NCT02386540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

3.8 years

First QC Date

February 14, 2015

Last Update Submit

December 14, 2018

Conditions

Keywords

Community Health WorkersCommunity Health Workers: utilizationEmergency ServicePrimary Health Care/utilizationHealth Services Accessibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Number of primary care visits

    6 month period after enrollment

  • Physical health and mental health (Validated measure - SF-12v2)

    Baseline, 1 month, 3 months, and 6 months after enrollment

  • Medication adherence (Validated measure - Morisky Medication Adherence Scale, MMAS-8)

    Baseline, 1 month, 3 months, and 6 months after enrollment

  • Patient activation (Validated measure - Patient Activation Measure, PAM)

    Baseline, 1 month, 3 months, and 6 months after enrollment

  • Type and frequency of health coach contact

    6 months after enrollment

  • +2 more secondary outcomes

Study Arms (2)

Health Coaching

EXPERIMENTAL

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.

Behavioral: Health Coaching

Usual Care

NO INTERVENTION

Patients randomized to the control arm receive usual care in the emergency department at enrollment.

Interventions

Health CoachingBEHAVIORAL

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.

Health Coaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Highland Hospital - Alameda Health System

Oakland, California, 94602, United States

Location

MeSH Terms

Conditions

Diabetes MellitusHypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chair for Research, Department of Emergency Medicine, Highland Hospital

Study Record Dates

First Submitted

February 14, 2015

First Posted

March 12, 2015

Study Start

February 6, 2015

Primary Completion

December 10, 2018

Study Completion

December 10, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Locations