Medical Monitoring Project 2012 Protocol

Medical Monitoring Project2012 ProtocolClinical Outcomes TeamBehavioral and Clinical Surveillance BranchDivision of HIV/AIDS PreventionNational Center for HIV/AIDS, Viral Hepatitis, STD, and TB PreventionCenters for Disease Control and PreventionJanuary 2012

ContentsList of Appendices . iiiAbbreviations, Acronyms, and Definitions .ivI. Introduction . 1A. Background . 1B. Purpose and Scope . 2C. Collaborating Agencies and Stakeholders . 3D. Initiation, Duration, and Project Period . 5II. Methods . 5A. Population of Inference . 5B. Population Definition Period (PDP) . 5C. Eligibility Criteria. 61. State and Local Health Departments . 62. Facilities . 63. Patients . 7D. Sampling Methods . 71. First-Stage Sampling. 82. Second-Stage Sampling . 83. Third-Stage Sampling . 14E. Data Collection . 171. Personal Interview. 172. Medical Record Abstraction . 223. Minimal Data . 23III. Data Management and Analysis. 24A. Data Management . 251. Tracking data . 252. Personal interview data . 253. Medical record abstraction data . 274. Minimal data . 285. Analytic data . 29B. Data Analysis . 29IV. Security and Confidentiality of MMP Data . 29V. Human Subjects Considerations . 31A. Non-research Determination . 31B. Anticipated Risks and Benefits . 31C. Vulnerable Populations . 31D. Adverse Events . 32E. Informed Consent . 32VI. Data Dissemination . 33A. Notifying Providers, Patients and the Community of Findings . 33VII. References . 34ii

List of AppendicesAppendix AFirst Stage Project Area SamplingAppendix B.1Guidance for Updating the MMP Facility Sampling Frame (FSF)2009-2013Medical Monitoring Project Guidance for Reconstructing the FacilitySampling Frame 2014-2018Facility Eligibility Determination AlgorithmResponse Sheet for Verification of HIV Facility Eligibility andEstimated Patient Load (for New Facilities)Response Sheet for Verification of HIV Facility Eligibility andEstimated Patient Load (for Facilities in the previous FacilitySampling Frame)Appendix B.2Appendix B.3Appendix B.4Appendix B.5Appendix CProject Area Identification Numbers and AbbreviationsAppendix DSecond Stage Facility SamplingAppendix EThird Stage Patient SamplingAppendix FPatient Sample Sizes by Project AreaAppendix G.1Appendix G.2Appendix G.3Appendix G.4Appendix G.52012 Interview Questionnaire2012 Spanish Interview Questionnaire2012 Short Interview Questionnaire2012 Spanish Short Interview QuestionnaireInterviewer Material ChecklistAppendix H.1Appendix H.2Statement of Informed Consent (English)Statement of Informed Consent (Spanish)Appendix IAppendix JInterviewer Evaluation FormInterjurisdiction Flow ChartAppendix K.1Appendix K.2Appendix L2012 Medical Record Abstraction Module―Medical History Form20112012 Medical Record Abstraction Module―SurveillancePeriod Summary Form20112012 Medical Record Abstraction Module―SurveillancePeriod Visit Form20112012 Medical Record Abstraction Module―SurveillancePeriod Inpatient FormMMP Minimum Data Set FieldsAppendix MNCHHSTP Non-research DeterminationAppendix K.3Appendix K.4iii

Abbreviations, Acronyms, and Definitions2012 datacollectioncycleThe period of time during which MMP interview and medical recordabstraction data will be collected for the 2012 patient sample. Thisperiod of time is from May 1, 2012 through May 31, 2012.Abstraction Software program for collecting MMP medical record data on laptopapplication computers developed by CDC utilizing Visual Basic.net and a Microsoftdatabase engine.ASDAdult/Adolescent Spectrum of HIV DiseaseCAPIComputer Assisted Personal Interview – A method of administeringinterviews in person or over the telephone using a personal computer,typically either a laptop or tablet personal computer.ComputedvariablesComputed variables have values that are the result of arithmetical orlogical manipulations performed using values from other, pre-existingvariables.DCCPortalThe Data Coordinating Center portal allows field staff to securelyexchange data with CDC that are considered sensitive or critical in nature.DesigneffectDesign effect is the increase in statistical variance that is introduced byusing a multi-stage complex sampling design to obtain patient or othersamples. Mathematically, design effect is the variance obtained using acomplex sampling design divided by the variance that would have beenobtained from a simple random sample of the same size. A design effectof 2 means that the variance obtained using a complex sampling designwas twice as large as the variance that would have been obtained from asimple random sample of the same size.EPLEstimated Patient Load - The estimated number of eligible patients in carefor HIV at a facility during the population definition period (PDP). Theseestimates are obtained prior to the end of the PDP from various datasources, including the HIV/AIDS Reporting System (HARS) or theenhanced HIV/AIDS Reporting System (eHARS), laboratory reports ofHIV-related tests, and facility contacts, and are used to select eligiblefacilities for MMP participation.FacilityFor MMP, a facility is defined as any clinic, health care institution, privateor group physician practice that shares common medical records or amedical record system. Thus, a facility is defined in terms of medicalrecord storage, not in terms of a physical location (address) or the namesof individual practitioners. For example, if the 5 physicians who comprise agroup practice keep their patients‟ charts in a single medical recordsystem, that group practice would be considered a single facility for MMP.iv

