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Safe administration of medicines intervention: a feasibility study

Safe Administration of Medicines Intervention (SAM-I): a feasibility study of an intervention to de-implement unnecessary double-checking of medicines in hospital

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40487014
Enrollment
1080
Registered
2026-08-07
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Public health Other

Interventions

The intervention is a structured, ward-level approach to reducing routine double-checking and support safe, single-checking for medication administration. It targets ward-level policies and systems, s

Sponsors

Bradford Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ward inclusion criteria: 1. NHS-funded inpatient wards within a participating NHS Trust 2. Wards where medicines administration is frequent and routinely undertaken by nursing staff 3. Wards where double-checking of medicines is embedded within local policy and/or established practice 4. Wards able to support implementation of the intervention, including staff training, policy updates and ward-level engagement activities 5. Wards able to support feasibility data collection, including structured observation of medication administration and access to relevant routine data sources (e.g., ePMA and incident reporting systems) Staff participant inclusion criteria: Staff will be eligible to participate in observation and qualitative evaluation components if they meet the following criteria: 1. Employed (permanent, bank or agency) within a participating ward/service during the study period 2. Directly involved in medicines preparation, administration or supporting the double-checking process (e.g., registered nurses, nurse associates) 3. Aged 18 years or over, consistent with their professional role 4. Willing and able to provide informed consent to participate in observations and other evaluation activities (e.g., questionnaires or interviews where applicable) We will aim to recruit staff representing a range of professional seniority and experience (from newly qualified to senior nurses), diverse ethnic backgrounds, and both substantive ward staff and those working bank or agency shifts to reflect the typical ward workforce. Patients: With CAG approval in place, case note review will be conducted for patients whose medication administration episodes are observed. This will allow comparison between observed practice and prescribed medicines without requiring individual patient consent in order to calculate primary and secondary outcomes. Where paediatric or neonatal wards are included, this may involve review of records for patients under the age of 18 years. Only the minimum necessary patient-identifiable information will be temporarily accessed for linkage purposes, in accordance with CAG approval and data governance procedures.

Exclusion criteria

Exclusion criteria: Patients: Patients will not be directly recruited; however, case note review will not be undertaken where: 1. The medication administration episode was not observed as part of the study 2. The patient (or parent/guardian, where applicable) has exercised their right to opt out of the use of their data for research purposes Only the minimum necessary information will be accessed under CAG approval, in line with approved governance procedures.

Design outcomes

Primary

MeasureTime frame
Observed medication administration errors measured using the SAM-I Case Note Review Form at pre- (month [M] 0) and post-implementation (M8-10), recording observed errors where a double-check would previously have been mandated by policy. This will be recorded as 'yes' or 'no' per observed medication administration.

Secondary

MeasureTime frame
1. Nurse attitudes to single-checking measured using the validated Single Checking and Administration of Medications Scale (SCAMS-II) at pre- (M0) and post-implementation (M8-10) 2. Omission of care measured using the care left undone scale at pre- (M0) and post-implementation (M8-10) 3. Double-checking practices measured using the SAM-I Observational Tool at pre- (M0) and post-implementation (M8-10) 4. Service readiness for single checking measured using a checklist and single binary measure at pre-implementation (M0) 5. Length of patient stays measured using routine data collection from electronic Prescribing and Medication Administration systems (ePMA) at post-implementation (M8-10) 6. Reported patient safety incidents (medication-related) measured using routine data collection from Local Risk Management Systems (LRMS) at post-implementation (M8-10) 7. Time spent implementing checks measured using the SAM-I Observational Tool at pre- (M0) and post-implementation (M8-10) 8. Delays in time-critical administrations measured using routine data collection from electronic Prescribing and Medication Administration systems (ePMA) at post-implementation

Countries

England, United Kingdom

Contacts

Public ContactLynn McVey
lynn.mcvey@bthft.nhs.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 25, 2026