives) to obtain their views and arrive at a consensus. - We will work with a part time research nurse employed for the study at UCLH to develop a ‘iHOST champion’ role description and think more broadly about how iHOST implementation can be supported to be sustainable within the complex culture of the hospital system in the long term. C. Patient involvement set up and workshops. We will work with a group of people with lived experience of opioid use (including being on OST) over the course of the study to seek input into and assess the acceptability of participant information materials, study methodology, findings interpretation and dissemination plans. We aim also to develop a ‘cultural safety’ framework with this group over the 36 months, drawing on findings from the process evaluation to understand what PWUO require to feel safe in hospital spaces and how providers and systems can change to facilitate equitable care. We will hold 4-6 workshops with a core group of PWUO (6-8), some of whom have already worked with the PI on previous studies and expressed an interest in participating. We will recruit additional members (n=2-3) to ensure participant diversity, particularly in relation to gender. Phase 2 [months 9-14] Test feasibility. Sites: UCLH, JSUH, RSUH and linked drug treatment services. A. Embed and test iHOST toolkit: - We will attend a staff meeting at each drug service local to UCLH to present the iHOST concept. We will provide a stock of MY Meds cards to each service for distribution to their clients. We will assess the acceptability of conducting observations of My Meds provision at the drug treatment services and arrange researcher visits if feasible. - If appropriate we will conduct non-participant observations of My Meds card provision in the DTS and use at UCLH to assess acceptability and iHOST implementation fidelity (n=~16 separate observations). - We will conduct non-participant observations of ‘iHOST champion’ interactions with UCLH staff to assess the acceptability and impact of methods to sensitise staff to the iHOST concept and toolkit. (n=~8 observations/occasions). - We will conduct in-depth interviews with 6 inpatient PWUO, 6 community based PWUO, 4 hospital staff, 4 drug treatment staff (n=20 total) to explore iHOST acceptability, impact on practice, contextual barriers and facilitators to implementation. Participants for qualitative interviews will be asked to fill in a brief form with demographic information, prior to the interview starting and after providing informed consent. This will not include personal participant identifers (an ID number only) and will enable us to ascertain diversity across the sample and provide an additional check regarding eligibility criteria. Interviews will be audio-recorded with consent and conducted in a private room at the recruiting service. B. Evaluate feasibility of outcome measures at UCLH. - We will work with a data scientist at UCLH, employed part time for the study, to compare clinical outcomes on the EPIC database before and after implementation of iHOST. These include process-related measures such as time from admission to provision of OST, and outcome-related measures such as the risk of DAMA. - We will conduct a controlled analysis of changes in two outcomes (DAMA and 28-day readmission) between UCLH and other hospitals across England, using Health Episodes Statistics (HES) database. C. Prepare for phase 3 implementation and evaluation. - We will hold two workshops with PWOU and providers at the same DTS as in phase 1 (Margarete centre and Better Lives) to discuss findings, assess and collaboratively refine intervention components. Participants: 8 providers & 12 PWUO, n=20. - We will work with hospital site data scientists (time costed) to review the clinical information systems at the hospitals and refine analysis plans if necessary. - We will conduct 4 focus groups, one at each of two drug treatment services (Staffordshire Humankind, Forward Leeds) and one at each linked hospital site (SJUH, RSUH) to explore local context, iHOST expectations and perceived quality of collaborative relationships between drug treatment and hospital services. Participants: drug treatment service FG = 14 PWUO & 6 providers, n=20; hospital FG = drug treatment liaison team, nurses on high burden wards & affiliated staff, n=16. Phase 3 [months 15-29]: Evaluation. Sites: JSUH, RSUH and linked drug treatment services. A. Embed iHOST toolkit at evaluation sites - We will distribute ‘My Meds’ cards and promotional materials to Staffordshire Humankind, Forward Leeds and any other DTS proximal to the hospital evaluation sites. - Work with JSUH and RSUH clinical leads to promote and fill the iHOST champion role. - Liaise with lead clinicians and iHOST champions to will coordinate training set up, staff sensitisation and training promotion. B. Quantitative evaluation - We will employ a difference-in-difference method to measuring patient outcomes in two groups (iHOST sites and control hospitals) at two points in time. At the first point in time, both groups are unexposed (i.e. iHOST is not implemented). At the second point in time, iHOST is implemented at iHOST sites only. The design is based on comparing the change in outcomes. Control data will be generated from the Hospital Episode Statistics database and iHOST data from local hospital database systems (such as EPIC). - We will assess the acceptability, reach and perceived impacts of staff training activities through analysis of selfcomplete survey data embedded into the training platform (n=~150 staff). - We will ask Drug Treatment Services to keep a record, where possible, of My Meds card uptake among service users and Release to record helpline call numbers. These anonymised data will be assessed to inform measures of iHOST reach. - All costs associated with iHOST will be mapped and categorised. Using results from clinical data review, we will perform a cost-consequences analysis assessing the comparative intervention and hospital costs and outcomes associated with providing and not providing iHOST over the study period. Hospital episodes will be costed using NHS Reference Costs, whereas NHS staff time will be costed using information from the Personal Social Services Research Unit (PSSRU). C. Qualitative process evaluation - We will conduct a process evaluation at both intervention sites to assess iHOST acceptability, perceived impact on practice, barriers and facilitators to implementation and uptake and contextual and un/anticipated mechanisms of