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Despite pharmacological treatments, patients undergoing cardiac surgery experience severe anxiety and pain, which adversely affect outcomes. Previous work examining pediatric and nonsurgical adult patients has documented the effectiveness of inexpensive, nonpharmacological techniques to reduce anxiety and pain as well as health care costs and length of hospitalization. However, the impact of nonpharmacological interventions administered by a dedicated
This trial aims to assess whether nonpharmacological interventions administered by a trained
To address these aims, we will perform a prospective, randomized controlled trial of 154 adult cardiac surgery patients at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery via sternotomy will be randomized to undergo targeted interventions from a
This trial, funded by Blue Cross Blue Shield of Michigan Foundation in 2019, is presently enrolling patients with anticipated manuscript submissions from our primary aims targeted for the end of 2020.
Data generated from this mixed methods study will highlight effective nonpharmacological techniques and support a multidisciplinary approach to perioperative care during the adult cardiac surgery patient experience. This study’s findings may serve as the foundation for a subsequent multicenter trial and broader dissemination of these techniques to other types of surgery.
ClinicalTrials.gov NCT04051021; https://clinicaltrials.gov/ct2/show/NCT04051021
DERR1-10.2196/21350
Adults undergoing inpatient surgery commonly develop both severe perioperative anxiety [
Certified child life specialists are frontline health care professionals trained to provide psychosocial care to pediatric patients and families facing stressful medical experiences. Child life specialists conduct thorough assessments and build therapeutic relationships with patients and families to support them to cope and protect emotional safety. Individualized interventions include fostering healing environments, therapeutic play, nonpharmacological pain management, procedural preparation, diagnosis teaching, sibling support, medical play, and bereavement support. Child life specialists obtain a bachelor’s degree with an emphasis on psychology, education, and human development. They complete comprehensive clinical training, pass a certification exam, and maintain certification through targeted continuing education [
Child life specialists work with pediatric patients to teach individualized coping strategies to mitigate anxiety and manage both acute and chronic pain. Play is the universal language of all children, and play-based coping strategies foster expression and promote a sense of control and mastery. Nonpharmacological interventions effective in pediatric and adolescent patients include calm breathing techniques, distraction, guided imagery, art, muscle relaxation, music, environmental modification, and comfort positioning [
We propose that providing a dedicated, trained comfort coach administering nonpharmacological interventions will improve cardiac surgery outcomes, including anxiety, self-reported pain, opioid use, and health care utilization. Periprocedural nonpharmacological approaches are well established in pediatrics [
Conceptual model. This conceptual model demonstrates the hypothesized effect of nonpharmacological interventions on the outcomes in this study rooted in gate-control theory.
Approximately 300,000 adults undergo cardiac surgery in the United States each year [
Data generated by this study may highlight effective techniques and support a multidisciplinary approach to nonpharmacological interventions to decrease pain, opioid use, anxiety, and health care utilization while increasing patient comfort and overall satisfaction during the adult cardiac surgery patient experience.
We will perform a prospective, double-armed, randomized, controlled trial of 154 cardiac surgical patients at a large academic center to assess whether nonpharmacological interventions by a trained comfort coach affect patient experience, opioid use, and health care utilization as compared with usual care. The individualized comfort coach interventions will be administered at 6 time-points: (1) at the preoperative clinic, (2) on the day of surgery, (3) at extubation, (4) at chest tube removal, (5) at hospital discharge, and (6) at the 30-day clinic follow-up.
This study has 3 specific aims: (1) assess the effect of a comfort coach on patient experience, (2) measure differences in inpatient and outpatient opioid use and postsurgical health care utilization, and (3) qualitatively evaluate the effectiveness of the comfort coach intervention. Toward aim 1, we will use validated survey metrics to capture anxiety and depression (preoperative clinic, discharge, 30-day follow-up, and 90-day follow-up), functional status (preoperative clinic and 30-day follow-up), surgery-related psychological stress (30-day follow-up), patient-reported in-hospital pain (discharge), and patient experience (30-day follow-up). Toward aim 2, we will compare inpatient and postdischarge opioid use and patient-reported outcomes, including pain scores and pain management practices between groups. In addition, the composite primary endpoint of the study will be recorded as the total number of days spent at home out of the first 30 after surgery, incorporating hospital length of stay, readmissions, number of days in an extended care facility, emergency room, urgent care, and unplanned doctor visits. Aim 3 will include semistructured interviews of patients in the intervention group to understand the role, impact, and acceptability of a comfort coach.
