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

NCT ID: NCT02347787

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 592 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-28
• Study Completion Date: 2018-07-31

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.

Conditions

Hypertension; Diabetes; Obesity; Tobacco Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual clinician support

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.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

CHW support

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.

Group Type: EXPERIMENTAL

IMPaCT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith A. Long, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania/Philadelphia Veterans Affairs Medical Center

References

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.

Reference Type: DERIVED

PMID: 30422224 (View on PubMed)

Other Identifiers

821368

Identifier Type: -

Identifier Source: org_study_id