The Humunculus is a metaphor for Clinical Process Improvement Frameworks

During the last 20 years, we have experienced wave after wave of new frameworks for improving health care.  Each had its own terminology, ardently promoted and enforced by its zealous advocates.  Each had a lifecycle that began with a long incubation period, followed by a period of explosive growth in popularity and influence, rapidly leading to unrealistic expectations, followed by a period of decline during which the framework was declared to have been ineffective.  We’ve been through health maintenance, outcomes management, clinical effectiveness, managed care, disease management, chronic care, care management, practice guidelines, care maps, evidence-based medicine, quality functional deployment, continuous quality improvement, re-engineering, total quality management, and six sigma.  We’re still in the thick of lean, patient-centered care,  value-based benefits, pay-for-performance and accountable care.

Four things I’ve noticed about this lifecycle of health care improvement frameworks:

  1. They are formulated by conceptual thinkers, but then get taken-over by more tactically-oriented people.  The tactical folks often focus too much on the tools, terminology and associated rituals.  The framework always gets “simplified” to be more suitable for mass consumption.  For example, continuous quality improvement somehow morphed into being primarily about assigning a timekeeper during team meetings and communicating progress on a felt-backed “story board,” rather than finding people with systems-thinking talent and applying that talent to understand sources of variation in complex processes.
  2. During the early part of the growth phase, the advocates are always desperate for examples of success, and shower a great deal of attention on early projects that are described using the terminology of the framework and that appear to have succeeded.  The desperation usually leads advocates to lower their standards of evidence during this phase.  This leads to over-promising and unrealistic expectations.  It stimulates lots of superficial imitation by people interested in hopping on the bandwagon.  And, it plants the seeds for the eventual decline, when people determine that their inflated expectations were not met.
  3. The decline phase, when the framework is declared to be ineffective, seems to always happen before the framework was ever really implemented in the way envisioned by the original formulators during the incubation phase.
  4. All the frameworks are really just restatements of the same underlying concepts, but with different terminology and tools, and different emphasis.  In other words, they all have the same anatomy, but different parts of the anatomy are emphasized.

This last point reminds me of the “humunculus,” also called the “little man.” When I was in medical school in the late 1980s, we used heavy text books that generally did a bad job of teaching the information. One notable exception was clinical neuroanatomy. We used a small, paperback text book playfully entitled “Clinical Neuroanatomy Made Ridiculously Simple” by Stephen Goldberg, MD. It contained a collection of clever drawings designed to explain the structures and functions of the brain and spinal cord. Perhaps the most famous of the drawings was the humunculus.

Cross section of somatosensory cortex, showing mapping to sensory input sources

This drawing was adapted from earlier work by an innovative neurosurgeon named Wilder Penfield, who invented new surgical procedures for patients with epilepsy during the late 1930s.  During those procedures, he used electrodes to stimulate different points on the surface of the brain.  He drew diagrams similar to the drawing above showing that the surface of the brain contained a little man hanging upside down. The diagram shows that a disproportionate portion of the brain surface is dedicated to the sense of touch and muscle movements in certain parts of the body.  Lots of brain surface is dedicated to highly sensitive and nimble areas like the lips, tongue, hands and feet.  Very little brain surface is dedicated to the arms, legs and back.  Many anatomic illustrators have drawn the humunculus as a cartoon character showing how this disproportional emphasis on different parts of the body looks on the little man.

The Humunculus

The humunculus is a great teaching tool, making it easy to remember these aspects of clinical neuroanatomy.  But, I think the humunculus is also a useful metaphor for the distorted emphasis that various health care improvement frameworks have placed on various parts of the underlying anatomy of health care improvement.