All requirements for conducting human subjects research at the University of Michigan have been met. The study protocol has been reviewed, and the University of Michigan Institutional Review Board has approved this trial (quantitative, HUM00161399, and qualitative, HUM00170502). This clinical trial has been registered at ClinicalTrials.gov (NCT04051021).
Cardiac surgical patients will be recruited from the Frankel Cardiovascular Center (FCVC) at Michigan Medicine. Opioid-naive patients undergoing first-time, elective cardiac surgery through a full median or miniature sternotomy beginning September 3, 2019, were screened for a targeted enrollment of 154 patients for randomization. Approximately 600 to 750 patients meeting these criteria underwent surgery at Michigan Medicine in 2017. Opioid-naive is defined as opioid-free at the time of preoperative clinic history and physical examination.
Patients lost to follow-up will be censored for data analysis, and missing individual intervention points will be dealt with by multiple imputations, as appropriate. We will compare the clinical and sociodemographic attributes of patients who decline participation and patients lost to follow-up with those of patients with complete follow-up to assess potential responder bias. We estimated a 20% rate of missingness, which was incorporated into our power calculation. On the basis of historical institutional data, we anticipated approaching 5 to 10 patients per week for potential enrollment, with an approximate 5 to 7 month enrollment period within a 12-month study period for completion of clinical follow-up, data analysis, and manuscript production. Although this timeline was affected by the COVID-19 pandemic forcing a pause in enrollment between March 14th and the time of writing, we were 93.5% (144/154) enrolled at the time of pausing and remained optimistic about completing enrollment within our 12-month study period. We used block randomization with randomly variable block sizes generated with Stata 15 software (StataCorp LLC, College Station, TX) and computer randomization occurred with the treatment assignment tool (Treatment Assignment Tool-University of Michigan [TATUM]) from the Michigan Institute for Clinical and Health Research.
Patients were approached, participated in the informed consent process, and were enrolled during the preoperative history and physical appointment, typically after being seen by a member of the advanced practice team. The study coordinator approached potential subjects either in exam rooms or in the clinic waiting room to describe the study and offer participation. Interested patients engaged with the study coordinator and gave informed consent, at which point the coordinator randomized and assigned a sequential subject identification number to each study patient using TATUM (
Preoperative clinic value stream map. Blue blocks with maize writing indicate the main steps in the clinic process, whereas maize blocks with blue writing summarize tasks performed by the study coordinator. APP: advanced practice providers; GAD-7: Generalized Anxiety Disorder 7-item scale; KCCQ-12: Kansas City Cardiomyopathy Questionnaire 12-item short-form; PHQ-9: Patient Health Questionnaire-9; TATUM: Treatment Assignment Tool-University of Michigan.
In this trial, the
Child life specialists are trained in lifespan development and family systems theories, specifically addressing pain and anxiety through individualized comfort techniques. Though they are trained specifically in pediatrics, these coping strategies translate across ages. Adults routinely express the desire for distraction techniques, guided imagery, and preparation procedures during procedural care [
In this study, patients randomized to the intervention group will meet the comfort coach in the preoperative clinic (#1), where the coach will perform an introductory emotional, medical, and psychosocial needs assessment to consider the impact of surgery on the patient. The comfort coach will also introduce a
Screening, enrollment, randomization, and study design are summarized in
Clinical trial CONSORT (Consolidated Standards of Reporting Trials) diagram. Patient population and clinical trial flow diagram. The timing of each
To address this aim, we will examine the effect of the comfort coach on perioperative anxiety, self-reported pain, functional status, and patient satisfaction. We will use the Generalized Anxiety Disorder 7-item scale (GAD-7) [
Outcome measures for aim 1 exclusively consist of validated measures for anxiety, depression, stress, pain, and patient satisfaction (
Generalized Anxiety Disorder 7-item Scale
A 7-item validated questionnaire to assess and potentially diagnose generalized anxiety disorder [
Patient Health Questionnaire
A 9-item validated questionnaire which generates a total score out of 27 used to diagnose 5 different degrees of depressive disorders [
Impact of Events Scale-Revised
A 22-item validated scale used to measure event-related stress with the potential to indicate clinical suspicion or diagnosis of posttraumatic stress disorder [
Picker Patient Experience Questionnaire
A 15-item questionnaire designed to capture the patient’s inpatient experience [
Brief Pain Inventory
Short-form 9-question inventory assessing patient pain location, severity, relief, and activity level [
Postoperative Opioid and Pain Management Questionnaire
An 11-item questionnaire developed at Michigan Medicine for collecting data on opioids prescribed, opioids used, pain scores, opioid storage and disposal practices, and assessment of opioid education.
