Advance Directives Completion Rates and an Intervention to Address Health Literacy in a Clinic Population

NCT ID: NCT02702284

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 529 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2018-11-15

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?

Conditions

Health Literacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Adequate health literacy, control

This 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.

Group Type: OTHER

Advance Directives without assistance

Intervention Type: BEHAVIORAL

This group of subjects will be provided with the advance directive and then referred to clinic staff for assistance.

Adequate health literacy, intervention

The 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.

Group Type: EXPERIMENTAL

Advance Directives

Intervention Type: BEHAVIORAL

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.

Limited health literacy, control

This 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.

Group Type: OTHER

Advance Directives without assistance

Intervention Type: BEHAVIORAL

This group of subjects will be provided with the advance directive and then referred to clinic staff for assistance.

Limited health literacy, intervention

The 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.

Group Type: EXPERIMENTAL

Advance Directives

Intervention Type: BEHAVIORAL

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.

Interventions

Advance Directives

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.

Intervention Type: BEHAVIORAL

Advance Directives without assistance

This group of subjects will be provided with the advance directive and then referred to clinic staff for assistance.

Intervention Type: BEHAVIORAL

Other Intervention Names

Living will; Living will

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

• Minimum Eligible Age: 51 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melanie G Hagen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Tower Hill Internal Medicine

Gainesville, Florida, United States

Internal Medicine at Medical Plaza

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33719708 (View on PubMed)

Other Identifiers

IRB201500776

Identifier Type: -

Identifier Source: org_study_id