Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03802825

Enrollment

110

Registered

2019-01-14

Start date

2019-03-01

Completion date

2021-06-30

Last updated

2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

In this pilot and feasibility study, the investigator will randomize 100 African-American, Hispanic, and/or Medicaid (all race/ethnicities) patients from KPNW with A1C ≥ 8 to one of two 6-month interventions: 1) patient navigation only; or 2) patient navigation + diabetes self-management training. Feasibility of a large-scale, pragmatic, randomized trial will be determined and preliminary effectiveness of treatment arms on A1C reduction among racial/ethnic minority and low-income patients with poorly managed diabetes will be examined.

Detailed description

The purpose of this feasibility study is to inform the design of a future large-scale, randomized trial that will test if there is added benefit to addressing both social and economic needs and diabetes self-management to improve diabetes management long-term among vulnerable populations. In this pilot, the investigator will randomize 100 African-American, Hispanic, and/or Medicaid (all race/ethnicities) patients from Kaiser Permanente Northwest (KPNW) with A1C ≥ 8 and poor follow-up in primary care to one of two 6-month interventions: 1) patient navigation only; or 2) patient navigation + diabetes self-management training. In both study arms, KPNW practice-embedded patient navigators will screen for medical, social and economic needs and connect participants to internal and external resources. In the second study arm, navigators will also refer participants to community health workers (CHWs) embedded in local community-based organizations, who will deliver diabetes self-management training. Feasibility of the full-scale trial will be based on several measures including recruitment, retention, success rate of referrals to navigators and CHWs, and whether medical, social, and/or economic needs are met. Qualitative interviews will be conducted with various stakeholders to assess intervention acceptability and determinants of implementation. Preliminary effects of A1C, diabetes-related care gaps, health care utilization, and medication adherence will also be examined. This pragmatic study design involves a collaborative effort among researchers, health system staff, health system senior leadership, and local community-based organizations. Findings from the full-scale trial will contribute critical knowledge on the most effective, sustainable model of care for integrating lay health workers in the efforts to improve diabetes management among high risk patient populations.

Interventions

BEHAVIORALDiabetes Self-Management Training

The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contact with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.

OTHERStandard Patient Navigation

Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Eligibility criteria for all study participants is a diagnosis of diabetes with A1C ≥ 8.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Diabetes diagnosis * Current Kaiser Permanente Northwest member * African-American, Hispanic/Latino (English, Spanish-speaking, or bilingual), and/or a Medicaid recipient (from any racial or ethnic background) * Age 18 or older * Most recent hemoglobin A1C test of ≥ 8 * Endorses 1 or more social and/or economic need on the Your Current Life Situation assessment

Exclusion criteria

* Patients who are unable to provide informed consent due to cognitive or psychiatric impairment.

Design outcomes

Primary

Measure	Time frame	Description
Percent of Participants With A1C < 8%	6 months	Using ITT analysis, percent of participants in each arm with A1C \< 8% at 6-month follow-up was calculated.

Secondary

Measure	Time frame	Description
Emergency Department (ED) Visits	6 months	Mean number of visits to the emergency department over the 6-month duration of the intervention.
Primary Care Visit No-show Rate	6 months	Mean number of missed primary care visits over duration of the intervention (6 months)
Medication Refills	6 months	Number of participants with 1 or more gaps in refilling oral diabetes medications during the study period. A gap is defined as not refilling prescription for 7 or more days after prescription has ran out.
Mean A1C Change	6 months	Change in A1C from baseline to 6-month follow-up

Countries

United States

Participant flow

Recruitment details

We used a targeted recruitment approach by first identifying potentially eligible patients in the electronic health record (EHR) and then emailing or mailing recruitment letters. Letters were followed by a phone call from study staff who described the study and further assessed eligibility by confirming race/ethnicity and health coverage and administering a social risks screener.

Participants by arm

Arm	Count
Patient Navigation Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator using a standard electronic health record-based referral process. Once the participant has completed the Your Current Life Situation (YCLS) assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 month period by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention. Participant will also receive monthly mailing of American Diabetes Association educational materials. Standard Patient Navigation: Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.	54
Patient Navigation+Diabetes Self-Management Support In addition to receiving navigation, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. Project Access NOW will connect participants to a community-based organization based on their preference, previous experience with an agency, geography, and capacity. The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the diabetes self-management training will be based on the needs of the participant. Diabetes Self-Management Training: The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.	56
Total	110

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to follow-up for intervention	12	3
Overall Study	Received only 1 component of intervention	0	13

Baseline characteristics

Characteristic	Total	Patient Navigation+Diabetes Self-Management Support	Patient Navigation
A1C	9.9 % of glycosylated hemoglobin STANDARD_DEVIATION 1.7	9.8 % of glycosylated hemoglobin STANDARD_DEVIATION 1.6	9.9 % of glycosylated hemoglobin STANDARD_DEVIATION 1.7
Age, Continuous	53.3 years STANDARD_DEVIATION 12	53.7 years STANDARD_DEVIATION 12.1	52.9 years STANDARD_DEVIATION 12.1
Primary Language English	96 Participants	50 Participants	46 Participants
Primary Language Spanish	14 Participants	6 Participants	8 Participants
Race/Ethnicity, Customized Black/African American	40 Participants	21 Participants	19 Participants
Race/Ethnicity, Customized Hispanic/Latino	29 Participants	13 Participants	16 Participants
Race/Ethnicity, Customized Multiple Races	3 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized White	38 Participants	20 Participants	18 Participants
Region of Enrollment United States	110 participants	56 participants	54 participants
Sex: Female, Male Female	77 Participants	39 Participants	38 Participants
Sex: Female, Male Male	33 Participants	17 Participants	16 Participants
Types of Social Needs Reported Financial Hardship	96 Participants	45 Participants	51 Participants
Types of Social Needs Reported Food Insecurity	67 Participants	33 Participants	34 Participants
Types of Social Needs Reported Insufficient Housing	33 Participants	18 Participants	15 Participants
Types of Social Needs Reported Lack of Transportation	37 Participants	19 Participants	18 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 54	1 / 56
other Total, other adverse events	0 / 54	0 / 56
serious Total, serious adverse events	7 / 54	7 / 56

Arm	Measure	Value (MEAN)	Dispersion
Patient Navigation	Primary Care Visit No-show Rate	0.85 missed visits	Standard Deviation 1.29
Patient Navigation+Diabetes Self-Management Support	Primary Care Visit No-show Rate	0.88 missed visits	Standard Deviation 1.62

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026