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Completed

NCT Number: NCT02386540

Health Coach Program to Improve Chronic Disease Outcomes Following an Emergency Department Visit

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Highland Hospital - Alameda Health System

Oakland, California, 94602, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Coaching

Behavioral

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.

Primary outcomes

  1. Number of emergency department visits

    Time frame: 6 month period after enrollment

    Self-reported measure collected via follow-up phone surveys at 1, 3, and 6 months.

Secondary outcomes

  1. Number of primary care visits

    Time frame: 6 month period after enrollment

    Self-reported measure collected by follow-up phone surveys at 1,3, and 6 months.

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

    Time frame: Baseline, 1 month, 3 months, and 6 months after enrollment

    Validated measure (SF-12v2) collected at baseline and follow-up phone surveys.

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

    Time frame: Baseline, 1 month, 3 months, and 6 months after enrollment

    Validated measure (Morisky Medication Adherence Scale, MMAS-8) collected at baseline and follow-up phone surveys.

  4. Patient activation (Validated measure - Patient Activation Measure, PAM)

    Time frame: Baseline, 1 month, 3 months, and 6 months after enrollment

    Validated measure (Patient Activation Measure, PAM) collected at baseline and follow-up phone surveys.

  5. Type and frequency of health coach contact

    Time frame: 6 months after enrollment

    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. Percent of action plan goals achieved (Health coach documentation notes)

    Time frame: 6 months after enrollment

    Health coach documentation notes will be analyzed to determine the percent of goals achieved during the intervention.

  7. 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

    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.

Sponsors and collaborators

Lead sponsor

Alameda County Medical Center

Other

Collaborators

  • Robert Wood Johnson Foundation
  • University of California, Berkeley

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 12, 2015
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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