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Steering Committee Notes: Nov. 23, 1999
corrected

COSP Steering Committee Teleconference Notes

November 23, 1999

11:00 a.m. – 1:10 p.m. Eastern Time

Present:          Tom Summerfelt (moderator), Crystal Blyler, Jean Campbell, Sally Clay, Pat Corrigan, Dianne Cote, Sita Diehl, Susan Essock, Rise Goldstein, Louetta Hix, Matt Johnsen, David Lambert, Betsy McDonel, Danyelle Mannix, Jo-Anne O’Connor, Ruth Ralph, Sally Rogers, Mark Salzer, Bonnie Schell, Steve Segal, Carol Silverman, Joe Sonnefeld, Greg Teague, Daphne Walker-Thoth  

Purpose of Teleconference

Tom Summerfelt stated that the purpose of the call was to iron out the final logistics issues and afterwards to attend to the outstanding common protocol items.

Data Collection Window

The Logistics Subcommittee Group recommended a one-month window around data collection points for follow up.  Sites can conduct the follow-up interviewsanywhere between one month before the collection period to one month after the collection period.  For example, for the 4-month collection point, sites can collect data from month 3 to month 5.  If interviews take place after the one-month window, the site should still collect the data and earmark it so that it is known it was collected after the grace period.  Consensus was reached—there were no objections.

Spanish Version of Common Protocol

The only site to indicate a possible need for translation of the common protocol into Spanish was Connecticut.  Because all of the classes at the COSP in Connecticut are given in English, participants’ English has to be good enough for them to be involved, so Connecticut is not sure it really needs the common protocol translated.  Daphne Walker-Thoth indicated that the Coordinating Center worked with Jaime Delgado and has identified a translator.  The translator indicated that the document needs to be translated into Spanish and then translated from Spanish back to English to make sure it is done correctly.  Daphne said if none of the sites will use the Spanish version, the Coordinating Center did not need to go through the expense of having the document translated.  California indicated that it may need to have the document in Spanish.  Crystal said that this decision needs to be worked out by the Coordinating Center, Connecticut, and California.

Confidentiality Certificate

The Logistics Subcommittee Group recommended that each study site apply for a confidentiality certificate.  It is not mandated, but strongly recommended.

Consensus was reached—every site will apply for a certificate.

COSP Exclusion Criteria

The Logistics Subcommittee Group recommended that more than minimal involvement in the past 6 months results in exclusion from the study; minimal involvement is defined as more than three visits/meetings at COSP like those under study and that meet the definition of COSP using the first three common ingredients structural criteria.

Consensus was reached.

TMHS Involvement

The Logistics Subcommittee Group recommended that traditional mental health services involvement must meet three core criteria: recentcy, longevity, and intensity.  Study participants must have been involved with any TMHS provider for a minimum of 12 months and received at least four services in the past year and the most recent must have been received in the past four months. Consensus was reached.

Sampling Procedures

Decisions about sampling procedures will be made after the common induction procedure is discussed.

Timing of Randomization

The Logistics Subcommittee Group recommended that randomization occur after baseline or co-incident with it.  Co-incident means randomization will occur within one working day.  Consensus was reached with California noting that some COSPs are closed on Mondays.

Intention-to-Serve Analysis

The Logistics Subcommittee Group recommended that all individuals enrolled in the study will be tracked.  Consensus was reached.

Mode of Data Collection

The Logistics Subcommittee Group recommended that all interviews be conducted face-to-face rather than self-administered because of concerns about literacy.  Consensus was reached.

Tracking of Participants

The tracking of study applicants needs to be resolved before data collection begins in January.  Sally Rogers indicated that the Logistics Subcommittee Group has 10 to 15 items it thinks should be part of tracking, but there are still a few issues that have not been resolved.  We can not track any “sensitive” information because people will not have given their permission at this point.  A distinction was made between the internal tracking databases the study sites are developing and the tracking database that will carry information needed by the multi-site study.  The internal databases will focus on information such as when it is time to conduct follow-up interviews with participants, whereas the multi-site tracking database will include information about such things as how many people were randomized.  There were some objections initially about capturing information such as diagnoses.  After a lengthy discussion, the Steering Committee agreed that:

1.      Rise Goldstein will be the contact person for communications issues related to tracking.  Anyone interested should contact her.

2.      Tom Summerfelt and Matt Johnsen will determine how to address tracking issues (i.e., through a teleconference or at the face-to-face meeting).

3.      Jo-Anne will send the housing tracking database to R.O.W. for review and possible adaptation.

4.      Tom will share the Tennessee tracking database for use by the other study sites.  R.O.W. has the capability to modify the Tennessee database.

