Clinical trial NCT06089499: Palliative Care Health Literacy Education and QOL Compared to Usual Care
Official title: The PACED Study: A Randomized Controlled Pilot Study of Palliative Care Education Compared to Usual Care on Health Literacy and Quality of Life Among Older Adults With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
Keywords: Health Literacy QOL Palliative Care COPD
Emergency Medicine Older Adults
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 treatment or control group. The goal of 15 participants in each arm of the pilot study.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Health Literacy Questionaire
timeFrame: Baseline and immediately after the intervention, through study completion up to 12 weeks
measure: Medical Outcomes Study-Short Form 36
timeFrame: Baseline and immediately after the intervention, through study completion up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: Sue Lasiter, PhD
role: STUDY_CHAIR
References: