Remembering the 100,000 Lives Campaign

Earlier this week the Institute for Healthcare Improvement (IHI) emailed its weekly bulletin celebrating that it has been ten years since the end of the 100,000 Lives Campaign (Appendix 1). This was the campaign, according to the bulletin, that put IHI on the map. The Campaign started at the IHI National Forum in December 2004, when IHI's president, Don Berwick, announced that IHI would work together with nearly three-quarters of the US hospitals to reduce needless deaths by 100,000 over 18 months. A phrase borrowed from political campaigns became IHI's cri de coeur: “Some is not a number. Soon is not a time.”

The Campaign relied on six key interventions:

• Rapid Response Teams
• Improved Care for Acute Myocardial Infarction
• Medication Reconciliation
• Preventing Central Line Infections
• Preventing Surgical Site Infections
• Preventing Ventilator-Associated Pnemonia [sic]

According to the bulletin, the Campaign’s impact rippled across the organization and the world. IHI listed some of the lasting impacts:

• IHI followed with the 5 Million Lives Campaign – a campaign to avoid 5 million instances of harm.
• Don Berwick and Joe McCannon brought lessons from leading the Campaigns to Centers for Medicare and Medicaid Services (CMS) and the Partnership for Patients.
• Related campaigns were launched in Canada, Australia, Sweden, Denmark, UK, Japan, and elsewhere.

IHI's profile definitely grew. One indicator tracked by IHI was media impressions, which rose to 250 million in the final year of the Campaign. IHI even put a recreational vehicle on the streets to promote their Campaign (Appendix 1). Campaign Manager Joe McCannon was on CNN to discuss the results of the Campaign.

How did IHI achieve such remarkable results in saving patients' lives? The answer is they did not. Review of the evidence basis for at least 3 of these interventions revealed fundamental flaws (1). The largest trial of rapid response teams failed to result in any improvements and the interventions to prevent central line infections and ventilator-associated pneumonia were non- or weakly-evidenced based and unlikely to improve patient outcomes (2-4). The poor methodology and sloppy estimation of the number of lives saved were pointed out in the Joint Commission’s Journal of Quality and Safety by Wachter and Pronovost (5). IHI failed to adjust their estimates of lives saved for case-mix which accounted for nearly three out of four "lives saved." The actual mortality data were supplied to the IHI by hospitals without audit, and 14% of the hospitals submitted no data at all. Moreover, the reports from even those hospitals that did submit data were usually incomplete. The most striking example is that the IHI was so anxious to announce their success that the data was based on only 15 months of data. The final three months were extrapolated from hospitals’ previous submissions. Important confounders such as the background of declining inpatient mortality rates were ignored. Even if the Campaign "saved" lives, it would be unclear if the Campaign had anything to do with the reduction (5). Buoyed by their success, the IHI proceeded with the 5,000,000 Lives Campaign (6). However, this campaign ended in 2008 and was apparently not successful (7). Although IHI promised to publish results in major medical journals, to date no publication is evident.

A fundamental flaw in the logic behind the 100,000 Lives Campaign was that preventing a complication, for example an infection, results in a life saved. Many of our patients in the ICU have an infection as their life-ending event. However, the patients are often in the ICU because their underlying disease(s). In many instances their underlying disease(s) such as cancer, heart disease, or chronic obstructive pulmonary disease are so severe that survival is unlikely. It is akin to poisoning, stabbing, shooting and decapitating a hapless victim and saying that had the decapitation been prevented, survival was assured. IHI also assumed that the data was collected completely and honestly. However, the data was incomplete as pointed out above and the honesty of self-reported hospital data has also been called into question (8).

The bulletin correctly pointed out that Berwick did carry this political campaign with its sloppy science to Washington as CMS' administrator. Under Berwick's leadership, CMS would announce a campaign, have the hospitals collect the data, extrapolate the mortality or other benefit, and prepare a press release. This scheme continues until this day (9). CMS further confounded the data by providing financial incentives to hospitals, often resulting in bonuses to hospital executives, making the data further suspect. Certainly, CMS would not examine the hospital data with skepticism because the success of their campaign was in their own political best interest.

