Table 1.
STAGE-12 | POATS | |
---|---|---|
Instructions | Programs were asked to provide this information for a 6-month period by admissions per month. | Programs were asked to provide site information, administrative data, and collect patient information on key eligibility criteria prospective for 30 days. |
| ||
Site Program/Policy | Are there any upcoming changes to policy or resource changes that could negatively impact the stability of the center or participation in the STAGE-12 protocol? | Are there any upcoming changes to policy or resource changes that could negatively impact the stability of the program or participation in the POATS? |
Walk through the intake process from 1st contact to beginning treatment | Does this information reflect a single clinic or multiple clinics? If multiple, how many sites? | |
Describe your current treatment schedule for someone who needs outpatient services in the range of 5–15 hours per week. | Does your CTP work with ERs and/or primary care clinics? (Please include both on-and off-site facilities.) | |
Describe how your program incorporates 12-step programs into therapy? | If yes, how many referrals do you receive from the following per month?
|
|
What are your community resources for 12-step meetings? Do you have AA, NA, CA, and CMA meetings? Are there many of them/enough? | ||
| ||
Study Participant Population | Please provide the total number of patients and the number of stimulant abusers admitted into outpatient treatment, providing 5–15 hours per week, who are not being provided housing as part of the treatment program. | How many opiate dependent patients did your facility admit during the prospective time period?
|
What is the number of patients currently enrolled in your program receiving 5–15 hours per week? | How many of those patients also meet ALL of the following criteria?
|
|
What will you do if you are unable to meet the enrollment requirements of the study through your usual patient flow? | How many of these patients, who did not meet the three criteria described above, how many did not because of:
|
|
In past studies, have you had to advertise for participants? What methods did you use? | ||
| ||
Facility | Will you be conducting any other clinical trials during the course of this study?
|
Are there ongoing or planned trials that would compete with this study for research participants?
|
Is the proposed budget (attached) enough to run the study at your site? | ||
Do you have a place to allow the patient to do the assessments with a separate computer and Internet hookup? | ||
Do you have room for staff from the DSC, CCC and Nodes visits, possibly lasting more than one day? | ||
What kind of space do you have for study procedures (i.e. RA/SC office space and treatment rooms)? | ||
| ||
Staff |
Research Staff: Who will be the Site PI for the study? What experience does the PI have in clinical trials research? Will you have the resources to hire and employ research staff this summer? Does the site have an experienced Research Assistant or Study Coordinator available to help with the study? |
Does your facility have physicians with buprenorphine experience available to treat study patients with buprenorphine over a 2-year period? If yes, how many? |
Therapeutic staff How many therapists do you have in your facility? What kind of burden could participating in this trial have on your therapist staffing? Do you have an idea on the interest level of your staff to participate in this trial? |
Provide details for up to 3 physicians available for the trial, including for each: usage type (detoxification, maintenance, or both), months buprenorphine experience, prior drug trial experience | |
Node Staff What services will your RRTC provide to your site during the course of the study? |
Does your facility have staff to provide weekly individual counseling? If yes, how many counselors are available? | |
| ||
Institutional Review Board (IRB) | How long has it taken, on average, to get a protocol through your IRB for approval? | Information not requested |
How many IRBs do you need to go through (i.e. Node, CTP, etc)? |