Overview

This trial is active, not recruiting.

Conditions hypertension, diabetes, obesity, tobacco dependence
Treatments impact, usual care
Sponsor University of Pennsylvania
Collaborator Patient-Centered Outcomes Research Institute
Start date January 2015
End date December 2016
Trial size 444 participants
Trial identifier NCT02347787, 821368

Summary

This is a multi-center randomized controlled trial comparing the effectiveness of community health worker (CHW) vs. usual clinician support in helping chronically-ill patients with low socioeconomic status to improve their health outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(Placebo Comparator)
Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site.
usual care
(Experimental)
Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention.
impact
The IMPaCT intervention has three stages: Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.

Primary Outcomes

Measure
SF-12 PCS
time frame: 6 months after enrollment

Secondary Outcomes

Measure
Chronic disease control
time frame: 6 months, 9 months
Change in perceived mental health
time frame: 6 months, 9 months
Quality of patient-centered care
time frame: 6 months, 9 months
Hospital admission/ER visits
time frame: 30 days, 6 months and 9 months
Qualitative assessment of intervention and mechanisms affecting achievement of primary outcome
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient of specific practice (Mutch/St.Leonards Court, Spectrum, PVAMC) for at least 1 yr defined as having one office visit within preceding 12 months - Resident of home ZIP code including ANY of the following 19104, 19131, 19139, 19142, 19145, 19146, & 19151 - Has 2 or more of the following conditions: 1. Obesity: BMI30 2. HTN: ICD9 relating to HTN from EMR problem list or EMR ICD9 encounter diagnosis x2) 3.DM: ICD9 relating to DM from EMR problem list or EMR ICD9 encounter diagnosis x2) 4. tobacco (from EPIC Social History/Vital Signs) - Has at least one poorly controlled condition based on the most recent value prior to enrollment: Obesity (BMI>=35); HTN (SBP >= 160); DM (HgBA1c >=9); Tobacco Use (>0 cigarettes)" - Is uninsured, insured by Medicaid, or dually eligible for Medicare and Medicaid or VA Insurance - Has a scheduled appointment at a study clinic in the future. - Community Health Workers/CHWs/IMPaCT Partners involved in the care of patients of the three practices will be included in the qualitative portion of this study. Exclusion Criteria: - Will not provide informed consent for this study. - Does not have the capacity to provide informed consent for this study. - Previously enrolled in this study. - Currently enrolled in another study focusing on chronic disease management. - Currently has a CHW - No one will be excluded on the basis of sex or race.

Additional Information

Official title A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
Principal investigator Judith A. Long, MD
Description Community Health Workers (CHWs) have the potential to improve chronic disease outcomes among patients with low socioeconomic status (SES). Yet, widespread use of CHWs has been hampered by lack of standardized, scalable and evidence-based models. Our community-academic-health system team used participatory action research with low-SES patients to design IMPaCT (Individualized Management for Patient-Centered Targets). A randomized controlled trial (RCT) of 446 hospitalized patients with varied diseases demonstrated that a 2-week dose of IMPaCT improved access to care, mental health, activation, and quality of communication, while reducing recurrent hospital readmissions. We have adapted IMPaCT for use among low-SES primary care patients with multiple chronic conditions. This RCT is designed to evaluate the newly adapted IMPaCT model in 3 primary care settings - academic, federally qualified health center, and VA. Upon enrollment in the trial, patients will collaboratively set a chronic disease management goal with their primary care provider. Patients will then be randomized to collaborative goal-setting versus goal-setting augmented by 6 months of support from an IMPaCT CHW. Follow-up will be conducted at 6- and 9- months post-enrollment. The study design is a single-blinded, 2- armed, multi-site randomized controlled trial involving three clinic sites and 444 patients.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.