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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802825
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Diabetes Self-Management Training Other: Standard Patient Navigation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligibility criteria for all study participants is a diagnosis of diabetes with A1C ≥ 8.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Active Comparator: 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.
Other: Standard Patient Navigation
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.

Experimental: Patient Navigation+Diabetes Self-Management Training

In addition to receiving patient navigation as described above, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. As part of the partnership with KPNW, Project Access NOW will be provided with participants' contact information via REDCap to facilitate the referral to a certified CHW within a community-based organization. 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.

Behavioral: Diabetes Self-Management Training
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 contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.




Primary Outcome Measures :
  1. Measuring A1C levels among participants [ Time Frame: 6 months ]
    Hemoglobin A1c measured via lab test


Secondary Outcome Measures :
  1. Emergency department (ED) visits [ Time Frame: 6 months ]
    Number of visits to the emergency department

  2. Primary care visit no-show rate [ Time Frame: 6 months ]
    The number of missed primary care visits

  3. Medication refills [ Time Frame: 6 months ]
    Number of on-time refills for diabetes medications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802825


Locations
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United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Stephanie L Fitzpatrick, PhD Kaiser Permanente
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03802825    
Other Study ID Numbers: 1R34DK119853-01 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases