Internal Medicine & Pediatrics Perception of provider communication among patients with diabetes: potential influences of medical mistrust and depression in a public health setting Richard White, MD, MSc Internal Medicine & Pediatrics Mayo Clinic Florida

Disclosures: In accordance with Accreditation Council for Continuing Medical Education (ACCME) guidelines, I, Richard White, MD, MSc, have disclosed that I have no financial relationships with pharmaceutical or medical manufactory companies that would pose a conflict of interest for this presentation. I am currently receiving funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK K23 Career Development Award) and Mayo Office of Health Disparities Research. I have no disclosures or conflicts of interest to report and would like to acknowledge my funding

Background: Despite advancements in our understanding of the optimal treatment of diabetes, disparities of care and outcomes persist particularly for low income and minority patients Patient-Provider communication is a critically important and potentially modifiable component of the diabetes primary care encounter Poor communication quality may be associated with both patient and provider factors and linked to diabetes-related outcomes, yet limited data exists addressing this question Despite advancements in our understanding of the optimal treatment of diabetes, disparities of care and outcomes persist particularly for low income and minority patients. Patient-Provider communication is a critical and potentially modifiable component of the diabetes primary care encounter; the quality of this communication may be associated with both patient and provider factors, and linked to diabetes-related outcomes, yet there is currently very limited data that seeks to address this issue.

Communication Quality Objective: We assessed the association between self-reported levels of medical mistrust, depressive symptoms, and glycemic control on communication quality in a public healthcare setting Medical Mistrust Depression Communication Quality A1C HL As part of a larger randomized trial, we sought to assess the association between patient’s reports of medical mistrust, depressive symptoms, and glycemic control on reported communication quality during diabetes encounters in a public healthcare setting. Recognizing a likely more complex interaction exists between these variables, for our analysis we hypothesized that HL may impact directly upon patient’s mistrust of the healthcare system, level of depression, and glycemic control and that these factors would be directly associated with reports of communication quality during encounters.

Methods: Study Design: Utilizing a cluster randomized controlled design, health care professionals from 10 TN state health department clinics were enrolled. 5 clinics were randomized to a literacy/numeracy-focused intervention Training in EHC & use of a literacy/numeracy sensitive educational toolkit during patient encounters 5 clinics were randomized to standard diabetes education (NDEP) Utilizing a cluster randomized controlled design, health care professionals and patients from 10 TN State Health Department Clinics were enrolled. TN is a located in the southeastern U.S. and in this region health department clinics typically service an uninsured, low income population. 5 clinics were randomized to a literacy-numeracy focused intervention that consisted of training for providers in Effective Health Communication and the use of a literacy-numeracy sensitive educational toolkit with diabetes patients. 5 clinics were randomized to an attention control that consisted of diabetes education adapted from the National Diabetes Education Program.

Methods: Study Design: Cross-sectional assessment of baseline data from larger trial Inclusion Criteria: Patient has Type 2 DM Age 18-85 English or Spanish speaking Most recent A1C > 7.5% Agrees to 2 yrs. participation Exclusion Criteria: Poor visual acuity (20/50) Dementia/psychosis Life expectancy <2 years Baseline data from the completed sample was used to conduct cross-sectional analyses. Patients were included if they carried a diagnosis of Type 2 diabetes, were between age 18-85, were English or Spanish speaking, had A1C > 7.5, and agreed to the duration of the study. Patient’s were excluded for poor visual acuity, significant dementia, or having a life expectancy < 2 years.

Methods: Measures: Demographics Health literacy (STOFHLA) Depression (CES-D) Medical mistrust (MMI) Glycemic control (A1C) Interpersonal Processes of Care (IPC-18) [patient’s perceptions] Lack of clarity Elicit concerns Decided together Explain results Compassion Covariates Primary Predictors Data collection included demographics, patient health literacy status, depression, medical mistrust, and glycemic control. The Interpersonal Processes of Care (IPC-18) served as our main outcome measure of interest and has been validated in a multi-ethnic population. This instrument measures patient’s perceptions of provider communication in the domains of clarity, elicitation of concerns, decision making, information sharing, and personal style. Scores range from 1-5 with higher score indicating better communication except for lack of clarity where higher score indicates poorer communication. The Medical Mistrust Index has also been validated in a multi-ethnic population and assesses patient’s general mistrust of the healthcare system in the areas of errors, accuracy & information sharing. Primary Outcomes; range 1-5

Methods: Analysis: Descriptive statistics of sample Unadjusted bivariate associations between predictors (MMI, Depression, A1c) and outcomes (communication quality) Our statistical approach consisted of descriptors of our sample and assessment of unadjusted bivariate associations between our primary predictors and outcomes of interest.

