Clinical trial NCT02347787: A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients
Official title: A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes
Obesity
Tobacco Dependence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-01-27
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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, 19143, 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.

Primary outcomes:
measure: Short Form Health Survey (SF-12) Physical Component Score (PCS)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Chronic Disease Control - Diabetes
timeFrame: Baseline, 6 months, 9 months
measure: Change in Chronic Disease Control - Obesity
timeFrame: Baseline, 6 months, 9 months
measure: Change in Chronic Disease Control - Tobacco Use
timeFrame: Baseline, 6 months, 9 months
measure: Change in Chronic Disease Control - Hypertension
timeFrame: Baseline, 6 months, 9 months
measure: Short Form Health Survey (SF-12) - Mental Component Summary (MCS)
timeFrame: Baseline, 6 months, 9 months
measure: Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness
timeFrame: 6 months, 9 months
measure: Number of Participants With Any Hospital Admission
timeFrame: 6 months and 9 months
measure: Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome
timeFrame: 6 months
measure: Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management
timeFrame: 6 months, 9 months
measure: Number of Participants With Multiple Hospital Admissions
timeFrame: 6 months and 9 months
measure: Number of Participants With 30 Day Hospital Readmissions
timeFrame: 30 days
measure: Hospital Admission - Total Hospital Days
timeFrame: 6 months and 9 months
measure: Hospital Admission - Mean Number of Hospitalizations
timeFrame: 6 months and 9 months
measure: Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization)
timeFrame: 6 months and 9 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania/Philadelphia Veterans Affairs Medical Center
name: Judith A. Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kangovi S, Mitra N, Norton L, Harte R, Zhao X, Carter T, Grande D, Long JA. Effect of Community Health Worker Support on Clinical Outcomes of Low-Income Patients Across Primary Care Facilities: A Randomized Clinical Trial. JAMA Intern Med. 2018 Dec 1;178(12):1635-1643. doi: 10.1001/jamainternmed.2018.4630.