Payers have been rolling out disease management programs as a way to both control costs and improve outcomes for patients with chronic diseases
, such as chronic obstructive pulmonary disease
and others. But what happens to health outcomes when components of care considered disease management in the United States are considered part of usual care elsewhere in the world?
A recent study, conducted in Israel where there is universal healthcare, examined the effects of adding disease management (DM) to recommended care (RC) in ambulatory patients with COPD. The study was published in the American Journal of Respiratory and Critical Care Medicine
The authors wrote that the effects of DM in the treatment of patients with COPD are uncertain, noting that a review of 26 randomized controlled trials showed improved outcomes, including quality of life and functional exercise capacity, and fewer respiratory-related hospital admissions and all-cause in-hospital days among patients with COPD. However, another study showed that a comprehensive chronic care program was associated with excess disease-related deaths and had a neutral effect on hospital admissions.
RC for patients with stable COPD includes inhaled long-acting bronchodilators and corticosteroids, inﬂuenza vaccines, smoking cessation for patients who are active smokers, and pulmonary rehabilitation.
But this may differ according to local settings—the authors noted that pulmonary rehabilitation, although considered part of recommended care under the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline: 2017 Update,
can be hard to obtain.
Indeed, a 2016 report published in The Lancet Respiratory Journal
, written by 28 US respiratory experts, noted the struggles that patients with COPD have with obtaining recommended care, including access to affordable medicine, access to pulmonary rehabilitation and other non-drug treatments, dealing with a fragmented payer system, and other issues.2
In the Israeli study, 1202 patients with moderate-to-severe COPD were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). All patients were 40 years or older.
RC included follow-up by pulmonologists, inhaled long-acting bronchodilators and corticosteroids, smoking cessation intervention, nutritional advice, psychosocial support if needed, and supervised physical activity sessions.
DM, delivered by trained nurses during patients’ visits to COPD centers and by remote contacts in between visits, included patient self-care education, monitoring patients’ symptoms and adherence to treatment, giving advice in case of acute disease exacerbation, and coordination of care with other providers. Off-hour consultations were also available with trained nurses in case of flare-ups, and patients were provided with prescriptions ahead of time (for steroids, antibiotics, and others) in case they were instructed to take them.
Participants were recruited between October 2009 and June 2012, and monitored until death or end of the study (July 2014). The median time of follow-up was 3 years. Most patients (77%) had their COPD classified as GOLD 3.
The mean (SD) age of participants was 67.5 (10) years; 855 (71.1%) were men. Current and past cigarette smoking was reported in 34% and 49% of the participants, respectively. The primary end point was ﬁrst hospital admission for respiratory symptoms or death from any cause.
During 3537 patient-years, 284 patients (47.2%) in the control group receiving just RC and 264 (44%) receiving DM from nurses had a primary end point event.
The median (range) time elapsed until a primary end point event was 1 (0-4) years among patients assigned to the DM group and 1.1 (0-4.1) years among patients assigned to the RC group (adjusted hazard ratio, 0.92; 95% CI, 0.77-1.08).
There were no statistically significant differences in secondary outcomes, either. Patients receiving both RC and DM were more likely to report improvement in their health status, as measured with the St. George’s Respiratory Questionnaire (adjusted odds ratio [OR], 1.32; 95% CI, 1.01-1.73; P
The 2 groups did not signiﬁcantly differ with respect to the likelihood of seeing improvements in health-related quality of life, depression, 6-minute-walk test, mean forced expiratory volume in 1 second, and severity of respiratory symptoms during follow-up.
Among patients who were active smokers at enrollment (n = 410), patients receiving RC plus DM were more likely to report that they were no longer smoking cigarettes at their last follow-up visit, compared with those receiving RC alone (57/221 [25.8%] vs 32/189 [16.9%], respectively; OR, 1.72; 95% CI, 1.05-2.82; P
In an email exchange with The American Journal of Managed Care®
, lead author Ofra Kalter-Leibovici, MD, director of the cardiovascular epidemiology unit at the Gertner Institute for Epidemiology and Health Policy Research in Ramat-Gan, Israel, said that the results of this study, showing no difference between the 2 groups, have more to do with how “disease management” and “recommended care” were defined and provided.
“In contrast to most other studies, in our trial all patients received care recommended by the GOLD practice guidelines for patients with moderate–to–very severe COPD, ie, care delivered by consultant pulmonologists, and where relevant, by dietitians and social workers,” Kalter-Leibovici wrote. “In addition, all patients received recommended medical care (inhaled corticosteroids and long-acting bronchodilators) and supervised physical exercise sessions. All patients who were active smokers, regardless of study group assignment, were referred to smoking cessation group sessions and received prescription for smoking cessation medications.”
The DM piece of the study centered on giving advice in case of acute disease exacerbations; monitoring adherence to healthy lifestyle and drug therapy for COPD; coordination of care among all caregivers, including primary care providers; and provision of additional behavioral support for smoking cessation among active smokers, said Kalter-Leibovici.
She said that when she reviewed other DM studies, components of recommended care, such as pulmonary rehabilitation or smoking cessation, were provided as a part of the DM intervention, while the control group, or patients getting “usual care,” did not receive those interventions.
“In my opinion, these are flaws in the design of [some of] the trials, since these components are not traditionally included in the scope of disease management interventions,” she said, adding later, “disease management interventions probably do not provide additional benefit to patients who already receive recommended care.”
1. Kalter-Leibovici O, Benderly M, Freedman LS, et al. Disease management plus recommended care versus recommended care alone for ambulatory patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med
. 2018;197(12):1565-1574. doi: 10.1164/rccm.201711-2182OC.
2. Han MK, Martinez CH, Au DH, et al. Meeting the challenge of COPD care delivery in the USA: a multiprovider perspective. The Lancet Respiratory Medicine
. 2016;4(6):473-526. doi: 10.1016/S2213-2600(16)00094-1.