Methods: Analysis: Adjusted analyses of the association between MMI, Depression, A1C and communication quality Each model controlled for age, race/ethnicity, gender, insurance, income, years since diagnosis, study status, literacy level For each model, binary HL status was included as an interaction term to assess the effect of literacy on the association between the main predictor and outcome. 1 2 We also conducted adjusted analyses using multivariable linear regression to assess the adjusted association between our predictor variables and communication quality. Each model was controlled for age, race/ethnicity, gender, insurance, income, years since diagnosis, study status, and literacy level (dichotomized to adequate vs. marginal or inadequate). Additionally, for each model, binary HL status was included as an interaction term along with the primary predictor variable to assess the effect of literacy on the predictor’s association with each of the communication variables being tested. 3

Recruitment Flow Chart: Approached: 573 Declined:162 No time No interest No transportation A1C too low Moving away Age Non Eng/Span Poor vision Consented: 411 Intervention: 213 Control: 198 Our sample was recruited from July 2011 through April 2013 with a final sample of 409 patients which for this analysis included only individuals who self-identified as either White, Black, or Hispanic. Disqualified/Excluded: 2 (not Eng/Span, race=other) Enrolled: 411 English 313 Spanish 98 Final Sample=409

Excluded: 3 (race=other) Analyzed: 408 Approached: 573 Consented: 411 Declined: 162 No time No interest No transportation A1C too low Moving away Age Non Engish/Spanish Poor vision Excluded: 3 (race=other) Our sample was recruited from July 2011 through April 2013 with a final sample of 409 patients which for this analysis included only individuals who self-identified as either White, Black, or Hispanic.

Results: Demographics Variable Mean ± SD or n (%)    N=409 Control N=197 Intervention N=212 p-value Age 49.5 ± 9.6 50.4 ± 9.5 0.39† Gender Male Female 80 (40%) 117 (60%) 81 (38%) 131 (62%) 0.62‡ Race/Ethnicity White Black Hispanic 109 (55%) 37 (19%) 49 (25%) 123 (58%) 35 (17%) 49 (24%) 0.27‡ Household Income <$10,000 $10,000-19,999 >$20,000 104 (53%) 58 (30%) 34 (17)% 115 (55%) 58 (28%) 36 (17%) 0.19‡ Insurance Status Uninsured Insured 173 (88%) 24 (12%) 185 (87%) 27 (13%) 0.86‡ Time since diagnosis, years 9.0 ± 7.1 8.8 ± 7.0 0.79† Insulin use Yes 119 (61%) 122 (57%) 0.47‡ On average age was 50, with a predominance of females. Just over ½ of the sample was composed of white patients with Black and Hispanic patients accounting for the remaining ½. 83% of the sample has annual incomes less than 20K, and the vast majority were uninsured. Average years with diabetes was around 9 and just over ½ of the sample was on insulin. No significant differences were noted in these observed variables indicating adequate randomization. t-test †;Chi-square ‡

Results: Unadjusted by Literacy Status Variable Mean ± SD, Median [IQR], or n (%)   High literacy (Adequate) N=330 Low literacy (Marginal + Inadequate) N=65  p-value Race/Ethnicity White Black Hispanic 225 (68%) 62 (19%) 42 (13%) 28 (43%) 6 (9%) 31 (47%) <0.0012* A1C 9.6 ± 2.1  9.8 ± 1.8   0.551 IPC-18 domains (1-5) Lack of Clarity (-) Elicited Concerns (+) Decided Together (+) Explained Results (+) Compassionate (+) 1.0 [1.0, 2.0]  5.0 [4.3, 5.0] 4.5 [3.5,5.0] 5.0 [4.5, 5.0] 4.3 [3.6, 5.0] 4.5 [4.5, 5.0] 5.0 [4.0, 5.0] 0.473 0.053* 0.693 0.353 0.633 MMI (Medical Mistrust) High Low 2.53 ± 0.5 272 (85%) 48 (15%) 2.67 ± 0.37 64 (97%) 2 (3%) 0.031* 0.0082* CES-D (Depressive Symptoms) 18.1 ± 12.4  19.8 ± 13.6  0.301 In unadjusted analyses stratified by HL status, Hispanics had significantly lower health literacy level compared to blacks and whites in the sample. Low literacy participants also reported poorer elicitation of their concerns by providers but no significant differences were noted in the other domains of communication by literacy status. In both groups high levels of medical mistrust and depressive symptoms were observed with lower literacy patients reporting significantly greater mistrust compared to higher literacy patients. t-test 1;Chi-square 2 , Wilcoxon test3 *P<0.05

