Palliative Care Health Literacy Education and QOL Compared to Usual Care

COPD Clinical Trial

— PACED  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06089499
• Other study ID #: IRB#2096893-AA
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: University of Missouri, Kansas City
• Contact: Kelly Counts, PhD (c)
• Phone: 618-444-9595
• Email: kdb7x9[@]umsystem.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

Behavioral:
• Get Palliative Care: four educational learning module videos
Organizational Sponsored public domain educational videos

Locations

Country	Name	City	State
United States	Missouri Baptist Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Literacy Questionaire	The HLQ has been validated for sample participants 65 years and older. The prose of the tool includes numeracy and comprehension. There are nine scales of multidimensional constructs of health and each scale is reliable and generates key information about an individual's perceived health literacy abilities, and their experiences. It was designed to be sensitive to change, identifying small differences between populations, and changes over time. The first five scales comprise items that ask the respondents to indicate their level of agreement on one of four response options (strongly disagree to strongly agree). The remaining scales (6-9) represent scales of self-reported capability and items within these scales are scored on one of five response options (cannot do; very difficult; quite difficult; quite easy; very easy).	Baseline and immediately after the intervention, through study completion up to 12 weeks
Primary	Medical Outcomes Study-Short Form 36	The Medical Outcomes Study Short Form-36 (SF-36) survey measures eight health concepts including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy/fatigue levels, emotional well-being, social functioning, and vitality to measure quality of life. The SF-36 survey uses a 5-point Likert scale ranging from one which is equivalent to poorer (or poor) health to five which is equivalent to excellent health. Lower scores represent poorer quality of life.	Baseline and immediately after the intervention, through study completion up to 12 weeks