The 100,000 Lives Campaign also had one other outcome. It made many of us who believe in the power of evidence-based medicine to enrich patients' lives to be suspicious of these political maneuvers. To rephrase a well-known quote, "The first victim of politics is the truth". These campaigns certainly financially benefit hospitals and their administrators and politically benefit bureaucrats, but whether they benefit patients is questionable. The bulletin from IHI should be viewed for what it is, a political self-promotion to rewrite the failed history of the 100,000 Lives Campaign.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Robbins RA. The unfulfilled promise of the quality movement. Southwest J Pulm Crit Care. 2014;8(1):50-63. [CrossRef]
2. Hillman K, Chen J, Cretikos M, Bellomo R, Brown D, Doig G, Finfer S, Flabouris A; MERIT study investigators. Introduction of the medical emergency team (MET) system: a cluster-randomised controlled trial. Lancet. 2005;365(9477):2091-7. [CrossRef] [PubMed]
3. Hurley J, Garciaorr R, Luedy H, Jivcu C, Wissa E, Jewell J, Whiting T, Gerkin R, Singarajah CU, Robbins RA. Correlation of compliance with central line associated blood stream infection guidelines and outcomes: a review of the evidence. Southwest J Pulm Crit Care 2012;4:163-73.
4. Padrnos L, Bui T, Pattee JJ, Whitmore EJ, Iqbal M, Lee S, Singarajah CU, Robbins RA. Analysis of overall level of evidence behind the Institute of Healthcare Improvement ventilator-associated pneumonia guidelines. Southwest J Pulm Crit Care 2011;3:40-8.
5. Wachter RM, Pronovost PJ. The 100,000 Lives Campaign: A scientific and policy review. Jt Comm J Qual Patient Saf. 2006;32(11):621-7. [PubMed]
6. Institute for Healthcare Improvement. 5 million lives campaign. Available at: http://www.ihi.org/about/Documents/5MillionLivesCampaignCaseStatement.pdf (accessed 6/24/16).
7. DerGurahian J. IHI unsure about impact of 5 Million campaign. Available at: http://www.modernhealthcare.com/article/20081210/NEWS/312109976 (accessed 6/24/16).
8. Meddings JA, Reichert H, Rogers MA, Saint S, Stephansky J, McMahon LF. Effect of nonpayment for hospital-acquired, catheter-associated urinary tract infection: a statewide analysis. Ann Intern Med. 2012;157:305-12. [CrossRef] [PubMed]
9. AHRQ Report: Hospital-Acquired Conditions Continue To Decline, Saving Lives and Costs. Dec 1, 2015. Available at: http://www.ahrq.gov/news/newsletters/e-newsletter/496.html#1 (accessed 6/24/16).

Cite as: Robbins RA. Remembering the 100,000 lives campaign. Southwest J Pulm Crit Care. 2016;12(6):255-7. doi: http://dx.doi.org/10.13175/swjpcc058-16 PDF 

The Evil That Men Do-An Open Letter to President Obama

"The evil that men do lives after them; the good is oft interred with their bones". William Shakespeare, Julius Caesar, Act 3, Scene 2

Dear President Obama:

Late in a second term, a President's attention often turns to framing their legacy. I suspect you are no exception and have given this considerable thought. You might wish to be remembered for the Affordable Care Act, even called Obamacare, which brought the US closer to universal healthcare coverage. However, I recall the end of President Clinton's second term a short 16 years ago. During that administration the Federal coffers were full; an unprecedented business boom occurred; and foreign entanglements that might have led to war were avoided. However, most of us do not remember those positives, but recall a White House intern and a certain blue dress. As pointed out by Shakespeare over 400 years ago powerful men are remembered not so much for the good they do but the bad.

Robert McDonald, your Secretary of Veterans Affairs (VA), was brought on board two years ago to deal with concerns about long waiting times for Veterans Administration medical services-concerns and the subsequent lies that were told to cover it up that led you to fire his predecessor, Eric Shinseki. McDonald was talking to reporters in the week leading up to Memorial Day, when attention always turns not just to honoring America's war dead but to whether the government is delivering services it promised living Veterans. The reporters asked McDonald why the VA doesn't publicly report the date when veterans first ask for medical care so as to better measure waiting times (1). His reply:

"The days to an appointment is really not what we should be measuring. What we should be measuring is the veteran's satisfaction. What really counts is: How does the veteran feel about their encounter with the VA? When you go to Disney, do they measure the hours you wait in line?"