Adjusted Multivariable Linear Regression  Independent variable (IV) Dependent variable (DV) β [95% CI]  p-value p for interaction effect of literacy and IV on DV Medical Mistrust Lack of Clarity Elicit Concerns Decided Together Explained Results Compassionate 0.14 -0.20  -0.15 -0.14 -0.20 [0.08, 0.45] [-0.46, -0.16] [-0.54, -0.11] [-0.41, -0.06] [-0.46, -0.15] 0.005* <0.001* 0.004* 0.008* ns 0.03* Depressive Symptoms 0.27 -0.34 -0.19 -0.13 [0.003, 0.04]  [-0.014, -0.002] [-0.05, -0.009] [-0.02, -0.006] [-0.01, -0.001] 0.02* 0.007* 0.003* 0.04* Glycemic Control -0.08 -0.04 -0.01 -0.07 [-0.08, 0.01] [-0.05, 0.02] [-0.06, 0.05] [-0.06, 0.03] [-0.06, 0.01] 0.15 0.45 0.85 0.46 0.18 In adjusted analyses, for each domain of the IPC-18, our main outcome variables, again 3 separate models were created using mistrust, depression, and glycemic control as the main predictors and adjusting for the aforementioned confounders. Medical mistrust was significantly associated with each of the measured communication domains and in the expected direction. For example, for each standard deviation increase in the reported level of mistrust, we observed a 0.14 increase in perceived lack of clarity by the provider. Of note was an observed modifying effect of health literacy status on the association between mistrust and patients perception’s of their provider’s ability to explain results of labs and physical exam findings. Likewise, symptoms of depression were significantly associated with each of the measured domains of communication quality. Another example is that for each standard deviation increase in reported depression score, we observed a 0.14 reduction in reports of providers ability to elicit patient concerns. Similarly, we again noted modifying effects of health literacy on the association between depression and a perceived lack of clarity and on reported shared decision making by providers. No significant associations were seen between glycemic control and reported communication quality. Where interaction terms were significant we conducted subgroups assessments stratified by literacy status to understand better the nature of the potential interactions. Each model controlled for age, race/ethnicity, gender, insurance, income, years since diagnosis, study status, literacy level *p<0.05, ns=non-significant

Independent Variable (IV) Dependent variable (DV) Interaction Effect of HL on Mistrust, Depression and Communication Quality Independent Variable (IV) Dependent variable (DV)  HL Status β [95% CI]  p-value Medical Mistrust Explained Results Low literacy -0.33 [-1.4, -0.19] 0.01* High Literacy -0.11 [-0.36, 0.02] 0.06 Depressive Symptoms Lack of Clarity 0.22 [-0.003,0.04] 0.09 High literacy 0.02 [-0.006,0.01] 0.70 Decided Together [-0.04, -0.005] -0.04 [-0.01, 0.006] 0.47 As expected, repeated multivariable regression modeling stratified by literacy status demonstrated that for lower literacy patients compared to higher literacy patients, medical mistrust and depressive symptoms had greater impact on perception of communication quality in the domains of explaining results, lack of clarity, and in shared decision making.

Conclusions: Among a diverse sample of low-income diabetes patients seeking care in a public health setting, we identified high prevalence of medical mistrust and symptoms of depression Medical mistrust and depressive symptoms were significantly associated with patient’s perception of the quality of provider communication after adjusting for important confounders For lower literacy patients, medical mistrust and depressive symptoms had greater impact on perceptions of communication in the areas of explaining results, lack of clarity, and deciding together. In conclusion, among a diverse sample of low-income diabetes patients seeking care in a public health setting, we identified a high prevalence of medical mistrust and symptoms of depression. Medical mistrust and depression were significantly associated with patients perception’s of the quality of provider communication after adjusting for important confounders. For lower literacy patients, medical mistrust and depressive symptoms had greater impact on perceptions of communication in the areas of explaining results, lack of clarity, and deciding together.

Limitations: Analysis is cross-sectional limiting our ability to infer causality between observed associations Our sample albeit diverse represents a single health system and may not be generalizable to other public health settings Measured variables are self-reported and may be subject to both social desirability and ceiling and floor effects Our analysis was limited by the nature of its cross-sectional design, and although or sample was diverse it was representative of a single region, thus may not be generalizable to other public health care settings. Also our measured variables were by collected self-report and may be subject to both social desirability and ceiling or floor effects.

Implications: Providers of diabetes care should be attentive to the possible presence of depression and mistrust particularly among their low-income and/or minority patients. Greater research is needed to understand better the relationship between patient factors (mistrust, depression), communication quality, and diabetes outcomes. Attention to more effective methods of communication in the primary care setting may prove to be important factors in improving the care experience and clinical outcomes for vulnerable patients with diabetes Finally, providers of diabetes care should be attentive to the possible presence of depression and mistrust particularly among their low-income and/or minority patients. Greater research is needed to understand better the relationship between patient factors (mistrust, depression), communication quality, and diabetes outcomes. Overall, attention to more effective methods of communication and ways to engender trust in the primary care setting may prove to be important factors in improving the care experience and clinical outcomes for vulnerable patients with diabetes.

Acknowledgements: NIDDK (K23 Career Development Program) Russell L. Rothman, MD, MPP (Mentor) Ken Wallston, PhD Sunil Kripalani, MD, MSc Mayo Office of Health Disparities Research Vanderbilt Program on Effective Health Communication

Figure 1: Partnership to Improve Diabetes Education (PRIDE Study)