Closing quality and value gaps (Part 3).

In Part 1 of this series on evidence-based medicine (The Physician Executive, January/February, 2005, Vol. 31, Issue 1), we described the problem of inappropriate care in the United States and how solutions to cost and quality in health care can be effectively dealt with at the organizational level, and noted that purchasers will be carefully evaluating the details of organizations' quality structures and processes.

In Part II (The Physician Executive, March/April, 2005, Vol. 31, Issue 2) we described in detail how work groups can effectively identify gaps for closing to improve health care quality, cost, satisfaction and uncertainty. We also described the steps involved in critically appraising and synthesizing the medical literature.

We conclude this series by emphasizing the need to analyze both economic and non-economic impacts of proposed changes in the care we deliver and discussing the development of information, decision and action aids. We strongly recommend that professionals working in the quality improvement area develop or acquire useful tools to assist their staff with implementation and measurement.

After examining the published evidence regarding benefits and harms of a potential practice change, the next step in the evidence and value-based clinical improvement process is to assess the possible impacts on cost, quality, satisfaction and other considerations of implementing the change. The sequential steps are outlined in Table 1.

At this point, a value judgment needs to be made. Workgroup leaders or oversight groups are now in an excellent position to decide if the group should proceed with the project, if further modifications should be made or if the project should be stopped.

If the latter, document and summarize your decision, the history of your efforts and your analyses. If the decision is to proceed, the next steps are to create information, decision and action tools that meet the needs of various target groups such as clinicians, patients, leaders and other health care staff. These final steps are outlined in Table 2.

It has been 16 years since Donabedian described the components of quality in terms of people, preferences, systems, effectiveness and the three core elements of evaluating effective clinical improvement work--structure, process and outcomes.

It is now possible to combine leadership with a systematic approach to quality improvement using evidence and value-based methodology and improve the quality of the care we deliver. Medical leaders can now:

* Compare their organization's current performance to optimal care as defined by the best available scientific evidence which can now be accomplished by taking advantage of powerful electronic search technology and the skills and tools of evidence-based medicine

* Create the needed organizational structures, processes and supports to evaluate that evidence in the context of other considerations for value and, combined with effective leadership, successfully implement and measure practice change

* Improve patient care, use their resources more optimally and demonstrate to patients, insurers, accreditors, regulators, purchasers and others that they have an efficient, effective evidence-based system which can achieve desired outcomes.

TABLE 1 Assessing Impacts in the Evidence-based Value Model

Now that you know the evidence, you need to anticipate the potential
impacts of change for your organization.

Process Step         Appraise: Assess Impacts of Change

Assess potential     Prepare data collection and evaluation tools for
program change       estimating, performing sensitivity analyses and
                     evaluating potential impacts of practice change and
                     assemble needed information.
                     Obtain internal data for population of interest.
                     Document current state--this should include such
                     considerations as utilization, current cost, health
                     status of the population, any impacts on patients,
                     satisfaction of both patients and clinical staff,
                     and other issues such as legal, marketing or public
                     relations.
                     Document anticipated changes to current state
                     (including range to be used or choices for
                     sensitivity analyses).
                     Conceptualize changes based on components and how
                     the change will be managed--examples include how
                     you are going to manage a change in procedures or
                     how staff roles might change.
                     Create potential scenarios for change, including
                     how you will implement and measure change.
                     Reviewing your anticipated changes, determine what
                     you would measure.
                     Develop plan to increase capabilities or capacity
                     if needed.
                     Develop evidence-based plan for implementation, and
                     plan for creation of information and decision aids,
                     such as summary statement, one-pager for
                     recommendations, algorithm, patient education and
                     documentation of the processes used to develop the
                     evidence-based clinical improvement.
                     Develop plan for maintenance of change.
Perform analysis of  Perform a cost analysis of all aspects of change:
economic and non-    Change in practice as documented above
economic changes
                     Increased capabilities if needed
                     Program management costs--tool creation,
                     implementation, maintenance and measurement
                     Others as needed
                     Consider doing sensitivity analyses to test out
                     various scenarios
                     Analyze potential non-economic impacts of practice
                     change such as marketing, public relations,
                     regulatory and possible legal issues, for example.

TABLE 2 Creating Decision Support and Implementing Change

Now that you know what you want to do, how do you successfully implement
and keep it going?

                                          Apply: Create Information,
Process Step                              decision and action aids

Develop tools--information, decision and  Possibilities include:
action aids that meet the needs of        * Content summary/one pager
various target groups and can be used to  * Algorithm or protocol
implement change                          * Selected study summaries
                                          * Evidence synthesis
                                          * Project documentation (e.g.,
                                            process of development,
                                            participants, most recent
                                            update)
                                          * Special tools for clinical
                                            staff and patients, (e.g.,
                                            formulary information, risk
                                            calculators, pharmacy
                                            alerts, messaging scripts)
                                          * Patient and clinical staff
                                            information, decision and
                                            action aids

Process Step                              Apply: Implement

Implement your change                     Disseminate information,
                                          decision and action aids using
                                          combinations of all
                                          appropriate methods and media:
                                          Decision support materials
                                          for:
                                          * Leaders
                                          * Clinicians
                                          * Other health care
                                            professionals
                                          Leadership buy-in and support
                                          Information dissemination and
                                          training
                                          Educational activities which
                                          benefit clinicians and
                                          patients
                                          Academic detailing
                                          Systems and administrative
                                          changes
                                          Examples:
                                          * Decision rules, decision-
                                            aids embedded into the
                                            electronic medical record
                                          * Periodic reminders
                                          * CME credit for self-study
                                          * Messages in newsletters
                                          * Registries
                                          * Nursing roles (phone and in-
                                            person management)
                                          * Patient-centered strategies
                                          Examples of including
                                          information/decision-aids in
                                          various vehicles:
                                          * Patient education materials
                                          * Pharmacy hand-outs
                                          * Newsletters

Process Step                              Apply: Measure and report

Measure your change and report on it      Decide if you want to measure
                                          health outcomes, performance
                                          or process. Often process
                                          measures are the best and most
                                          valid methods for measuring
                                          the success of implementation
                                          of a clinical improvement and
                                          are more likely to be seen by
                                          target audiences as under
                                          their control, whereas health
                                          outcomes may result from
                                          patient factors such as
                                          compliance or the
                                          interventions of others. Using
                                          your change impact assessment,
                                          consider what is changing and
                                          which changes are easy to
                                          measure. This can help you
                                          determine the effectiveness of
                                          the implementation.

Process Step                              Apply: Measure and report

"A"s Again                                "A"s Again--Cycle back through
                                          the 4 "A"s to update and
                                          improve
                                          Update and improve
                                          Check the medical literature
                                          every two years minimum or as
                                          required by regulatory/
                                          external agencies/quality
                                          assurance accreditors and when
                                          significant new studies are
                                          published.

By Sheri Strite and Michael E. Stuart, MD

Sheri Strite is principal and managing partner at Delfini Group, LLC in San Diego. She can be reached at [e-mail] or 619-683-3819.

Michael E. Stuart, MD, is clinical assistant professor of family medicine at the School of Medicine at University of Washington in Seattle, Wash. He is also president of Delfini Group, LLC. He can be reached at [e-mail] or 206-522-4279.