Barriers to care Adverse Event Protocol

Created 7.20.2012

Version # 1

Barriers to Care Adverse Event Protocol

1. Summary of Barriers to Care Adverse Event Protocol

The Barriers to Care adverse event protocol can be summarized as the following steps:

1. Identification of an adverse event

   • An interviewer hears the respondent indicate immediate or future harm to self

2. Handling an adverse event

   • The interviewer will ask the respondent if she would like to be transferred to a hotline and/or provide hotline numbers

3. Documenting an adverse event

   • Once the respondent is off the phone the interviewer will fill out an electronic form to submit to the on-duty DataStat call center supervisor

4. Reporting an adverse event

   • Once the supervisor receives an electronic adverse event form from an interviewer the supervisor will e-mail the report to the COTR and other VHA representatives (TBD).

The adverse event protocol will be considered complete when an e-mail notification is sent.

*Outside of the adverse event protocol, the DataStat Project Manager will e-mail the COTR and Project Manager the next business day to generally report the adverse event and details of the protocol execution (Any problems with delivering the encrypted file? Etc.)

2. Identifying an Adverse Event

During the course of a CATI interview the respondent may indicate harm to self or others. It is necessary to identify these incidents to ensure that the veteran receives help. Adverse events can be classified as the following:

1. Immediate or future harm to self

Examples:

"I am considering suicide, as I am going through a divorce and not able to see my children".

“I would like someone to follow up with me because I feel suicidal.”

2. Immediate or future harm to others

Example: “I want to go shoot someone.”

3. Handling an Adverse Event

1. The DataStat interviewer identifies an adverse event

2. The DataStat interviewer then does the following:

1. Offers to provide the respondent with the following numbers or connect them directly. *if the respondent does not wish to be connected, the interviewer will not transfer her, but will greatly encourage the respondent to contact a helpline.

• The National Suicide Prevention Hotline 1-800-273-TALK (8255). 

• For information about VA benefits, you may call the VA Telephone Assistance Service at 1-800-827-1000.

• For information about VA healthcare benefits, you may call the VA Health Revenue Center at 1-877-222-8387.

*If the respondent does not wish to be transferred to a hotline the interviewer will use his/her best judgment and/or discuss with the respondent whether to continue or terminate the survey.

3. After the respondent is off the line, the DataStat interviewer will initiate the adverse event reporting form via the CATI program. Some elements of the form will be automatically populated. The form will contain the following information:

1. Survey name (automatic)

2. Short, written summary of the event (interviewer)

3. Respondent was/was not connected to a helpline (interviewer)

4. Date/time of the threat (automatic)

5. Respondent information (automatic –from sample data)

   1. Name

   2. Telephone number

4. When complete, the form will be automatically sent electronically to the on-duty DataStat supervisor with high alert.

5. The supervisor will edit the written summary for clarification and submit the report in an e-mail to the COTR and Altarum Project Manager. The COTR and Altarum Project Manager will have an agreed-upon, static password for adverse event files.

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