If, however, each of those 5 physicians stored his/her patients‟ charts in adifferent medical record system from those of the other 4 physicians, theneach physician would be defined as a unique MMP facility. Note thatfacilities must meet additional eligibility requirements for participation inMMP.HAPIHandheld Assisted Personal Interview – A method of administeringinterviews in person or over the telephone using a hand-held personalcomputer.HARSHIV/AIDS Reporting SystemeHARSEnhanced HIV/AIDS Reporting SystemHIV medical For identifying facilities that are eligible for MMP, HIV medical care iscaredefined as conducting CD4 or HIV viral load testing and/or providingprescriptions for antiretroviral medications in the context of treating andmanaging a patient‟s HIV disease on an outpatient basis. Thus, facilitiesproviding HIV care could include outpatient facilities such as hospitalaffiliated clinics, free-standing clinics, and private physician offices; andVeterans Administration facilities. Note that although inpatient facilities,prisons and jails, federal military and penitentiary facilities, and emergencydepartments may provide HIV care, these types of facilities are notconsidered eligible for the 2012 data collection cycle.IRBInstitutional Review BoardMHFMMPMedical History FormMedical Monitoring ProjectMRAMedical Record AbstractionMDSMinimum Data Set – Basic core surveillance information obtained for allsampled patients. This information will be obtained from HARS oreHARS. These data are referred to as minimal data.PDPPopulation Definition Period – For a given year or cycle of data collection,a predetermined period of time which defines the population of inference.The PDP for the 2012 data collection cycle is the 4 month period fromJanuary 1 – April 30, 2012.PDP PLPopulation Definition Period Patient Load - The actual count of individualHIV-infected patients seen at a facility during the PDP (i.e., the total PDPpatient load derived from a facility‟s patient list or lists). These counts willdiffer from the EPLs used to construct the facility sampling frame, becausethe latter only estimate the PDP PL.v

PPSProbability Proportional to Size – A method of sampling in which theprobability of selection for each unit on the sampling frame is proportionalto some measure of size. For the 2012 MMP data collection cycle, themeasure of size for first stage sampling of project areas was the numberof reported living AIDS cases as of December 2002. For second stagesampling of HIV care facilities, it is the best estimate of the number ofeligible HIV-infected patients who received care at each facility during thePDP (i.e., the best EPL obtainable). Thus, in the second stage ofsampling, facilities with more eligible HIV patients have higher selectionprobabilities than facilities with fewer patients.ProviderA provider is an individual health practitioner (physician, nurse, etc.) withina facility (see Facility definition).PSUPrimary Sampling Unit – The element, or entity, that is sampled in the firststage of sampling. For MMP the 50 U.S. states, plus the District ofColumbia and Puerto Rico, were the 52 primary sampling units.QDSQuestionnaire Development System - Software (NOVA ResearchCompany, Bethesda, Maryland) used to develop the MMP interviewquestionnaire applications deployed on laptop and hand-held personalcomputers (see CAPI and HAPI definitions).SamplingframeIn probability sampling, the probability of selection of any element or unit,such as a patient, in the population must be known. In order for selectionprobabilities to be known, a list of population elements is developed fromwhich the sample can be selected. Such a list is called a sampling frameand has the property that every element in the population has a knownchance of being selected for the sample. For multistage sampling, aseparate sampling frame is developed for each stage of sample selection.Each of the sampling frames after the first selection stage does not list allelements in the entire population, however; each subsequent frame onlyincludes the population of elements within a sampled unit from the priorstage of selection. In MMP, patient sampling frames within a project areawill not list all eligible HIV infected persons in care in the project area butonly those in care at the sampled participating facilities. Because theprobability of selection for each facility from which patient lists areobtained is known, the overall probability of selection for each patientselected during the final patient sampling stage can be determined.SDNSecure Data Network – The SDN allows field staff and public healthpartners to securely exchange data with CDC that are consideredsensitive or critical in nature. The SDN will be used for any confidentialcommunication directly from the project areas to CDC.SHASSupplement to HIV/AIDS SurveillanceSHDCSurvey of HIV Disease and Carevi

SHDC-Plus Survey of HIV Disease and Care PlusShortQuestionnaireAbbreviated form of the questionnaire conducted only under limitedcircumstances, such as when a patient is too ill or otherwise unableto complete the longer standard interview, or when translation isrequired.SPIFSurveillance Period Inpatient FormSPSFSurveillance Period Summary FormSPVFSurveillance Period Visit FormStandardQuestionnaireUnabridged form of the questionnaireSurveillance The 12 months prior to patient interview, if the sampled patient wasPeriodinterviewed, or the 12 month period prior to the date of first attempt tocontact the sampled patient, if an interview is not obtained (e.g., theparticipant refused to participate, is known to have died, or is lost tofollow-up).vii