Section 8: The Care Management Evidence Base

Considering the evidence on the efficacy of different care management interventions is important for States as they plan and design a care management program. States should use the evidence base for care management to gain support from stakeholders, choose diseases, and select interventions. The evidence also can help States determine the timeframe in which they should expect changes from their programs. This information allows States to better set expectations for their program and choose appropriate measures.

This section of the Guide, The Care Management Evidence Base, presents a review of published literature relating to care management programs in the public and private sectors. General findings appear in the body of the section, with more specific findings for diabetes, asthma, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and coronary artery disease (CAD) outlined in individual synopses that follow.

General Findings

The literature review examined the effects of common care management interventions, as discussed in Section 4: Selecting Care Management Interventions, on outcome and process measures. Diabetes and asthma were addressed most frequently in the literature, followed by CHF, COPD, and CAD, respectively. In general, the impact of different interventions varied widely depending on the disease and type of measure. Noting that few studies reviewed just one intervention is important. Many study participants received multiple interventions (e.g., telephonic care management and patient education), and the studies were unable to isolate the impact of each individual intervention. The literature is also limited regarding the timing needed to see the effects of care management interventions. Within the literature reviewed, study duration varied from 30 days to 5 years, and the intervention length did not have a clear impact on the outcomes. Despite these study limitations, the literature review found evidence of care management interventions improving outcomes across all diseases successfully.

Diabetes

Medicaid care management programs target diabetes frequently because of its high prevalence and cost. The literature review found significant evidence that care management can impact clinical outcomes and process measures positively. The literature addressed utilization and cost-saving measures less frequently for diabetes than for the other diseases, except for CAD. For diabetes, in-person and telephonic care management were the only interventions that impacted utilization or cost. As with other diseases, in-person care management was the most effective intervention overall, but several other interventions also proved effective, including self-management education, provider education, and provider profiling and feedback.

• In-Person Care Management. Of the interventions addressed in the literature, in-person care management exerted the strongest impact on clinical outcomes and process measures. It significantly affected measures such as blood pressure, lipid screening and levels, HbA1c screening and levels, and eye and foot exams. For example, 10 articles on in-person care management detailed a significant reduction in average HbA1c levels, a significant increase in the proportion of patients with good HbA1c control, or a significant increase in blood sugar control. Significant positive outcomes were primarily experienced when interventions lasted 12 to 36 months. In fact, among the 13 articles that provided interventions for 12 months to 36 months, seven studies provided in-person care management for 36 months.
• Provider Education. For diabetes, provider education was the second most effective intervention in terms of number of measures impacted. Studies found that provider education exerted a positive impact on lipid levels, HbA1c screening, eye exam rates, and lipid screening rates. Noting that provider education most often impacted measures tied to provider services (i.e., exams and screenings) is important. For example, six articles implementing provider education interventions show significant increases in low density lipoprotein (LDL) screenings (20 percent to 43 percent), high density lipoprotein (HDL) screenings, or Healthcare Effectiveness Data and Information Set (HEDIS) score for lipid screening or a significant decrease in the racial disparity in LDL screenings (33 percent).
• Self-Management and Monitoring. Compared to other types of measures, self-management and monitoring had the greatest impact on clinical outcome measures controlled by the patient (e.g., blood sugar levels). These outcome measures are largely determined by a patient's behavior (e.g., exercise, medication adherence). For example, seven studies implementing self-management and monitoring interventions reported significant improvements in HbA1c control. Five articles demonstrated a significant decrease in HbA1c levels (ranging from 1.4 to 2.1 percentage points).

Other interventions, such as telephonic care management, were associated with positive clinical outcomes but less frequently than the interventions listed above. Overall, the literature review found that care management impacted diabetes outcome and process measures positively but that its impact on utilization and cost measures was limited. The most common intervention length for diabetes was 12 months, though studies used interventions up to 5 years. Although diabetes cost and utilization outcomes were limited, no utilization or cost outcomes occurred as a result of interventions lasting fewer than 12 months.

