Diabetes, HbA1c
Conditions
Brief summary
The goal of this study is to evaluate the effectiveness and implementation process of a multi-level, integrated intervention to decrease HbA1c among South Asians with uncontrolled diabetes, including four components: 1) an EHR-based registry function to increase identification of South Asian patients with uncontrolled diabetes; 2) CHW-led health coaching of registered patients to promote health behavior change; 3) HIT-enabled and CHW-facilitated identification and referral to culturally relevant community resources for patients; and 4) HIT-enabled care coordination between the CHW and other members of the healthcare team.
Interventions
BEHAVIORALCommunity Health Worker (CHW)-Led Health Coaching
CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.
OTHEREHR-Embedded Alerts
An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* South Asian ethnicity (identified through a race and language code available in the EHR); * an appointment with a physician for routine non-emergent primary care in the last 12 months * diagnosis of diabetes * an HbA1c reading of \>7 in the last 12 months
Exclusion criteria
* Pregnant women and visits to obstetrician/gynecologist are excluded from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months | Baseline, Month 6 | Measured via complete lipoprotein panel. |
Countries
United States
Participant flow
Pre-assignment details
Primary care providers (PCPs) were not considered enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Wait-List Control Participants in the wait-list control group will be receive care as usual during the first round for data abstraction and offered CHW group education sessions during the second round as a point of service (i.e., not for research purposes). | 419 |
| CHW-Led Health Coaching Participants in the treatment group will be randomized to receive the CHW group education session intervention in either the first or second round.
Community Health Worker (CHW)-Led Health Coaching: CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.
EHR-Embedded Alerts: An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes. | 419 |
| Total | 838 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 14 | 6 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Wait-List Control | Total | CHW-Led Health Coaching |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 9.7 | 55.1 years STANDARD_DEVIATION 9.7 | 55.1 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 419 Participants | 838 Participants | 419 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 419 Participants | 838 Participants | 419 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 419 participants | 838 participants | 419 participants |
| Sex: Female, Male Female | 222 Participants | 445 Participants | 223 Participants |
| Sex: Female, Male Male | 197 Participants | 393 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 419 | 0 / 440 |
| other Total, other adverse events | 0 / 419 | 0 / 440 |
| serious Total, serious adverse events | 0 / 419 | 0 / 440 |
Outcome results
Primary
Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months
Measured via complete lipoprotein panel.
Time frame: Baseline, Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wait-List Control | Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months | 32.1 Percentage of participants |
| CHW-Led Health Coaching | Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months | 35.2 Percentage of participants |