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

NCT03802825 | Completed Results

• 1 other identifier: 1R34DK119853-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With A1C < 8%

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

  6 months

Secondary Outcomes (4)

• Emergency Department (ED) Visits

  6 months

• Primary Care Visit No-show Rate

  6 months

• Medication Refills

  6 months

• Mean A1C Change

  6 months

Study Arms (2)

Patient Navigation

ACTIVE COMPARATOR

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

Patient Navigation+Diabetes Self-Management Support

EXPERIMENTAL

In addition to receiving patient navigation as described, participants in this arm will also be referred to Project Access NOW by study staff using REDCap. 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

Interventions

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.

Patient Navigation+Diabetes Self-Management Support

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.

Patient Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are unable to provide informed consent due to cognitive or psychiatric impairment.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Related Publications (2)

• 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.

  PMID: 34013093 BACKGROUND

• 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.

  PMID: 35849138 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Stephanie L. Fitzpatrick, Senior Investigator
• Organization: Kaiser Permanente Center for Health Research

Stephanie.L.Fitzpatrick@kpchr.org

502-345-1476

Study Officials

• Stephanie L Fitzpatrick, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligibility criteria for all study participants is a diagnosis of diabetes with A1C ≥ 8.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 14, 2019
• Study Start: March 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 29, 2022
• Results First Posted: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)