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

Primary Purpose

Hypertension, Diabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IMPaCT
Usual care
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Usual clinician support

    CHW support

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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
    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.
    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.
    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
    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
    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
    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
    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

    Full Information

    First Posted
    January 21, 2015
    Last Updated
    June 13, 2019
    Sponsor
    University of Pennsylvania
    Collaborators
    Patient-Centered Outcomes Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02347787
    Brief Title
    A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients
    Acronym
    IMPaCT
    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

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 28, 2015 (Actual)
    Primary Completion Date
    January 5, 2017 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania
    Collaborators
    Patient-Centered Outcomes Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Diabetes, Obesity, Tobacco Dependence

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    592 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual clinician support
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    CHW support
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    IMPaCT
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Usual care
    Primary Outcome Measure Information:
    Title
    Short Form Health Survey (SF-12) Physical Component Score (PCS)
    Description
    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.
    Time Frame
    Baseline, 6 months
    Secondary Outcome Measure Information:
    Title
    Change in Chronic Disease Control - Diabetes
    Description
    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.
    Time Frame
    Baseline, 6 months, 9 months
    Title
    Change in Chronic Disease Control - Obesity
    Description
    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.
    Time Frame
    Baseline, 6 months, 9 months
    Title
    Change in Chronic Disease Control - Tobacco Use
    Description
    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.
    Time Frame
    Baseline, 6 months, 9 months
    Title
    Change in Chronic Disease Control - Hypertension
    Description
    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.
    Time Frame
    Baseline, 6 months, 9 months
    Title
    Short Form Health Survey (SF-12) - Mental Component Summary (MCS)
    Description
    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.
    Time Frame
    Baseline, 6 months, 9 months
    Title
    Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness
    Description
    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.
    Time Frame
    6 months, 9 months
    Title
    Number of Participants With Any Hospital Admission
    Description
    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
    Time Frame
    6 months and 9 months
    Title
    Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome
    Description
    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.
    Time Frame
    6 months
    Title
    Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management
    Description
    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.
    Time Frame
    6 months, 9 months
    Title
    Number of Participants With Multiple Hospital Admissions
    Description
    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
    Time Frame
    6 months and 9 months
    Title
    Number of Participants With 30 Day Hospital Readmissions
    Description
    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
    Time Frame
    30 days
    Title
    Hospital Admission - Total Hospital Days
    Description
    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
    Time Frame
    6 months and 9 months
    Title
    Hospital Admission - Mean Number of Hospitalizations
    Description
    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
    Time Frame
    6 months and 9 months
    Title
    Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization)
    Description
    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
    Time Frame
    6 months and 9 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judith A. Long, MD
    Organizational Affiliation
    University of Pennsylvania/Philadelphia Veterans Affairs Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30422224
    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.
    Results Reference
    derived

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

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