Table 1 Summary of major protocol amendments
Date of amendment | Wording pre-amendment | Wording post-amendment |
|---|---|---|
14 October, 2013 | Follow-up at day 91 post-discharge face-to-face interviews by RA at participant’s home. | Follow-up at day 91 post-discharge. |
Telephone or face-to-face interviews by RA at participant’s home. | ||
14 October, 2013 | Follow-up to be completed at day 91 (+/− 3 days) post-discharge. | Follow-up to be completed at day 91 (−7/+28 days) post- discharge. |
14 October, 2013 | Patients excluded at discharge will be excluded from the length of stay (LOS) analysis, but a sensitivity analysis using proxy LOS models will be used to check the robustness of the exclusion. | The final intention-to-treat analysis will include all randomised participants for whom the follow-up assessment of the primary outcome measure is available. Per protocol analysis will include all randomised participants who are deemed to have no protocol violations. |
14 October, 2013 | Additional paragraph. | Modified client services receipt inventory: GP practices may be contacted by the research team to confirm visit data supplied by the participant. |
10 March, 2014. | We propose to conduct the trial on two wards which will give the required numbers within our proposed timetable for the study. | We propose to conduct the trial on two to three wards which will give the required numbers within our proposed timetable for the study. |
10 March, 2014. | Additional paragraph. | The RA will contact the therapist involved with looking after the patient at two time points during the day, from admission onto the ward until the patient is discharged from the ward, and continuing if applicable into the participant’s place of residence for a period of two weeks Data collected will be coded and entered into the database recording total time spent with the patient (face-to-face and non-contact). A summary of location codes will be extrapolated from phase two. |