Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/16/2019 |
| Start Date: | February 4, 2019 |
| End Date: | August 31, 2020 |
| Contact: | Stephanie L Fitzpatrick, PhD |
| Email: | stephanie.l.fitzpatrick@kpchr.org |
| Phone: | 503-335-6773 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Portland, Oregon 97227
Principal Investigator: Stephanie L Fitzpatrick, PhD
Phone: 503-335-6773
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