Although McDonald later apologized for his remarks, they were offensive to me as a physician who worked in the VA, and I might point out wrong on several fronts. First, Disney does track its wait times. Second, the remark shows a fundamental disconnect between upper echelon management and healthcare. As we pointed out several years ago, satisfaction with healthcare does not mean better healthcare, in fact, it may mean worse care, perhaps because the focus is more on satisfaction than good care (2). Third, McDonald's remark was truly disingenuous. McDonald is concerned about wait times which led you to fire his predecessor. Otherwise, why would the VA lift the supervision requirement for nurse practioners which they did later in the week (3)?

The prolonged wait times occurred because an insufferable VA administration created a hostile work environment for physicians. Many left and the VA was unable to replace them. Although salary is part of this, it is less of a problem than those inside the Beltway believe. The VA abandoned its academic affiliations and created a work environment where physicians seeing patients is largely put in the same category as janitors waxing a floor. Middle level administrators who know nothing about healthcare are now directing physicians on what they should do. The goal has become less about healthcare than the administrators being in charge. The replacement of physicians by nurse practioners is in line with this concept. The goal will not be as much to deliver quality healthcare, a concept that is often nebulous and hard to define, but rather to redefine quality. For example, replacing timely and good care with a measure such as making sure that on each visit the Veteran is reminded to fasten their safety belt (a current requirement), is certainly measurable, cheap and does not require a physician. In most businessmen's minds it matters little whether it does any good or not. It is a measure of someone's concept of quality and the VA will deliver quality as long as it does not cost too much and an administrator can receive a bonus for it. Based on the VA, many physicians are suspicious that this is the long term goal of Obamacare.

So on this Memorial Day, let us remember our Veterans, Mr. President, and consider your legacy. My view is that unless changes are made, your misdirection of healthcare both at the VA and nationally through Obamacare, could be your White House intern in a blue dress.

Richard A. Robbins, MD*

Editor, SWJPCC

References

1. Capital Gazette editorial board. Our say: McDonald gaffe points to a deeper problem. Capital Gazette. May 30, 2016. Available at: HTUhttp://www.capitalgazette.com/opinion/our_say/ph-ac-ce-our-say-0529-20160529-story.htmlUTH (accessed 5/30/16).
2. Robbins RA, Rashke RA. A new paradigm to improve patient outcomes: a tongue-in-cheek look at the cost of patient satisfaction. Southwest J Pulm Crit Care 2012;5:33-5. Available at: HTUhttp://www.swjpcc.com/editorial/2012/7/17/a-new-paradigm-to-improve-patient-outcomes.htmlUTH (accessed 5/30/16).
3. Japsen B. VA would join 21 states already lifting nurse practitioner hurdles. Forbes. May 26,2016. Available at: HTUhttp://www.forbes.com/sites/brucejapsen/2016/05/26/va-would-join-21-states-lifting-nurse-practitioner-hurdles/#2d4e391e9f2cUTH (accessed 5/30/16).

*The views expressed are those of the author and do not necessarily represent the views of the Arizona, New Mexico, Colorado or California Thoracic Societies.

Cite as: Robbins RA. The evil that men do-an open letter to President Obama. Southwest J Pulm Crit Care. 2016 May;12(5):201-2. doi: http://dx.doi.org/10.13175/swjpcc048-16 PDF

Using the EMR for Better Patient Care

The medical record was developed in the US in major teaching hospitals in the 19th century and widely adopted when it was realized the records benefited patients, nurses and doctors (1). These paper records continued (although with many alterations) until the early 21st century when electronic medical or healthcare records (EMR) were mandated by the Federal government. EMRs offer great promise by handling the enormous amounts of data generated in healthcare. Furthermore, in those instances where early identification of disease process seems to make a difference, EMRs would seem an ideal tool to alert nurses and doctors. Sepsis is a disease process which would seem appropriate for early identification by EMR since early recognition can be difficult but early intervention improves outcomes (2). However, previous attempts to use the EMR to identify septic patients have been disappointing (3,4). In this issue of the SWJPCC Fountain and her colleagues (5) used clinical decision support systems (CDSSs) incorporated into EMRs to successfully identified septic patients with reasonable sensitivity and positive predictive value.

