The baseline version of the Common Protocol (CP) will be administered to all participants who sign an Informed Consent and agree to be in the study.  The date of the baseline interview becomes the index date from which all subsequent interview appointments should be calculated.  The target dates for data collection should not be altered if the intervention does not start in a timely way, as it may not in at least one site. The Follow-up version of the CP should be re-administered at 4 months, 8 and 12 months post the baseline date of administration. The 12 month follow-up is optional but highly recommended.

Data Collection Window

A one-month window around data collection points for follow up is acceptable.  Sites can conduct the follow-up interviews anywhere between one month before the collection period to one month after the collection period.  For example, for the 4-month data 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. Calculations can then be made from the date of the baseline to the date of any particular follow-up to determine what percentage are outside of the acceptable window.

Spanish Version of Common Protocol

Two sites may need for translation of the common protocol into Spanish: Connecticut and Florida. Any site having concerns about needing the Common Protocol in a language other than English should contact the Coordinating Center. Since we are presently unsure of the demand for the Common Protocol in a language other than English, the CC will not translate it at the present time until contacted by a site.

Confidentiality Certificate

Every site should apply for a Confidentiality Certificate from SAMSHA.  Appendix A contains information about the Confidentiality Certificate.  The Certificate provides some protection for participants in research studies to help keep the information they provide confidential and prevent it from being summoned by a court of law if the research participant is involved in a criminal justice proceeding.  Each site must apply for the Confidentiality Certificate when their local IRB’s have signed off on the project and on the Informed Consent.  Please note that there is specific language that is required in an Informed Consent to obtain a Confidentiality Certificate.

Exclusion and Inclusion Criteria

            COS Involvement

More than minimal involvement in the past 6 months in a COS similar to the ones under study (i.e., drop-in centers, education and advocacy programs and peer support programs) results in exclusion from the study.  “Minimal involvement” is defined as more than three visits/meetings at COSP like those under study.  In order to qualify as a COS, the program has to meet the definition of COSP using the first three common ingredients structural criteria (see Appendix B).

TMHS Involvement

In order to be included in the study, the GFA states a potential participant must be a recipient of traditional mental health services for at least one year.  The individual does not need to be a recipient of services with the same TMHS provider, but must have been on a TMHS roster during that period.  The traditional mental health services involvement must meet three core criteria: recency, longevity, and intensity. 

1)      RECENCY OF INVOLVEMENT (an individual coming into the study would have to have had received services within the past 4 months prior to the date of “application” to the study);

2)      LONGEVITY (an individual coming into the study would have had to be involved with a TMHS provider for a full 12 months prior to the date of application to the study);

3)      FREQUENCY (an individual coming into the study would have to have received services at least 4 times in the past year, for example, 4 visits with a case manager, 4 visits for medication checks, etc.).

            TMHS Diagnosis

Participants in this study must meet the diagnostic criteria in the GFA which states that the target population for this grant is individuals with a serious mental illness.  Therefore, applicants to the study must have a DSM-IV Axis I diagnosis of serious mental illness.  Co-occurring substance abuse disorders are acceptable for entrance as long as the person has a mental health diagnosis in addition to their substance abuse diagnosis.  Severe mental illness is usually defined as meeting three criteria: diagnosis, duration, and disability. Certain DSM-IV diagnoses are usually associated with severe disability: schizophrenia, schizoaffective disorders, any diagnosis with psychotic features, major depression, and some personality disorders.  In addition, duration is usually a factor in determining disability, with two years being the commonly accepted cutoff.  Finally, functional impairment (disability) as a result of the diagnosis is needed.  Criteria two and three (duration and disability) are difficult to ascertain when simply screening for entry.  Therefore, we must rely primarily on diagnosis for inclusion.

Sites may impose additional inclusion and exclusion criteria as long as they do not conflict with these basic criteria.

In their recruitment, sites should target the programs and people within the TMH system that serve people with major mental illness. Baseline data on diagnosis and functional impairment (e.g., employment status) should be examined by individual sites and by the multi-site study after 3 months of data collection, and periodically thereafter to insure that we are reaching our intended population for the study in conformance with the GFA.

Guardianship

We recognize that the ability to give informed consent and to successfully participate in this project is not necessarily limited by guardianship status (that is, some individuals without guardians may not be able to give full and knowing consent while some individuals with guardians may).  Unless an individual site’s IRB has required that they exclude individuals with guardian’s, every attempt should be made to include those individuals in their recruitment process. At the time of this draft manual, two sites planned to exclude individuals with guardians (FL possibly, and ME) but they will revisit their procedures.  The TN tracking database will allow us to track the number of individuals with guardians who apply for the study.

Recording Diagnosis for the Data Repository

The collection of an individual’s mental health diagnosis will not be made during the face-to-face interviews with the participants in the study.  Each study site must make arrangements to collect diagnosis from the TMH provider.  Each site should use the data entry structure created by the Data Repository committee to enter diagnositic information. This will allow merging of the diagnostic information with the data from the CP.  Every attempt should be made to obtain the most complete and up-to-date diagnosis possible.  All Axis I and Axis II diagnoses should be recorded. Three fields for Axis I and three fields for recording Axis II diagnoses using the numbering nomenclature found in the DSM-IV (e.g., 395.80) will be available.