Framework

Emphasis

Health maintenance Preventive services
Outcomes Management Measurement of function, patient experience and health status
Clinical Effectiveness Measurement of outcomes in real world settings, rather than laboratory controlled conditions
Managed Care Prospective review of appropriateness of referrals, procedures and expensive drugs, and retrospective review of cost of care
Disease Management Role of nurses in training patients to be more effective in self-management
Chronic Care Teamwork in primary care clinic and importance of organizational and community environment
Care Management Role of nurses in coordinating services delivered by different providers and in different settings
Practice Guidelines Consensus about which ambulatory services are appropriate in which situations
Care Maps Consensus about the sequence of inpatient services for different diagnoses
Evidence-based Medicine Weight of scientific evidence about efficacy of a service (without regard to cost)
Quality Functional Deployment Focus on the demands made by patients
Continuous quality improvement Small experiments to determine if incremental process changes are improvements
Re-engineering Designing new processes from scratch, rather than making incremental changes
Total Quality Management Importance of organizational culture and management processes
Six Sigma Focus on reducing frequency of defects
Lean Focus on eliminating non-value-adding process steps and reducing cycle time
Patient-centered care Focus on the needs of patients and the involvement of patients in their own care
Value-based Benefits Financial incentives to motivate patients to comply with recommended treatments that reduce overall cost
Pay-for-performance Financial incentives to motivate individual physicians to improve quality and reduce cost
Accountable care Financial incentives to motivate health care organizations to improve quality and reduce cost

Over the years, I have assimilated the concepts, terminology and tools from these various improvement frameworks into an approach that attempts to achieve balance, with each aspect of the framework shown without over-emphasis.

This framework puts the patient in the center, surrounded by the health care processes, which are surrounded by improvement processes.  It attempts to balance between focusing on care planning (the clinical decision-making regarding what services are needed) vs. focusing on care-delivery (the teamwork to execute the care plan and provide health care services to the patient).  It balances between measuring outcomes and measuring quality and cost performance.  It balances between implementing best practices through guidelines and protocols vs. improving practices through performance feedback and incentives. By avoiding a distorted over-emphasis on any one part of the anatomy, hopefully it can have greater lasting power than some of the more humunculus-like frameworks that have come and gone.   This framework is described more fully here.

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The Smoking Intervention Program, a Provider-based Care Management Process

Smoking cessation is an important public health concern, and has been the subject of a recent Agency for Health Care Policy and Research (AHCPR) guideline, as well as a HEDIS measure.   A point prevalence study conducted with the Henry Ford Health System found a 27.4% prevalence of smoking, and an additional 38.6% former smokers.

The CCE developed a first-generation smoking-dependency clinic which was staffed by trained non-physician counselors and overseen by a physician medical director. The original intervention was a 50-minute initial evaluation and counseling visit, with nicotine replacement therapy prescribed for all patients with a high level of nicotine dependency. This intervention was subsequently updated to reflect the AHCPR recommendation that, unless contraindicated, all smoking cessation patients be prescribed nicotine replacement therapy.

Because relapse is a normal part of smoking cessation, the intervention was explicitly designed to address relapse. This was done through return visits, an optional support group, and follow-up telephone counseling calls throughout the year, as illustrated in the following figure.

The program was designed to be inexpensive and simple to execute within the clinic. This was accomplished by automating the logistics of both the intervention and the collection of outcomes measures. The Flexi-Scan System, an internally developed computer application which helps automate outcome studies and disease-management interventions was used to automate (1) data entry through a scanner, (2) prompting of follow-up calls and mailings, and (3) the generation of medical-record notes and letters to the referring physicians. A database that can be used for outcomes-data analyses is acquired as a part of this process.

As illustrated on the figure below, this first-generation program achieved a twelve-month quit rate of 25%. Such a quit rate is about twice as high as the rate achieved with brief counseling intervention.

To evaluate the cost-effectiveness of this program, a decision analytic model was constructed. This model was constructed using the Markov method.  Key assumptions of the model include the following:

  • One year quit rate for usual care (optimistically assumed to consist of brief physician advice) was 12.5%.
  • Spontaneous quit rate of 1% per year in “out years.”
  • Relapse rate for recent quitters of 10%.
  • Age, Sex distribution based on Smoking Clinic patient demographics
  • Life expectancy of smokers and former smokers by age and sex based on literature (life tables).
  • Cost of clinic intervention – $199
  • Cost of nicotine therapy Smoking Clinic – $101 (Assuming 0.9 Rx/Patient)
  • Usual Care – $33 (Assuming 0.3 Rx/Patient)
  • Future health care costs were not considered
  • Annual discount rate of 5%

The results of this model were presented at the annual meeting of the Society for Medical Decision-Making.  The model results are presented in the form a table called a “balance sheet” (a term coined by David Eddy, MD, PhD).  As shown below, the model estimated that the first-generation smoking-dependency clinic cost about $1,600 for each life year gained.

