Advance Directives Completion Rates and an Intervention to Address Health Literacy in a Clinic Population
1 other identifier
interventional
529
1 country
2
Brief Summary
The ability to communicate with patients is profoundly impacted by their health literacy - the ability to interpret documents, read and write prose, use quantitative information and speak and listen effectively. Limited health literacy is commonplace and associated with multiple poor health outcomes including frequent readmission's and high mortality. Advance directives are an important tool in respecting patient autonomy in health care interventions. Advance directives can also reduce health care costs by avoiding unwanted, unnecessary care at the end of life. At the University of Florida (UF) Health currently an initiative is underway to improve the delivery of advance directives to patients in the hospital as well as the outpatient clinics. The aim of this research study is to enhance completion rates of advance directives by taking into consideration a patient's health literacy level. Specifically, the investigators plan to assess the impact of an ambulatory intervention on the completion rate of advance directives for patients with adequate and limited health literacy. The hypothesis is that both groups (adequate and limited health literacy) will benefit from the intervention, but patients with limited health literacy will show a greater improvement in the advance directives completion rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedStudy Start
First participant enrolled
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2018
CompletedNovember 19, 2018
November 1, 2018
1.4 years
February 29, 2016
November 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of advance directive scanned into electronic medical record
The research assistant will review the subject's electronic medical record for a copy of a signed advance directive.
6 months from enrollment
Secondary Outcomes (2)
Number of reminder phone calls needed
6 months
Client Evaluation of Services Questionnaire
day of study
Study Arms (4)
Adequate health literacy, control
OTHERThis group of subjects will be referred to clinic staff for assistance with the advance directives (AD) and will not receive assistance from a research assistant. In addition, the research assistance will ask questions regarding the information received for the AD.
Adequate health literacy, intervention
EXPERIMENTALThe subjects in this group will hear a research assistant review the advance directive and be offered an opportunity to watch a video about advance directives.
Limited health literacy, control
OTHERThis group of subjects will be referred to clinic staff for assistance with the advance directives (AD) and will not receive assistance from a research assistant. In addition, the research assistance will ask questions regarding the information received for the AD.
Limited health literacy, intervention
EXPERIMENTALThe subjects in this group will hear a research assistant review the advance directive and be offered an opportunity to watch a video about advance directives.
Interventions
These subject's will have a research assistant (RA) review and walk through the advance directives brochure. The RA will read all of the brochure to the patient and prompt for questions. In addition, a link to an educational video on advance directives. The advance directive link will be either texted or emailed or given in paper per the subject's preference.
This group of subjects will be provided with the advance directive and then referred to clinic staff for assistance.
Eligibility Criteria
You may qualify if:
- No advance directive in electronic medical record,
- speaks English,
- has intact cognitive function
You may not qualify if:
- Age 50 or under,
- already has an advance directive in electronic medical record,
- does not speak English,
- cognitive dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tower Hill Internal Medicine
Gainesville, Florida, 32607, United States
Internal Medicine at Medical Plaza
Gainesville, Florida, 32610, United States
Related Publications (1)
Barker PC, Holland NP, Shore O, Cook RL, Zhang Y, Warring CD, Hagen MG. The Effect of Health Literacy on a Brief Intervention to Improve Advance Directive Completion: A Randomized Controlled Study. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211000221. doi: 10.1177/21501327211000221.
PMID: 33719708DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melanie G Hagen, MD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 8, 2016
Study Start
June 5, 2017
Primary Completion
November 15, 2018
Study Completion
November 15, 2018
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share