NCT04784611

Brief Summary

People with physical disabilities experience well documented barriers to healthcare access, quality and outcomes. The purpose of this study is to implement and evaluate a 12-month peer health navigator intervention (called Our Peer-Empowerment and Navigational Support) designed to help Medicaid beneficiaries with physical disabilities break down barriers to care through a systematic process of 1) rapport building, 2) identification of healthcare needs and priorities, 3) identification of barriers and supports, 4) co-creation of goal and action plans, and 5) provision of social and informational support. It is hypothesized that people in the interventional trial will experience: improved patient activation, increased social support, increased access to care, increased quality of care, and increased health outcomes compared to people in the control group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

2.6 years

First QC Date

March 1, 2021

Last Update Submit

March 4, 2021

Conditions

Keywords

peer health navigatorcommunity health worker

Outcome Measures

Primary Outcomes (4)

  • Change in Patient Activation Measure (PAM) scores

    13-item self-report measure of perceived knowledge, skills \&confidence in self-management

    baseline to 6-months

  • Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0

    Self-report measure of consumer's experiences, Composite scores - access and availability of care, experience of care, special considerations for people with disabilities.

    baseline to 6-months

  • Change in Patient Activation Measure (PAM) scores

    13-item self-report measure of perceived knowledge, skills \&confidence in self-management

    baseline to 13-months

  • Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0

    Self-report measure of consumer's experiences, Composite scores - access and availability of care, experience of care, special considerations for people with disabilities.

    baseline to 13-months

Secondary Outcomes (14)

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score

    baseline to 6-months

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score

    baseline to 6-months

  • Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score

    baseline to 6-months

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue

    baseline to 6-months

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score

    baseline to 6-months

  • +9 more secondary outcomes

Study Arms (2)

Group 1 - OP-ENS Intervention

EXPERIMENTAL

Participants will be matched with a peer health navigator. As part of this complex behavioral intervention, participants and peer health navigators will engage in a systematic process of barrier and strength identification, goal setting and action planning related to issues of healthcare access and quality. Participants and peers will meet at least monthly over the course of the 12-month study period (but frequency is determined by participant need). Given the nature of the disability and healthcare experience, we anticipate the needs and therefore frequency will fluctuate over the duration of the study period. Beginning in month 10, participants and peers will engage in a period of transition planning to ensure that participants have the strategies and supports in place to assume the role of their own health navigator.

Behavioral: Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention

Group 2 - Usual Care

NO INTERVENTION

Participants randomized to the usual care group will continue with their usual health and healthcare routines. Participants in the usual care group will receive a monthly newsletter with general interest information relevant to the disability community.

Interventions

Disability peer health navigator mentored and manualized process of barriers identification, asset mapping, goal setting, and action planning along with on-going social support and information sharing.

Group 1 - OP-ENS Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medicaid beneficiary
  • self-identified as person with a disability
  • ability to provide legal consent
  • ability to communicate in English

You may not qualify if:

  • diagnosis of several persistent mental illness, substance abuse, primary diagnosis of pain with narcotic management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

Study Officials

  • Susan Magasi

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Given the nature of the intervention it is not possible to mask participants and interventionists to group assignment. Outcome assessors and investigators will be unaware of group assignment.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention or usual care groups using block randomization with randomly selected blocks of 4, 8 or 12. Randomization sequence will be generated using SAS algorithm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 5, 2021

Study Start

April 16, 2018

Primary Completion

November 17, 2020

Study Completion

September 30, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations