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Tuesday, October 30, 2012

In the Federal Register Oct 31st: yet another healthcare workflow study proposal

A mere $800k ("$799,929" to be "exact"; props to EHR Intelligence).

Billing Code 4160-90-M

Agency for Healthcare Research and Quality

SUMMARY: This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: "Using Health Information Technology in Practice Redesign: Impact of Health Information Technology on Workflow." In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The Agency for Healthcare Research and Quality (AHRQ) is a lead Federal agency in developing and disseminating evidence and evidence-based tools on how health information technology (IT) can improve health care quality, safety, efficiency, and effectiveness.

Health IT has the potential to improve the quality, safety, efficiency, and effectiveness of care. In particular, health IT can aid health care professionals in improving care delivery by redesigning care processes to be more effective and efficient (e.g., engaging care settings in practice redesign). The use of health IT to support practice redesign requires a deep understanding of the interaction between health IT and workflow, ideally through a human factors and socio-technical framework.
Unfortunately, these health IT-workflow interactions are poorly understood and the research to date has largely focused on large academic medical centers and large health maintenance organizations, while the impact of health IT on workflow in smaller, ambulatory care practices is not well studied.

To that end, AHRQ conducted an in-depth study of existing research and evidence in the area of the impact of health IT on workflow, its linkage to clinician adoption, and its links to the safety, quality, efficiency, and effectiveness of care delivery. However, most of the articles found were not focused directly on workflow, so the quality of evidence related to workflow change varied substantially. The majority of studies described research completed in large clinics affiliated with academic medical centers, health maintenance organizations or national health systems outside the U.S., limiting applicability to other settings, particularly small and medium-sized primary care and other ambulatory care settings. Also, most of the studies did not use a scientifically rigorous design. Finally, most of the literature did not include descriptions of the socio-technical context of health IT implementations and use, making it difficult to understand the role of potentially conflating or mediating factors such as training, technical support, and organizational culture.

These gaps and limitations of existing research study designs and findings related to health IT and workflow limit the relevance and quality of the available evidence for health care organizations wishing to effectively implement health IT systems to support current work without negatively affecting existing workflow processes. The existing evidence is of equally limited utility to those organizations seeking to use health IT systems to support redesign of their ambulatory care settings.

The goal of the project is to understand the impact of implementing health IT-enabled care coordination on workflow within small community-based primary care clinics in various stages of practice redesign. The focus of this study is the interaction of health IT and care coordination workflow in the context of practice redesign. This study will focus on clinic staff caring for patients with diabetes within small primary care clinics to understand enablers and barriers to care coordination workflow through the use of health IT.

The study will be conducted over a 14-month period in six Vanderbilt University Medical Center (VUMC) affiliated-clinics that each have an electronic health record (EHR) but are in different phases of introducing the health IT component of a care coordination redesign program called My Health Team (MHT). MHT was launched at Vanderbilt University Medical Center to redesign ambulatory care delivery for patients with three chronic conditions (diabetes, hypertension, and congestive heart failure) through intensified patient engagement, dedicated care coordinators, and specific health IT tools to facilitate scalable chronic disease management. The health IT component of MHT, layered on a mature EHR, enables (1) diabetes, hypertension and congestive heart failure registries, (2) a shared view of the care plan for the patient among clinical staff, (3) alerts and reminders to track patients' acute care episodes, (4) closed-loop feedback of patient self-management through at-home physiological monitoring and two-way electronic clinical messaging (via the patient portal), and (5) frequent patient contact with coordinators in between physician visits by telephone and using a secure patient portal.

This study is intended to address existing gaps and generate findings of particular relevance to health IT and workflow by employing a mixed-methods, theoretically-grounded research design that focuses on the socio-technical factors in smaller, ambulatory care settings.
Combining this formal approach with iterative observations and analysis across six clinics for 14 months will generate a detailed understanding of changes in health IT workflow interaction for each clinic over time, and across clinics in various implementation phases (pre-MHT, early-MHT, or mature-MHT). Each clinic will be observed at two time points: the first (time = 0 months) to capture baseline interactions, and the second (time = 12 months) to capture interactions later in adoption. Although each clinic will be observed over a period of 12 months, the total study period will span 14 months to allow for staggered observation windows for the clinics. All clinics are anticipated to exhibit changes to health IT-workflow interactions over time given that learning and efforts to streamline workflow at each practice are ongoing. The early-MHT clinics, engaged actively in practice redesign, will be observed at a third time point — midway between the first and second observation period — since more changes, and possibly more rapid changes in workflow and the use of health IT could occur. The 6-month interval between observation periods was chosen based on prior experience with MHT implementation in which many adoption changes occur during a 3-5 month period during practice redesign. Thus, in clinics anticipated to experience slower change, an observation period of one year is anticipated to allow capture of workflow patterns that have occurred; in fast-changing clinics, a 6-month observation interval will improve capture of key interactions.

This study is being conducted by AHRQ through its contractor, RTI International, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2)...
What's not to love? (in particular the all-important "Billing Code")
Method of Collection
To achieve the goals of this project the following activities will be carried out:

1) Project orientation meeting—Researchers will hold an orientation meeting for clinic staff to introduce them to the study. Up to ten staff members at each clinic will be asked to participate in the orientation meetings. During the orientation meeting, research staff will explain the purpose of the study, provide an overview of the study schedule, explain processes for recruiting individual clinic staff to participate, and answer any questions that clinic staff might have.
2) Direct observation by researchers of clinic staff performing care coordination activities with patients, caregivers, and providers to capture their workflow, health IT usage, and work processes. A total of 14 observation periods will take place across the six clinics. Each site will have an initial observation period that occurs over several weeks, with an estimated 60 hours of observation time per site. The two sites in the early MHT phase of implementation will also have a middle observation period (at 6 months), and all six sites will have a final observation period (at 12 months). The middle and final observation periods, which build on data gathered during the initial observation period, are shorter—approximately 30 hours of observation per site, because observations will be more targeted as a result of the previously collected contextual data.
Observations will be recorded on the Direct Observation Field Notes Form. This data collection will not burden the clinic staff and is not included in the burden estimates in Exhibit 1.
3) Artifact and spatial data collection—Artifacts such as paper notes or forms, or reminder postcards identified by researchers during direct observations as relevant to understanding workflow and health IT, will be collected.
Spatial data, such as still photographs of the workplace and/or objects in the workplace, will be collected to augment observation data. These will enable the researcher to capture spatial relationships and other dimensions, such as the proximity of work stations, exam rooms, and technology. For example, a health IT tool may include the functionality to print information to give to the patient, but if the printer is not conveniently located for the user, busy clinic staff may choose not to use this function. An image or drawing of this spatial relationship can be included in the data and will be coded in the data analysis phase. The choice of using a photograph or a drawing will be dependent upon the type of information that is needed to better understand the context of the workflow. For example, to capture the overall configuration of the workspace, photographs will be taken. When other information such as process flows are being captured, the observer will draw a sketch of that process. This may include the steps that a nurse takes to retrieve a patient chart, call the patient from the waiting room, escort the patient to a station where vital signs are measured, and escort them to an exam room.
Artifacts and spatial data will be used to enrich the understanding of the environment in which care coordination activities and health IT interact and will add information that is important for modeling workflow. This data collection will not burden the clinic staff and is not included in the burden estimates in Exhibit 1.
4) Semi-structured individual interviews and surveys with clinic staff to further understand their use of health information technology and work routines. During each observation period, up to six staff members at each clinic will be
asked to participate in semi-structured interviews and to complete the Technology Assessment Model (TAM) survey. The interview will address up to five key topic areas: demographics; general experience with technology; work routines; interactions with computers in the work context; and strategies for dealing with unanticipated health IT or workflow challenges. The survey will be used to consistently assess the staff attitudes that may impact their experience of using health IT and adapting workflow to their needs.
5) Semi-structured interviews and surveys with patients with diabetes to gather information from patients as participant-observers of clinical workflow and health IT, to understand the impact of work processes on their experience of care, and to identify enablers and barriers in clinic work processes from their perspective. During the initial observation period in each clinic, and during the final observation period in two of the clinics (early-MHT), eight patients with diabetes will be invited to participate in semi-structured interviews and to complete the Patient Activation Measure and Summary of Diabetes Self-Care Activities surveys (64 patients total). Since fewer changes are anticipated in the pre-MHT and mature-MHT clinics, patients will be interviewed at baseline only in these four clinics. Since the pre-MHT and mature-MHT clinics will not undergo changes in technology during the study period, it is anticipated that saturation of patient experiences and observations of workflow, technology use and interactions will occur during the initial observation period. Greater changes are anticipated at the early-MHT clinics as they adopt MHT, therefore, patient interviews will be conducted at these two clinics twice. The purpose of the patient interviews is to gather information from patients as participant- observers of clinical workflow and health IT, to understand the impact on their experience of care, and to identify enablers and barriers in work processes from their perspective. The interviews will address six key areas related to care coordination, including (1) general care experience; (2) patient workflow; (3) information needs; (4) barriers; (5) strategies; (6) evaluation. The Patient Activation Measure (PAM) and Summary of Diabetes Self-Care Activities (SDSCA) surveys will be used to understand patient motivation for self-care and the potential impact on care processes and workflows.
The focus of this research is anticipated to be relevant to many other settings in which health IT is used to support care coordination activities for diabetes and other chronic conditions. This focus is especially important given the cost and illness burden of diabetes. Information collected by the study will help researchers and practitioners better understand the impact of workflow and health IT in ambulatory care practices.
The lessons learned from this research may be used in a variety of ways: 1) to identify additional workflow components that ambulatory practices should consider when implementing health IT systems; 2) to identify issues to address in best practice guidelines health IT implementation; and 3) to identify issues for consideration in the design and evaluation of other health IT tools.
The study findings will be widely disseminated to health IT researchers and implementers via AHRQ's National Resource Center for Health IT Website, e-mail alerts, and conference presentations.
See any crippling methodology "generalizability" problems here? Need I enumerate?


