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Pre-operative behavioural intervention for risky drinkers before elective orthopaedic surgery

PRE-OPerative Behavioural Intervention for Risky Drinkers before elective orthopaedic Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36257982
Enrollment
122
Registered
2016-01-06
Start date
2016-03-01
Completion date
Unknown
Last updated
2020-06-01

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

Conditions

Risky drinking Mental and Behavioural Disorders

Interventions

Behavioural Intervention. The intervention will be delivered over two sessions – the first session will last approximately 30 minutes, while the second session will be an optional, booster session and

Sponsors

The Newcastle upon Tyne Hospital NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Screening and Intervention Health Care Professionals: 1. Currently employed in the primary centre as a preoperative assessment nurse 2. Willing and able to attend study specific training Health Care Professionals Focus Groups: 1. Currently involved in the orthopaedic patient pathway in one of the three centres identified for the RCT Patient Participants: 1. Adults aged = 18 years listed for elective primary hip or knee arthroplasty 2. Patients scoring = 8 on AUDIT and at least weekly drinking of 6 units or more in one session 3. Capacity to provide informed written consent 4. Ability to write and converse in English (able to understand English sufficiently to complete the study questionnaires without the need for an interpreter)

Exclusion criteria

Exclusion criteria: Health Care Professionals: 1. Those not willing to consent to audio recordings of intervention sessions which are required for fidelity assessment Patient Participants: 1. Patients scoring <8 on AUDIT 2. Patients who do not consume 6 units of alcohol or more in one session at least weekly 3. Patients likely to undergo sequential (on different dates) joint replacements (for bilateral disease) within the scope of the proposal (due to reduced availability for 6 month follow up) 4. Patients displaying current (active) withdrawal from alcohol; these individuals will be referred for review by an addiction psychiatrist 5. Severe psychiatric disorder requiring medical therapy and severe cognitive impairment/dementia impacting on ability to interact with intervention and increasing likelihood of postoperative delirium

Design outcomes

Primary

MeasureTime frame
Feasibility Study (Phase 1): 1. Acceptability and feasibility assessment of themes identified in Framework analysis of staff and patient interview transcripts. External Pilot RCT (Phase 2): Primary outcome measures to judge the success of the external pilot: Recruitment and randomisation rates defined by; 1. Proportion of eligible patients who agree to participate in the trial and 2. Proportion of enrolled patients successfully followed up 6 months after baseline assessment

Secondary

MeasureTime frame
Feasibility Study (Phase 1): 1. Fidelity of delivery assessment via audio recordings of interventions delivered 2. Characterisation assessment of themes identified in Framework analysis of focus group transcripts External Pilot RCT (Phase 2): 1. Rates of eligibility and reasons for ineligibility (captured through screening logs) 2. Acceptability of the study design including attendance rates at the second session, completion of outcome measures, retention and reasons for drop-outs; as well as via qualitative work 3. Alcohol consumption as measured by AUDIT score at preoperative assessment (baseline), before surgery (night before or day of surgery), at 6 weeks post-surgery and at 6 months after preoperative assessment

Countries

United Kingdom

Contacts

Public ContactNicola Goudie

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026