Table 1 Feasibility elements of trial procedures and stoppage criteria
Feasibility elements to be evaluated to improve for full-scale triala | |
|---|---|
Trial procedure | Data to be collected |
Recruitment and enrollment procedures | Information on eligible SPIN Cohort participants who consent to be enrolled need to be extracted from the SPIN Cohort platform and integrated with information from participants recruited externally and who enroll via a Qualtrics survey into an Excel tracking sheet. We will evaluate procedure efficiency and accuracy. |
Proportion of eligible participants who consent to participate in trial | In cases where patients who are eligible for SPIN-SELF decline to participate in the feasibility trial, the trial team will collect information on why they declined via Qualtrics, including suggestions to improve recruitment or enrollment procedures. |
Contact protocol adherence | Participants who consent to enroll will be contacted by a member of the SPIN research team to confirm their availability, and answer their questions. All contacts with participants will be tracked. We will evaluate adherence to the contact protocol and whether procedures can be improved. |
Personnel requirements to enroll participants, support facilitators, and help participants accessing the different platforms used (Qualtrics, GoToMeeting, SPIN-SELF) | Should there be barriers in these procedures, personnel input will be collected to identify ways to improve them. |
Intervention enrollment procedure | We will provide intervention group participants access to the SPIN-SELF online program by enrolling them via a user registration platform. This platform will ensure that only intervention participants are granted access to the program. We will conduct an audit of registered users with access and compare to allocation lists every 3 days (during enrollment), and we will evaluate our procedures if errors occur. |
Proportion of eligible patients who consent to participate in the feasibility trial | If fewer than 50% of eligible patients consent to participate in the feasibility trial, the full-scale trial may proceed but barriers will need to be identified to improve participation. Participant feedback will be used to modify recruitment and enrollment procedures accordingly. |
Fidelity of the delivery of the intervention (i.e., group sessions) | We will evaluate fidelity to group session protocols using a pre-established checklist. If sessions are not delivered according to the pre-specified program, the trial team will investigate to identify barriers to the delivery of the intervention and will modify the intervention procedures accordingly. |
Group format of the SPIN-SELF sessions | We will collect feedback from intervention group participants on the format of the intervention (via the CSQ-8 and PEMAT questionnaires). We will also contact trial participants who miss 2 or more group sessions, to inquire why they missed those sessions and ask them what about the trial procedures could have been improved to ensure their attendance. |
Stoppage criteriab | |
Trial procedures | Criteria |
Recruitment and enrollment of trial participants | If participants who are eligible based on their self-efficacy scores (SEMCD ≤ 7.0) are not recorded as eligible in the SPIN Cohort platform and not recruited, then the programming errors in the platform will need to be addressed and procedures will need to be re-set before the full-scale trial can commence. If more than 6 non-eligible participants (15% of 40 enrolled) are erroneously identified as eligible and assigned to the intervention or waitlist control, we will address programming errors, modify our procedures and conduct the full-scale trial as a new trial. |
Fidelity of the delivery of the intervention (i.e., group sessions) | If by the end of the feasibility trial > 20% of the components of the 8 sessions were not delivered according to the pre-specified program, we will investigate to identify barriers to the delivery of the intervention and will modify the intervention procedures accordingly, before proceeding to the full-scale trial. The full-scale trial would need to commence as a new trial. |
Group format of the SPIN-SELF sessions | If participants across groups consistently suggest similar changes to the format of the SPIN-SELF Program, then we will modify the format of the intervention sessions according to this consensus feedback. These modifications would be made before commencing the full-scale trial as a new trial. |