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

NCT02347787 | Completed Results DMC

• 1 other identifier: 821368
• Study Type: interventional
• Target: 592
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Diabetes; Obesity; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survey (SF-12) Physical Component Score (PCS)

  The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment.

  Baseline, 6 months

Secondary Outcomes (14)

• Change in Chronic Disease Control - Diabetes

  Baseline, 6 months, 9 months

• Change in Chronic Disease Control - Obesity

  Baseline, 6 months, 9 months

• Change in Chronic Disease Control - Tobacco Use

  Baseline, 6 months, 9 months

• Change in Chronic Disease Control - Hypertension

  Baseline, 6 months, 9 months

• Short Form Health Survey (SF-12) - Mental Component Summary (MCS)

  Baseline, 6 months, 9 months

Study Arms (2)

Usual clinician support

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.

Other: Usual care

CHW support

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.

Behavioral: IMPaCT

Interventions

IMPaCT 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.

CHW support

Usual care OTHER

Usual clinician support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Patient-Centered Outcomes Research Institute: collaborator

Related Publications (1)

• 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.

  PMID: 30422224 DERIVED

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Obesity; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Lindsey Norton
• Organization: University of Pennsylvania School of Medicine

lindsey.turr@uphs.upenn.edu

215-573-9961

Study Officials

• Judith A. Long, MD

  University of Pennsylvania/Philadelphia Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: January 28, 2015
• Primary Completion: January 5, 2017
• Study Completion: July 1, 2018
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-06