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Completed

NCT Number: NCT01900470

Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease

The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.

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Key information

Conditions

Obesity Asthma/COPD With Tobacco Dependence Body Weight Cardiovascular Diseases Chronic Disease Diabetes Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Multiple Chronic Conditions Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
  • Home ZIP code including ANY of the following: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
  • 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
  • Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
  • Patients who have scheduled appointments in the future.

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

Treatment and study plan

CHW Goal Support

Behavioral

IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients. 3) IMPaCT Partners conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals. As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits. 4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm. This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.

Other names: IMPaCT

Primary outcomes

  1. Change in standardized score

    Time frame: Six months after enrollment

    Six months after enrollment, the IMPaCT arm will have a higher (more negative) mean change in standardized score for chronic disease outcome of interest compared with usual care

Secondary outcomes

  1. Goal achievement

    Time frame: Six months after enrollment

    Six months after enrollment, patients in the IMPaCT group will have higher proportion of patients who achieve their individualized chronic disease management goal compared with usual care

  2. SF-12

    Time frame: Six months after enrollment,

    Six months after enrollment, patients in the IMPaCT group will greater improvements in their self-rated health (as measured by mean change in MCS and PCS of the SF-12) than patients receiving usual care.

  3. CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)

    Time frame: Six months after enrollment

    Six months after enrollment, the IMPaCT arm will have higher perceived quality of patient-centered medical care (as measured by the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey) than the usual care arm. Specifically, we will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care.

  4. Hospitalization

    Time frame: 6 months after enrollment

    Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.

  5. Patient Activation

    Time frame: Six months after enrollment

    Six months after enrollment, patients in the IMPaCT arm will have greater improvements in their activation (as measured by mean change in PAM score) compared with patients in the usual care arm.

Other outcomes

  1. Hospitalizations at 12 months

    Time frame: 12 months after enrollment

    Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.

  2. Medical Adherence

    Time frame: Six months after enrollment

    Six months after enrollment, patients in the IMPaCT arm will have higher levels of adherence to medical recommendations than the usual care arm, as measured by the Medical Outcomes Study (MOS) Measures of Patient Adherence.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Community Health Worker Support to Help Patients Control Chronic Disease

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Jul 16, 2013
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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