Kansas City Cardiomyopathy Questionnaire
A 12-item questionnaire assessing the impact of heart failure on the patient’s daily activities and lifestyle [
The survey and questionnaire instruments were used as part of specific aim #1 to evaluate anxiety (Generalized Anxiety Disorder 7-item scale [GAD-7]), depression (PHQ-9), functional status (Kansas City Cardiomyopathy Questionnaire short-form [KCCQ-12]), stress (Impact of Events Scale-Revised [IES-R]), and patient experience (Picker Patient). Patient-reported pain levels (BPI) and postdischarge opioid use and pain management practices (Postoperative Opioid and Pain Management Questionnaire [OPIOID]) were collected as part of specific aim #2.
Mean total GAD-7 and PHQ-9 scores at each of the 4 time-points (
Schedule of survey instrument administration. The survey administration schedule is indicated for both study cohorts (ie, all patients).
Preoperative clinic visit for History and Physical | Day of discharge | 30-day postoperative clinic visit | 90-day postoperative clinic visit or phone call |
GAD-7a | GAD-7 | GAD-7 | GAD-7 |
PHQ-9b | PHQ-9 | PHQ-9 | PHQ-9 |
KCCQ-12c | BPId | Picker Patiente | N/Af |
N/A | N/A | IES-Rg | N/A |
N/A | N/A | OPIOIDh | N/A |
N/A | N/A | KCCQ-12 | N/A |
aGAD-7: Generalized Anxiety Disorder 7-item scale.
bPHQ-9: Patient Health Questionnaire-9.
cKCCQ-12: Kansas City Cardiomyopathy Questionnaire 12-item short-form.
dBPI: Brief Pain Inventory.
ePicker Patient: Picker Patient Experience Questionnaire.
fN/A: not applicable.
gIES-R: Impact of Events Scale-Revised.
hOPIOID: Postoperative Opioid and Pain Management Questionnaire.
Inpatient postoperative opioid use will be recorded for 3 inpatient calendar days before discharge in oral morphine equivalents (OME) per day. Outpatient opioid use and pain scores will be assessed through an 11-item questionnaire administered at 1-month follow-up. Hospital length of stay, number of days in an extended care facility, emergency room, urgent care, unplanned doctor office visits, and readmission will be recorded in a composite endpoint defined as total days spent at home within the first 30 days after surgery. We hypothesize that patients who receive a comfort coach consume less opioids after surgery and demonstrate lower postsurgical health care utilization.
Opioid amounts will be converted to OME [
The primary endpoint of this trial is a composite outcome defined as the total number of days spent at home within the first 30 days after surgery. Each partial or full day spent in the hospital (during index or readmission hospitalization), at any extended care facility, emergency room, urgent care center, or doctor’s office for an unplanned visit will be subtracted from 30 to generate the total number of full days spent at home. This number will reflect total health care utilization within the immediate postoperative period, with lower values indicating more utilization. The number of days in an extended care facility, outside hospital emergency room or urgent care visits, and readmissions are routinely discussed at the 30-day postoperative clinic appointment and will be captured through a combination of chart review by 2 study team members and conversations with patients. In addition, the number of telephone calls made by each patient or patient’s family member to the University of Michigan hospital system regarding the clinical concerns of the patient within the first 30 postoperative days will be captured through chart review and independently verified by 2 study team members. If necessary, we will then use Michigan Value Collaborative data to quantify differences in health care utilization by comparing total and component 90-day episode payments among Medicare, Blue Cross Blue Shield of Michigan, and Medicaid beneficiaries, as our team has previously done in both coronary artery bypass (CABG) [
Mean inpatient opioid use, prescription size, postdischarge opioid use (in OME), and mean postsurgical health care utilization days will all be compared between groups using two-tailed
We will perform semistructured one-on-one interviews with 50 patients who had a comfort coach to understand (1) their experience with and perceived role of the intervention on their surgical experience and (2) the acceptability of the intervention. Insights from this thematic analysis will guide the identification and development of tools for broader implementation.
Interviews will be conducted by 2 study members (AB and MB) either in the FCVC cardiac surgery outpatient clinic area or over the telephone. Interviews will be audio recorded on an encrypted recorder, transcribed verbatim by an external HIPAA (Health Insurance Portability and Accountability Act)–approved professional transcriptionist, and redacted for all identifying information. Participants will be compensated with a gift card for their participation. After March 14, 2020, interviews were exclusively performed over the phone because of human subject research restrictions owing to the COVID-19 pandemic.
