Table 2.
Major protocol changes
| Description | Date |
|---|---|
| Remuneration for counseling sessions 3–6 was added to protocol based on participant feedback that their participation was limited because phone calls were using up limited cell phone minutes | 11/12/2018 |
| Provision of study issued cell phones to participants without other telephone access was added to the protocol to increase recruitment | 7/31/2019 |
| Protocol was updated to allow for recruitment of patients hospitalized for ACS related treatment or complications within 30 days of an index ACS event. This change was made to increase recruitment, particularly of those who are discharged quickly following index ACS but have a planned return for revascularization treatment | 9/24/2019 |
| Participants living more than a 1.5 h drive away were allowed to participate if they were willing to do all post-discharge study procedures remotely, including bio-verification of smoking status via mail. This change was made to increase recruitment and because a device (i.e., the Bedfont iCO Smokerlyzer®) that allows for remote measurement of exhaled carbon monoxide had recently become available | 9/24/2019 |
| The protocol was updated to allow recruitment and consent up to 1-week post-discharge. This change was made due to COVID-19 related hospital inpatient unit access restrictions | 5/4/2020 |
| Procedures allowing for remote (i.e., without in person contact) written consent were added to the protocol. These changes allowed for the consent discussion via phone with signed documents mailed, scanned, or dropped off/picked up with no in person contact. This change was made due to COVID-19 related restrictions | 5/4/2020 |
| The original protocol hypothesized group differences in intermediate cardiac outcomes (i.e., blood pressure, HDL-cholesterol, fibrinogen, and high sensitivity C-reactive protein). These measures were originally collected via in person blood draws at outcome assessments. Due to COVID-19 restrictions on in person visits, collection of these outcomes was suspended on 3/17/2020. Collection of these outcomes was dropped permanently from the study protocol in 7/8/21 due to significant missing data and continued participant preference for remote visits due to COVID-19 | 3/17/2020 (collection suspended) |
| 7/8/21 (removed from protocol) | |
| The protocol was updated to allow for digital signing of consent and HIPAA forms allowable (via REDCap). This change was made to streamline the remote consent process | 8/7/2020 |
| Secure Zoom video conferencing allowed for all contacts as needed | 8/7/2020 |