Treatment Adjustment and Medication Adherence for Complex Patients With Diabetes, Heart Disease, and Depression: A Randomized Controlled Trial

Elizabeth H. B. Lin; Michael Von Korff; Paul Ciechanowski; Do Peterson; Evette J. Ludman; Carolyn M. Rutter; Malia Oliver; Bessie A. Young; Jochen Gensichen; Mary McGregor; David K. McCulloch; Edward H. Wagner; Wayne J. Katon

doi:10.1370/afm.1343

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Figure 1
Recruitment flow diagram.

BP = blood pressure; HbA_1c = glycated hemoglobin; LDL = low-density lipoprotein; PHQ-2 = 2-item Patient Health Questionnaire.
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Figure 2
Incidence of first treatment adjustment in medication classes.

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Table 1

Key Elements of Multicondition Collaborative Care Management

Tasks and Objectives	Process	Participants
Identify goals or target	Collaborate to formulate specific and measurable targets (eg, BP, PHQ-9 [depression], HbA_1c or BG, walk number of steps)	Patient, primary care physicians, care managers
Support self-care	Motivate, problem-solve to promote self-monitoring, adherence to medications, lifestyle change	Patient; care managers
Monitor progress	Systematic, proactive tracking, population-based	Patient, care manager, multi-disciplinary consultant
Treat-to-target case reviews	Weekly multidisciplinary caseload review, formulate treatment adjustment recommendations to primary care physician Case-by-case training Accountability for improving outcomes	Treat-to-target physician consultants, care manager
Care coordination	Communicate and coordinate (eg, EHR, telephone, fax, or in person)	Care manager

BG = blood glucose; BP = blood pressure; EHR = electronic health record; HbA_1c = glycated hemoglobin.

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Table 2

Baseline Clinical Characteristics

Characteristic	Intervention n = 90 Mean (SD)	Usual Care n = 91 Mean (SD)
HbA_1c, %	8.1 (2.1)	8.0 (1.9)
Blood pressure, mm Hg	137 (18.0)	131 (17.0)
LDL cholesterol, mg/dL	106.7 (35.4)	107.5 (37.4)
PHQ-9 depression score^a	14.5 (3.8)	13.7 (3.0)
Diabetes (alone or with CHD), % (n)	88.9 (80)	83.5 (76)
CHD (alone or with diabetes), % (n)	24.4 (22)	28.6 (26)
Insulin use, % (n)	45.6 (41)	37.4 (34)
Oral hypoglycemic medication use, % (n)	70.0 (63)	57.1 (52)
Antihypertensive medication use, % (n)	87.8 (79)	83.5 (76)
Lipid-lowering medication use, % (n)	75.6 (68)	79.1 (72)
Antidepressant medication use, % (n)	52.2 (47)	56.0 (51)

CHD = coronary heart disease; HbA_1c = glycated hemoglobin; LDL = low-density lipoprotein; PHQ-9 = 9-item Patient Health Questionnaire.
↵a Scored on a range from 0 to 27; higher score indicates greater depresson severity.

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Table 3

Medication Adherence

Medication Class	Intervention Mean (SD)			Usual Care Mean (SD)

	No.	Baseline	12 mo	No.	Baseline	12 mo
Oral hypoglycemic	66	0.83 (0.19)	0.85 (0.17)	58	0.83 (0.20)	0.83 (0.18)
Antihypertensive	73	0.85 (0.18)	0.88 (0.14)	68	0.86 (0.18)	0.88 (0.16)
Lipid lowering	59	0.82 (0.21)	0.85 (0.17)	57	0.85 (0.18)	0.88 (0.13)
Antidepressant	43	0.79 (0.23)	0.85 (0.16)	40	0.80 (0.19)	0.80 (0.19)

Note: Sample excludes new medication starts. There were no significant differences between the intervention and usual care group for all medication classes.

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Table 4

Rate of Treatment Adjustment (Number of Adjustments Over 12 Months)

Therapeutic Class	Rate (95% CI)		Relative Rate^a (95% CI)
Therapeutic Class	Intervention	Usual Care	Relative Rate^a (95% CI)
Antidepressant	3.37 (2.92–3.89)	0.53 (0.34–0.82)	6.20^b (3.88–9.90)
Insulin	3.26 (2.43–4.36)	1.02 (0.67–1.55)	2.97^b (1.83–4.83)
Oral hypoglycemic	0.62 (0.44–0.88)	0.34 (0.23–0.50)	1.80^c (1.07–3.01)
Antihypertensive	2.33 (1.86–2.92)	1.11 (0.81–1.51)	1.86^b (1.28–2.71)
Lipid lowering	0.81 (0.64–1.03)	0.55 (0.42–0.72)	1.56^c (1.10–2.20)

Note: Treatment adjustment defined as (1) an increase in the number of medication classes prescribed, (2) a change in dosage of at least 1 ongoing medication class, (3) a switch to a medication in a different class, or (4) a switch to a different medication within the same class over the 12-month intervention period. Medication adjustment includes initiations and subsequent treatment changes.
↵a Adjusted for baseline Poisson regressions with robust (Huber-White) standard errors predicting the rate of adjustments (baseline to 12 months) within each therapeutic class.
↵b P value <.001.
↵c P value <.05.

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The Article in Brief

Background Patients with multiple chronic diseases have unfavorable health outcomes and present challenges to both patient care and medical costs. This study examines the effect of a team-based care management intervention on the initiation and adjustment of drug therapy for patients with uncontrolled diabetes and/or coronary heart disease and depression.

What This Study Found The randomized controlled trial of 214 patients with poorly controlled diabetes or coronary heart disease and coexisting depression found that patients in the intervention group (1) increased self-monitoring of key disease parameters relative to usual care patients and (2) had higher pharmacotherapy adjustment rates compared with usual care patients. At 12 months, the average rate of blood pressure monitoring was more than 3 times higher in the intervention group compared with the usual care group, and the average blood glucose monitoring rate was 4.9 days per week vs 3.8 days per week, respectively. Pharmacotherapy initiation and adjustment rates were 6 times higher for antidepressants, 3 times higher for insulin therapy, and nearly 2 times higher for antihypertensive medications among patients in the intervention group relative to usual care. There was no difference in medication adherence rates.

Implications

Results of this trial suggest that improving specific patient and clinician behaviors (close monitoring of disease control parameters and timely treatment adjustments to achieve individualized goals) can improve disease control and quality of life among multicondition patients with complex health care needs.