Diabetes
Conditions
Keywords
Health Literacy, Diabetes
Brief summary
The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes. The primary aims are to: 1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients; 2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to: 3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness; 4. determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and 5. assess the costs associated with implementing the intervention from a health system perspective.
Detailed description
The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes: 1. a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; 2. a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); 3. a training module for physicians, nurses, and medical assistants that prepares providers to assume educator/counselor roles with the Diabetes Guide as a teaching tool; 4. electronic tracking and monitoring tools for primary care practices. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes. The primary aims are to: 1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients; 2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to: 3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness; 4. determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and 5. assess the costs associated with implementing the intervention from a health system perspective.
Interventions
American Colleges of Physicians (ACP) Living Well with Diabetes Guide
American Diabetes Association (ADA) Living Well with Diabetes Workbook
Sponsors
Study design
Eligibility
Inclusion criteria
* 21 years of age or older * English speaking * active patient at regional family medical center study site * confirmed diagnosis of type 2 diabetes as documented in the electronic health record * recent Hemoglobin A1c reading of \>7.5% and less than or equal to 10%
Exclusion criteria
* uncorrectable visual impairments * hearing impairments * cognitive impairments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C (HbA1C) | Six months | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Knowledge | Three months | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. |
| Diabetes Knowledge (0-13) | Six months | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Usual Care ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook: American Diabetes Association (ADA) Living Well with Diabetes Workbook | 394 |
| Intervention ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months
ACP Living with Diabetes Guide: American Colleges of Physicians (ACP) Living Well with Diabetes Guide | 362 |
| Total | 756 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month HbA1c | No value collected during window | 138 | 102 |
| 3 Months | Lost to Follow-up | 40 | 29 |
| 3 Months | Missed 3 month clinic visit | 27 | 19 |
| 6 Month | Lost to Follow-up | 33 | 39 |
| 6 Month HbA1c | No value collected during window | 69 | 50 |
| Baseline | Partial baseline interview completed | 1 | 0 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 11.8 | 55.8 years STANDARD_DEVIATION 11.7 | 56.1 years STANDARD_DEVIATION 11.4 |
| Education College Graduate | 40 Participants | 90 Participants | 50 Participants |
| Education High School Graduate | 141 Participants | 268 Participants | 127 Participants |
| Education Less than High School | 87 Participants | 153 Participants | 66 Participants |
| Education Refused to answer question | 0 Participants | 2 Participants | 2 Participants |
| Education Some College | 126 Participants | 243 Participants | 117 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 388 Participants | 741 Participants | 353 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Health Literacy (NVS) Adequate | 184 Participants | 363 Participants | 179 Participants |
| Health Literacy (NVS) Limited | 210 Participants | 393 Participants | 183 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 220 Participants | 411 Participants | 191 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 166 Participants | 326 Participants | 160 Participants |
| Sex: Female, Male Female | 275 Participants | 510 Participants | 235 Participants |
| Sex: Female, Male Male | 119 Participants | 246 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 394 | 3 / 362 |
| other Total, other adverse events | 0 / 394 | 0 / 362 |
| serious Total, serious adverse events | 0 / 394 | 0 / 362 |
Outcome results
Hemoglobin A1C (HbA1C)
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Time frame: Six months
Population: 119 individuals were excluded from analysis, because they did not have a 6 month HbA1c value within the designated window.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Hemoglobin A1C (HbA1C) | 8.4 Percentage of glycated hemoglobin |
| Intervention | Hemoglobin A1C (HbA1C) | 8.3 Percentage of glycated hemoglobin |
Hemoglobin A1C (HbA1C)
HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome.
Time frame: Twelve months
Population: 240 individuals were excluded from analysis, because they did not have a 12 month HbA1c value within the designated window.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Hemoglobin A1C (HbA1C) | 8.5 Percentage of glycated hemoglobin |
| Intervention | Hemoglobin A1C (HbA1C) | 8.4 Percentage of glycated hemoglobin |
Diabetes Knowledge
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
Time frame: Three months
Population: 116 participants were excluded, missed 3 month visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Diabetes Knowledge | 9.2 Score on a scale |
| Intervention | Diabetes Knowledge | 9.3 Score on a scale |
Diabetes Knowledge (0-13)
A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge.
Time frame: Six months
Population: 142 participants were excluded, missed 6 month visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Enhanced Usual Care | Diabetes Knowledge (0-13) | 9.5 Score on a scale |
| Intervention | Diabetes Knowledge (0-13) | 9.7 Score on a scale |