change. Methods comprise: - In-depth interviews with 8 PWUO and 6 providers at 4 sites (n=32 PWUO; 24 providers): the 2 intervention hospitals and 2 linked drug treatment services. - Observations of iHOST delivery at each site and at the linked DTS. We will develop an observation tool/template comprising categories identified in phase 1 (for example, types and frequency of patient provider interactions, use of the My Meds card, management and recording of DAMA). Fieldnotes will also be taken of observations (narrative accounts). No audio recordings will take place during observations and no names or identifiers will be included in fieldnotes. D. PPI / logic model and theory development - At the end of each phase we will hold a workshop with our PPI group, to feedback findings to date and collaboratively develop our logic model and cultural safety framework. Phase 4 [months 29-36]: Dissemination. Sites UCLH, JSUH, RSUH and linked drug treatment services. A. Co-produce final iHOST toolkit - We will hold a co-production workshop at each site (n= 3, London, Staffordshire, Leeds) to disseminate findings, consolidate lessons, co-produce & finalise outputs with 18 PWUO & 12 providers (n=30) - In collaboration with Exchange Supplies, our Advisory Board and PPI group we will finalise protocols and/or hard copies of card, helpline, policy template and training module for dissemination; develop an implementation toolkit for dissemination of iHOST to other NHS trusts and online live webinar training and slide-sets to accompany the toolkit targeted at commissioners, drug treatment providers, hospital consultants, A&E, pharmacy and high burden wards. B. Multi-disciplinary dissemination and policy advocacy - We will produce a policy-orientated health service delivery report and disseminate findings, and policy advocacy through meetings and webinars involving UK Health Security Agency and Office for Health Improvement and Disparities; National Drug Treatment Providers; Specialist Pharmacy Service; NHS England, Royal College of General Practitioners; ICS commissioners; Royal Pharmaceutical Society; College of Mental Health Pharmacy and Royal College of Psychiatrists. - Working with our PPI group we will co-produce a resource aimed at people who use drugs, to be designed by Linnell publications |
| Intervention type | Other |
| Primary outcome measure | Measured using patient records: 1. Discharge against medical advice (measured at hospital discharge) 2. Emergency readmission at any hospital in England (measured in the 28 days after discharge). |
| Secondary outcome measures | Measured using patient records: 1. Provision of opioid substitution therapy (OST) 2. Dose of OST 3. Duration between admission and provision of OST 4. Records of illicit substance use while admitted to hospital |
| Overall study start date | 01/03/2022 |
| Overall study end date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 746; UK Sample Size: 746 |
| Participant inclusion criteria | PWUO: 1. People who have a history of opioid use for non-medical reasons AND/OR are prescribed OST in a community setting for illicit opioid dependence 2. Aged 18 years or over 3. Assessed as capable to consent (not in debilitating withdrawal or intoxicated) 4. Presenting at A&E, an acute admissions ward or inpatient at one of the hospital sites OR a client at one of the linked drug treatment services Providers: 1. Healthcare staff involved in the prescribing, supply or administration of medicines to patients within A&E, acute admissions and high-burden inpatient wards 2. Staff at linked drug treatment services |
| Participant exclusion criteria | 1. People who are under 18 years of age 2. In secure services 3. Lacking capacity for informed consent 4. No history of opioid dependence 5. (For providers) are not involved in OST-related service provision |
| Recruitment start date | 01/11/2022 |
| Recruitment end date | 31/03/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
NW1 2PG
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Sponsor information
Hospital/treatment centre
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 2079272626 |
|---|---|
| rgio@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Not expected to be made available |
| Publication and dissemination plan | 1. The iHOST toolkit • The staff training module will be hosted on the Exchange Supplies training platform. It will be free to access by NHS staff, and contribute to CPD. We will seek to have this endorsed by NICE • iHOST champion role description and resource pack for NHS Trusts. • My Meds card template, purchase and information links for drug treatment services/commissioners • Policy framework template and best practice guidelines for OST provision in secondary care settings. • Dedicated patient and provider OST helpline, incorporated in Release’s advocacy support services. 2. Cultural safety framework developed with PWUO over the research duration. 3. Peer-reviewed publications (systematic review, protocol, policy review paper, > 3 findings papers) 4. Articles in publications aimed at: addiction specialists; healthcare providers and PWUO. 5. Resource designed by Linnell publications, informed by PPI and targeted toward PWUO. 6. International and national conference presentations. 7. Full study report detailing the research, findings and its policy, managerial and practice implications. 8. Project blog/website and Twitter account to disseminate lay information about the study. |
| IPD sharing plan | Researchers can apply to NHS Digital to use this resource using the DARS service (https://digital.nhs.uk/services/data-access-request-service-dars). The data are not publicly available to protect patient confidentiality. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 04/02/2022 | 11/07/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 18/11/2024 | 05/12/2024 | Yes | No |
Additional files
Editorial Notes
05/12/2024: Publication reference added.
13/11/2024: The recruitment end date was changed from 30/11/2024 to 31/03/2025.
1. The recruitment end date was changed from 01/08/2024 to 30/11/2024.
2. The overall study end date was changed from 28/02/2025 to 31/05/2025.
3. The intention to publish date was changed from 30/03/2026 to 30/06/2026.
26/02/2024: Website was added.
24/11/2022: The scientific contact's details have been updated.
15/08/2022: Internal review.
05/08/2022: The study contact has been updated and the plain English summary has been updated accordingly.
04/07/2022: Trial's existence confirmed by the NIHR.
