Clinical trial NCT04784611: Our Peers - Empowerment and Navigational Support
Official title: Our Peers - Empowerment and Navigational Support: - A Peer Health Navigator Intervention for Medicaid Beneficiaries With Physical Disabilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disabled Persons
Keywords: peer health navigator
community health worker
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
name: Oakland University
name: Access Living
First posted: 2021-03-05
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The purpose of this study is to evaluate the preliminary effectiveness and social validity of the OP-ENS (Our Peers - Empowerment and Navigational Support). a 12-month peer health navigator intervention sing a clinical trial design in a sample of community-dwelling adult Medicaid beneficiaries with physical disabilities.

Participants will be recruited through community and clinical networks and screened for eligibility. Participants will be randomly assigned to either the intervention or usual care groups. Participants in the intervention group will be matched with a trained peer health navigator (who is also a person with a physical disability). Using a structure process of barrier identification, goal setting and action planning peer health navigators will work with participants to help address their healthcare needs and concerns, including such things as patient-provider communication, transportation, access to durable medical equipment. It is important to note that peer health navigators are not healthcare providers and do not provide medical or health advice. Participants in the intervention trial are asked to meet with their peer health navigator at least once a month during the study period. To encourage participation in this intervention, progressive micro-incentives are integrated into the study protocol. To promote equipoise, a similar micro-incentive schedule is created for the usual care group.

Data Collection - All participants, regardless of group assignment, will be interviewed at 3 time points (baseline, 6 months, 13 months) using a self-report measures of healthcare access, quality, and outcomes as well as measures of social support and patient activation. Data collectors will be blinded to group assignment and not involved in the delivery of the OP-ENS intervention.

Data Analysis - The investigators will employ mixed effects model using each study outcome as a time-varying dependent variable and treatment group (PHN vs. usual care) as the main fixed effect. Baseline characteristics including race/ethnicity, gender, and socioeconomic status will be entered as time-invariant covariates if baseline group differences are observed (in spite of randomization). Subject intercept will be modeled as a random effect. The null hypothesis will be rejected if a significant group\*time interaction effect is observed. The investigators hypothesize that PHN will have a more favorable trajectory slope of study outcomes than the matched control group. For each hypothesis, post-hoc analysis will be conducted to assess difference in each outcome variable between the two groups at different time points. The mixed models will run using PROC MIXED from of SAS 9.3 (Cary, NC). The method of estimation will be maximum likelihood (ML). A variety of covariance structures (first order regressive, compound symmetry, toeplitz, variance components, unstructured) will be carefully examined and compared for best model fit, Akaike's Information (AIC) and Bayesian Information Criteria (BIC). These statistics are functions of the log likelihood and can be compared across models. As missing data are inevitable in a longitudinal study, values will be imputed where possible using either mean (median) substitute or formal imputation procedures such as EM algorithm if missing data are MCAR (missing completely at random) or MAR (missing at random). If missing data are NMAR (not missing at random), the "pattern mixture" approach will be used to compute a "weighted average" of the parameters that are associated with the missing data to estimate what the data would have been.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Patient Activation Measure (PAM) scores
timeFrame: baseline to 6-months
measure: Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0
timeFrame: baseline to 6-months
measure: Change in Patient Activation Measure (PAM) scores
timeFrame: baseline to 13-months
measure: Change in Health care access and quality using CAHPS - Adult Medicaid Survey 5.0
timeFrame: baseline to 13-months
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
timeFrame: baseline to 6-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
timeFrame: baseline to 13-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
timeFrame: baseline to 13-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
timeFrame: baseline to 13-months
measure: Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
timeFrame: baseline to 13-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
timeFrame: baseline to 13-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
timeFrame: baseline to 13-months
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
timeFrame: baseline to 13-months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois, Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Susan Magasi
role: PRINCIPAL_INVESTIGATOR
References: