This preliminary pilot study supports the usefulness of a brief primary care based integrated care intervention to improve adherence to oral hypoglycemic agents and antidepressants, blood glycemic control, and depression symptoms among older African-Americans. Primary care older African-American patients randomized to an integrated care intervention in comparison with older African-American patients randomized to usual care showed higher rates of adherence to oral hypoglycemic agents and antidepressants at 6 weeks and lower amounts of glycosylated hemoglobin in their blood and fewer depressive symptoms at 12 weeks.
Before discussing the implications of the findings, the limitations of this study require discussion. First, the results were obtained from patients who received care at one primary care site that might not be representative of most primary care practices. However, this practice was probably similar to other primary care practices in the region. Second, this preliminary investigation was limited to 58 participants and the follow-up period was short, but the participants were randomized to the intervention or usual care. Third, the intervention would require additional resources in primary care settings. However, the intervention has a simple design and future implementation will explore whether ancillary health personnel could be trained to carry out the intervention. Fourth, MEMS Caps were used to measure adherence. All methods for assessing adherence have limitations. MEMS caps were used as the primary measure of adherence because MEMS caps have a low failure rate58
and may be more sensitive than other adherence measures.59
In addition, prior studies have shown that MEMS caps do not significantly influence adherence.58, 60
Also, any effect of MEMS caps on medication adherence would be experienced equally in both groups and therefore would not influence a comparative assessment by randomization assignment. The adherence threshold of was 80% in this analysis. While this threshold has been assessed in some clinical research,58
the clinical relevance of this threshold has not been tested for many medications. Lastly, psychological variables, such as depression, cannot be observed directly and the measures employed may not reflect the construct being measuring.
Despite the limitations of this study, findings from this study deserve attention because previous intervention trials to reduce the burden of Type 2 DM in primary care targeting older African-Americans have not addressed depression.61-66
Integrated interventions may be more feasible and effective in real world practices with competing demands for limited resources and have been found to be more engaging and acceptable to African-Americans.21, 22, 67
In this intervention, depression treatment was integrated into care for Type 2 DM so a single program could assist older African-Americans with Type 2 DM and depression. Consistent with the hypothesis patients randomized to the integrated intervention had a greater proportion of participants with 80% or greater adherence to an oral hypoglycemic agent and an antidepressant at 6 weeks as well as lower amounts of glycosylated hemoglobin and fewer depressive symptoms in their blood at 12 weeks.
A recent review of diabetes self-management interventions noted that an assessment of the feasibility of many interventions is limited by failure to report overall contact time with study participants.68
The total contact time for this study was 2 hours (three 30 minute in-person meetings and two 15 minute telephone contacts). The minimal time involved in the study implementation supports prior findings that integrated interventions may provide a feasible and effective solution in real world practices with competing demands for limited resources.69
Another distinguishing factor of this intervention was the high retention rate of study participants (100%). The high retention rate is aligned with findings indicating that older primary care patients are more likely to be engaged in integrated care than other forms of care provision70
and integrated care models are particularly effective in improving access to and participation in mental health services among African American primary care patients.21
Interventions to narrow ethnic disparities have addressed patient-level, health care system-level, and community-level factors. This study sought to modify the health behaviors of individual patients and evaluated the effectiveness of a relatively brief pilot randomized controlled trial with a focus on adherence for the management of Type 2 DM as well as depression in older African-American primary care patients. Further research is needed to evaluate this intervention in a larger, more representative sample, with longer periods of follow-up. Although statistically significant clinical outcomes were found at 12 weeks, the pilot results did not provide information on how long the improvement might continue or the maximal improvement. Finding similar results in a larger sample over a longer follow-up period would provide information for primary health care practices and providers on possible approaches to the care of depressed older African-Americans with Type 2 DM.
Implications for Practice
Depressed older African-Americans with Type 2 DM randomized to an integrated care intervention in comparison with depressed older African-Americans with Type 2 DM randomized to usual care demonstrated improved medication adherence and clinical outcomes. Because the sample was derived from primary health care, the public health significance is high. Further research supporting the extent of the clinical benefit of this intervention in primary care is the first step in implementing this type of program. Future investigations could explore enhancing and sustaining the effect of the intervention for example through the training of ancillary health personnel, such as Licensed Practical Nurses, who are already working in primary care practices to carry out the intervention. These findings should propel the development and dissemination of models of care that better integrate depression management for African-Americans with diabetes and other chronic conditions.