Why did Fountain et al. succeed while others failed? The 20 year old definition of sepsis that required two or more systemic inflammatory response syndrome criteria to define sepsis did not identify the sickest patients at the greatest risk for death (6). Realizing this weakness, Fountain and colleagues shifted their diagnostic focus from systemic inflammation to infection-triggered organ failure consistent with the new definition of sepsis proposed by the international Sepsis Definitions Task Force (7). This insight would seem most likely to account for their success.

Fountain's success also raises the question of why so many EMR interventions for sepsis and other disease processes have failed to improve patient care. In order to be successful, CDSSs need to pick diseases with well grounded criteria and interventions. This requires extensive expertise in reading and evaluating the medical literature. It seems too often a quick internet search by a non-expert committee chooses poorly. For example, ventilator-associated pneumonia is a disease with no well established criteria or accepted prevention other than extubation. Too often EMRs have increased workload and inefficiency without apparent patient benefit, even potential patient harm as suggested by some.

If Fountain's criteria is replicated in randomized trials and early identification improves outcomes, it may represent a major step forward in sepsis care. However, perhaps more importantly it could represent a major step forward in how CDSSs are conceived and developed.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Gillum RF. From papyrus to the electronic tablet: a brief history of the clinical medical record with lessons for the digital age. Am J Med. 2013 Oct;126(10):853-7. [CrossRef] [PubMed]
2. Miller RR 3rd, Dong L, Nelson NC, Brown SM, Kuttler KG, Probst DR, Allen TL, Clemmer TP; Intermountain Healthcare Intensive Medicine Clinical Program. Multicenter implementation of a severe sepsis and septic shock treatment bundle. Am J Respir Crit Care Med. 2013 Jul 1;188(1):77-82. [CrossRef] [PubMed]
3. Tafelski S, Nachtigall I, Deja M, Tamarkin A, Trefzer T, Halle E, Wernecke KD, Spies C. Computer-assisted decision support for changing practice in severe sepsis and septic shock. J Int Med Res. 2010 Sep-Oct;38(5):1605-16. [CrossRef] [PubMed]
4. Umscheid CA, Betesh J, VanZandbergen C, Hanish A, Tait G, Mikkelsen ME, French B, Fuchs BD. Development, implementation, and impact of an automated early warning and response system for sepsis. J Hosp Med. 2015 Jan;10(1):26-31. [CrossRef] [PubMed]
5. Fountain S, Perry J III, Stoffer B, Raschke RA. Design of an electronic medical record (EMR)-based clinical decision support system to alert clinicians to the onset of severe sepsis. Southwest J Pulm Crit Care. 2016 Apr;12(4):153-60. [CrossRef]
6. Kaukonen KM, Bailey M, Pilcher D, Cooper DJ, Bellomo R. Systemic inflammatory response syndrome criteria in defining severe sepsis. N Engl J Med. 2015 Apr 23;372(17):1629-38. [CrossRef] [PubMed]
7. Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. [CrossRef] [PubMed] 

Cite as Robbins RA. Using the EMR for better patient care. Southwest J Pulm Crit Care. 2016 Apr;12(4):161-2. doi: http://dx.doi.org/10.13175/swjpcc034-16 PDF 

State of the VA

Earlier this week, President Obama gave his last State of the Union Address. Although this usually is a speech giving the President the opportunity of flaunt his accomplishments, no mention was made of the VA (1). Given the troubles at the VA, there seems little to tout.