To help evaluate whether this cost-effectiveness ratio is favorable, a league table was constructed (see below).  The league table shows comparable cost-effectiveness ratios for other health care interventions.  Interpretation of the table suggests that the smoking cessation intervention is highly favorable to these other health care interventions.

League Table

Intervention Cost per Quality-adjusted Life Year Gained
Smoking Cessation Counselling $6,400
Surgery for Left Main Coronary Artery Disease for a 55-year old man $7,000
Flexible Sigmoidoscopy (every 3 years) $25,000
Renal Dialysis (annual cost) $37,000
Screening for HIV (at a prevalence of 5/1,000) $39,000
Pap Smear (every year) $40,000
Surgery for 3-vessel Coronary Artery Disease for a 55 year-old man $95,000

Although this first generation program was effective and cost-effective, it was targeted only at the estimated 16,500 smokers in the HFMG patient population who were highly motivated to quit.

The estimated 66,000 other smokers in the HFMG patient population would be unlikely to pursue an intervention that involved visiting a smoking dependency clinic. Even for the smokers who were highly motivated to quit, the smoking cessation clinic had the capacity to provide counseling to about 500 people each year, or about 3% of these highly motivated smokers.

Second Generation Smoking Intervention Program

In response to this problem, the CCE developed a “second generation” Smoking Intervention Program.” This program uses a three tiered approach which includes (1) a “front-end” process for primary care and specialty clinics to use to identify smokers and provide brief motivational advice, (2) a centralized telephone-based triage process to conduct assessment and make arrangements for appropriate intervention, and (3) a stepped-care treatment tier.

In the “front-end” process, clinic physician and support staff were trained to screen their patients from smoking status and readiness to quit and provide tailored brief advise. Each participating clinic was provided with a program “kit” including screening forms, patient brochures, and posters to assist them in implementing the program. Patients who are interested in further intervention are referred to a centralized triage counselor for further assessment and intervention. These counselors are trained, non-physician care providers. They proactively call each patient referred, conduct an assessment of the patients smoking and quitting history and triage into a stepped-care intervention program.

An important part of this intervention has been providing information to clinicians, including a quarterly report showing the number of patients they have referred to the Smoking Intervention Program, the status of those patients, the type of intervention they are receiving, and the number of patients who report not having smoked in the preceding six months.

The clinician-specific data is presented in comparison to data for the medical group as a whole. These reports have a strong motivational effect on clinicians, as evidenced by a sharp increase in Smoking Intervention Program referrals after each reporting cycle.

As shown above, the second generation program achieved a six month quit rate of about 25%. This rate is virtually identical to the first generation program.  The new program, however, has much larger capacity and lower cost per participant. Patient satisfaction with the Smoking Intervention Program is encouraging, with 85% reporting that they would refer a friend to this program.

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Improving Total Hip Replacement Surgery

Background

Joint replacement is a costly and frequently performed inpatient procedure.  In 1995, Henry Ford Hospital carried out 280 total hip replacements and 225 total knee replacements.  To decrease unnecessary inpatient utilization and enhance functional outcomes of joint replacement surgery, Henry Ford Hospital established a multi-disciplinary improvement team, including representatives from Orthopedic Surgery, Physical Therapy, Home Health Care,  Social Work, Utilization Management, the Center for Clinical Effectiveness, and Marketing.

Methods

The team developed and implemented a best practice guideline in the form of a “care-map”, describing the default plan of care for delivering multi-disciplinary services to the patient for each day of the planned length of stay.   These interventions included outcomes assessments, tests & diagnostics, consults, treatments, procedures, medications, diet & nutrition, elimination goals, activity goals, and safety goals, skin condition goals, educational interventions and learning goals, and discharge planning.

To support the evaluation of the work of the team, comparative data was used.   These data included comparative outcomes data obtained through a collaborative Outcomes Measurement Consortium organized through the American Medical Group Association (AMGA).  Comparative process data was obtained through the Group Practice Improvement Network (GPIN).  In addition, a periodic audit process was used to measure variance from the care-map.  Additional process and outcomes data were collected and managed using software applications developed by the Center for Clinical Effectiveness:

  • Complications Tracking System used to enter and report on trends in various joint-replacement complications. This system was used to support the Department of Orthopedic Surgery morbidity and mortality conferences.
  • Outcomes data acquisition was accomplished using the “Flexi-Scan” forms scanning and study management software.
  • Cross-institutional pooling of outcomes data data pooling and quarterly analysis was accomplished by staff of the American Group Practice Association usuing the Flexi-Scan analytic dataset builder and other tools developed by the Center for Clinical Effectiveness.

