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

Not Applicable

Completed

Conditions: Diabetes

Interventions: Other: Standard Patient Navigation
Behavioral: Diabetes Self-Management Training

Registration Number: NCT03802825

Lead Sponsor: Kaiser Permanente

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Navigation	Standard 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.
Patient Navigation+Diabetes Self-Management Support	Diabetes Self-Management Training	In addition to receiving patient navigation as described, 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Primary Care Visit No-show Rate	6 months	Mean number of missed primary care visits over duration of the intervention (6 months)
Mean A1C Change	6 months	Change in A1C from baseline to 6-month follow-up
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.
Emergency Department (ED) Visits	6 months	Mean number of visits to the emergency department over the 6-month duration of the intervention.