Agenda:
Roll Call
Research Subcommittee – Greg Teague & Matt Johnsen
Greg Teague announced that minutes from the 12/5/00 call
regarding recruitment issues would be sent to the SC. The Research committee has developed two documents.
One addresses the values and procedures on which baseline analyses
occurs. The other document is a
matrix that defines content, types of analyses, and who is doing to do what.
A Research F2F meeting at R.O.W. in Rockville, Maryland on
January 24 will focus on two areas of concern.
One is the situational analysis with information coming from the
consultants. The committee will be
looking at recruitment to see where things are after the September 2000 F2F, and
they will develop recommendations to present to the SC regarding cross-site
designs and analysis plans. The second issue of concern is the clarification,
refinement, and respecification of the study hypothesis leading to specific
plans for both baseline and longitudinal analysis. Other tasks to be clarified include reliability testing
plans, work plans, and timelines.
Cost subcommittee – Brian Yates
Core Cost study for COSP data is
due on Dec.31 for the months of September, October, and November.
There is not much progress on the Enhanced Cost study since the focus has
been on the Core Cost study for the COSP data. Work has begun on the Core Cost
study for the TMHS, and the committee is trying to develop a list of services
that cost data can be collected on. Some of the problems to be worked out are
what to do about the pharmacy and the residential costs.
The cost study narratives from
the sites are in, and the committee has been working to put them together as one
Cost Study narrative.
The next teleconference is on January 5, 2001.
Logistics
Subcommittee – Sally Rogers & Sarah Diwan
The Logistics Committee will focus on the site recruitment
reports that are sent into the CC. They
plan to synthesize and summarized what works at the different sites, and to
search for creative ways to increase recruitment and engagement.
Sarah Diwan will look at the reasons for the non-attendance of people at
the COSP. Sally Rogers reported
that if sites can submit their data on the Illinois/Tennessee form or a
variation of that form along with their code book by January 15 a summary could
be prepared for discussion by the end of January.
The Study Blind policies and the definitions for tracking
that the SC agreed upon by electronic vote have been added to the Logistics
Manual. An updated copy of the
manual has been sent out to the sites. Jean
Campbell asked that an amendment be added to the Study Blind.
This will go out for an electronic vote.
It was noted that people may be
coming into the study from different recruitment approaches, and it’s possible
the different approaches might be affecting the balance of the experimental and
the control groups. Rita Adkins will be setting up a teleconference with Joe
Sonnefield and Sally Rogers to explore what needs to be done with the
information, and where it should go in the tracking database.
Individuals coming into the study in a dramatically different way than
the sites proposed and/or documented will need to be tracked carefully, and
records on how these people are getting into the study will need to be kept.
The Qualitative Subcommittee reviewed the multi-site
qualitative proposals presented at the September 2000 F2F.
The CC proposal developed by Karen Hirsch on collaboration within the
multi-site was considered problematic due to the level of trust and buy-in that
would be required. In addition, the Federal team’s emphasis on the need to
focus resources on enrollment, engagement, and randomization, lead to the
decision to withdraw the CC’s proposal. The Qualitative Committee will move
forward to work on the analysis strategy for the qualitative questions within
the Baseline and Follow Up protocol.
CAP
- Sally Clay
The CAP drafted a letter for Bob Glover to send to all of
the state commissioners asking for their support of the COSP sites.
The CAP will make a presentation at the NASMHPD Conference in July.
Sally Clay reported that in a CAP call Mike English promised to advocate
for an extension on the project to increase the power of the research.
Betsy McDonel-Herr emphasized that Mike E. wanted people to focus on the
present, and on finding solutions to the recruitment and engagement problems.
She said that if the results show a good scientific effort, Mike would
advocate.
Bonnie Schell made a
motion that “The SC approve the CAP’s request to organize, with the
assistance of researchers, a dialogue between consumer providers and researchers
on respective ways of knowing by consumers and researchers at the April F2F, or
later.” Tom Summerfelt seconded the motion.
Jean Campbell moved to table the motion unless a friendly
amendment could be added that supported the item in theory. Ruth Ralph objected,
and after a brief discussion Pat Corrigan called for the SC to vote:
“Yes” to table the CAP proposal to a later time, or
“NO” to move on to a vote by the SC on the CAP proposal. The motion
to table the discussion did not pass. The motion to have the CAP lead a
discussion between consumer providers and researchers on knowing at the April
F2F, or later, passed 14-2.
Brainstorming on Recruitment – Eugenia Coakley, Judith Cook, Debra Rog
Eugenia Coakley, Judith Cook, and Debra Rog shared
recruitment and enrollment problems experienced in their multisite studies:
1.
A lack of communication with the providers who did not always let the
researchers
know
when housing was available.
2.
Sites need to be more pro-active as to who is eligible for study.
3.
The role of consumers engaging other consumers required removing
language that raised red flags, such as: substance abuse, mental health,
research study, government funded. They
learned to use more user-friendly language to make sure people didn’t think
they had been single out because they have problems.
4.
Provider not making contact with the consumer, or not communicating
well that the consumer should make contact with the researcher. It was noted
that the endorsement of the Primary Care Physician makes a difference when it
comes to trust, buy-in, and assuring people that this is an OK study to
participate in.
Other issues
addressed were funding, extensions, and carry-over funding. Jean Campbell
reminded the SC members that the CC in Missouri was funded for the same length
of time as the sites. Crystal
Blyler said that the COSP should not count on an extension because it is
difficult to secure.
A discussion ensued about whether any inclusion or exclusion criteria was
altered or broadened to get recruitment up.
The only problem reported was with the employment criteria at Eugenia
Coakley’s multisite. Some consumers were working 20-30 hours a week and still
enrolled in the study in order to get the subject fee.
Enrollment solutions that could be of benefit to the COSP project were
suggested. Cut sites that can’t meet their recruitment numbers early because
in the end their data is useless and costly to the multisite study. There needs
to be competition to be in a multisite study. Compare the initial consumers with
those who come into the study later.
There are different models in COSP. There
is no mutant of the basic model in the COSP.
Sites thought they had the power to do their own power
analyses. Even the playing field so that the same assumptions could be used by
all sites. Subsets of the cross-site can be pooled to get power at the site
level. Betsy said the COSP was not in a good position to cluster.
The suggestion was made that an external consultant should come in.
Eugenie, Judith and Debra said more information on the problems and recruitment
numbers of the COSP were needed in order to be of more specific help.
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