Finally, patient satisfaction and subjective feedback data was obtained using patient focus groups arranged by Center for Clinical Effectiveness and staff from the Marketing Department.

Results

The implementation of the care-map led to a further one-day reduction of the length-of-stay, as illustrated in the following figure.

Functional outcomes data revealed that hip replacement surgery led to rapid reduction in bodily pain to normal age and sex-adjusted levels. (Note that in the following graph, pain is expressed on the SF-36 pain scale, in which higher numbers represent better functional status, or less pain).

As shown in the following figure, physical function is also improved, although not as rapidly nor as dramatically as bodily pain.

The following figure shows the distribution in bodily pain and physical function, showing that although the average improvement is favorable, 15% of patients have worse pain one year after surgery, and 22% have worse physical function after surgery.

An analysis was conducted to identify baseline variables (collected prior to the surgery) which could predict failure to acheive improvement in pain and function.   As shown in the following table, mild pre-operative pain was among the strongest predictors of failure to achieve an improvement in pain.

In order to optimize the ability to predict which patients would fail to achieve a pain reduction from hip replacement, a neural network was trained based on 13 baseline variables collected from the patient before surgery.  The neural network was then used to calculate a predictive score for each of the patients.  The frequency distribution of predictive scores for patients that did achieve a pain benefit, as well as the distribution for those that did not experience a pain reduction are shown in the following figure.

If the neural network was perfectly predictive, these two distributions would not overlap at all.  A threshold predictive score was selected such that the model could be said to be 85% sure about making a prediction that a given patient would not achieve a pain reduction from surgery.  Of the 185 patients that experieced an improvement, only 2 had a neural network predictive score below 0.3.  Of the 36 patients that experienced an improvement, 13 of them had scores under 0.3.  So, for the 15 patients with a score below 0.3, 85% failed to experience a pain reduction.   The sensitivity of the model in predicting this type of treatment failure was 35%.   In other words, of 100 patients considering hip replacement therapy, about 15 of these will fail to achieve a pain reduction.  Of the 15, about 5 of these patients can be identified in advance using this neural network and using a cut-off threshold of 0.3.  If implemented in clinical practice, this model could lead to the elimination of the treatment cost and risk of complications associated with these 5 patients.  On the down side, approximately one patient who would have benefited from the surgery would have been incorrectly told that they were unlikely to benefit.  Such a patient would unnecessarily suffer pain that could have been relieved by the surgery.

As shown in the following figure, analysis also revealed that patients had unrealistic expectations of the time it would take for them to feel fully recovered after the surgery.

Finally, the data revealed that, compared to other institutions, Henry Ford experienced an unusually long physical function recovery period among patient receiving revision total hip replacement (operations on patients that had previously received hip replacement surgery).  Such data, shown in the following figure, led to a re-evaluation of Henry Ford’s approach to post-operative rehabilitation.

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Improving Adult Flu Immunization

Background

The US Preventive Services Task Force established national evidence-based guidelines for adult immunization as part of their 1993 and 1996 review processes. After a review by Henry Ford Health System (HFHS) general internists, family practitioners, and infectious disease specialists, these guidelines were endorsed by the HFHS Prevention Committee. The Prevention Committee’s recommendations were subsequently accepted by the Henry Ford Medical Group Clinical Practice Committee and by the Health Alliance Plan Quality Management Committee to form practice guidelines for the medical group and health plan, respectively.

Methods

A multi-faceted implementation approach was used to improve immunization performance within the Henry Ford Medical Group, one of the provider groups that serve the Health Alliance Plan. Multi-faceted implementation efforts have been found to be most effective for improvement processes that involve behavior change. The implementation effort involved staff training, patient and member education, continual quality improvement, and medical informatics facets.

