Table 13 Progression criteria
Criteria | Indicator | Method of assessment | Was this achieved? |
|---|---|---|---|
1. Were hospital-based study procedures feasible to deliver and acceptable to staff involved (hospital staff onsite and study staff delivering)? (E.g. referral, recruitment, assessment, SP session delivery) | Progression to be agreed in conjunction with Trial Steering Committee (TSC)1 based on qualitative data captured around experienced and potential barriers to delivery • No current barriers, or those emerging, have been minor, planned for, and overcome in the past during the course of the feasibility study • Some barriers but for which plans have been made/alternatives prepared • Barriers for which no feasible plan or alternative can be offered/developed | Qualitative data collected in SAFETEL intervention provider focus groups, and clinical staff interviews, analysed as part of the process evaluation and reported on to the TSC Barriers identified, and changes made to study protocol as a result will be reported to TSC Given the small number of participants offering qualitative feedback, value will be placed on individual reports of barriers, not simply those barriers that are frequently reported by different participants | Yes The target number of participants was achieved, and all relevant participant medical records were obtained. Feedback from stakeholders indicate that this intervention is acceptable within a hospital setting |
2. Were study procedures feasible to deliver and acceptable to participants (including control arm)? (E.g. recruitment, consent/information given, assessment, safety planning session, follow-up phone calls) | Progression to be agreed in conjunction with Trial Steering Committee (TSC) based on qualitative data captured around experienced and potential barriers to delivery • No current barriers, or those emerging, have been minor, planned for, and overcome in the past during the course of the feasibility study • Some barriers but for which plans have been made/alternatives prepared • Barriers for which no feasible plan or alternative can be offered/developed | Qualitative data collected in SAFETEL study participant interviews (intervention and control arms) analysed as part of the process evaluation and reported on to the TSC Complaints made by participants or relevant adverse events will be recorded and reported on to TSC Given the small number of participants offering qualitative feedback, value will be placed on individual reports of barriers, not simply those barriers that are frequently reported by different participants | Yes Participant interviewees expressed that their involvement in the study (in both arms) was both acceptable and flexible to their needs. No complaints were made from participants, and all adverse events were documented and reviewed |
3. Was it feasible to deliver Safety Plan in the hospital? | Feasibility of intervention delivery • Green: > 90% of Safety Plans delivered at hospital • Amber: 60–90% • Red: < 60% | % of safety plans delivered | 97.5% (n = 78) of participants allocated to the SPI + TAU arm completed the Safety Plan |
4. Was it feasible to deliver 1st follow-up phone call attempt within 72 h? | Was the progression criteria met? • Green: > 90% of first calls made within 72 h of discharge • Amber: 60–90% • Red: < 60% | Feasibility of intervention delivery Research staff attempted to contact 95% of participants in the SPI + TAU arm. Reasons for not attempting contact for the remaining four participants were due to participant unavailability or declining the telephone intervention. In all cases, this was established during baseline contact with the participant | 91.3% of 1st follow-up call delivered within 72 h. Additional qualitative data from SAFETEL intervention provider focus groups, risk log, changes to study protocol identifying barriers, and facilitators to implementation reported to TSC |
5. Was the target rate of recruitment and retention achieved? (Are appropriate and effective routes of recruitment available to achieve a powered sample size in a full trial?) | Actual recruitment rate vs. target Recruitment rate • Green: > 80% of participants • Amber: 60–80% • Red: < 60% | Actual recruitment rate vs. target recruitment rate Actual participant recruitment rate and target recruitment rate will be measured to support projection of a powered sample for a full trial | Yes The recruitment of 120 participants in Phase III was achieved |
6. Was it feasible to attain a minimum dose target required to justify a full trial? | Adherence rates • Green: over 80% • Amber: 60–80% inclusive • Red: less than 60% | Feasibility of attaining minimum dose % of participants who completed minimum dose participation (i.e. SP + 1 follow-up call) | Yes Over 80% of participants engaged with the minimum dose criteria of this study. Therefore, the outcome of these criteria is ‘green’ |
7. Was a target rate of completed baseline measures achieved? | Completion of core measures • Green: more than 90% data completion • Amber: 70–90% inclusive • Red: less than 70% | Completion of core measures • % of participants completed the core questionnaires • % of missing data from completed core questionnaires | Yes A total of 99.99% of all study items were completed by Phase III participants. Therefore, the outcome of this criteria is ‘green’ |
8. Are identified barriers and challenges to implementation of and adherence to the intervention planned for and surmountable? | Progression to be agreed in conjunction with Trial Steering Committee based on qualitative data captured around experienced and potential barriers to implementation of and adherence to the intervention beyond those already captured in criteria 1 and 2. | Process evaluation report SWOT analysis | No major barriers were identified |