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OBJECTIVE: To develop and test an inexpensive visual tool to help patients with diabetes improve glycemic control.
METHODS: A multidisciplinary team developed a 1-page form, the “Take-home Diabetes Record” (THDR), providing feedback to patients by displaying per cent glycosylated hemoglobin (GHb) values graphically over time, with target levels highlighted. Patients with type 2 diabetes in an inner-city clinic were randomized to THDR use (n = 57) or not (n = 70) over 15 months. Self-care activities were discussed, linked with GHb results, and charted at each clinic visit. Initial and final GHb were compared.
RESULTS: Mean GHb fell significantly in THDR patients (−0.94, P = .003), but not in control patients (−0.18, P = .36). Mean GHb decrease was greater in THDR patients (P = .047). A greater proportion of THDR patients (51%) than control patients (18%) achieved a decrease in GHb ≥0.9 (P = .001).
CONCLUSIONS: A graph linking GHb and self-care activities shows promise for improving glycemic control.
Improving care for inner-city patients with chronic diseases is a challenge. Obstacles include poverty,1 lack of insurance,2 rising drug costs,3 failed appointments,4 attending multiple clinics,5 substance abuse,6 psychiatric illness,7,8 and budgetary pressures on providers.9 Effective communication between physician and patient may be limited by language barriers related to high immigration rates,10 illiteracy,11,12 or cultural differences.13 These problems are not unique to urban areas, but often are concentrated there.
Diabetes, in particular, is a disease where good communication is important. Outcomes improve when patients understand their treatment,14 receive immediate feedback,15 or report that their physicians are collaborative rather than directive.14 Outcomes also improve when professional interpreters are available,16 and with the use of frequent computerized reminders17 or intensive nursing management.18
We hypothesized that visual, nonverbal communication could be helpful in this setting. Despite calls for behavioral research in diabetes,19 a medline (Ovid) search from 1966 to 2002 (keywords: diabetes, feedback, patient education, communication, graph, urban population) revealed only 1 letter briefly describing visual communication with diabetic patients,20 and 3 reports of trials with other groups of patients.21–23
This report describes the design and testing, in a randomized controlled trial, of a communication tool to improve diabetes care in a primary care clinic in an inner-city neighborhood in Minneapolis, Minnesota. The central idea was to communicate visually rather than verbally, using a graph of glycosylated hemoglobin (GHb) at every visit.
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Table 1 shows demographic and clinical characteristics of the randomized patients. There were no statistically significant differences between groups. The immigrant patients were from Somalia, Ethiopia, Mexico, Egypt, Liberia, Laos, Togo, Russia, Tibet, Vietnam, and the Philippines.
Table 1. Clinical and Demographic Characteristics of the Randomized Patients
|Patient Characteristic||Control (N = 70)||Intervention (N = 57)||Control–Intervention Difference P Value*||Dropped Out (N = 37)|
| Geometric mean||51||54||.87||52|
| Range||20 to 91||32 to 83|| ||29 to 78|
|Gender, n (%)|| || ||>.99|| |
| Female||37 (53)||31 (54)|| ||22 (59)|
| Male||33 (47)||26 (46)|| ||15 (41)|
|Treatment modality, n (%)|| || ||.44|| |
| Non-insulin–based therapy||51 (73)||37 (65)|| ||25 (66)|
| Insulin-containing therapy||19 (27)||20 (35)|| ||12 (32)|
|Entry GHb, %|
| Geometric mean||8.2||8.7||.16||8.4|
| Range||5.4 to 13.0||5.0 to 14.0|| ||5.9 to 13.5|
|Diabetes educator visits, 1998, n (%)|| || ||.35|| |
| No visits||50 (71)||46 (81)|| || |
| 1–5 ||20 (29)||11 (19)|| || |
|Comorbid conditions†, n (%)|| || ||>.99|| |
| Major psychiatric diagnoses||19 (33)||17 (39)|| ||7 (29)|
| Alcoholism||6 (10)||6 (14)|| ||3 (13)|
|Insurance, n (%)|| || ||.32|| |
| Medicare/Medicaid||41 (59)||34 (60)|| ||22 (59)|
| None||21 (30)||12 (21)|| ||7 (19)|
| Private||8 (11)||11 (19)|| ||8 (22)|
|Ethnic background, n (%)|| || ||.60|| |
| European American||27 (39)||23 (40)|| ||10 (27)|
| African American||20 (29)||20 (35)|| ||15 (41)|
| Recent immigrant||15 (21)||7 (12)|| ||8 (22)|
| Native American||4 (6)||2 (4)|| ||1 (3)|
| Other/unknown||4 (6)||5 (9)|| ||3 (8)|
Of the 127 patients randomized, 37 did not have a usable GHb pair, because no final GHb was drawn during the 15-month study period (n = 34) or the final GHb was drawn within 3 months of the initial GHb or first use of the THDR (n = 3). These patients were evenly divided between the intervention (n = 18) and control (n = 19) groups. Chart examination showed that the THDR had never been used in 12 intervention patients, but to avoid selection bias, these patients were included in the intention-to-treat analysis.
