Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
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|ClinicalTrials.gov Identifier: NCT03802825|
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2019
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Behavioral: Diabetes Self-Management Training Other: Standard Patient Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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.
- Measuring A1C levels among participants [ Time Frame: 6 months ]Hemoglobin A1c measured via lab test
- Emergency department (ED) visits [ Time Frame: 6 months ]Number of visits to the emergency department
- Primary care visit no-show rate [ Time Frame: 6 months ]The number of missed primary care visits
- Medication refills [ Time Frame: 6 months ]Number of on-time refills for diabetes medications
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
|United States, Oregon|
|Kaiser Permanente Northwest|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Stephanie L Fitzpatrick, PhD||Kaiser Permanente|