Asthma

The prevalence of asthma is significantly higher for Medicaid beneficiaries as compared with the commercial population. Medicaid beneficiaries often face environmental factors and barriers to care that result in higher emergency room (ER) utilization for asthma. The asthma literature review found a greater number of positive outcomes, especially in terms of utilization and cost measures, as compared with the other diseases. The literature review found that asthma care management can impact clinical outcomes, process, utilization, and cost measures effectively.

• In-Person Care Management. As with diabetes, in-person care management proved the most effective intervention, impacting all types of measures. In-person care management for asthma yielded the largest utilization and cost results as compared with the other diseases and interventions. Several studies found decreased health care utilization overall, including lower ER use and hospitalizations. Studies also found that in-person care management increased savings, often due to changes in utilization.
• Patient Education. The asthma literature review found much stronger evidence for using patient education than the diabetes literature review. The review found that patient education impacted process, clinical outcomes, and activation measures positively, though not utilization or cost measures. Patient education impacted measures such as medication use, self-management, asthma knowledge, and quality of life. Patient education often is combined with other interventions, which might increase its effectiveness.
• Telephonic Care Management. The asthma literature also found much stronger evidence for using telephonic care management than the diabetes literature review. Telephonic care management impacted clinical outcomes, process, activation, utilization, and cost measures positively. Telephonic care management especially impacted measures that reflect a patient's quality of life. For example, three studies found that telephonic care management significantly reduced the number of patient-reported symptoms.
• Provider Education. The most effective provider intervention studied, provider education, impacted measures such as adherence to guidelines, followup visit rates, medication use, and utilization positively. For example, three studies found that provider education helped significantly reduce the number of outpatient visits, ER visits, hospital admissions, and acute office visits.

Congestive Heart Failure

A highly prevalent disease among the Medicaid population, CHF is targeted consistently in care management programs. A literature review looking at efficacy of care management interventions on CHF found that care management can impact clinical outcomes, process, utilization, and cost measures positively.

• In-Person Care Management. The CHF literature review yielded less evidence for using in-person care management compared with diabetes and asthma, yet it found that in-person care management exerted the greatest impact, compared with all other interventions, on hospital readmission rates. For example, one study found a 74 percent reduction in hospital readmissions within 6 months. In-person care management also impacted clinical outcomes and cost measures. No evidence was found suggesting improvements in process measures.
• Telephonic Care Management. The majority of research found in this literature review assessed the impact of telephonic care management, although results were inconclusive. Telephonic care management showed strong evidence for reducing utilization, specifically hospital readmissions, with some studies experiencing a 45 percent drop in hospital readmissions. Evidence for cost savings and improved clinical outcomes were less conclusive. Some studies found significant improvements, but others failed to see a significant difference when telephonic interventions were applied.
• Self-Management and Monitoring. Self-management and monitoring was found to be one of the most effective interventions for CHF, impacting clinical outcomes, process, utilization, and cost measures. For example, studies found that fewer patients died when a self-management and monitoring intervention was used. As for the impact of self-management and monitoring on cost savings, one study found that the return on investment (ROI) ranged between $1.08 and $1.15 per dollar spent.
• Decision Support. Although fewer articles assessed the impact of decision support on CHF compared with self-management and telephonic care management, evidence suggests decision support can improve clinical outcomes, process, utilization, and cost measures significantly. For example, studies found that decision support improved the administration of ACE inhibitors significantly.

Other interventions, including patient and provider education, also were associated with positive results, but less frequently than the interventions listed above. Study lengths addressing CHF ranged from 1.5 months to 24 months and varied greatly across interventions and outcomes. A notable exception includes studies examining utilization measures in which no outcomes occurred as a result of interventions lasting fewer than 12 months. Overall, the literature review found that care management impacted CHF positively, but the evidence base is stronger for asthma and diabetes.

Chronic Obstructive Pulmonary Disease

Although COPD is commonly targeted by care management programs, only a limited body of research explores the effects of care management interventions on managing the disease. The literature review found significant evidence suggesting that care management led to substantial savings per patient, but results are inconclusive looking at interventions' impact on clinical outcomes and utilization rates.