Screening for Exclusion and Inclusion Criteria

Appendix C contains a copy of a Screening Questionnaire that can be used by sites to insure that they are screening in and screening out people who might not be eligible for the study based on the criteria in the GFA.  Use of this Screening Questionnaire is not mandatory, however, each site must have a way of tracking the screening criteria on the last page of the Questionnaire for reporting to the CC.  All sites should send a copy of their final, complete inclusion/exclusion criteria to the CC.

Randomization Procedures

Randomization to the experimental (COS + TMHS) and control (TMHS only) will occur after the baseline CP is administered.

A multi-site randomization process was not agreed upon: sites will block on gender and will generate their own randomization schedules based on gender.   Sites are free to add blocking variables to the randomization process as long as they document their randomization procedures for the CC. Sites should guard against any attempts to influence the random assignment of participants by having the PI closely monitor the process, by taking the random assignment out of the hands of the interviewers, and by developing procedures that are “game-proof”.

Appendix D contains a summary of the randomization procedures across sites and an example of a randomization schedule that can be generated by Proc Plan using SAS software.  Any site needing technical assistance to carry out their randomization procedures should contact ROW Sciences.  Any site needing a randomization schedule can contact Sally Rogers at Boston University.

Intention-to-Serve Analysis

The overall study approach agreed upon was an “intention-to-serve” (a.k.a., Intention to Treat) design where all individuals enrolled in the study will be tracked regardless of the amount of each condition they receive. This approach has power implications.  (That is, the more individuals who are randomized to the COS condition that don’t participate in it, the less likely we will see a difference between the COS + TMHS and the TMHS group alone.) 

Therefore, it is important that each site emphasize strategies to maximize the retention of study participants in the respective conditions.  Secondly, whatever each site can do within ethical constraints to keep crossover to a minimum will help preserve the power of the study. If individuals refuse to participate in a scheduled follow-up interview, the interviewer must assess whether the individual simply does not want to participate on that day, or is refusing participation for the duration of the study.  The interviewer should make several attempts (being sensitive to the individual’s wishes and rights as a research participant) to complete a follow-up interview, unless the individual emphatically refuses.

“Administrative withdrawals” are individuals who cannot participate in the study condition to which they are assigned (e.g., they are arrested shortly after random assignment and would not be able to receive either COS or the TMH service).  For these individuals we can do early replacement of them in the study, meaning we can treat them as though they were never in the study and randomly assign someone else to take their place. We cannot do any other kind of replacement of participants since we are using an “intention to serve” approach.  Some sites may over-sample to insure they have sufficient power, but they will still track every person entered into the study.

If individuals want to re-enter the study after an administrative withdrawal they will not be allowed to.  If an individual withdraws from the service component, they will still be a research participant.  If a participant wants to withdraw from the research and the services, he or she can do that and request that their data be destroyed.  In that case, locally held data should be destroyed and Matthew Hile should be instructed to delete data from the repository.

Any withdrawal or re-entry scenario that does not fit the above description should be posted to the Logistics Subcommittee listserv for comment and final decision making so that we can keep a log and a protocol for these unusual situations.

Mode of Data Collection

All interviews be conducted in a face-to-face mode rather than self-administered because of concerns about literacy. The paper-and-pencil CP instruments provided by the CC can be used, or computer-assisted interviewing (CAI) can be performed.  Tom Summerfelt, PI of the TN site has the Access program for the computer-assisted interviewing.  Using computer-assisted interviewing conserves resources for data entry, but special steps need to be taken to preserve and back up the data and to verify the data entry.  Data entry verification will not be necessary with CAI. Contact Matthew Hile at the CC at MIMH for the data verification protocol for regular data entry.

Place of Data Collection

The baseline interview with the Common Protocol should not be held at the consumer operated program for any participants.  Because randomization occurs after baseline, we do not want individuals who will be randomly assigned to the control condition to be “exposed” to the experimental condition, nor do we want any particular demand characteristics of the setting to influence the baseline data collection.

Tracking of Participants

The tracking of study applicants needs to occur to provide the information that will be requested by the CC each quarter. Tom Summerfelt, PI of the TN site has developed an Access database and screen program that will track these data elements and generate the reports needed to CMHS.  This tracking software can also be used as a tickler system to help plan and manage the interviews.  Managing the interviews and interviewer resources is critical for having complete datasets.  

Each site is strongly encouraged to use the Tennessee tracking software. Sites that adapt the TN software or develop their own should insure that they can generate reports that provide the information required in the quarterly report and/or any other tracking needs that the CC may have. Rise Goldstein at ROW is the contact person for questions pertaining to tracking.

We will not to track any demographic items on potential participants because they will not have given their permission at that point. 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. Sites can keep track of that information if they choose, but it is not mandatory.