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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertension, Diabetes, Obesity, Tobacco Dependence

Intervention / Treatment
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* Behavioral: IMPaCT
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual clinician support<br>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<br> <br> |
| Experimental: CHW support<br>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<br>* The IMPaCT intervention has three stages: 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. 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. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Chronic Disease Control - Diabetes | We will asses change in chronic disease control using biometric testing (HgA1c). At six months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: HgbA1c. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months | 
| Change in Chronic Disease Control - Obesity | We will asses change in chronic disease control using biometric testing (kg/m^2). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: height and weight. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months | 
| Change in Chronic Disease Control - Tobacco Use | We will asses change in chronic disease control using patient self-report (cigarettes per day). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months | 
| Change in Chronic Disease Control - Hypertension | We will asses change in chronic disease control using biometric testing (systolic blood pressure in mm Hg). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest. | Baseline, 6 months, 9 months | 
| Short Form Health Survey (SF-12) - Mental Component Summary (MCS) | 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 will assess this outcome using the SF-12 Mental Component Summary (MCS) score. The MCS reliably detects differences in mental health over time. We will measure the between-arm difference in mean change in SF-12 MCS score between baseline, 6- and 9- month follow-up. | Baseline, 6 months, 9 months | 
| Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness | We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the comprehensiveness question at 6 and 9 months post-enrollment. | 6 months, 9 months | 
| Number of Participants With Any Hospital Admission | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months | 
| Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome | At 6-months post-enrollment, a trained qualitative interviewer on our study team will conduct an in-depth qualitative semi-structured interview with 40 intervention arm patients and their CHWs. Qualitative interviews will be audio-taped and transcribed. Patients will be purposively sampled across each study site in order to be able to make comparisons between those who achieved a minimally important improvement in the primary outcome and those who did not. These interviews will be guided by the Integrative Behavior Model (IBM). UPDATE: After beginning interviews, our team decided that 26 interviews was sufficient to reach thematic saturation. | 6 months | 
| Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management | We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the supportiveness of disease self-management question at 6 and 9 months post-enrollment. | 6 months, 9 months | 
| Number of Participants With Multiple Hospital Admissions | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months | 
| Number of Participants With 30 Day Hospital Readmissions | We will measure admission to hospital at 30 days after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 30 days | 
| Hospital Admission - Total Hospital Days | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months | 
| Hospital Admission - Mean Number of Hospitalizations | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months | 
| Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization) | We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record | 6 months and 9 months |