Palliative Care Health Literacy Education and QOL Compared to Usual Care

NCT ID: NCT06089499

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-03-31

Brief Summary

The goal of this pilot randomized controlled trial is to compare health literacy (HL) and quality of life (QOL) among older adults with chronic obstructive pulmonary disease (COPD) who completed a series of standardized palliative care (PC) educational video learning modules to usual care (US). The main question[s] it aims to answer are:

Between Groups:

• What effect does completing a series of standardized PC education video learning modules have on HL among older adults with COPD treated in the emergency department (ED) compared to usual care?
• What effect does completing a series of standardized PC education video learning modules have on QOL among older adults with COPD treated in the ED compared to usual care?

Within Groups:

• What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on HL?
• What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on QOL?
• What is the change from baseline to study completion for older adults with COPD who receive UC on HL?
• What is the change from baseline to study completion for older adults with COPD who receive UC on QOL?

All participants will complete a baseline and study completion health literacy questionnaire (HLQ) and Medical Outcomes Study: Short Form 36 survey. The treatment group will view one standardized learning module per week for four weeks provided by Get Palliative Care and log their weekly completion in REDCap. The control group will receive usual COPD care. Researchers will compare the treatment group receiving weekly palliative care education to usual care to see if HL and QOL change.

Detailed Description

Purpose: The purpose of this study is to conduct a pilot randomized controlled trial (RCT) to compare health literacy (HL) and quality of life (QOL) among older adults with chronic obstructive pulmonary disease (COPD) who completed a series of standardized palliative care (PC) educational video learning modules to usual care. Problem: Older adults aged 65 years and older with COPD are living longer, reported one in four have low HL, overall poorer health, and often seek emergency department (ED) care for the relief of symptoms impacting their QOL. Significance: The incidence of aging, the risk for chronic disease development like COPD with unpredictable disease trajectories, increased end-of-life healthcare costs, and limited HL have resulted in poor QOL. Limited research has been conducted on HL related to PC in the ED. Innovation: The pilot RCT will be a unique contribution to critical care nursing research by demonstrating the importance HL has on PC while improving overall QOL for older adult COPD patients seeking care in the ED. A 2030 Healthy People initiative is to decrease ED visits for COPD. Theory: The Expanded Chronic Care Model incorporates PC constructs focusing on older adults at risk for poor health outcomes while adding emphasis on digital constructs and educational training programs. Design: The study design is pilot RCT comparing QOL and HL among older adults with COPD treated in the ED who complete a series of standardized PC educational learning modules compared to usual care (UC). Setting: The study will be conducted at Missouri Baptist Medical Center, a community-based geriatric-designated ED in Saint Louis, Missouri. Sample: A convenience sample of older adults aged 65 or older with a diagnosis of COPD who seek care in the ED is the target population. This is a pilot study and, therefore, will have no statistical power with the overall goal of enrolling 30 participants. Intervention: All consenting participants will complete a baseline and study completion HL questionnaire (HLQ) and QOL survey. The treatment group will view one standardized learning module per week for four weeks provided by Get Palliative Care and log their weekly completion in REDCap. The control group will receive usual COPD care. Procedure: Informed consent will be obtained from participants who meet inclusion criteria and volunteer to participate in the study. Recruitment will take place for 30 days, and the study duration will be 30 days from the time of enrollment. A 1:1 randomization will be used to assign participants to the intervention or control group. Instrument: The Medical Outcomes Study Short Form-36 QOL survey and HLQ will measure the outcome variables at baseline and study completion. Analysis Plan: Demographic data using descriptive statistics will be calculated. Trends of the mean scores from baseline to study completion among groups and between groups will be conducted. REDCap will securely store all study-related data.

Conditions

COPD

Study Design

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

Study Groups

Get Palliative Care: four educational learning module videos

Get Palliative Care educational learning module videos available online in the public domain. A Webinar: How to Manage Shortness of Breath and Improve Your Quality of Life (2019) presented by Tara Liberman, DO reviews how to live with COPD, where and when palliative care can be implemented, what alternatives to treatment may look like, and final provides a summary of the benefits of palliative care. Each learning module is approximately five to seven minutes in length. The four learning modules are accessible at https://youtu.be/\_\_phRXS4jZs?si=TivFch6cFE6roXDZ. After completing the weekly learning module, the participant will log their viewing in REDCap via a link provided to the participant by the email provided at the time of enrollment.

Group Type: EXPERIMENTAL

Get Palliative Care: four educational learning module videos

Intervention Type: BEHAVIORAL

Organizational Sponsored public domain educational videos

Usual Care

Usual care for COPD includes oxygen therapy, steroid therapy, chest radiography, nebulized bronchodilators, and antimicrobial therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Get Palliative Care: four educational learning module videos

Organizational Sponsored public domain educational videos

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 65 years of age or older
• COPD diagnosis
• English speaking
• Access to technology and Internet/online services

Exclusion Criteria

• Enrolled in hospice care
• Cancer diagnosis stage IV or greater

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri, Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Kelly Counts

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sue Lasiter, PhD

Role: STUDY_CHAIR

University of Missouri, Kansas City

Locations

Missouri Baptist Medical Center

St Louis, Missouri, United States

Countries

United States

Central Contacts

Kelly Counts, PhD (c)

Role: CONTACT

kdb7x9@umsystem.edu

618-444-9595

Sue Lasiter, PhD

Role: CONTACT

lasiterr@umkc.edu

816-235-6766

Facility Contacts

Kelly Counts, PhD (c)

Role: primary

kdb7x9@umsystem.edu

618-444-9595

Other Identifiers

IRB#2096893-AA

Identifier Type: -

Identifier Source: org_study_id