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Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT04051021
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
Blue Cross Blue Shield of Michigan Foundation
Information provided by (Responsible Party):
Julie Piazza, University of Michigan

Brief Summary:
This study will assess whether non-pharmacological interventions by a comfort coach affect the amount of opioid pain medication used, as well as perceived physical pain and emotional anxiety and healthcare utilization for adult cardiac surgery patients. Participants that are eligible for the study will be randomized to the comfort coach arm or standard of care. Both groups will complete surveys at the specific time frames in order to compare their outcomes. The study hypothesis is that there will be a decrease in opioid use in the intervention group compared to the standard of care arm during the 90-day perioperative course, as well as a decrease in pain and anxiety along with a lower composite outcome of healthcare utilization.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Behavioral: Comfort Coach Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
Official Title: The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Usual Care 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).




Primary Outcome Measures :
  1. Number of days spent at home within the first 30 days after surgery [ Time Frame: up to 30 days after discharge from the hospital ]
    Number of days spent at home compared between groups

  2. Number of days admitted to the hospital for the surgery [ Time Frame: average 5-7 days ]
  3. Number of days admitted to an extended care facility after discharge from the hospital [ Time Frame: Up to 30 days after discharge from the hospital ]
  4. Number of emergency room visits after discharge from the hospital [ Time Frame: up to 30 days after discharge from the hospital ]
  5. Number of re-admissions to the hospital following discharge [ Time Frame: up to 30 days after discharge from the hospital ]

Secondary Outcome Measures :
  1. Brief pain inventory (short) [ Time Frame: hospital discharge (within 48 hours prior to being discharged) ]
    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.

  2. 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.

  3. 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.


  4. 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.

  5. 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

  6. 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).

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving a first-time elective status open heart cardiac surgery procedure in the Frankel Cardiovascular Center at Michigan Medicine during the recruitment period through a full or miniature sternotomy incision
  • Opioid-naïve, defined as not taking a home opioid medication at time of preoperative H&P

Exclusion Criteria:

  • Patients undergoing cardiac transplantation, implantation of ventricular assist device, reoperation, and any use of circulatory arrest
  • Chronic opioid users defined as taking an opioid for pain management at time of preoperative clinic visit
  • Non-English speaking
  • Inability to understand or complete surveys
  • Pregnancy
  • Unable to sign legal consent form (legal guardian signature not acceptable)

Information from the National Library of Medicine

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


Contacts
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Contact: Alex Brescia, M.D. 734-936-0359 abrescia@med.umich.edu
Contact: Julie Piazza 734-232-5629 julipiaz@med.umich.edu

Locations
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United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Alex Brescia, MD    734-936-0359    abrescia@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Blue Cross Blue Shield of Michigan Foundation
Investigators
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Principal Investigator: Julie Piazza University of Michigan

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Responsible Party: Julie Piazza, Project Manager, University of Michigan
ClinicalTrials.gov Identifier: NCT04051021     History of Changes
Other Study ID Numbers: HUM00161399
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Piazza, University of Michigan:
Surgery
Cardiac
Opioids
Anxiety