Comparing two methods of site initiation for centres recruiting patients into a surgical trial

A nested randomised controlled trial evaluating the cost-effectiveness of two different methods of site initiation in a surgical trial - remote versus on-site visits

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78899574

Enrollment

Registered

2013-05-08

Start date

2013-05-01

Completion date

Unknown

Last updated

2018-11-12

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

Conditions

Trial methodology Not Applicable

Interventions

Hospital sites will be randomised to one of two forms of site initiation: 1. On-site face to face visits 2. Remote initiation via email and telephone correspondence

Eligibility

Inclusion criteria

Inclusion criteria: Hospital sites being contacted to set up to recruit patients into a randomised controlled trial in orthopaedic surgery will be eligible for inclusion.

Exclusion criteria

Exclusion criteria: The hospital site of the Chief Investigator and trial sponsor will be excluded.

Design outcomes

Primary

Measure	Time frame
There is no primary outcome as such and a range of outcomes will be explored descriptively and by trial arm in order to inform the feasibility of undertaking such a comparison across other trials. These include: Set-up: 1. Time from first contact to R&D submission 2. Time from first contact to R&D approval 3. Time from first contact to set-up meeting prior to recruitment commencing Recruitment: 1. Number of eligibility forms returned (estimate of screening activity) 2. Proportion of consenting patients out of eligible patients screened 3. Number of patients recruited: Total 4. Number of patients recruited: For the number of months the last site set up has to recruit 5. Time from first contact to time of first recruited patient per site 6. Time from first contact to average time to recruitment per site 7. Time from first contact to time of recruitment of each patient Data collection: 1. Hospital forms: Proportion returned (after first request and in total) 3. Patient questionnaires: Proportion returned 4. Patient questionnaires: Time to return (after first request and in total)	—

Measure

Time frame

There is no primary outcome as such and a range of outcomes will be explored descriptively and by trial arm in order to inform the feasibility of undertaking such a comparison across other trials. These include: Set-up: 1. Time from first contact to R&D submission 2. Time from first contact to R&D approval 3. Time from first contact to set-up meeting prior to recruitment commencing Recruitment: 1. Number of eligibility forms returned (estimate of screening activity) 2. Proportion of consenting patients out of eligible patients screened 3. Number of patients recruited: Total 4. Number of patients recruited: For the number of months the last site set up has to recruit 5. Time from first contact to time of first recruited patient per site 6. Time from first contact to average time to recruitment per site 7. Time from first contact to time of recruitment of each patient Data collection: 1. Hospital forms: Proportion returned (after first request and in total) 3. Patient questionnaires: Proportion returned 4. Patient questionnaires: Time to return (after first request and in total)

—

Secondary

Measure	Time frame
No secondary outcome measures.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026