An initial interview guide will be developed and modified during the interview period through iterative steps. Data will be coded in MaxQDA20 (VERBI Software, 2019) qualitative analysis software. The team will meet to examine codes and identify emerging patterns and concepts that will be organized into themes. We will use the thematic analysis framework [
Our primary endpoint is composite of health care utilization, defined as the total number of days spent at home within the first 30 days after surgery. Secondary endpoints include mean GAD-7 and PHQ-9, KCCQ-12, Picker Patient Experience Questionnaire, IES-R, and Brief Pain Inventory Scores and mean inpatient and outpatient opioid use.
We will compare mean days with a two-tailed
An 11-patient feasibility study in aortic surgery patients (HUM00138828) was performed at the FCVC, 6 of whom were randomized to the control and 5 to the intervention arm. Extremely useful insight from this feasibility trial included feedback from intervention patients regarding the time-points at which their dedicated, trained comfort coach was most beneficial. This feedback was used to solidify the 6 touchpoints for our full clinical trial. In addition, an assumption about utilizing nonpharmacological interventions was that pain management and recovery after surgery were individualized processes. In contrast, we received feedback that family and relatives are intimately involved in patients' healing and emotional well-being. Furthermore, some patients indicated that their family members benefited from the comfort coach interventions, in some instances, even more than the patient. In addition, family interaction and socialization during the perioperative process were identified as important to pain management.
Executing the feasibility trial also provided direct insights for our study team. Using certified child life specialists in dual roles as full-time specialists at the children’s hospital and on-call for the feasibility trial proved to be a barrier to effective intervention, primarily because of the distance between the hospitals creating time-related challenges for meeting each touchpoint. Accordingly, these experiences informed the development of the full clinical trial by highlighting the importance of hiring a full-time, dedicated comfort coach to enhance the number of touchpoints met and increase care continuity. Most importantly, this preliminary trial demonstrated that it would be feasible to perform the comfort coach study protocol at the University of Michigan.
After completing the feasibility study, the study team performed telephone interviews of study patients and former open-heart surgery patients through the FCVC’s Patient Family Advisory Council to gain further insight into the patient experience and use this input to select the most appropriate survey instruments for the full clinical trial.
Our clinical trial is funded by Blue Cross Blue Shield of Michigan Foundation, and enrollment is currently ongoing. As of June 2020, 144 patients have been enrolled and randomized in the trial, and 50 semistructured qualitative interviews have been performed. Since March 14, 2020, all survey touchpoints and interviews have been conducted remotely via telephone, online, or mail because of human subject research restrictions implemented at the University of Michigan to limit exposure to patients and staff during the COVID-19 pandemic. Comfort coach touchpoints for patients in the intervention group have continued during their inpatient hospitalization, whereas 30-day follow-up visits with the comfort coach are now conducted remotely. We have completed our qualitative interview process and are currently evaluating our coded data, with plans to publish our qualitative findings by the end of 2020. We anticipate that enrollment, data collection, and analysis will be completed by September 2020 and expect to submit our initial quantitative results for publication by the end of 2020.
Nonpharmacological interventions administered by a comfort coach have the potential to decrease anxiety, self-reported pain, and stress while improving functional status and overall patient experience in the hospital for cardiac surgery patients, which would mirror findings in pediatric and nonsurgical adult populations [
The role of surgery in the opioid epidemic has been well described [
The effect of the comfort coach’s interventions on anxiety, pain, stress, and opioid use can also be measured through overall health care utilization. As patient anxiety and pain decrease while satisfaction and comfort increase, we expect them to be better equipped and more prepared to leave the hospital. In addition, whereas individual nonpharmacological techniques such as preoperative educational prompts [
We expect the comfort coach intervention to be extremely impactful. In contrast to testing 1 individual technique [
Previous evaluations within pediatric [
We anticipate that our coaching intervention may have more profound impact when evaluated within an adult inpatient surgical population. Relative to nonsurgical and many other types of surgical populations, our cardiac surgical population has greater anxiety, more pain and opioid use, and longer average lengths of stay. Even with our conservative effect sizes estimating a 10% reduction in the published mean episode payments for CABG and valve surgery [
By decreasing health care utilization, the comfort coach intervention may have profound economic implications, particularly in decreasing the amount of time patients spend in the hospital. For payers, less health care utilization will decrease episode payments, which reach up to US $15 billion annually in the cardiac surgery population [
Whereas patients receiving the control treatment may report improvement because of the healthy volunteer effect [
Our trial may be susceptible to spillover effects, both internally in our intervention and from external forces such as competing institutional interventions. Specifically, opioid reduction efforts for specific general surgery procedures at our institution have demonstrated spillover effects into additional general surgery procedures, with corresponding reductions in opioid use found [
If the intervention tested is beneficial, a generalizable implementation of trained comfort coaches for surgical patients may be questioned. To overcome this generalizability barrier, we will first consider our qualitative third aim to describe how these techniques were effective or ineffective. If specific techniques are effective, they can be translated into a scalable paper or electronic tool that can be broadly implemented. Second, the health care utilization is found to be lower among those who receive a comfort coach, we plan to financially quantify this difference with 90-day episode payments between arms and perform a cost-effectiveness analysis incorporating the cost of comfort coaching to demonstrate cost savings that can be used by other health systems to assess whether to implement these methods.
