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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02386540
Other study ID # IRB 14-08123E
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2015
Est. completion date December 10, 2018

Study information

Verified date December 2018
Source Alameda County Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 295
Est. completion date December 10, 2018
Est. primary completion date December 10, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Coaching
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.

Locations

Country Name City State
United States Highland Hospital - Alameda Health System Oakland California

Sponsors (3)

Lead Sponsor Collaborator
Alameda County Medical Center Robert Wood Johnson Foundation, University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of emergency department visits Self-reported measure collected via follow-up phone surveys at 1, 3, and 6 months. 6 month period after enrollment
Secondary Number of primary care visits Self-reported measure collected by follow-up phone surveys at 1,3, and 6 months. 6 month period after enrollment
Secondary Physical health and mental health (Validated measure - SF-12v2) Validated measure (SF-12v2) collected at baseline and follow-up phone surveys. Baseline, 1 month, 3 months, and 6 months after enrollment
Secondary Medication adherence (Validated measure - Morisky Medication Adherence Scale, MMAS-8) Validated measure (Morisky Medication Adherence Scale, MMAS-8) collected at baseline and follow-up phone surveys. Baseline, 1 month, 3 months, and 6 months after enrollment
Secondary Patient activation (Validated measure - Patient Activation Measure, PAM) Validated measure (Patient Activation Measure, PAM) collected at baseline and follow-up phone surveys. Baseline, 1 month, 3 months, and 6 months after enrollment
Secondary Type and frequency of health coach contact 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. 6 months after enrollment
Secondary Percent of action plan goals achieved (Health coach documentation notes) Health coach documentation notes will be analyzed to determine the percent of goals achieved during the intervention. 6 months after enrollment
Secondary 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) 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. 6 months after enrollment
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