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Steering Committee Meeting Notes:
December 7, 1999

8:15 a.m. – 1:00 p.m.

Embassy Suites

Washington, D.C.

Putting Baseline Common Protocol “To Bed”

The Consumer Advisory Panel (CAP) moved to adopt the revised introduction to the common protocol.  Greg Teague offered a friendly amendment to modified the language to indicate that study results will be sent to respondents “if they wish.”  CAP accepted the amendment.

It was clarified that in the paragraph in the introduction that addresses respondents who might be a danger to themselves or others that sites can refer respondents back to their TMHS provider and therefore the list of providers offered can consist of a single provider.

Mark Salzer expressed concern that the new introduction mentioned the national study and the eight study sites.  He believed this would complicate things in Pennsylvania.  Tom Summerfelt said when he first read the statement, he thought it was repetitious.  Jo-Anne O’Connor said from a consumer’s perspective, she believed telling the person he/she is part of building a collaborative process is important.  Mark said the language would make it necessary for Pennsylvania to try to explain the relationship between the Coordinating Center and local site.  Ed Kramer pointed out that part of the appeal for participation in the study is that respondents know they will be joining their brothers and sites in eight sites to make a difference.  Betsy McDonel said we need to raise multi-site consciousness.  Mark moved to remove the third sentence of the first paragraph of the introduction.  The motion was not seconded. Mark withdrew it.

The motion to adopt the revised introduction to the common protocol with the amendments was passed with no objections.  Consensus was reached.

Jo-Anne moved to keep the employment section question “Is having a paying job important to you?” in the baseline protocol and remove the question “why” that comes after the negative response and add a question that asks the respondents to tell more about their answer regardless if they answered affirmatively or not.  In addition a process will be formed whereby the Demographic and Qualitative Work Groups will review responses to that question for development of a follow-up response set.  The motion was seconded by Ruth Ralph and passed.

Follow-up Common Protocol

Tom indicated that the Research Subcommittee reviewed R.O.W.’s recommendations for the follow-up common protocol.  The follow-up protocol must be completed by February 11.  During a discussion with the Steering Committee, the following action was taken:

1.      The first page of the follow-up common protocol was changed to reflect the revised introduction developed by the CAP.

2.      The gender item will be removed.  There were no objections from the Steering Committee.

3.      Date of birth will be asked for the purpose of identification verification check.  There were no objections from the Steering Committee.

4.      The race and ethnicity questions will be removed.  There were no objections from the Steering Committee.

5.      The primary language question will be removed.  There were no objections from the Steering Committee.

6.      The sexual orientation question will be removed.  There were no objections from the Steering Committee.

7.      It was agreed that education needs to be assessed so the Demographic/Employment Work Group was asked to identify some wording and to structure the timeframe that will be asked about by January 15, 2000.  One point of discussion was that some people may have entered school or completed a degree during the four-month period between the interviews.

8.      The military question will be removed.  There were no objections by the Steering Committee.

9.      The question regarding what would make your life better right now was assigned to the Qualitative Research Subcommittee Group for revision.  Suggestions included letting the responses to the baseline form the follow-up question or asking how much better your life is now compared to 4 months ago. 

10.  The employment question will be changed to “Have you been employed at any time during the past 4 months?  There were no objections by the Steering Committee.

11.  The question “Is having a paying job important to you?” was sent to the Demographic and Qualitative Research Work Groups for formulation of a follow-up question.

12.  In the housing section, respondents will be asked “Have you been homeless at any time in the past 4 months?”  There were no objections by the Steering Committee.

13.  The consumer-operated service satisfaction section will be added to the follow-up protocol after the traditional mental health services satisfaction section.  Sites will be allowed to use the name of their COSPs for this section.  In addition to NANS and NASK, a “not applicable” column will be added to the table for sites like Iowa.  There were no objections by the Steering Committee.

14.  Mark indicated that the Steering Committee had voted previously to take out the wording “as a direct result of traditional mental health services…” in the satisfaction section, but that the wording had not been changed in the baseline protocol.  He will check the meeting notes. 

15.  The following questions will be removed from the lifetime service use section: #2-11.  There were no objections.  The CP Formatting Work Group will review placement of the medication questions in the follow-up protocol. 

16.  The service utilization grid will not be added to the follow-up protocol.  There were no objections by the Steering Committee.

Sally Rogers asked if the program activities section will be used for the cost study.  She said the section does not map to the way people do billing and reimbursement.  She asked if the information would be used to validate billing reimbursement or Medicaid data.  Brian Yates indicated that the program activities section will not be used for validation of the cost information, but that the service utilization section will.  A data analysis plan for the cost study was requested so that the Cost Analysis Subcommittee’s intentions are clear.