Approximately 20% of patients during the trial will have received inpatient care either during or after the peak of the COVID-19 pandemic. The usual amount of fear and anxiety elicited by cardiac surgery and the associated recovery period enhance patients’ typical need for close physical, emotional, and psychological support from their loved ones. The hospital-wide policy prohibiting all visits during COVID-19 may cause an increase in the levels of fear and anxiety caused by surgery and recovery owing to enhanced feelings of isolation, separation, and possibly even abandonment—at such a crucial time of need—by the most important loved ones in their lives. These policy changes may enhance the impact of a comfort coach on the intervention arm, simply by adding more human contact through a caring and empathetic individual at these critical touchpoints of care, irrespective of the nonpharmacologic therapy the coach provided.
In contrast, the control patient group during the COVID-19 pandemic may be at a potential disadvantage compared with the control patient group before COVID-19 because the pre-COVID control group had the usual level of support from family, friends, and significant others. These 2 opposing effects, namely, a potential enhancement for the intervention group and additional tension and anxiety from isolation and separation among the control group, may have affected the study results. However, it is also possible that patients in the intervention group during COVID-19 remained anxious and fearful despite having a comfort coach because of separation from loved ones, fear of infection in the hospital, or other factors. Although we cannot mitigate the impact of COVID-19, we will perform a subset analysis of patients who received care during COVID-19 to evaluate for any significant differences in our data.
This clinical trial aims to evaluate the impact of a comfort coach administering nonpharmacological interventions on patient experience, opioid use, and health care utilization compared with usual care in adult cardiac surgery patients. Findings from this study may serve as the foundation for a subsequent multicenter trial, establishment of this role in the adult setting, and broader dissemination of these techniques to other types of surgery.
Supplemental material.
Peer Review Comments and Author Responses.
coronary artery bypass
Frankel Cardiovascular Center
Generalized Anxiety Disorder 7-item scale
Impact of Events Scale-Revised
Kansas City Cardiomyopathy Questionnaire short-form
oral morphine equivalents
Patient Health Questionnaire-9
Treatment Assignment Tool-University of Michigan
This project was supported by an Investigator Initiated Grant award to AB and the team by Blue Cross Blue Shield of Michigan Foundation (Grant #002812.II). The opinions, beliefs, and viewpoints expressed by the authors do not necessarily reflect the opinions, beliefs, and viewpoints of Blue Cross Blue Shield of Michigan Foundation or any of its employees. AB is supported by the National Research Service Award postdoctoral fellowship (#5T32HL076123).
The authors would like to acknowledge essential members of the Child and Family Life team at CS Mott Children’s Hospital, who served as back-up coaches for the trial’s head comfort coach (JJ) in delivering comfort coach interventions and without whom this clinical trial would not have been possible: Marlee Blanch, BA, CFLE, CCLS; Jenn Holly, MS, CCLS; Denali Katnik, BA, CCLS; Kim Manasco, BA, CCLS; Heather Meyer, LLMSW, CCLS; Kylie Nutt, BA, CCLS; Ashley Oteney, MPH, CCLS; Lydia Paradysz, BA, CCLS; Rachel Rice, BA, CCLS; Steve Rubinstein, BS, CCLS; Bailea Scanlon, BA, BS, CCLS; Lexi Stroeters, BA, CCLS; Lauren Watt, BS, CCLS; Whitney White, BS, CCLS; and Jasmine Ybarra, MS, CCLS.
DL served as consultant to AmSECT, and declares funding from NIH and AHRQ.