| Outcome . | A priori minimum threshold to progress . | Results . | Go/No-Go . | Response . |
|---|---|---|---|---|
| Intervention retention (intervention feasibility) | 80% of PSP participants complete >2 sessions, complete the card sort, develop an action plan, and complete ≥1 follow-up visit | 60% (6 of 10) eligible, randomized Veterans | No-Go | For future trials, re-evaluate the referral process to peers, consider streamlining delivery, and consider alternative delivery formats |
| Recruitment rate (research feasibility) | Recruits 20 eligible patients over 4 months (5 per month) | Overall: 3.5 per month Initial: 1.8 per month Final: 9.5 per month | Go | Recruitment was changed to fully virtualb and then the recruitment rate met the threshold |
| Assessment retention (research feasibility) | 80% of all enrolled participants complete each follow-up assessment | 75% completed follow-up | No-Go | In future trials increase follow-up efforts to re-engage participants, streamline assessments, and offer more modalities for assessments |
| Staff acceptability | Staff report high acceptability and feasibility | Staff were unable to provide feedback on PSP | Unable to determine | Unable to be determined because of limited primary care staff interaction with the peer |
| Veteran Acceptability | Participants report high acceptability and satisfaction on measures | CSQ-8: high satisfaction; WAI: strong relationship; card-sort acceptability: 12 of 13 good fit | Go | No response needed; Veteran acceptability was high |
| Change in Veteran outcomes (utility) | More PSP (vs. TAU) participants demonstrate improvements consistent with a large effecta | PSP > TAU for proportion with large individual changes on outcomes (see Fig. 2) | Go | No response needed; outcomes were encouraging |
| Outcome . | A priori minimum threshold to progress . | Results . | Go/No-Go . | Response . |
|---|---|---|---|---|
| Intervention retention (intervention feasibility) | 80% of PSP participants complete >2 sessions, complete the card sort, develop an action plan, and complete ≥1 follow-up visit | 60% (6 of 10) eligible, randomized Veterans | No-Go | For future trials, re-evaluate the referral process to peers, consider streamlining delivery, and consider alternative delivery formats |
| Recruitment rate (research feasibility) | Recruits 20 eligible patients over 4 months (5 per month) | Overall: 3.5 per month Initial: 1.8 per month Final: 9.5 per month | Go | Recruitment was changed to fully virtualb and then the recruitment rate met the threshold |
| Assessment retention (research feasibility) | 80% of all enrolled participants complete each follow-up assessment | 75% completed follow-up | No-Go | In future trials increase follow-up efforts to re-engage participants, streamline assessments, and offer more modalities for assessments |
| Staff acceptability | Staff report high acceptability and feasibility | Staff were unable to provide feedback on PSP | Unable to determine | Unable to be determined because of limited primary care staff interaction with the peer |
| Veteran Acceptability | Participants report high acceptability and satisfaction on measures | CSQ-8: high satisfaction; WAI: strong relationship; card-sort acceptability: 12 of 13 good fit | Go | No response needed; Veteran acceptability was high |
| Change in Veteran outcomes (utility) | More PSP (vs. TAU) participants demonstrate improvements consistent with a large effecta | PSP > TAU for proportion with large individual changes on outcomes (see Fig. 2) | Go | No response needed; outcomes were encouraging |
Abbreviations: COVID-19, coronavirus disease; CSQ-8, Client Satisfaction Questionnaire; PSP, Personalized Support for Progress; TAU, treatment as usual; WAI, Working Alliance Inventory.
The original analytic plan was adjusted because the data structure (higher than expected drop-out differentially affecting the PSP group and higher than expected variability affecting normality assumptions) made group analyses for effect size inappropriate. The updated criterion was updated by team consensus after data collection before analysis.