I reported on our self-described "Lead Federal Agency" back in March: "Yet another federal public comment period announcement." See also specifically "ObamaScare Section 5405," subsection "More HH$ News." (scroll down).


No one can accuse me of being oblivious to or dismissive of the need for continual evaluation/re-evaluation of any and all processes. If health care delivery processes are not systematically improved, health care outcomes improvement will be spotty and random.

I am troubled, though, by what looks to be the prospect of federally funded, marginally scientific (to be charitable) "Plan-Study-Study-Study-Study-Study-Study-Study..."

More shortly. I just got home.

OCT 31st a.m. UPDATE

Lots of wonderfully rendered stuff. Caveat emptor on the scientific substance, though.
Reflecting on Our IT Progress
Oct 31, 2012, John D. Halamka MD, Life as a CIO Blog, re-posted

In a time of EHR naysayers, mean-spirited election year politics, and press misinterpretation (ONC and CMS do not intend to relax patient engagement provisions), it's important that we all send a unified message about our progress on the national priorities we've developed by consensus.

1.   Query-based exchange - every country in the world that I've advised (Japan, China, New Zealand, Scotland/UK, Norway, Sweden, Canada,  and Singapore)  has started with push-based exchange,replacing paper and fax machines with standards-based technology and policy.   Once "push" is done and builds confidence with stakeholders, "pull" or query-response exchange is the obvious next step.  Although there are gaps to be filled, we can and should make progress on this next phase of exchange.   The naysayers need to realize that there is a process for advancing interoperability and we'll all working as fast as we can.   Query-based exchange will be built on top of the foundation created by Meaningful Use Stage 1 and 2.

