Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04051021|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : September 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery||Behavioral: Comfort Coach Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Research assistants consenting patients and collecting and analyzing data will be blinded to the allocation.|
|Official Title:||The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients|
|Actual Study Start Date :||September 4, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||January 2021|
Other: Usual Care
Patients will complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).
|Experimental: Comfort Coach||
Behavioral: Comfort Coach
A trained comfort coach will provide emotional and psychological interventions at six time points: preoperative clinic, day of surgery, extubation, chest tube removal, discharge, 30-day clinic follow-up, and 90-day post-discharge. Patients will also complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).
- Number of days spent at home within the first 30 days after surgery [ Time Frame: up to 30 days after surgery ]Number of days spent at home compared between groups
- Number of days in the hospital after surgery [ Time Frame: average 5-7 days ]
- Number of days admitted to an extended care facility after discharge from the hospital [ Time Frame: up to 30 days after surgery ]
- Number of emergency room visits after discharge from the hospital [ Time Frame: up to 30 days after surgery ]
- Number and length of readmissions to the hospital following initial discharge after surgery [ Time Frame: up to 30 days after surgery ]
- Brief pain inventory (short) [ Time Frame: hospital discharge (within 48 hours of time of hospital discharge) ]This is a 9-question inventory which assesses both pain intensity (sensory dimension) and the interference (reactive dimension) of pain in daily activities. Pain intensity is measured on a 0 - 10 scale, with 0 being no pain and 10 being worst possible.
- Postoperative Opioid and Pain Management Questionnaire [ Time Frame: approximately 30 days after discharge ]This is an 11-item questionnaire collecting data on opioids prescribed, opioids used, pain scores, opioid storage and disposal practices, and assessment of opioid education.
- Picker Patient Experience Questionnaire (PPE-15) [ Time Frame: approximately 30 days after discharge ]
This is a 15-item questionnaire designed to capture the patient's inpatient experience.
Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.
- Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: up to approximately 90 days after discharge ]This is a self-administered patient questionnaire with 7 items that measures generalized anxiety disorder. Through a 4-point Likert scale from 'not at all' to 'nearly every day', it is asked how often the patient has been bothered by any of the presented problems. The GAD-7 index is obtained by adding the scores from the questionnaire, after having assigned 0 to the least severe situation, 3 to the most severe one, and 1 and 2 to the intermediate ones. The cut off points 5, 10 and 15 allow to classify the anxiety as none/normal (0-4), mild (5-9), moderate (10-14), and severe (15-21). This will be completed at 4 different times in every patient, ranging from preoperative clinic through 90 (+/-7) day follow up.
- Patient Health Questionnaire (PHQ-9) [ Time Frame: up to approximately 90 days after discharge ]This is a self-administered instrument that will be used to measure depression in each subject. The PHQ-9 score can range from 0-27 with each of the 9 items can be scored from 0-3 corresponding to "no at all", "several days", "more than half the days" and "nearly every day" responses, respectively. This will be completed at 4 different times in every patient, ranging from preoperative clinic through 90 (+/-7) day follow up
- Impact of Events Scale-Revised (IES-R) [ Time Frame: approximately 30 days after discharge ]This is a 22-item self-report questionnaire measuring post traumatic stress disorder symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score ranging from 0 (not at all) to 88 (extremely).
- Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [ Time Frame: preoperative clinic visit, approximately 30 days after discharge ]This a 12-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-12 clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051021
|Contact: Alex Brescia, M.D.||email@example.com|
|Contact: Julie Piazzafirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Alex Brescia, MD 734-936-0359 email@example.com|
|Principal Investigator:||Julie Piazza||University of Michigan|