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COSP Multi-Site Research Design Overview
Section 9: Consumer Data Collection 
& Treatment Documentation

 

Index
9.1               Common Protocol 
9.2               Domains
9.3               Origins of the Instruments used in the Common Protocol
9.4               References
    Exhibit 9.1
9.5               Pilot Testing of Common Protocol
9.6               Training of Interviewers
    Exhibit 9.5

9.1 Common Protocol

To maximize the potential for pooling data within the multi-site study, each of the study sites utilizes a Common Protocol (CP) for collecting information from persons enrolled in the COSP study. The Common Protocol instrument includes questions which are designed to collect a range of information, including information about individual background and experience and outcomes that are likely to result from using consumer operated services or mental health programs. The CP was developed with extensive involvement of the Research Subcommittee, a variety of Subcommittees which worked under the auspices of the Research Subcommittee, three separate polls to generate input about potential instruments, involvement of the COSP Steering Committee, and an extensive multi-site pilot.

The basic approach of the multi-site study involves using two different Common Protocols: the Baseline Common Protocol administered upon enrollment to each participant, and the Follow-up Common Protocol administered on at least two occasions (4 and 8 months post-Baseline).

The Baseline Common Protocol (BCP) is administered to each person who has agreed to participate in the COSP Study immediately upon their agreement to participate and before their randomization to one or the other of the two study conditions. For each participant, the protocol is administered in a face-to-face interview prior to their enrollment within the target consumer-operated service within the area. The intention is that this interview will provide true baseline (i.e. prior to COS exposure) on a variety of different constructs. The baseline interview begins by providing the study participant with background to the study as a whole. It continues by eliciting demographic information, including employment, and education. It asks about lifetime and more recent service use. It asks questions about outcomes which the GFA has deemed as important, including: satisfaction, housing, employment, empowerment, and health. In addition, it asks about quality of life, attitudes toward recovery, symptoms and hope.

The Follow-up Common Protocol (Follow-up CP) is administered to each participant on at least two occasions: 4 months after the BCP and 8 months after the BCP. The Steering Committee decided that all sites will administer the follow-up protocol at 4 and 8 months. In addition, a number of study sites participating in the COSP expect to administer the Follow-up CP at additional time points, including 12 months and others. Items included in the Follow-up CP represent a subset of items in the Baseline CP. Items that are time invariant are not included in the Follow-up CP. All other questions, including questions about service use and all of the outcomes, will be administered at the second and third time points to trace the impact of participation in the consumer operated service and mental health service over time.

Instruments were selected for inclusion in the CP on the basis of ten criteria articulated by the Research Committee. These criteria include:

1 Appropriateness: Does the instrument or item measure what the members of the Steering Committee thought was appropriate, given the stated purposes of the GFA and the project?

2 Reliability: Does the instrument measure the concept in a consistent and stable way? The instruments selected for inclusion should display good inter-rater and test-retest reliability.

3 Validity: Is there a good fit between an operationalized definition and the concept it is purported to measure?

4 Sensitivity to change: Because the COSP Multisite Research Initiative will be investigating change in 4 month intervals, is the instrument reasonably sensitive to change during that period?

5 Reactivity: To what extent does use of the instrument create change within the subject which would be likely to influence results?

6 Cultural competence: Are the tools free of offensive language, and reasonably well understood by potential participants of all cultural and ethnic backgrounds?

7 Time to complete: Are instruments economical in their use of the time of consumer participants and interviewers, maximizing the information return for every minute added to the CP?

8 Burden to consumer: Related to the previous item, does the CP limit burden on consumers by limiting the time to administer the full CP to a reasonable overall limit?

9 Clarity: Does the instrument avoid questions in which responses would be difficult or impossible to clearly interpret? For example, does it avoid double-barreled questions which ask about two things at once?

10 Consumer involvement in development: Did the instruments involve consumer in the development of the instrument? Instruments which included consumers in the development process may be somewhat more sensitive to issues which consumers feel are relevant.

Of course, it is impossible to maximize each of these criteria simultaneously, and the instrument selection process included many opportunities to weigh these criteria. The process of developing the CP involved extensive involvement of a variety of individuals from each study site, the coordinating center, and the federal representatives to the COSP initiative. Initial steps to outline the responsibilities and timeline were laid out by the Research Subcommittee, one of the three standing Subcommittees of the COSP. To facilitate the process, the Research Subcommittee divided its work among several Subcommittees, including: Demographics/Employment/ Substance Abuse, Satisfaction/Quality of Life, Empowerment and Housing. In addition, ad hoc committees were formed to carry out particular tasks.

Each Subcommittee was responsible for: (1) reviewing the instruments the eight study sites had proposed in their proposals as well as searching out other appropriate instruments to consider; (2) collecting information about these instruments; (3) weighing each of these instruments on the basis of the 10 criteria listed; and (4) providing recommendations in the form of proposed items for inclusion in the CP to the Research Committee. In some cases, where the Subcommittee was unable to come up with a single recommendation, it presented the Research Subcommittee with several alternatives.

After reviewing pieces submitted by the Research Committee, the Coordinating Center put together an initial draft of the CP for review and discussion by the Steering Committee as a whole. Steering Committee review of the Baseline CP was accomplished through discussion during a number of Steering Committee Meetings, but also through a formal process of generating input on selection of particular instruments. Three polls were taken to review the CP. These were developed by the Coordinating Center, and results of these polls were distributed by the Coordinating Center: The CP Evaluation provided an opportunity for steering committee members to provide feedback on the overall suitability of items and measures for the CPs; the CP Consumer Information Evaluation provided an opportunity for consumer participants in the COSP initiative to provide feedback according to the extent that particular instruments were consistent with values delineated within a consumer research perspective, including relevancy, sensitivity, and involvement of consumers in the development of the instrument; and the CP Scientific Evaluation in which COSP participants with training, education and experience in scientific evaluation of instruments provided feedback on appropriateness of candidate instruments on the basis of scientific issues such as reliability, validity, appropriateness for study group, etc. Final decisions about about inclusion were made through a unanimous vote of the full Steering Committee.

 

9.2 Domains in the Common Protocol

The following domains represented in the CP as described in Chapter 4.1. Though the GFA required the inclusion of only 5 domains, members of the Steering Committee went go beyond that requirement, taking a more comprehensive approach to the added benefit of consumer-operated services. As the populations that each COSP serve vary considerably from rural Tennessee to urban Pennsylvania and Florida, the most critical issues for these populations also vary considerably. Therefore, the final decision of the domains to explore was based on a need to address the full range of issues affecting consumers in the all sites of the project.

The order of the CP was discussed at great length. The steering committee wanted to create a user-friendly instrument. The document begins with demographic items that open up conversation and that do not present too many difficulties. Items of greatest interest to consumers are then addressed (i.e. employment, finances and entitlement, housing and satisfaction). The next section deals with some of the more difficult items to discuss (i.e. social inclusion, social acceptance, discrimination, quality of life and symptoms). The steering committee discussed the importance of ending on a positive note and therefore the instruments that address recovery, meaning of life and hope conclude the CP.

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