  • Staff Training.  All senior medical staff within the Henry Ford Medical Group were sent a copy of internal adult immunization guidelines, which were incorporated into a larger preventive health services manual. In addition to this mailing, a number of clinicians had the opportunity to discuss these guidelines in an on-site continuing medical education program on the provision of preventive health services.
  • Patient education was accomplished by publishing an article in the Health Alliance Plan’s member newsletter, which is mailed to all health plan members. A slogan and cartoon character were also developed for a program to promote immunization compliance. This content was incorporated into posters and tent cards, which were placed in clinics lobbies and waiting areas.
  • Local continuous quality-improvement teams were established to develop and implement process changes. These teams launched Saturday morning walk-in flu immunization clinics during flu season. By using this approach to immunization, wait times were reduces and patients were able to avoid setting up an appointment to get the immunization.
  • Medical informatics approaches were pursued, leveraging the capabilities of the clinical information system and data depositories that are available within the insitution. Computer-generated reports were created, listing immunization status for HFHS adult patients. These reports were used by staff of the Saturday morning walk-in flu clinics. In addition, computer-generated reminder postcards and letters to patients at high risk for influenza were printed and mailed.

Evaluation

These mailings were formally evaluated in a randomized trial conducted during the first year of the HFHS flu immunization program. The entire patient population for whom flu immunizations were indicated were randomized into four groups. The control group (usual care) received only the posters and tent cards in the clinic. Patients in each of three treatment groups received this same clinic-based intervention and either (1) a generic postcard, (2) a tailored postcard, or (3) a tailored letter containing an explicit statement of why flu immunization was indicated for them. Indications included age over 65 and the presence of one of a number of disease states, as ascertained from diagnosis coding of ambulatory visits and inpatient admissions. These letters or postcards were addressed from the patients’ primary care clinicians. The results of randomized trial showed a 5 percentage point increase in the rates of immunization in the patient population receiving the tailored letter compared to those receiving usual care.

The cost of the letter, including printing and postage, was 42 cents. The vaccine costs just over $4.00. From the literature, it is known that annual hospital costs are reduced from an average of $355 to $215 as a result of flu immunization. Therefore, during a non-epidemic year, the flu immunization program was calculated to save the HFHS over $180,000, net of the cost of the intervention. During an epidemic year, this savings is increased to almost $400,000. Therefore, the flu immunization project serves as an example of a clinical-practice improvement effort that simultaneously benefits the health status of patients and reduces health care cost.

The National Committee for Quality Assurance (NCQA) adopted in 1996 a new adult immunization performance measure which is included in the Health Plan and Employer Data and Information Set (HEDIS 3.0). These quality indicators have been reported by hundreds of health plans across the country, and are compiled in the NCQA Quality Compass, a national health plan quality database.

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Necessary Elements of Care Management & Clinical Process Improvement Initiatives

A number of core elements are key to ensure the success of any care management or clinical process improvement initiative. As illustrated in the figure below, these elements include: conducting a preliminary needs assessment or problem identification; establishing an appropriate improvement team; defining the target population; identifying measurable goals and objectives; articulating the desirable decision making or care processes; designing a plan for implementation; and developing a means for ongoing monitoring.

Necessary Elements of a Care Management Initiative

Although these elements are necessary, they are not sufficient. Ultimately, the success of each clinical effectiveness initiative is dependent upon the ability to tailor the overall approach to the specific application.

Needs Assessment & Problem Identification

Care management initiatives begin with the identification of an opportunity for improvement. Such opportunities can be identified through a variety of channels. These might include review of the medical literature, observation of local practice patterns, benchmarking with peer organizations, or suggestions by leadership or patients. Regardless of the source, the key is that opportunities originate from the identification of needs or problems, not solutions. That is, although it is often tempting to propose interventions or solutions prior to stepping back and understanding the underlying clinical processes, it is only when a clear understanding of the underlying needs or problems exists that an appropriate (and therefore successful) improvement effort can be undertaken.

Establishing Improvement Team

Once a thorough understanding of the improvement opportunity exists, the next step is to identify individuals to participate in the effort. These individuals should include those with clinical and administrative expertise in the area, as well as individuals whose clinical practices are likely to be affected. By including key stakeholders in the initial improvement process, not only does the improvement effort benefit from the diversity of perspectives represented, but the process of achieving buy-in is initiated from the beginning. Attempts should be made to have multidisciplinary representation on the team.

