NCT02347787

A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients

A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hypertension
• Diabetes
• Obesity
• Tobacco Dependence

Interventions

Type	Name	Description
BEHAVIORAL	IMPaCT	The IMPaCT intervention has three stages: 1. 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. 2. 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. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
OTHER	Usual care

Timeline

• Start date: 2015-01-28
• Primary completion: 2017-01-05
• Completion: 2018-07-01
• First posted: 2015-01-27
• Last updated: 2019-08-05
• Results posted: 2019-08-05