• In-Person Care Management. In-person care management was the most researched intervention, and though some studies suggest improved clinical measures and utilization, others found no significant impact. For example, one study suggested in-person care management led to improvement in quality of life, dyspnea (difficult or labored respiration), emotional function, and fatigue, but a randomized clinical control study found no significant difference in quality of life between the group with in-person care management and the control group. Regarding utilization, one study found significant decreased hospital and ER utilization, another article found no significant decrease in use of such resources. Only one study examined the impact of in-person care management on cost and found a savings of more than $13,000 per patient.
• Decision Support. Only one article examined use of decision support and found that it exerted the greatest impact on utilization. This study suggests that decision support led to significant reduction in average hospital stay, which reduced from 7.8 days to 5.6 days and helped reduce significantly the cost of an average case from $4,050 to $3,170.
• Provider Education. Only one study researched provider education's impact on COPD and found that this intervention had no significant effects on clinical outcomes or utilization.

Due to the limited amount of research surrounding care management interventions' effect on COPD, results are inconclusive, including results regarding timing. Nevertheless, studies suggest that care management interventions can potentially lead to cost savings and improved clinical outcomes and utilization rates.

Coronary Artery Disease

Of all the diseases, the least amount of evidence exists for the effect of care management on CAD. The literature review found five studies, and all showed positive impacts on clinical outcomes, process, or activation measures. As with the other diseases, in-person care management proved the most effective intervention. None of the studies found care management interventions that exerted a significant impact of utilization or cost related to CAD.

• In-Person Care Management. Studies have found that in-person care management can improve clinical outcomes, process, and activation measures. For example, studies revealed that in-person care management reduced angina frequency and CAD-related physical limitations, while significantly increasing angina stability and the percentage of people with LDL levels below 130 mg/dl and 100 mg/dl.
• Self-Management. Evidence suggests that self-management can improve clinical outcomes and processes. Two studies found that self-management education helped increase use of aspirin, beta-blockers, ACE inhibitors, and statins. An additional study found that the percentage of patients with LDL levels less than 100 mg/dl increased significantly when self-management education interventions were applied.
• Provider Interventions. Studies also found improvements associated with other interventions, including physician decision support tools and provider education. Two studies found that these provider interventions were able to reduce the percentage of patients with LDL levels greater than 130 mg/dl and improve use of aspirin, beta-blockers, ACE inhibitors, and statins.

Evidence for the effectiveness of care management on CAD is sparse, and impact of time is unclear. Studies have found positive results, but additional research is needed to allow for firm conclusions.

Conclusion

States can use the evidence base for care management to select diseases and interventions and to set appropriate expectations for program outcomes. The literature review identified a few important findings across diseases.

• Care Management Success. Across all diseases, the literature found examples of successful care management programs in terms of intervention outcomes. Although the body of literature was significantly smaller for certain diseases and, therefore, less conclusive, successful interventions still can be identified.
• Intervention Effectiveness. Although interventions ideally would prove equally effective for all diseases, the literature review found that they might vary among diseases in terms of their overall efficacy and, in particular, which outcomes they impact. For example, the literature review found that telephonic care management was more effective overall for asthma as compared with diabetes.
• In-Person Care Management. In-person care management was the most effective intervention across all five diseases. Although it can be more difficult and expensive to implement, in-person care management is the best intervention to use to generate cost savings and improve clinical outcomes.
• Provider Interventions. As expected, provider interventions exerted the greatest impact on measures that target provider processes such as HbA1c screening or medication use. States can employ provider interventions to impact process measures or, in some cases, utilization or cost, but overall provider interventions had minimal impacts on clinical outcomes.

The following disease-specific synopses outline the impact of multiple care management interventions. For more information on specific outcomes, please refer to the Review Synopses.

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Review Synopsis: Diabetes

To evaluate the effect of care management on diabetes, we reviewed 61 articles. Of those articles, 40 examined the impact of patient interventions, 17 examined the impact of provider interventions, and 3 examined the impact of a combination of patient and provider interventions. The interventions evaluated most commonly were:

• In-person care management (15 articles).
• Self-management and monitoring (13 articles).
• Provider education (6 articles).
• Telephonic care management (10 articles).

Findings are organized below by measurement category (i.e., clinical outcome measures, clinical process measures, activation measures, utilization measures).

Clinical Outcome Measures

We reviewed 39 articles that evaluated the impact of care management interventions on clinical outcomes, 35 of which found these interventions can lead to improved outcomes. Clinical outcomes examined include:

• Glycosated hemoglobin levels (HbA1c).
• Blood pressure.
• Lipid (cholesterol and triglyceride) levels.

Of the intervention categories, in-person care management, which lowered HbA1c levels, blood pressure, and lipid levels significantly in several studies, appeared to exert the strongest impact on clinical outcomes. Disease registry and practice site improvement appeared to have the weakest effects, demonstrating no significant impacts on clinical outcomes.

Impact on Blood Sugar

• In-Person Care Management. Ten articles studying in-person care management detailed a significant reduction in average HbA1c levels, a significant increase in the proportion of patients with good HbA1c control (under 7.0 percent or 7.5 percent), or a significant increase in blood sugar control. In these studies, average HbA1c levels were reduced by 0.4 to 1.1 percentage points, while the proportion of patients with good HbA1c control rose by approximately 40 percent.^1-10
• Self-Management and Monitoring. Seven studies implementing self-management and monitoring interventions reported significant improvements in HbA1c control. Five articles demonstrated a significant decrease in HbA1c levels (ranging from 1.4 to 2.1 percentage points), while one article showed significant improvements in low-literacy populations, and another demonstrated a significant increase in patients' mean fasting sugar-to-insulin ratio.^11-16
• Pharmacist-Led Care Management. All four studies investigating pharmacist-led care management found a significant reduction in HbA1c levels (ranging from 0.8 to 2.1 percentage points).^11,17-19 One of these studies found this reduction to be larger in patients with HbA1c levels greater than 8.5 percent (2.7 percentage points) and also found a significant increase in the proportion of patients with HbA1c levels less than or equal to 7 percent.¹⁸

Impact on Blood Pressure

• In-Person Care Management. Three articles addressing in-person care management demonstrated significant reductions in both systolic and diastolic blood pressure, ranging from 4 to 8 mm Hg and from 3 to 8 mm Hg, respectively.^4,6,20
• Self-Management and Monitoring. Similarly, three articles examining self-management and monitoring showed significant reductions in blood pressure in either the general patient population or in hypertensive patients.^13-15

Impact on Lipid Levels

• In-Person Care Management. Four in-person care management studies documented one or more improvements in cholesterol: two articles found significant reductions in total cholesterol (of approximately 28 mg/dl), three found significant reductions in LDL (16 mg/dl), and one found significant improvement in HDL (3 mg/dl).^4,5,8,10
• Self-Management and Monitoring. Three studies featuring self-management and monitoring interventions documented significant lipid improvement. One article found significant improvement in total cholesterol; two articles found significant improvement in HDL levels (6 mg/dl); and one found significant improvement in LDL cholesterol.^13,15,21 Additionally, one study demonstrated a significant decrease in triglycerides.¹⁵
• Provider Education. One education article found a reduction in LDL levels, while another found a reduction in racial disparity in LDL levels (71.4 percent).^22,23

Clinical Process Measures

We evaluated 26 articles that examined the impact of care management interventions on clinical process measures, 25 of which found that these interventions can generate improvement. The clinical process measures we looked at were HbA1c screening, eye exams, foot exams, lipid screening, aspirin use, and pneumococcal vaccine administration. Of the intervention categories, the intervention that appeared to exert the strongest impact on clinical process measures was in-person care management, which affected HbA1c screening, eye exams, foot exams, and pneumococcal vaccine administration significantly. Profiling and feedback and provider education were also effective in improving clinical process measures.

Impact on HbA1c Screening

• In-Person Care Management. Three in-person care management studies found significant improvement in HbA1c screening rates.^1,2,24
• Profiling and Feedback. Two profiling and feedback studies found significant improvement in the likelihood of HbA1c screening, with the rate increasing by 29 percent.²⁵
• Provider Education. Four provider education articles found significant improvement in screening rates. Two studies found that the odds ratio of having an HbA1c screening ranged from 2.1 to 7.0 (as compared to baseline), while another study found that the intervention led to a 12.5 percent increase in screening.^26-28 An additional study found that HbA1c screening increased 15 percent.²⁹

Impact on Eye Exams

• In-Person Care Management. Two in-person care management studies showed significant increases in retinal exams.^1,24
• Telephonic Care Management. Two telephonic care management studies demonstrated either a significant increase in eye exams or a significant increase in frequency of dilated retinal exams.^30,31
• Profiling and Feedback. Two studies using profiling and feedback found this intervention significantly increased eye exams. One study found a 16 percent increase in eye exams (from 14 percent to 30 percent).^24,32
• Provider Education. Two studies investigating provider education found that the intervention increased eye exam referrals significantly (by 30.6 percent) or resulted in significantly higher HEDIS scores for eye screening (22 percent).^27,29

Impact on Foot Exams

• In-Person Care Management. Three of the studies using in-person care management found that the intervention improved the rate of foot exams by approximately 34 percent.^1,6,24
• Telephonic Care Management. Two of the telephonic care management studies found that foot exam frequency was improved, as was likelihood of both physician-administered foot exams and foot self-exams.^30,31
• Profiling and Feedback. Two articles investigating profiling and feedback found the practice to improve the rate of foot exams. One study showed that likelihood of an exam increased by 36 percent, while another found that rate of exam was increased by five percentage points.^24,32

Impact on Lipid Screening

• Provider Education. Six articles implementing provider education interventions show significant increases in LDL screenings (20 percent to 43 percent), HDL screenings (odds ratio, compared to baseline: 5.6), or HEDIS score for lipid screening or a significant decrease in the racial disparity in LDL screening (33 percent).^23,26-29,33

Impact on Aspirin Use

• Pharmacist-Led Care Management. Two studies revealed that pharmacist-led care management increased aspirin use. One study showed that aspirin use increased significantly (57 percent), while another found that the proportion of patients taking aspirin daily rose significantly (48 percent).^17,18

Impact on Pneumococcal Vaccine Administration

• In-Person Care Management. Two studies found that this intervention increased the likelihood of inoculation (79 percent) significantly.^1,6

Activation Measures

Because of the broad array of activation measures, these outcomes are measured inconsistently across or within the varying interventions. In fact, the only measure to yield significant results more than once for any given intervention is patient satisfaction: two studies using in-person care management demonstrated significant increases in patient satisfaction (odds ratio, compared to control: 2.88).^8,34

Utilization Measures

Resource utilization was addressed sparingly in the diabetes care management literature, and significant results were reported only in studies employing in-person care management and telephonic care management.

• In-Person Care Management. Four in-person care management articles featured significant findings pertaining to utilization. One article found a significant decrease in the risk of hospitalization (16 percent), while another found that the proportion of patients for whom the cost of medications, monitors, and test strips presented an obstacle to care was reduced.^6,35 Further, another study found that routine visits increased by 39 percent when the intervention was employed.³⁶ However, one study found that in-person care management increased total costs by almost $1,350 (31 percent).⁴
• Telephonic Care Management. Four studies investigating telephonic care management reported significant utilization data. One study reported a significant increase in need-based primary care visits, while another demonstrated a significant decrease in outpatient visits (49 percent).^37,38 The latter study also reported reductions in inpatient admissions (32 percent) and ER visits (34 percent); these findings were insignificant with p-values under 0.10.³⁸ Overall, according to one study, telephonic care management led to a significant reduction in the cost of care, while another study reported ROI of 3.37 (significance not reported).^30,39

Conclusion

The majority of the relevant articles evaluated the impact of care management interventions on clinical outcomes, and most of those articles found that these interventions can lead to improved outcomes. Several articles also found improved clinical process measures when in-person care management, profiling and feedback, provider education, telephonic care management, and pharmacist-led care management interventions were used. However, because of the inconsistent measures used for activation outcomes, results for activation measures were too broad and were not subject to generalized findings. Limited evidence exists addressing the effects of utilization and savings when employing care management interventions for diabetes maintenance.

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