Defining Target Population

The next step is to define the target population. Such populations are often defined based upon a clinical condition or disease. Because not all patients with the same condition or disease have the same needs, it is important to understand the different risks and severity levels within a target population. Such information can, at times, be gathered through automated data or the medical record, but often may need to be solicited from the patient regarding their perceived needs and desires (e.g., a health risk appraisal). It is often through the population identification and risk stratification process, that the specific goals and objectives of the effort begin to take form. The challenge is to establish goals and objectives that are measurable, and allow for the assessment of improvement over time.

Care Process Design

The next step is to articulate the desired care processes. Care management initiatives generally fall into two categories: those whose efforts are directed at improving existing processes versus those whose efforts are directed at more extensive process re-engineering. At times it may be appropriate to begin with a sub-process rather than attempting to change all aspects of care at once. In fact, it is often more productive to make small incremental changes than to attempt large far-reaching changes that offer a smaller probability of success.

Implementation Planning

Once the desired care processes are known, a plan for implementation can be developed. As described earlier, strategies for implementation may include patient education, staff training, local quality improvement teams, the use of information technology, and a number of other approaches. The key is to develop a multi-faceted approach to implementation and to articulate clearly what resources are required, who will be responsible for each aspect of the plan, and over what time frame the steps will occur.

Monitoring and Evaluation

The final step involves developing a means for ongoing monitoring and evaluation of efforts. To be successful, measurement and feedback must be an integral part of the care processes, not an after thought. Because measurement is costly, any measurement effort must carefully select a handful of key quality indicators. These may include measures of both process performance and patient outcomes. Outcome measures ideally include those reflective of immediate and long term impacts on patient health, satisfaction, and well being, but may also include measures of resource utilization (e.g., hospital admissions) and costs.

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The Managed Care College and Pediatric Asthma Management

The Managed Care College

The Managed Care College is a comprehensive professional development program that is intended to go beyond the transfer of information. It attempts to persuade clinicians that change is necessary and desirable, to provide leadership and guidance in seeking change, to create opportunities to collaborate with colleagues in planning and implementing change, and to provide ongoing provider performance feedback to monitor change. The College is an on-site, continuous program. The notion behind the College was that continuing medical education should not be removed from everyday clinical practice, but instead should be a part of it. The College offers a variety of courses, ranging from clinical epidemiology to customer oriented service provision. There is also a series of courses directed at specific conditions.

Pediatric Asthma Management Course

One of the courses within the Managed Care College focused on the ambulatory management of pediatric patients with bronchial asthma.  Within the context of this asthma course, and with guidance from course faculty, the participants did the following:

  • Completed directed reading and received a lecture to review the epidemiology and pathophysiology of asthma,
  • Agreed on a definition of pediatric asthma, based on billing codes.  To inform this process, participants conducted a chart review from an initial computer-generated list of their own asthma patients to identify coding issues.  Based on agreed-upon definitions, a registry of asthma patients was established for each participant.
  • Studied and discussed the implications of a computer-generated list of their own patients in the asthma registry, flagging patients with a recent emergency room visits and admissions and those who had submitted no claims for inhaled steroids, a preventive treatment for asthma. The list also identified the 20% of patients who had been seen by an allergy specialist, or who had poor continuity of care by primary care clinicians.
  • Reviewed externally developed guidelines for patients with bronchial asthma. These guidelines were then discussed within the context of specific patient scenarios to evaluate the appropriateness and feasibility of adapting them within the HFHS.
  • Developed a clinical-process flowchart to identify barriers to implementation of asthma guidelines, with special focus on barriers to patient education.

With this as background information about their own clinical practices, and after having reviewed a number of externally developed guidelines, the class adapted the National Heart, Lung, and Blood Institutes guidelines for the diagnosis and management of pediatric asthma. Ultimately, after several reviews and approvals, those guidelines became the guidelines adapted by the entire HFHS. As part of these guidelines, some specific tools were developed. For example, a standardized “zone sheet” was developed, including an action plan for the patient to follow depending upon their self-measurement of peak expiratory flow rate. A peak-flow diary was also created to record results of self-monitoring.

Evaluation

As part of a formal program evaluation of the Managed Care College, pre- and post-surveys were administered to all course enrollees.

