The goal of this clinical trial is to learn if a remote peer navigator intervention (OP-ENS - CL) for people with newly acquired physical disabilities returning to community living after rehabilitation improves self-reported social support, health, and community participation. The main questions it aims to answer are: Do people with acquired physical disabilities who receive the remote peer navigator intervention experience greater social support and self-efficacy than people in the control group? Do people with acquired physical disabilities who receive the remote peer navigator intervention have better self-reported health and social participation outcomes than people in the control group? Is the OP-ENS - CL intervention acceptable to people with newly acquired physical disabilities returning to community living?
The purpose of this study is to evaluate the efficacy and social validity of the OP-ENS - CL (Our Peers - Empowerment and Navigational Support - Community Living) a remote 12-month peer navigator intervention using a clinical trial design in a sample of adults with newly acquired with physical disabilities transitioning to community living. 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 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 - CL 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 PN 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
Op-ENS - CL is a 12-month, remote delivered peer navigator intervention. Participants will meet with a trained peer navigator who mentors nad supports them through a manualized process of collaborative conversations, barrier identification, asset mapping, goal setting, and action planning along with on-going social support and information sharing.
University of Illinois Chicago, Department of Occupational Therapy
Chicago, Illinois, United States
Patient Activation Measure
The 13-item self-report measure assesses perceived knowledge, skills, and confidence for self-management
Time frame: Baseline, 6 months, 13 months.
PROMIS Self-Efficacy Short Form
4-item self-report short form measure assessing confidence in one's ability to perform specific tasks or behaviors
Time frame: Baseline, 6 months, 13 months.
PROMIS Emotional Support, short form
8-item self-report short forms assessing the availability of 3 types of emotional support
Time frame: Baseline, 6 months, 13 months.
PROMIS informational support, short form
8-item self-report short forms assessing the availability of informational support
Time frame: Baseline, 6 months, 13 months.
PROMIS Instrumental Support, short form
8-item self-report short forms assessing the availability of instrumental support
Time frame: Baseline, 6 months, 13 months.
PROMIS Global Health
8-item self-report short form assessing perceived physical, mental, and social health.
Time frame: Baseline, 6 months, 13 months.
PROMIS Depression
8-item short form assessing self-reported affect, views of self, social cognition, and decreased positive affect
Time frame: Baseline, 6 months, 13 months.
PROMIS Ability to Participate in Social Roles and Activities
8-item short form assessing perceived ability to perform one's usual social roles and activities
Time frame: Baseline, 6 months, 13 months.
Community Participation Indicators, Enfranchisement Scale
19-item self-report measures 3 subjective domains of participation, choice and control, contributing to one's community, and feeling valued.
Time frame: Baseline, 6 months, 13 months.
Canadian Occupational Performance Measure
Semi-structured interview including 5 step process to identify subjects' goals. Subjects rate their perceived performance and satisfaction on 1 - 5 goals.
Time frame: Baseline, 6 months, 13 months.
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