Clinical trial NCT04051021: Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients
Official title: The Impact of Non-Pharmacological Interventions on Patient Experience, Opioid Use, and Healthcare Utilization in Adult Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Surgery
Cardiac
Opioids
Anxiety
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2019-08-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 planned use of circulatory arrest
* Chronic opioid users defined as taking an opioid 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)

Primary outcomes:
measure: Number of days spent at home within the first 30 days after surgery
timeFrame: up to 30 days after surgery
measure: Number of days in the hospital after surgery
timeFrame: average 5-7 days
measure: Number of days admitted to an extended care facility after discharge from the hospital
timeFrame: up to 30 days after surgery
measure: Number of emergency room visits after discharge from the hospital
timeFrame: up to 30 days after surgery
measure: Number and length of readmissions to the hospital following initial discharge after surgery
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Brief pain inventory (short)
timeFrame: hospital discharge (within 48 hours of time of hospital discharge)
measure: Postoperative Opioid and Pain Management Questionnaire
timeFrame: approximately 30 days after discharge
measure: Picker Patient Experience Questionnaire (PPE-15)
timeFrame: approximately 30 days after discharge
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: up to approximately 90 days after discharge
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: up to approximately 90 days after discharge
measure: Impact of Events Scale-Revised (IES-R)
timeFrame: approximately 30 days after discharge
measure: Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: preoperative clinic visit, approximately 30 days after discharge
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Julie Piazza
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brescia AA, Piazza JR, Jenkins JN, Heering LK, Ivacko AJ, Piazza JC, Dwyer-White MC, Peters SL, Cepero J, Brown BH, Longi FN, Monaghan KP, Bauer FW, Kathawate VG, Jafri SM, Webster MC, Kasperek AM, Garvey NL, Schwenzer C, Wu X, Lagisetty KH, Osborne NH, Waljee JF, Riba M, Likosky DS, Byrnes ME, Deeb GM. The Impact of Nonpharmacological Interventions on Patient Experience, Opioid Use, and Health Care Utilization in Adult Cardiac Surgery Patients: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2021 Feb 16;10(2):e21350. doi: 10.2196/21350.