An interventional study of Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention in Disabled Persons, sponsored by University of Illinois at Chicago. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Supportive care
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.
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.
University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Change in Patient Activation Measure (PAM) scores
13-item self-report measure of perceived knowledge, skills \&confidence in self-management
Time frame: 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.
Time frame: baseline to 6-months
Change in Patient Activation Measure (PAM) scores
13-item self-report measure of perceived knowledge, skills \&confidence in self-management
Time frame: 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.
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
8-item self-report measure of an individual's physical, mental, and social health. Items are rated on a Likert-scale. The PROMIS Global scale produces a physical and a mental health score from 4 items each. (minimum raw score 4; maximum raw score 20 for each physical health and mental health.
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of pain interference.
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
8-item self-report measure of negative mood, views of self, and social cognition as well as decreased positive affect and engagement. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional distress.
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
8-item self-report measure of the consequences of the experience and consequences of fatigue physical, mental and social activities. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of fatigue and fatigue impact.
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
8-item short form of perceived availability of helpful information or advice. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher availability of information support..
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
8-item self report of perceived perceived feelings of being cared for and valued as a person. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional support.
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
8-item self-report of perceived ability to perform one's usual social roles and activities. 8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of better ability to participate in social activities and roles.
Time frame: baseline to 6-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Score
8-item self-report measure of an individual's physical, mental, and social health. Items are rated on a Likert-scale. The PROMIS Global scale produces a physical and a mental health score from 4 items each. (minimum raw score 4; maximum raw score 20 for each physical health and mental health.
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score
8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of pain interference.
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) fatigue
8-item self-report measure of the consequences of the experience and consequences of fatigue physical, mental and social activities. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of fatigue and fatigue impact.
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information Systems (PROMIS) Depression Score
8-item self-report measure of negative mood, views of self, and social cognition as well as decreased positive affect and engagement. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional distress.
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Informational Support Score
8-item short form of perceived availability of helpful information or advice. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher availability of information support..
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Support Scores
8-item self report of perceived perceived feelings of being cared for and valued as a person. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of higher level of emotional support.
Time frame: baseline to 13-months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scores
8-item self-report of perceived ability to perform one's usual social roles and activities. 8-item self-report measure of the consequences of pain on relevant aspects of life. Each item is rated on a 5-point Likert scale. Minimum raw score = 8; maximum raw score = 40. Higher scores are indicative of better ability to participate in social activities and roles.
Time frame: baseline to 13-months
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University of Illinois at Chicago