Tom said in the next two weeks, the Research Subcommittee will go through the follow-up protocol to review the timeframe issue and come up with other suggestions for issues like use of the words “traditional services.”  Florida said its TMHS provider does not want to be referred to as providing “traditional services.”  Sita Diehl suggested expanding the reference in the Q-by-Q to traditional services rather than changing the common protocol.

It was mentioned that additional interviewer instructions are needed for the program activities section so interviewers know to ask about additional programs beyond the first one mentioned by the respondent.  Jean suggested that this recommendation be posted on the interviewer listserv. 

In addition, Sarah Diwan suggested that the timeline developed for service utilization be used throughout the common protocol.  This will also be posted on the interviewer listserv.

Tom assigned sections of the follow-up protocol to the Coordinating Center and study sites so that they could make sure the timeframe is correct and consider putting in “at any time” if it is appropriate.  The recommendations should be sent to the Coordinating Center.

Zahira DuVall introduced a resolution to the effect that the Steering Committee is pleased with the follow-up common protocol, but will be open to minor editing of the questions.  There were no objections.

Progress Reports

Publications Work Group

Pat Corrigan indicated that the current work of the group is to draft a policy for the dissemination of information.  An interim policy was developed, but now the group is charged with coming up with a permanent policy.  He said the group is trying to promote dissemination and not suppress it.  Another task is to decide how to archive publications and presentation information.  The Coordinating Center will house the archive, but the group needs to figure out how to get the materials to the Coordinating Center.

The group would like to promote minority opinions and the diversity of perspectives, but would also promote caution in what is submitted, especially in terms of research protocol up front.  The group is struggling with its review function—currently it reviews everything that is going out for publication or presentation, but it does not want to be put into the position of turning down items.  There is a question about what the review function means and who owns what in terms of intellectual property.

The group is also trying to determine priorities (i.e., do certain articles have to be written first before others are written?) The housing multi-site study has core papers that have to be written before anything else.  The group adopted the “Mark Salzer procedure” for moving ahead with work that involves the selection of two reasonable people to develop proposed drafts for review by the entire work group.  Pat and Ruth Ralph were assigned to come up with some preliminary draft language for review by the work group.   In addition, Mark and Jean Campbell will draft a dispute policy.

Pat said another question was what role does the work group have in maintaining policy.  Betsy McDonel reminded the work group that it makes recommendations to the Steering Committee and not decisions. Therefore, controversial issues end up back with the Steering Committee for a decision.

The work group reviewed a set of slides/overheads developed by the Coordinating Center for use during presentations.  They will be posted on the website and a diskette can be provided to the study sites upon request. 

Sarah moved to amend the interim policy to allow the Publications Work Group to post a periodic summary of what it is reviewing on the listserv.  The summary would include the title, author, date, time, and intent for use.  Presentations on site-specific topics will be excluded.  Any comments provided will be related to facts only and will not attempt to change the author’s style.  The motion was seconded.  There were no objections.  Consensus was reached.

Jean encouraged anyone interested in publication/presentation issues to join the work group.

Logistics Subcommittee Group

Sally Rogers reported that the group discussed randomization procedures, the tracking database, how old a diagnosis could be, a protocol for recycling respondents back through the study, and a draft screening questionnaire.

Issues related to randomization included taking the burden of randomization off the interviewer, ensuring a random process, and ensuring balanced control and experimental groups given small waves.  A question that remains is if the sites have different randomization and blocking procedures, can the data still be pooled?

After a discussion about a centralized randomization number, the group decided it would not be feasible and that local control over randomization is best.  Each study site must describe in detail the exact mechanics of randomization and send it to the Logistics Subcommittee Group by December 13.  This description should include blocking procedures.

During the last face-to-face meeting, Joe Rogers raised the question about how old the diagnosis could be that is secured from the traditional mental health service provider.  The group discussed this and decided that study sites should obtain the most recent diagnosis and that a place be designated in the common protocol database to record both Axis I and Axis II diagnoses.

Protocols need to be developed for when people withdraw from the study and decide to re-enter—in other words, they are recycled through the study.  Under the intent-to-serve approach, anyone who is randomized is a study participant and must be followed even if he/she goes to the COSP once and never returns.  Anyone who is randomized is in the study unless he/she tells us otherwise.  It is necessary to maximize retention of respondents so that our ability to detect effect won’t be reduced if a lot of people stop going to the COSP.  “Hard refusals” are people who withdraw from the research –they will be called “administrative withdrawals.”

Administrative withdrawals can be replaced in the pool if there is no ability for them to obtain the intervention, otherwise we can’t do early replacements due to issues of differential withdrawal.  Some scenarios will be compiled.

In regard to the screening questionnaire, the first two pages of the draft are not mandatory.  Every site should have a summary of the inclusion/exclusion criteria form completed for every study participant.

