Table 7 Major protocol revisions, rationale, and dates
Protocol domain | Protocol revision | Rationale | Date approved |
|---|---|---|---|
Behavioral Health Screener | Added items to behavioral health screener to increase sensitivity in detecting potential behavioral health issues. Additional items assess healthcare behavior, chronic stress, and chronic disease related distress | We expanded the screener to detect other behavioral health concerns that we felt the original screener was missing, thus increasing the pool of eligible patients who can benefit from the program | The amendment was approved on 10/27/2016 |
Retention | Began sending a letter to participants in our intervention group when unable to contact for telephone follow up | When unable to contact participants through other means, we send a letter reminding them of available services, and asking them to contact us if desired | The amendment was approved on 10/27/2016 |
Baseline and follow-up surveys | Housing status item added to baseline and follow-up (3 and 6 month) surveys | Housing and homelessness are important factors that may affect program outcome | The amendment was approved on 1/24/2017 |
Retention | Began using a public search directory to update phone numbers and contact information when not available from medical records | This change was enacted to maximize participants’ benefit from the intervention, which takes place in part by phone, and to maximize data quality and completeness for outcome assessment | The amendment was approved on 1/24/2017 |