- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347787
A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients (IMPaCT)
A Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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.
|
|
Experimental: 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.
|
The IMPaCT intervention has three stages:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form Health Survey (SF-12) Physical Component Score (PCS)
Time Frame: Baseline, 6 months
|
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
Time Frame: Baseline, 6 months, 9 months
|
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
Time Frame: Baseline, 6 months, 9 months
|
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
Time Frame: Baseline, 6 months, 9 months
|
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
Time Frame: Baseline, 6 months, 9 months
|
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)
Time Frame: Baseline, 6 months, 9 months
|
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
Time Frame: 6 months, 9 months
|
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
Time Frame: 6 months and 9 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months, 9 months
|
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
Time Frame: 6 months and 9 months
|
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
Time Frame: 30 days
|
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
Time Frame: 6 months and 9 months
|
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
Time Frame: 6 months and 9 months
|
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)
Time Frame: 6 months and 9 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Judith A. Long, MD, University of Pennsylvania/Philadelphia Veterans Affairs Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 821368
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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