Some new issues that will be addressed by the Logistics Subcommittee Group are (1) should consents be reviewed or administered at each interview, (2) should there be a blind study, and (3) should each interview be followed by a validity review.

There were no objections to the group’s recommendation on diagnoses.  Consensus was reached.

There were no objections to the group’s recommendation to adopt the intent-to-serve approach.  Consensus was reached.

There were no objections to the group’s recommendation to adopt study withdrawal and recycling procedures.  Consensus was reached.

In regard to tracking, there are several types of tracking that need to take place.  First, each site needs to track the number of people approached, the number of people who are randomized, etc.  This information will go on the quarterly report and be sent to the Coordinating Center. 

Second, study sites need tickler systems to make sure those individuals who need to be interviewed at follow-up are contacted.

Third, information about withdrawal, cross over, inability to complete interview, etc. is needed for the common protocol database.  Tom presented an example of a tracking system that has been developed by Tennessee. 

Any site interested in Tennessee’s database was asked to contact Tom.  He said a users’ manual can be developed jointly.  Betsy discouraged cost sharing because of its complexity.  Sally Rogers said the study sites can establish consulting agreements with Tennessee’s programmer.  Betsy advised that clarification on this be sought from grants management.

Sally suggested that if all study sites bought into Tennessee’s database, this would be one way to establish a common process for submitting information to the Coordinating Center.  Crystal asked that some time be given next month to how the information will be transmitted to the Coordinating Center.  It was suggested that a list of the recommended data fields be posted to the listserv within the next few weeks to reach agreement on what fields and what information will be transmitted to the Coordinating Center and when.

Assignments

Daphne Walker-Thoth posted a list of assignments generated during the face-to-face meeting.  It will be typed and posted to the listserv after Tom has attached some deadlines to the tasks.  The assignment list was reviewed and some additional tasks added.

Sita recommended that SAMHSA host the multi-site summit because the COSP is such a small group.  Matt Johnsen suggested that somehow it be tied to the June COSP Steering Committee meeting.  Jean said the Coordinating Center will work with SAMHSA to explore options and evaluate its own resources for accomplishing the task.  Tom will be involved in the exploration as the chair of the Steering Committee.

Time Lines

A Supplement Work Group will be formed to explore overall timelines.  Anyone interested in participating in the work group should e-mail Tom.  The work group will be prepared to make some recommendations during a January Steering Committee teleconference.

This group will address issues such as when is the deadline to finish the common protocol follow-up interviews, when is the deadline for taking the last case for the multi-site study, when is the last date to be able to add on a 12-month data collection period, at what rate do sites need to enroll study participants, what is the deadline for submitting the last data to the Coordinating Center.  The official end of the COSP is August 2002.  Betsy needs four months’ notice to determine if CMHS can supplement some of the study activities.  It was mentioned that all study participants might have to be enrolled between January and December of 2000.  Connecticut can not enroll 160 people in a year.

Jean mentioned that there is an expectation that a conference will be held at which the study data will be presented—it might have to be moved back.

Future Face-to-Face Meetings

Several members expressed the desire for the face-to-face meetings to be less intense.  Crystal asked how all of the work could be accomplished and suggested that a week might be needed to get everything done instead of 2½ days.  Sally Rogers said she didn’t think we could get much more efficient at the face-to-face meetings, but did think we need to have regular Steering Committee and Logistics Subcommittee Group teleconferences.  She is willing to help absorb some of the costs for Logistics teleconferences so that the work gets done.

The following suggestions were made about the face-to-face meetings and teleconferences:

1.      When the rough draft of the face-to-face agenda is posted by the Coordinating Center, read it and make specific recommendations on how to re-organize it. (Tom Summerfelt)

2.      Use a couple of people to get the bulk of the work done – the “Mark Salzer procedure” -- so we don’t have to re-hash issues. (Ed Kramer)

3.      Consider giving up the practice of everyone having to be involved in everything so that we can be more efficient. (Betsy McDonel)

4.      During Year 03, stop meeting on the weekends and move the winter meeting to Florida. (Dianne Cote)

5.      Each site create a mini-teleconference so only one line has to be used for each site for teleconferences.  The people who are not voting members of the Steering Committee could travel to the site where the voter is for the calls. The sites could invest in the conference speakerphones. Each subcommittee and work group will be given a teleconference budget. (Brian McCorkle, Janine Elkanich)

6.      Change the length of the face-to-face meeting on the last day so that members can stay until the end of the meeting.  This might require some sites staying over an additional night, but would ensure that a quorum is present. (Jean Campbell)

Rotation of Subcommittee and Work Group Chairs

The question was raised on evaluation forms from the August face-to-face meeting about whether chairs of subcommittee and work groups would be rotated. 

The Steering Committee decided that this decision is left up to each individual group.  If the chair wants to resign, this would force the group to fill the vacancy.  Consensus was reached.