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

NCT04051021 | Completed

• 1 other identifier: HUM00161399
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

Surgery; Cardiac; Opioids; Anxiety

Outcome Measures

Primary Outcomes (5)

• Number of days spent at home within the first 30 days after surgery

  Number of days spent at home compared between groups

  up to 30 days after surgery

• Number of days in the hospital after surgery

  average 5-7 days

• Number of days admitted to an extended care facility after discharge from the hospital

  up to 30 days after surgery

• Number of emergency room visits after discharge from the hospital

  up to 30 days after surgery

• Number and length of readmissions to the hospital following initial discharge after surgery

  up to 30 days after surgery

Secondary Outcomes (7)

• Brief pain inventory (short)

  hospital discharge (within 48 hours of time of hospital discharge)

• Postoperative Opioid and Pain Management Questionnaire

  approximately 30 days after discharge

• Picker Patient Experience Questionnaire (PPE-15)

  approximately 30 days after discharge

• Generalized Anxiety Disorder Scale (GAD-7)

  up to approximately 90 days after discharge

• Patient Health Questionnaire (PHQ-9)

  up to approximately 90 days after discharge

Study Arms (2)

Usual Care

OTHER

Other: Usual Care

Comfort Coach

EXPERIMENTAL

Behavioral: Comfort Coach

Interventions

Comfort Coach BEHAVIORAL

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).

Comfort Coach

Usual Care OTHER

Patients will complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 33591291 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Julie Piazza

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research assistants consenting patients and collecting and analyzing data will be blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: September 4, 2019
• Primary Completion: November 8, 2020
• Study Completion: January 5, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)