N/A
N=592
A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients
Hypertension · Diabetes · Obesity · Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02347787 ↗Enrolled (actual)
592
Serious AEs
11.3%
Results posted
Aug 2019
Primary outcome: Primary: Short Form Health Survey (SF-12) Physical Component Score (PCS) — 2.3; 0.6 score on a scale — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IMPaCT (Behavioral); Usual care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Form Health Survey (SF-12) Physical Component Score (PCS) |
2.3; 0.6 | 0.30 |
| SECONDARY Change in Chronic Disease Control - Diabetes |
-6.5; -10.9; -10.4; -17.9 | 0.21 |
| SECONDARY Change in Chronic Disease Control - Obesity |
-0.3; -0.5; -0.4; -0.5 | 0.21 |
| SECONDARY Change in Chronic Disease Control - Tobacco Use |
-3.1; -3.5; -3.5; -4.1 | 0.21 |
| SECONDARY Change in Chronic Disease Control - Hypertension |
-6.2; -10.9; -10.4; -17.9 | 0.21 |
| SECONDARY Short Form Health Survey (SF-12) - Mental Component Summary (MCS) |
1.7; 2.2; 1.2; 2.2 | 0.41 |
| SECONDARY Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness |
83; 137; 97; 139 | <0.001 sig |
| SECONDARY Number of Participants With Any Hospital Admission |
35; 38; 51; 52 | 0.98 |
| SECONDARY Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome |
10; 10; 6 | — |
| SECONDARY Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management |
95; 157; 112; 145 | <0.001 sig |
| SECONDARY Number of Participants With Multiple Hospital Admissions |
14; 4; 21; 15 | 0.02 sig |
| SECONDARY Number of Participants With 30 Day Hospital Readmissions |
9; 3; 14; 6 | 0.04 sig |
| SECONDARY Hospital Admission - Total Hospital Days |
345; 155; 471; 300 | — |
| SECONDARY Hospital Admission - Mean Number of Hospitalizations |
1.5; 1.1; 1.6; 1.4 | 0.09 |
| SECONDARY Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization) |
9.9; 4.1; 9.2; 5.8 | 0.06 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02347787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.