Clinical trial NCT02702284: Advance Directives Completion Rates and an Intervention to Address Health Literacy in a Clinic Population
Official title: Advance Directives Completion Rates and an Intervention to Address Health Literacy in a Clinic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Keywords: Advance Directives
Healthcare power of attorney
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 529
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The purpose of this research study is to improve completion of Advance Directives. These are documents that patients use to let doctors know what their wishes for treatment are and who they would want to make decisions for them if they could not make decisions for themselves.

At the time of the clinic visit to the Internal Medicine at Medical Plaza (IMMP) or the Internal Medicine at Tower Hill (IMTH) subjects will be invited to participate in the study.

Research Assistant(s) RA Responsibilities:

All Potential Study Subjects:

1. RA will interview study subject in a private area (exam room or empty office).
2. RA will assess eligibility criteria.
3. RA will obtain informed consent.
4. RA will randomize the subjects to either intervention or control.
5. RA will explain to the subjects how to return the advance directive (AD)

For the Intervention group:

1. RA will review and walk through the University of Florida (UF) AD brochure
2. RA will offer subjects a link to a patient education video on advance directives. The link will be texted or emailed or given in paper per the subject's preference.
3. RA will conduct a brief satisfaction questionnaire addressing the activity review of the UF AD brochure.
4. RA will ask

   1. Did addressing advance directives enhance today's experience at the clinic?
   2. Do you think that advance directives be routinely addressed at visits to the doctor?

Control group:

If the subject is ready to complete an advance directive they will be referred to clinic staff for assistance.

RA will ask

1. Did addressing advance directives enhance today's experience at the clinic?
2. Do you think that advance directives should be routinely addressed at visits to the doctor?

Eligibility criteria: Inclusion Criteria:

* No advance directive in electronic medical record,
* speaks English,
* has intact cognitive function

Exclusion Criteria:

* Age 50 or under,
* already has an advance directive in electronic medical record,
* does not speak English,
* cognitive dysfunction

Primary outcomes:
measure: Presence of advance directive scanned into electronic medical record
timeFrame: 6 months from enrollment
Secondary outcomes:
measure: Number of reminder phone calls needed
timeFrame: 6 months
measure: Client Evaluation of Services Questionnaire
timeFrame: day of study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Tower Hill Internal Medicine
state: Florida
city: Gainesville
country: United States
facility: Internal Medicine at Medical Plaza
state: Florida
Study officials:
affiliation: University of Florida
name: Melanie G Hagen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.