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Completed

NCT Number: NCT03802825

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes Self-Management Training

Behavioral

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.

Standard Patient Navigation

Other

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.

Primary outcomes

  1. Percent of Participants With A1C < 8%

    Time frame: 6 months

    Using ITT analysis, percent of participants in each arm with A1C < 8% at 6-month follow-up was calculated.

Secondary outcomes

  1. Emergency Department (ED) Visits

    Time frame: 6 months

    Mean number of visits to the emergency department over the 6-month duration of the intervention.

  2. Primary Care Visit No-show Rate

    Time frame: 6 months

    Mean number of missed primary care visits over duration of the intervention (6 months)

  3. Medication Refills

    Time frame: 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.

  4. Mean A1C Change

    Time frame: 6 months

    Change in A1C from baseline to 6-month follow-up

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 14, 2019
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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