Clinical trial NCT03802825: Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
Official title: Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligibility criteria for all study participants is a diagnosis of diabetes with A1C ≥ 8.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Participants With A1C < 8%
timeFrame: 6 months
Secondary outcomes:
measure: Emergency Department (ED) Visits
timeFrame: 6 months
measure: Primary Care Visit No-show Rate
timeFrame: 6 months
measure: Medication Refills
timeFrame: 6 months
measure: Mean A1C Change
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Stephanie L Fitzpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papajorgji-Taylor D, Francisco M, Schneider JL, Vaughn K, Lindberg N, Smith N, Fitzpatrick SL. Bridge to Health/ Puente a la Salud: Rationale and design of a pilot feasibility randomized trial to address diabetes self-management and unmet basic needs among racial/ethnic minority and low-income patients. Contemp Clin Trials Commun. 2021 Apr 30;22:100779. doi: 10.1016/j.conctc.2021.100779. eCollection 2021 Jun.
citation: Fitzpatrick SL, Papajorgji-Taylor D, Schneider JL, Lindberg N, Francisco M, Smith N, Vaughn K, Vrany EA, Hill-Briggs F. Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients. Transl Behav Med. 2022 Jul 18;12(7):783-792. doi: 10.1093/tbm/ibac016.