Clinical trial NCT01900470: Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease
Official title: Community Health Worker Support to Help Patients Control Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Hypertension
Asthma/COPD With Tobacco Dependence
Keywords: Multiple chronic conditions
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 302
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in standardized score
timeFrame: Six months after enrollment
Secondary outcomes:
measure: Goal achievement
timeFrame: Six months after enrollment
measure: SF-12
timeFrame: Six months after enrollment,
measure: CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)
timeFrame: Six months after enrollment
measure: Hospitalization
timeFrame: 6 months after enrollment
measure: Patient Activation
timeFrame: Six months after enrollment
Other outcomes:
measure: Hospitalizations at 12 months
timeFrame: 12 months after enrollment
measure: Medical Adherence
timeFrame: Six months after enrollment
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shreya Kangovi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17.
citation: Kangovi S, Mitra N, Turr L, Huo H, Grande D, Long JA. A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol. Contemp Clin Trials. 2017 Feb;53:115-121. doi: 10.1016/j.cct.2016.12.009. Epub 2016 Dec 10.
citation: Kangovi S, Mitra N, Smith RA, Kulkarni R, Turr L, Huo H, Glanz K, Grande D, Long JA. Decision-making and goal-setting in chronic disease management: Baseline findings of a randomized controlled trial. Patient Educ Couns. 2017 Mar;100(3):449-455. doi: 10.1016/j.pec.2016.09.019. Epub 2016 Sep 25.