Over 70% of the VA medical centers were discovered to have falsified wait times (2). Because of the wait scandal, VA Secretary Eric Shinseki resigned and VA undersecretary, Robert Petzel MD, retired under pressure. Ironically, Shinseki, a retired Army general and member of the Joint Chiefs of Staff, was viewed in a favorable light by the current administration because of a spat with the Bush administration's Secretary of Defense, Donald Rumsfeld, over the number of troops needed to secure Iran and Afghanistan (3). However, during Shinseki's tenure the number of VA "medical troops", doctors and nurses, was insufficient to care for the number of veterans. It is unclear if the new secretary, Bob McDonald, has done much to correct the problem.

Locally, the director of the Phoenix VA regional office, Susan Bowers, retired under pressure and former Phoenix VA Director Sharon Helman was fired (4). However, Helman was allowed to keep her bonus for the falsely reported shorter wait times and is appealing her firing. Her deputies, Lance Robinson and Brad Curry, were placed on administrative leave, but after over a year and a half have recently returned to work in the Phoenix VA regional office. Darren Deering DO, the Phoenix chief of staff, underwent a VA internal investigation because of retaliating against one of the Phoenix VA whistleblowers, Katherine Mitchell MD. Disciplinary action was recommended but no action was taken. In October 2015, the IG released a new report citing critical staffing shortages at the Phoenix VA.

Earlier this week the Senate Veterans Affairs Committee approved the nomination of Washington lawyer Michael Missal as the new permanent Department of Veterans Affairs inspector general (VAIG) (5). Lawmakers from both parties have sought a permanent VAIG for over 2 years. The chairman of the Senate veterans panel, Republican Sen. Johnny Isakson of Georgia, says the top priority of the inspector general must be to "hold bad actors at the VA accountable" for chronic delays for veterans seeking medical care and other problems at the agency.

If confirmed by the full Senate which is expected, Missal might be busy. Whether Isakson is serious or this is more political posturing is unclear. Rather than a few “bad actors” the wait scandal suggests that fraud, waste and abuse are common, perhaps even rampant, within the VA. Rather than being held “accountable”, the bad actors are more often protected and even rewarded by VA Central Office. Although Veterans and the public might be optimistic, it is likely that they will be disappointed by Missal, as they have by VAIGs and others charged with VA oversight in the past.

Richard A. Robbins, MD*

Editor, SWJPCC

References

1. Graf N. Veterans' affairs left out of State of the Union; Phoenix VA whistleblower disappointed in speech. ABC15 Arizona. January 13, 2016. Available at: http://www.abc15.com/news/region-phoenix-metro/central-phoenix/veterans-affairs-left-out-of-state-of-the-union-phoenix-va-whistleblower-disappointed-in-speech (accessed 1/15/16).
2. Klimas J. Huge backlog: 70 percent of VA facilities used alternative waitlists. Washington Times. June 9, 2014. Available at: http://www.washingtontimes.com/news/2014/jun/9/audit-more-57000-await-initial-va-visits/?page=all (accessed 1/15/16).
3. DeFrank T. How Donald Rumsfeld complicated Eric Shinseki’s last administration exit. National Journal. May 31, 2014. Available at: http://www.nationaljournal.com/white-house/2014/05/31/how-donald-rumsfeld-complicated-eric-shinsekis-last-administration-exit (accessed 1/15/16).
4. Arizona Republic. VA in crisis: the Republic investigation. Available at: http://www.azcentral.com/investigations/vahealthsystem/ (accessed 1/15/16).
5. Daly M. Senate panel backs lawyer Missal as VA watchdog. Washington Post. January 12, 2016. Available at: https://www.washingtonpost.com/politics/whitehouse/senate-panel-backs-lawyer-missal-as-va-watchdog/2016/01/12/d13db550-b96d-11e5-85cd-5ad59bc19432_story.html (accessed 1/15/16).

*The opinions expressed are those of the author and not necessarily the opinions of the Arizona, New Mexico, Colorado or California Thoracic Socities or the Mayo Clinic.

