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

Not Applicable

Completed

• Conditions: Diabetes

• 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.

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2019-03-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2022-08-03
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Results First Posted: 2022-11-29
• Last Update Posted: 2022-11-29

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

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
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.
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

Trial Locations

Locations (1)

Kaiser Permanente Northwest; 🇺🇸 Portland, Oregon, United States