Analysis of the 90 patients with a usable GHb pair showed that control patients had an initial GHb of 8.1 (geometric mean), and a drop of 0.18 during the study (P = .36). Patients assigned to THDR use had an initial GHb of 8.8 (geometric mean), and a drop of 0.94 during the study (P = .003). Comparing the 2 groups, the decrease in GHb in patients assigned to THDR use was significantly larger than in controls (P = .047). Fifty-one percent of patients randomized to THDR use achieved a decrease in GHb ≥0.9, compared with18% of control patients (P = .001).
Patients who dropped out from the control group were similar to those who dropped out from the intervention group with respect to mean age (51, 53 years), initial GHb (8.6, 8.7), and immigrant status (26%, 17%); patients who dropped out were similar to patients in the randomized groups (Table 1).
Mean GHb change was plotted for the group of patients assigned to each resident. This produced a nearly normal distribution (mean, −0.25; median, −0.05; interquartile range, −1.1 to 1.0) with minimal skewness or kurtosis caused by resident outliers.
Mean change in GHb was greater in patients who used the THDR 4 or more times (−1.6) than in those who used it 1 to 3 times (−1.1), a nonsignificant difference.
By chance, the initial mean GHb in patients randomized to THDR use was higher than in controls (Table 1). The separate effect of these 2 variables (initial GHb and THDR use) was assessed by covariant analysis for the control patients and the patients who actually used the THDR. The influence of THDR use on change in GHb was significant (P = .02) independent of initial GHb.
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The patients and physicians in this study achieved lower GHb values over 15 months when they used a visual communication tool—a graph—directed toward a simple goal. The magnitude of GHb improvement was similar to that associated with improved long-range outcomes in the United Kingdom Prospective Diabetes Study (0.9%), which studied a wider demographic cross-section of a fully insured British population.26 More than half the patients who used the THDR achieved a drop in GHb ≥0.9%, compared with 18% of usual care patients. This improvement was achieved at minimal cost, and in the presence of many of the barriers encountered in providing health care in urban America.27
Design of the THDR was guided by reports calling for behavioral science research in treatment of chronic diseases,19 awareness of cultural differences in communication style and the role of the family,28 and a model of care emphasizing an alliance between patient and provider, in contrast to simply asking for patient compliance with physician directives.29 The THDR allowed patients to choose a visual goal (moving the plotted GHb dot into the green zone), and learn specific small steps they could take to accomplish it. There was regular opportunity for discussion and learning at each clinic visit, and for new behavior to be rewarded.
We recognize several limitations of this study. We did not determine whether using the THDR changed patient behavior, resident physician behavior, or both, and we did not investigate the extent of family input. Patients were exposed to the THDR for varying lengths of time; while there was a trend toward larger declines in GHb with more use of the THDR, a longer and larger study would provide more definitive data.
Twenty-seven percent of the randomized patients had no GHb recorded during the study, most lost to clinic follow-up. Although this is a high rate from a statistical standpoint, it is not a high rate of patient loss at 15 months in an inner-city clinic. It seems unlikely that losing these patients affected the results, because those who dropped out of the treatment group and out of the control group were similar with respect to age, immigrant status, and initial GHb.
The randomization process helped protect the integrity of usual care and avoid the Hawthorne effect (GHb was stable in the control group), but raises the possibility that a few individual residents who were unusually effective (or ineffective) could unduly influence the results. However, an analysis of GHb change in the group of patients assigned to each resident did not indicate any unusual clustering of outcomes.
Initial GHb was by chance higher in patients randomized to treatment, raising the possibility that the larger fall in GHb in this group could be partly explained by having more room for improvement. This was addressed directly by covariant analysis, which showed a significant impact of THDR use independent of initial GHb.
These results reinforce the importance of patient education and collaboration with physicians in treating diabetes. They suggest a role for visual communication techniques, at least in patients with potential barriers to verbal communication. They also suggest that improving care does not have to be expensive; the THDR required no nursing time, and cost 17 cents per copy.
The authors wish to thank Michael Schmitz, PsyD, Mary Fredrick, RN, Carole Hektner, RN, Nicole Barnes, MSW, Noelle Nelson, MD, Mark Prebonich, MD, and Dan Ruppman, MD for advice in designing the THDR and the study; Varia Kirchner for data analysis; Claus Pierach, MD for manuscript suggestions; and Terry Rosborough, MD for statistical help.