Health LiteracyNCT02702284
Advance Directives Completion Rates and an Intervention to Address Health Literacy in a Clinic Population
A study testing Advance Directives and Advance Directives without assistance in people with Health Literacy, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Literacy
- What is being tested?
- Advance Directives and Advance Directives without assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jun 2017to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No advance directive in electronic medical record,
- speaks English,
- has intact cognitive function
Who cannot join
- Age 50 or under,
- already has an advance directive in electronic medical record,
- does not speak English,
- cognitive dysfunction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tower Hill Internal Medicine
Gainesville, Florida, 32607
Internal Medicine at Medical Plaza
Gainesville, Florida, 32610
About this study
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.
Read the 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:
- RA will interview study subject in a private area (exam room or empty office).
- RA will assess eligibility criteria.
- RA will obtain informed consent.
- RA will randomize the subjects to either intervention or control.
- RA will explain to the subjects how to return the advance directive (AD)
For the Intervention group:
- RA will review and walk through the University of Florida (UF) AD brochure
- 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.
- RA will conduct a brief satisfaction questionnaire addressing the activity review of the UF AD brochure.
- RA will ask
- Did addressing advance directives enhance today's experience at the clinic?
- 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
- Did addressing advance directives enhance today's experience at the clinic?
- Do you think that advance directives should be routinely addressed at visits to the doctor?
- Conditions
- Health Literacy
- Being tested
- Advance Directives, Advance Directives without assistance
- Keywords
- Advance Directives, Healthcare power of attorney
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance DirectivesBehavioural
Also called Living will
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.
Advance Directives without assistanceBehavioural
Also called Living will
This group of subjects will be provided with the advance directive and then referred to clinic staff for assistance.
| Study group | Role | What they receive |
|---|---|---|
| Adequate health literacy, control | Other | 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. Receives: Behavioral: Advance Directives without assistance |
| Adequate health literacy, intervention | Experimental | 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. Receives: Behavioral: Advance Directives |
| Limited health literacy, control | Other | 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. Receives: Behavioral: Advance Directives without assistance |
| Limited health literacy, intervention | Experimental | 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. Receives: Behavioral: Advance Directives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months from enrollment
Secondary outcomes (2)
Number of reminder phone calls needed
- All subjects' charts will be reviewed to see if the subjects have submitted AD.
- If a subject has not submitted an AD, the RA will remind them to return their advance directive papers via phone call 1, 3 and 5 months after they are enrolled
Measured: 6 months
Client Evaluation of Services Questionnaire
Score 8 - 32
- How would you rate the quality of services you have received at your visit today?
- Did you get the kind of service you wanted?
- To what extent has your visit met your needs?
- If a friend were in need of similar help, would you recommend our office to him or her?
- How satisfied are you with the amount of help you have received?
- Have the services you receive helped you to deal more effectively with your problems?
- In an overall, general sense, how satisfied are you with the service you have received at the visit?
- If you were to seek help again, would you come back to our office?
- Did addressing Advance Directives enhance your clinic experience today?
- Do you think Advance Directives should be routinely addressed at your doctor's visit?
Measured: day of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start5 Jun 2017
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie G Hagen, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702284
- Sponsor's protocol ID
- IRB201500776
- Status last verified
- Nov 2018
- First submitted
- 29 Feb 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33719708
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Directives Completion Rates and an Intervention to Address Health Literacy in a Clinic Population
- ClinicalTrials.gov ID
- NCT02702284
- Acronym / sponsor ID
- IRB201500776
- Conditions
- Health Literacy
- Keywords
- Advance Directives, Healthcare power of attorney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- RA will interview study subject in a private area (exam room or empty office).
- RA will assess eligibility criteria.
- RA will obtain informed consent.
- RA will randomize the subjects to either intervention or control.
- RA will explain to the subjects how to return the advance directive (AD)
For the Intervention group:
- RA will review and walk through the University of Florida (UF) AD brochure
- 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.
- RA will conduct a brief satisfaction questionnaire addressing the activity review of the UF AD brochure.
- RA will ask
- Did addressing advance directives enhance today's experience at the clinic?
- 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
- Did addressing advance directives enhance today's experience at the clinic?
- Do you think that advance directives should be routinely addressed at visits to the doctor?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adequate health literacy, control | Other | Behavioral: Advance Directives without assistanceThis 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 | Experimental | Behavioral: Advance DirectivesThe 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 | Other | Behavioral: Advance Directives without assistanceThis 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 | Experimental | Behavioral: Advance DirectivesThe 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. |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No advance directive in electronic medical record,
- speaks English,
- has intact cognitive function
Key exclusion criteria (4 listed)
- Age 50 or under,
- already has an advance directive in electronic medical record,
- does not speak English,
- cognitive dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance DirectivesAlso: Living willThese 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. | Behavioural | Adequate health literacy, intervention, Limited health literacy, intervention |
| Advance Directives without assistanceAlso: Living willThis group of subjects will be provided with the advance directive and then referred to clinic staff for assistance. | Behavioural | Adequate health literacy, control, Limited health literacy, control |
Primary outcome
Presence of advance directive scanned into electronic medical record
Time frame: 6 months from enrollment
The research assistant will review the subject's electronic medical record for a copy of a signed advance directive.
2 secondary outcomes
Number of reminder phone calls needed
Time frame: 6 months
Client Evaluation of Services Questionnaire
Time frame: day of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Derived from this study: PubMed 33719708Barker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie G Hagen, MD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Directives and Advance Directives without assistance in people with Health Literacy, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of advance directive scanned into electronic medical record (time frame: 6 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702284, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.