Changes to recruitment methods were already in progress because of problems with the recruitment rate when the trial was temporarily shut down because of restrictions on in-person appointments because of COVID-19 restrictions.
| Outcome . | A priori minimum threshold to progress . | Results . | Go/No-Go . | Response . |
|---|---|---|---|---|
| Intervention retention (intervention feasibility) | 80% of PSP participants complete >2 sessions, complete the card sort, develop an action plan, and complete ≥1 follow-up visit | 60% (6 of 10) eligible, randomized Veterans | No-Go | For future trials, re-evaluate the referral process to peers, consider streamlining delivery, and consider alternative delivery formats |
| Recruitment rate (research feasibility) | Recruits 20 eligible patients over 4 months (5 per month) | Overall: 3.5 per month Initial: 1.8 per month Final: 9.5 per month | Go | Recruitment was changed to fully virtualb and then the recruitment rate met the threshold |
| Assessment retention (research feasibility) | 80% of all enrolled participants complete each follow-up assessment | 75% completed follow-up | No-Go | In future trials increase follow-up efforts to re-engage participants, streamline assessments, and offer more modalities for assessments |
| Staff acceptability | Staff report high acceptability and feasibility | Staff were unable to provide feedback on PSP | Unable to determine | Unable to be determined because of limited primary care staff interaction with the peer |
| Veteran Acceptability | Participants report high acceptability and satisfaction on measures | CSQ-8: high satisfaction; WAI: strong relationship; card-sort acceptability: 12 of 13 good fit | Go | No response needed; Veteran acceptability was high |
| Change in Veteran outcomes (utility) | More PSP (vs. TAU) participants demonstrate improvements consistent with a large effecta | PSP > TAU for proportion with large individual changes on outcomes (see Fig. 2) | Go | No response needed; outcomes were encouraging |
| Outcome . | A priori minimum threshold to progress . | Results . | Go/No-Go . | Response . |
|---|---|---|---|---|
| Intervention retention (intervention feasibility) | 80% of PSP participants complete >2 sessions, complete the card sort, develop an action plan, and complete ≥1 follow-up visit | 60% (6 of 10) eligible, randomized Veterans | No-Go | For future trials, re-evaluate the referral process to peers, consider streamlining delivery, and consider alternative delivery formats |
| Recruitment rate (research feasibility) | Recruits 20 eligible patients over 4 months (5 per month) | Overall: 3.5 per month Initial: 1.8 per month Final: 9.5 per month | Go | Recruitment was changed to fully virtualb and then the recruitment rate met the threshold |
| Assessment retention (research feasibility) | 80% of all enrolled participants complete each follow-up assessment | 75% completed follow-up | No-Go | In future trials increase follow-up efforts to re-engage participants, streamline assessments, and offer more modalities for assessments |
| Staff acceptability | Staff report high acceptability and feasibility | Staff were unable to provide feedback on PSP | Unable to determine | Unable to be determined because of limited primary care staff interaction with the peer |
| Veteran Acceptability | Participants report high acceptability and satisfaction on measures | CSQ-8: high satisfaction; WAI: strong relationship; card-sort acceptability: 12 of 13 good fit | Go | No response needed; Veteran acceptability was high |
| Change in Veteran outcomes (utility) | More PSP (vs. TAU) participants demonstrate improvements consistent with a large effecta | PSP > TAU for proportion with large individual changes on outcomes (see Fig. 2) | Go | No response needed; outcomes were encouraging |
Abbreviations: COVID-19, coronavirus disease; CSQ-8, Client Satisfaction Questionnaire; PSP, Personalized Support for Progress; TAU, treatment as usual; WAI, Working Alliance Inventory.
The original analytic plan was adjusted because the data structure (higher than expected drop-out differentially affecting the PSP group and higher than expected variability affecting normality assumptions) made group analyses for effect size inappropriate. The updated criterion was updated by team consensus after data collection before analysis.
Changes to recruitment methods were already in progress because of problems with the recruitment rate when the trial was temporarily shut down because of restrictions on in-person appointments because of COVID-19 restrictions.
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