Cite as: Robbins RA. State of the VA. Southwest J Pulm Crit Care. 2016;12(1):28-9. doi: http://dx.doi.org/10.13175/swjpcc008-16 PDF

Kaiser Plans to Open "New" Medical School

The not-for-profit health maintenance organization (HMO) giant, Kaiser Permanente, announced plans to open a medical school in Southern California with the first class expected to enroll in the fall of 2019 (1). Kaiser is taking the unusual step of creating its own medical school instead of partnering with a university like recent deals made by North Shore-Long Island Jewish in New York and Beaumont Health in suburban Detroit. “We're not just launching another medical school,” Kaiser CEO Bernard Tyson said. “This is really a medical school in which we're bringing forward all the knowledge and wherewithal we've accumulated over the years as our physicians continue to innovate and drive population health and individual health.” Kaiser still has to work through the details of how the school will be funded and the amount of their investment. Kaiser's annual revenue was $56.4 billion last year, with an operating income of $2.2 billion (2).

Kaiser also announced that Dr. Christine Cassel would leave her role as CEO of the National Quality Forum to lead a team tasked with designing the school's teaching approach (1). Until 2013 Cassel was President and CEO of the American Board of Internal Medicine.

The Association of American Medical Colleges (AAMC) estimates a shortage of between 45,000 and 90,000 U.S. physicians by 2025 (3). “The opening of a new medical school will help address this shortage,” Dr. John Prescott, AAMC chief academic officer. However, Kaiser’s announcement is just the first step in building and operating a medical school, which must be accredited by the Liaison Committee on Medical Education, recognized by the U.S. Department of Education as the reliable authority for accrediting medical schools. “It’s a multistage process of moving from an idea to a fully accredited medical school,” Prescott said. “What Kaiser has done is announce its intentions. It’s years away from being a fully accredited school.”

Health care experts say opening its own medical school will provide a steady stream of physicians trained in the "Kaiser way" – a team approach of doctors, nurses, therapists and social workers working on behalf of patients (1). Prescott noted that the establishment of a school was a logical step forward for Kaiser (2).

Commercial interests are becoming increasingly involved in medical education. The University of Arizona's College of Medicine-Phoenix medical school was cited in June by the AAMC in four areas that needed to be addressed to avoid probation or loss of accreditation (4). Two of the four areas stemmed from uncertainties about Banner Health's alliance with the medical school after completing a $1 billion-plus acquisition of the two-hospital University of Arizona Health Network in Tucson.

The question is whether medical education will be independent from commercial interests. The physician should be first and foremost the patient’s advocate. However, the perception of many physicians is they are increasingly impaired in this role by the healthcare delivery systems in which they practice. A major concern is whether financial concerns of healthcare delivery systems might be the real motivation behind corporate interest in medical education. This conflict of interest should be a major concern to the AAMC and raises the important question of who will determine the medical education program in Kaiser's medical school-Kaiser or an independent medical school faculty?

Being a physician is a profession. Doctors should be trained to be doctors, not to be employees of healthcare delivery systems. The tone of the announcement is that Kaiser plans on training the latter.

Richard A. Robbins, MD

Editor, SWJPCC

References

1. Rubenfire A. Kaiser plans to take care model to the source: physician training. Modern Healthcare. December 17, 2015. Available at: http://www.modernhealthcare.com/article/20151217/NEWS/151219881?utm_source=modernhealthcare&utm_medium=email&utm_content=20151217-NEWS-151219881&utm_campaign=am (accessed 12/18/15).
2. Terhune C. HMO giant Kaiser Permanente plans to open a medical school in Southern California. Los Angeles Times. December 17, 2015. Available at: http://www.latimes.com/business/la-fi-kaiser-school-of-medicine-20151217-story.html (accessed 12/18/15).
3. Gordon LK. Managed care giant Kaiser to open medical school. Yahoo! Health. December 18, 2015. Available at: https://www.yahoo.com/health/managed-care-giant-kaiser-to-1323494699909174.html (accessed 12/18/15).
4. Alltucker K. UA pursues medical-school fixes for accreditors. Arizona Republic. December 10, 2015. Available at: http://www.azcentral.com/story/news/arizona/investigations/2015/12/10/ua-pursues-medical-school-fixes-accreditors/77106640/ (accessed 12/18/15).

Cite as: Robbins RA. Kaiser plans to open "new" medical school. Southwest J Pulm Crit Care. 2015;11(6):275-6. doi: http://dx.doi.org/10.13175/swjpcc156-15 PDF