5.      It was generally agreed that people who refuse to participate in the study not be asked “why” they refuse.  They might be asked if they are willing to share why they refused, and then if the information is volunteered, it can be used to help improve future recruitment.

Data Collection Waves

A lengthy debate ensued about the proposed 0-month, 4-month, 8-month, and optional 12-month data collection waves.  Although it was recommended and agreed to by the Logistics Subcommittee Group with Pennsylvania doing 0-months, a point in between and 12-months, it was never formally voted on by the Steering Committee. Mark Salzer argued from a research perspective that the 0,4,8,12 month intervals did not make the best sense.  He expressed concern that by not choosing intervals that made sense scientifically, we would compromise the multi-site study.  Susan Essock explained that part of the reason for the intervals was that Connecticut needed to collect data shortly after the end of its advocacy course.  It needed a measurement at the end of the intervention because its intervention is not ongoing.  Tennessee had the same concern.  Pennsylvania, on the other hand, doesn’t expect to see change until further out and is concerned about the expenditure of resources in the first year.  Ruth indicated that Maine concurred with Mark about being able to detect change that occurs further out.

Mark moved that Pennsylvania be allowed to collect data at 0-month, 8-month, and 12-month intervals.  The motion was seconded by Steve Segal.  Betsy expressed concern that whenever a study site becomes an outlier, it contributes less to the multi-site by diluting the power and placing a greater burden on the other sites.  Jean Campbell said the only reason for making an exception is that there is a compelling reason the site can not comply because of logistics.  Pat Corrigan expressed concern about the “slippery slope” and indicated that he could think of 4 or 5 amendments to make on behalf of the Illinois study site. 

The motion failed with 9 votes against, 4 votes in favor, and 1 abstention.

For the record, Mark indicated that this should have been discussed a long time ago and that there had been no indication that what Pennsylvania wanted to do was a problem.  Susan noted that if sites did not budget for 4 collection waves, the requirement now to do 4 could place them into trouble. 

It was determined that California and Pennsylvania would not do the optional 12-month collection point.

The Logistics Subcommittee Group’s original recommendation that 0, 4,8, and an optional but highly recommended 12^th month be adopted as the data wave collection points was considered.  The recommendation passed with 10 votes in favor, 3 votes against, and 1 abstention.

Common Induction and Sampling Procedures

Tom indicated that Greg Teague posted on the listserv a draft of proposed language for the common induction and that Matt Johnsen had distributed a draft at the August Steering Committee face-to-face meeting.  Both drafts fully inform prospective study participants about randomization and what is expected of them. 

The Logistics Subcommittee Group recommended use of a common induction procedure.  Steve Segal expressed major concern with the wording proposed by Greg to reduce cross-over from the control to the experimental group because under California’s managed care system, none of the organizations or agencies participating in the study can discourage people from using services.  Steve said he clearly wants to inform people about randomization, but the language would put California in a detrimental position.  He volunteered to help re-write the language.   He also expressed concern about providing prospective participants with too much information before they commit to becoming involved in the study.  He specifically voiced an objection to giving people a list of crisis resources as part of informed consent—this might discourage them from enrolling.

Jean indicated that from her perspective, she didn’t see the language as prohibiting people from using any kind of service.  She said the wording could be clearer, but that people need to realize that if they enroll in the COSP from the control group, they are dropping out of the study.  She said payment to participants might be construed as being coercive and sites might need to adjust payment so that it isn’t coercive to impoverished participants.

Ruth said it seemed that what Steve was proposing was the minimal set of information that every site could use and then individual sites or groups of sites could add more if they desired. 

Jean moved that a common induction approach be adopted.  Tom seconded the motion.  

The mechanics of whether or not to incorporate this in the informed consent procedure and the specific language can be worked out later.  Steve expressed his concern about voting on an approach without having the specific language first.   The motion passed with 12 votes in favor, 1 vote against, and 1 abstention. 

Next Steps

There was not enough time on the teleconference to address the common protocol issues.   It was decided that a follow-up teleconference will be held Monday, November 29 at 1:30 p.m. Eastern Time for the purpose of reviewing proposals around the common induction, voting on a screening questionnaire, and making decisions about the health, housing, and substance use sections of the common protocol.   Any common induction proposals should be posted on the listserv by Wednesday, November 24. 

Jean pointed out that the Coordinating Center won’t have time to make all of the needed changes and submit the IRB application by December 1 if the teleconference is not until November 29.  The application will have to be submitted January 1, so we probably won’t get approval until February 1.  Matt said there might be some ways to expedite this process.  Sita said if Tennessee doesn’t get into the field by January, it will blow another semester.