2.  Billing - although several reports have linked EHRs to billing fraud/abuse and the recent OIG survey seeks to explore the connection between EHR implementation and increased reimbursement, the real issue is that EHRs, when implemented properly, can enhance clinical documentation.  The work of the next two years as we prepare for ICD-10 is to embrace emerging natural language processing technologies and structured data entry to create highly reproducible/auditable clinical documentation that supports the billing process.  Meaningful Use Stage 1 and 2 have added content and vocabulary standards that will ensure future documentation is much more codified.

3.  Safety - some have argued that electronic health records introduce new errors and safety concerns.  Although it is true that bad software implemented badly can cause harm, the vast majority of certified EHR technology enhances workflow and reduces error.  Meaningful Use Stage 1 and 2 enhance medication accuracy and create a foundation for improved decision support.  The HealtheDecisions initiative will bring us guidelines/protocols that add substantial safety to today's EHRs.

4.  Privacy and Security - some have argued that EHRs reduce security by making records available in electronic form, possibly over internet connections.   Efforts to enhance certification of the security of EHRs, encrypt data at rest, and create guidance for EHR modules that interoperate with built in security will further protect the data that needs to be shared for care coordination and population health.

5. Innovation - some have argued that meaningful use led to the growth of a small number of vendors and dependency/lock in with those vendors.    Meaningful Use Stage 2 requires interoperability between vendors, export of data from EHRs to reduce lock in, and standards that will enable a new generation of modular "plug ins".   I'm confident that SHARP grant funded work, like the SMART initiative will lead to an ecosystem of applications from small vendors - an app store for health.

Thus, our mantra should be that Meaningful Use Stage 1 and 2 have created a foundation for query-based exchange, accurate billing, safety, security, and innovation.

Stage 3 work is already in progress and from the early thinking that I've seen (will post a blog about that in a few weeks), the trajectory of Meaningful Use will address all the naysayers concerns.
Life as a CIO Blog (John D. Halamka MD) / CC BY-NC-SA 3.0
Lots of issues. Much work to be done.

But, as JD Kleinke observes on THCB in a comment:
The operating realities of Obamacare beneath the mile-thick river of ideological spew against it are all sheer paradox: Obamacare, precisely like Romneycare, is based on previously conservative, market-based ideas about people taking responsibility for carrying private insurance – belatedly standardized to bring transparency and price competition to bear on the process – and about people getting access to it through markets corrected for distortions like medical discrimination and unaffordability by the working poor...

...If people would stop hyperventilating for a moment, they’d realize that Obamacare is nothing more or less than a violent endorsement and expansion than the status quo. How else to explain the deafening quiet from the insurers, drug companies, AMA, AHA? The only reason the Rs hate it is because it contains, thanks to their two-year sneer campaign since its passage, “Obama” in the name. The law could contain free care for all (which it certainly does not) and a cure for all cancers (nor the mandate that IPAB work to preclude finding one) and none of that would matter. The law has been turned into a political football for two sides of the American polity that seem to want to agree and cooperate on exactly nothing these days. Here in DC, scoring points rather than solving problems is the ONLY goal – and for that, we ALL suffer.

3.1 Security Components
In order to provide the security capabilities needed to enable the scenarios described in Section 2, every mobile device requires a set of security components—foundational security elements that can be leveraged by the device, OS, and applications. This section provides a concise overview of the three required security components: Roots of Trust (RoTs), an application programming interface (API) to expose the RoTs to the platform, and a Policy Enforcement Engine (PEnE). Section 4 of this document describes how these primitives will be leveraged by three new security capabilities: device integrity, isolation, and protected storage.
3.1.1 Roots of Trust (RoTs)
Roots of Trust (RoTs) are the foundation of assurance of the trustworthiness of a mobile device. As such, RoTs are security primitives composed of hardware, firmware and/or software that provide a set of trusted, security-critical functions. They must always behave in an expected manner because their misbehavior cannot be detected.
Well, okee-dokee. Hmmm... Emphasis mine.

More to come...

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