Clinical trial NCT02386540: Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: Community Health Workers
Community Health Workers: utilization
Emergency Service
Primary Health Care/utilization
Health Services Accessibility
Lead sponsor: Alameda County Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
name: Robert Wood Johnson Foundation
First posted: 2015-03-12
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether health coaching initiated in the emergency department (ED) reduces subsequent ED visits, increases primary care visits, and positively impacts health outcomes in patients with diabetes and/or hypertension.

Detailed description: Patients will be recruited by health coaches from the Highland Hospital Emergency Department. Eligible patients who agree to participate will be randomized to the control and experimental groups in a 2:1 ratio respectively because experimental group size is limited by health coach availability and greater loss-to-follow up is expected among the control group. Repeated measures analysis will be used to compare each outcome over the study period. In addition, subgroup analyses will be performed in order to stratify by baseline survey measures or amount of ED visits in the pre-observation period.

Eligibility criteria: Inclusion Criteria:

* Willing to work with a health coach
* Plans to reside in Alameda County for the next year
* Has a reliable phone number
* Speaks English or Spanish
* 18 years of age or older
* Meets at least one of the following three criteria: (1) Low medication adherence defined as a continuous medication gap of at least 1 month in the past year OR a new diagnosis of diabetes and/or hypertension; (2) No patient-identified primary care provider (PCP) or no visit to PCP in 1 year; (3) One or more visits to the ED in the last 6 months.

Exclusion Criteria:

* Life-expectancy less than 1 year
* Poorly controlled psychiatric illness
* Homeless
* Active and frequent use of illicit substances
* Currently incarcerated
* Already enrolled in a program for patients with high rates of hospitalization and/or emergency department visits
* Unable to consent due to an unstable condition or serious emotional or neurologic condition
* Admitted or anticipated to be admitted to the hospital from the ED

Primary outcomes:
measure: Number of emergency department visits
timeFrame: 6 month period after enrollment
Secondary outcomes:
measure: Number of primary care visits
timeFrame: 6 month period after enrollment
measure: Physical health and mental health (Validated measure - SF-12v2)
timeFrame: Baseline, 1 month, 3 months, and 6 months after enrollment
measure: Medication adherence (Validated measure - Morisky Medication Adherence Scale, MMAS-8)
timeFrame: Baseline, 1 month, 3 months, and 6 months after enrollment
measure: Patient activation (Validated measure - Patient Activation Measure, PAM)
timeFrame: Baseline, 1 month, 3 months, and 6 months after enrollment
measure: Type and frequency of health coach contact
timeFrame: 6 months after enrollment
measure: Percent of action plan goals achieved (Health coach documentation notes)
timeFrame: 6 months after enrollment
measure: Qualitative analysis of action plans (Health coach documentation notes will be analyzed, data will be coded to identify themes such as type of goals, barriers to care, and resources identified in the action plan)
timeFrame: 6 months after enrollment
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Highland Hospital - Alameda Health System
state: California
Study officials:
affiliation: Highland Hospital - Alameda Health System
name: Jocelyn Freeman-Garrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Highland Hospital - Alameda Health System
name: Berenice Perez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Highland Hospital - Alameda Health System
name: Harrison Alter, MD
role: PRINCIPAL_INVESTIGATOR
References: