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

ID: NCT02347787
Status: Active, not recruiting
Phase: N/A
Start Date: January 01, 2015
First Submitted: January 21, 2015
Last Updated: February 22, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania, Patient-Centered Outcomes Research Institute
Location: N/A
Conditions: Hypertension, Diabetes, Obesity, Tobacco Dependence
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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.
Condition or disease Intervention/treatment Phase

Diabetes

Hypertension

Obesity

Tobacco Dependence

Behavioral: IMPaCT
Other Names
Other: Usual care
Other Names
N/A

Tracking Information

First Submitted DateJanuary 21, 2015
Last Update Posted DateFebruary 22, 2018
Start DateJanuary 01, 2015
Anticipated Completion DateJuly 01, 2018
Primary Completion DateJuly 31, 2017
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • SF-12 PCS [Time Frame: 6 months after enrollment]

    The main dependent variable is mean change in standardized score for self-rated physical health. We assess this outcome using the SF-12 Physical Component Summary (PCS) score. The PCS is a measure of perceived physical health that predicts several objective outcomes including future hospitalizations and mortality. It is relevant across age, disease, and treatment group. We will measure the between-arm Page 12 of 27 difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Chronic disease control [Time Frame: 6 months, 9 months]

    We will asses this outcome using biometric testing (HgA1c, manual blood pressure, weight, and anabasine tobacco assay). We will measure both change in these clinical parameters (continuous) and achievement of each patient's chronic disease management goal (dichotomous: yes/no). At six months after enrollment, all patients will undergo a clinic visit and the appropriate laboratory testing depending on their chronic conditions: HgbA1c, manual blood pressure, weight, and self-report of tobacco use and anabasine assay which indicates tobacco cessation. Patients' measurements on these parameters will be used to determine their change in standardized score for their outcome of interest. All outcome measures will be ascertained by a team of blinded outcomes assessors (the Research Coordinator and Research Assistants) at 6 months after study enrollment. We will use EMR data +/- 4 weeks of baseline or 6-month f/u to replace missing data if we are unable to obtain study labs or measurements.

  • Change in perceived mental health [Time Frame: 6 months, 9 months]

    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.

  • Quality of patient-centered care [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 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.

  • Hospital admission [Time Frame: 30 days, 6 months and 9 months]

    We will measure admission to hospital at 30 days, 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 [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).

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleA Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients
Official TitleA Multi-center Trial of Clinician Versus Community Health Worker Support to Help Low Socioeconomic, Chronically-ill Patients Achieve Health Goals
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.

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
444
Allocation
Randomized
Interventional Model
Single Group Assignment
Masking
Single
Primary Purpose
Health Services Research
Conditions
Diabetes
Hypertension
Obesity
Tobacco Dependence
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: IMPaCT

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.

Other Names
Other: Usual care

Other Names
Study Groups/Cohorts
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.

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.

Study Arms
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.
Behavioral : IMPaCT
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.

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.
Other : Usual care

Arm Intervention/Treatment
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.
Behavioral : IMPaCT
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.
Other : Usual care

Recruitment Information

Recruitment Status:Active, not recruiting
Enrollment444
Completion DateJuly 01, 2018
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, 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Not Available

Administrative Information

NCT Number:NCT02347787
Other Study ID Numbers
821368
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator
Judith A. Long, MD
University of Pennsylvania/Philadelphia Veterans Affairs Medical Center