Our Peers - Empowerment and Navigational Support

Disabled Persons Clinical Trial

— OP-ENS  

Official title:

Our Peers - Empowerment and Navigational Support: - A Peer Health Navigator Intervention for Medicaid Beneficiaries With Physical Disabilities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04784611
• Other study ID #: 2015-1207
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: September 30, 2021
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disabled Persons

Intervention

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

Locations

Country	Name	City	State
United States	University of Illinois, Chicago	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Access Living, Oakland University, Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Activation Measure (PAM) scores	13-item self-report measure of perceived knowledge, skills &confidence in self-management	baseline to 6-months
Primary	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
Primary	Change in Patient Activation Measure (PAM) scores	13-item self-report measure of perceived knowledge, skills &confidence in self-management	baseline to 13-months
Primary	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	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.	baseline to 6-months
Secondary	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.	baseline to 6-months
Secondary	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.	baseline to 6-months
Secondary	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.	baseline to 6-months
Secondary	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..	baseline to 6-months
Secondary	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.	baseline to 6-months
Secondary	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.	baseline to 6-months
Secondary	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.	baseline to 13-months
Secondary	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.	baseline to 13-months
Secondary	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.	baseline to 13-months
Secondary	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.	baseline to 13-months
Secondary	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..	baseline to 13-months
Secondary	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.	baseline to 13-months
Secondary	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.	baseline to 13-months