  • At the end of the course, enrollees were more likely to agree that they understood the “zone sheets.”
  • Enrollees were also more likely to indicate that home monitoring of peak expiratory flow rates was important, consistent with the practice guideline.
  • Sixty four percent of enrollees indicated that their participation in the course changed their approach to the management and treatment of patients with asthma.
  • Almost three-quarters agreed with the statement that participation in the course increased the percentage of patients for whom they recommend home monitoring of peak flows.
  • About 63% said the course increased the percentage of patients for whom they prescribed preventive or maintenance medications.
  • Just over 50% indicated that participation increased the frequency with which their patients with asthma received education.
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Implementation of Best Practices

The implementation of best practices to improve the quality and efficiency of health care involves making changes to both decision-making and care-delivery processes. The care management methods for improving these processes are largely borrowed from the work of Deming, Crosby, Juran, Ishikawa, and other practitioners of industrial process improvement. These methods are alternatively described as Continuous Process Improvement (CQI) and Total Quality Management (TQM). Berwick, James, and others described the adaptation of these methods for health care.

On a practical level, clinicians apply these methods by working with other members of their clinical team to make local improvements, or, in larger health care organizations, by participating in multi-disciplinary teams organized at an organizational level. These teams often require expert consultation in analytical and statistical methods. Statistical process control involves the application of quality engineering concepts to administrative, support and care delivery processes in order to (1) detect changes in process performance over time, (2) identify assignable causes of variation, and (3) adjust relevant process input variables so as to maintain a process performance criterion within a desirable range.

Another implementation approach is staff training or continuing medical education. This involves the development and delivery of classes and organized curricula, with the objective to improve knowledge and skills to increase the effectiveness of clinicians, administrative staff, and support staff. Some training is intended to increase knowledge and skills in process improvement methods, to improve the effectiveness of CQI or TQM teams. Other training is intended to have a more direct effect to improve decision-making and care delivery processes by teaching clinicians about specific diagnosis and treatment strategies. Traditionally, this latter approach has been accomplished through grand rounds and seminars. Another approach, based on methods developed for the marketing of pharmaceuticals and devices, is academic detailing. Academic detailing is a form of educational outreach involving the the personal delivery to clinicians of brief educational messages designed to change clinical practice behaviors.

Another approach to implementation involves patient education. Therefore, the methods of patient education materials development represent an important domain of care management. These methods involve the development and pilot testing of brochures, pamphlets, audio and video tapes, class materials, web-based materials, and other products designed to provide useful and timely information to patients regarding their health. An understanding and appreciation of the principles of adult learning are essential to this process.

Finally, clinical policy implementation requires the effective application of information technology. Medical informatics is the term used to describe the broader field of information technology applications to health and medical care. Managing intranet resources is an emerging methodological domain of care management, involving the development of internal web-based materials, such as a best practices library or a care management support system. Another important medical informatics method involves the development of computer-based decision aids such as reminders, alerts, and prompts. These are incorporated into the electronic health record as well as associated structured data capture into the clinician workstation and other information systems used by care providers as part of routine practice.

A review of rigorous evaluations of clinical policy implementation methods conducted by Grimshaw, et al. revealed the importance of the methods of guideline development, dissemination, and implementation in predicting clinician behavior change (see table below).

Effectiveness of Guideline Development, Dissemination, and Implementation Methods in Terms of Clinician Behavior Change (adapted from Grimshaw, et al)

Most Effective Moderately Effective Least Effective
Guideline Development Internal development External, local development National development
Guideline Dissemination Specific educational interventions Continuing education

Targeted mailing

Publication in Journals
Guideline Implementation Patient-specific reminders at the time of the clinical encounter Feedback measures General reminders

In general, multi-faceted implementation approaches have been found to be most effective for improvement processes that involve physician behavior change.

These clinical policy implementation methods are used to effect change in clinical processes. However, many care management initiatives, including those described in this web site, involve the establishment and ongoing management of a new set of resources to support improved clinical processes, including the following:

  • Call centers, which receive customer calls and either provides customer service or directs the customer to appropriate staff or resources. Such services may include on-call nurse advice, appointment scheduling, lab result reporting, directions to facilities, billing inquiries, etc.
  • Telephone survey and counseling staff make outgoing calls to patients for the purpose of acquiring information from the patient, such as for a health risk appraisal, survey or follow-up call. They also offer information or services to the patient, such as counseling, needs assessment, and patient education.
  • Distribution of care management materials, including the management of a mail room and stock room to efficiently route care management materials to patients, including patient educational materials and self care supplies.
  • Case managers, typically nurses or other allied health professionals, are required to track patients with defined conditions, assess patient needs, solve problems and deliver other patient services such as counseling, patient education, and social services.

In large health care organizations and health plans, these resources may be developed internally.  In small and medium size organizations, these services can be outsourced to a growing number of external service suppliers.

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CQI Methods Used Improve the Quality of Cervical Cancer Screening

A baseline evaluation of “Pap” smears done in a large multi-specialty group practice revealed that over 25% of samples were designated “less than optimal” because of the absence of observed endocervical cells, an indicator of sample adequacy. In addition, there was a large variation in the rates of sample adequacy achieved by different physicians and at different clinic sites.

In response to these concerns about sample adequacy, clinical leaders encouraged the formation of a multidisciplinary clinical quality improvement team to work to improve the process by which cervical cytology samples were obtained and assessed for adequacy. This team included cytopathology staff, obstetrician-gynecologists, internists and clinical effectiveness staff.

The team used a quality improvement framework developed at Hospital Corporation of America (HCA), described by the acronym “FOCUS-PDCA.”  The team prepared process flow charts and identified an initial improvement in the design of the cytology requisition form to provide data required for future analyses of Pap smear adequacy and management of cervical neoplasia.  The team also defined and implemented a new, more reproducible operational definition of the key quality characteristic: the proportion of samples with at least five observed endocervical cells.  Although no direct relationship between observed endocervical cells and decreased cervical cancer mortality has been demonstrated, the team conducted a retrospective analysis which showed an increased prevalence of abnormalities found in samples with endocervical cells (14.9% vs. 6.3%), and for mild abnormalities (11.9% vs. 5.2%), and also an increased prevalence of severe abnormalities found (3.0% vs 0.8%).

The team then prepared “run charts,” plotting monthly sample adequacy rates over a two-year period, stratified by clinic location and specialty.  Then, based on a literature review and input form consultants, an “Ishikawa diagram” was prepared, outlining the known factors that could cause inadequate samples.  A study conducted in the Netherlands found that the cytobrush, a plastic sampling tool with a tip which resembles a pipe cleaner, together with a wooden spatula, produced a higher proportion of samples with endocervical cells in the hands of paramedical sample takers when compared to other commonly used tools, including the cotton swab traditionally used within the institution.  The team conducted a retrospective study and a second prospective study which confirmed these findings.

Based on these results, the team prepared a cost-benefit analysis, and drafted a proposal for an intitutional clinical practice policy calling for sampling using the cytobrush and wooden spatula for screening Pap smears for non-pregnant women.  The policy was approved, and was communicated to the primary care medical staff through a series of scripted 13-minute slide presentations presented at local staff meetings at clinic sites throughout the institution.

Two approaches were used to assess the success of these staff training efforts. First, the team conducted a survey of clinic nurses and assistants to determine which sampling tools each internist and obstetrician-gynecologist used during each month of the study period. The survey was repeated to update information on two occasions.  These surveys revealed a dramatic transition from traditional sampling methods using a spatula, with or without a cotton swab, to methods using the cytobrush.  Second, the team confirmed this survey data by tracking orders for cytobrushes through the purchasing department, revealing that the overall volume of cytobrushes being ordered was consistent with the volume implied by merging survey data with physician-specific Pap smear volume data.

To assess the impact of changes in methods of sampling, the team used a “run chart” to track the proportion of inadequate Pap smears each month.  The run chart shows that the proportion of inadequate smears plunged from baseline levels of 20-25% per month to less than 10%. Possibly due to a decrease in the number of repeat Pap smears needed, the overall volume of Pap smears dropped by more than 10%. Consequently, the number of women who received a Pap smear report with the “less than optimal”designation was cut by well over 50%.

The estimated economic impact of these changes was favorable. On an annual basis, the additional costs from using a more expensive sampling tool was $15,000. The cost of additional physician sampling time for a “two tool” method added $11,000. The cost of added physician cytopathologist interpretation due to discovering an additional 1068 abnormalities added $20,000. However, these costs were far outweighed by a savings of $158,000 from fewer repeat visits and fewer repeat Pap interpretations, leading to a net savings of $212,000 per year.

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