- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02386540
Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit
December 14, 2018 updated by: Harrison J. Alter, Alameda County Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
295
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Oakland, California, United States, 94602
- Highland Hospital - Alameda Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health Coaching
Patients randomized to the experimental arm receive six months of post-ED health coaching from the Alameda County Health Coach Program (ACHCP) in addition to usual care in the emergency department at enrollment.
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The Alameda County Health Coach program pairs patients with a language-concordant health coach for six months following an ED visit.
Health coaches are young adults from the local community employed through Alameda County and trained for three months in topics such as self-management support and motivational interviewing.
Health coaches work one-on-one with participants in order to develop an action plan in order to achieve patient-identified health goals.
Communication between the health coach and participant includes text messages (weekly), phone calls (twice a month), face-to-face visits (at least once), and accompaniment to a primary care visit (at least once).
Health coaches may also assist participants in accessing community resources as related to the individualized action plan.
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No Intervention: Usual Care
Patients randomized to the control arm receive usual care in the emergency department at enrollment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of emergency department visits
Time Frame: 6 month period after enrollment
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Self-reported measure collected via follow-up phone surveys at 1, 3, and 6 months.
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6 month period after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of primary care visits
Time Frame: 6 month period after enrollment
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Self-reported measure collected by follow-up phone surveys at 1,3, and 6 months.
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6 month period after enrollment
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Physical health and mental health (Validated measure - SF-12v2)
Time Frame: Baseline, 1 month, 3 months, and 6 months after enrollment
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Validated measure (SF-12v2) collected at baseline and follow-up phone surveys.
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Baseline, 1 month, 3 months, and 6 months after enrollment
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Medication adherence (Validated measure - Morisky Medication Adherence Scale, MMAS-8)
Time Frame: Baseline, 1 month, 3 months, and 6 months after enrollment
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Validated measure (Morisky Medication Adherence Scale, MMAS-8) collected at baseline and follow-up phone surveys.
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Baseline, 1 month, 3 months, and 6 months after enrollment
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Patient activation (Validated measure - Patient Activation Measure, PAM)
Time Frame: Baseline, 1 month, 3 months, and 6 months after enrollment
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Validated measure (Patient Activation Measure, PAM) collected at baseline and follow-up phone surveys.
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Baseline, 1 month, 3 months, and 6 months after enrollment
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Type and frequency of health coach contact
Time Frame: 6 months after enrollment
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Health coach documentation notes will be analyzed to determine the average percent of each type of contact (text, phone, or in-person) and frequency of contact.
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6 months after enrollment
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Percent of action plan goals achieved (Health coach documentation notes)
Time Frame: 6 months after enrollment
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Health coach documentation notes will be analyzed to determine the percent of goals achieved during the intervention.
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6 months after enrollment
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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)
Time Frame: 6 months after enrollment
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Health coach documentation notes will be analyzed using a grounded theory approach, where transcribed data will be coded to identify themes such as type of goals, barriers to care, and resources identified in the action plan.
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6 months after enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jocelyn Freeman-Garrick, MD, Highland Hospital - Alameda Health System
- Principal Investigator: Berenice Perez, MD, Highland Hospital - Alameda Health System
- Principal Investigator: Harrison Alter, MD, Highland Hospital - Alameda Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2015
Primary Completion (Actual)
December 10, 2018
Study Completion (Actual)
December 10, 2018
Study Registration Dates
First Submitted
February 14, 2015
First Submitted That Met QC Criteria
March 6, 2015
First Posted (Estimate)
March 12, 2015
Study Record Updates
Last Update Posted (Actual)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 14, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 14-08123E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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