Patient Reported Outcomes
Conditions
Brief summary
The aim of this study is to understand and improve the experience of patients after surgery by comparing two methods of following symptoms while the patient recovers at home.
Interventions
OTHERTeam Monitoring
In this cohort, the electronic system will provide advanced informatics support for push notifications to the care team based on the severity of the symptoms reported. This platform promotes early detection and intervention. The care team is alerted when patients experience symptoms out of the expected range or if symptoms are worsening. Nurses receive secure message notifications and will contact the patient by phone depending on symptom severity. If a patient responds with a moderate-severe answer, the office team gets an alert and calls the patient during business hours.
OTHEREnhanced Feedback
In this cohort, the electronic system will provide tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The information provided to patients in the Enhanced Feedback group will be procedure specific and based on continuously updated PRO-CTCAE data from previous patients. Patients are thus able to see their own recovery trajectory relative to that of patients who have undergone the same procedure. Care is patient activated in that patients will use the information about expected symptoms to decide whether they should call the care team (e.g., if they are experiencing symptoms that are more severe or more prolonged than expected). If a patient reports severe symptoms, they are instructed to immediately contact their physician's office or seek medical attention.
Sponsors
Brigham and Women's Hospital
University of Rochester
Weill Medical College of Cornell University
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All patients \>18 years of age who are scheduled for ambulatory cancer surgery at JRSC and their caregivers will be eligible for study participation.
Exclusion criteria
* Inability to speak English * Inability to access a computer, tablet, or mobile phone * For patients: not interested in/unable to sign up for the MyMSK Patient Portal * For caregivers: Unable to provide an email address * Cognitive impairment that prohibits informed consent or understanding of the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | 30 days | To compare the effectiveness of Team Monitoring and Enhanced Feedback with regard to urgent care, emergency department visits, and readmissions up to 30 days post-operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 30 days post-operatively | To evaluate the difference in unplanned clinic visits and phone referrals to clinic between each study arm up to 30 days post-operatively. |
| Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 30 days post-operatively | To evaluate the difference in pain management referrals between each study arm up to 30 days post-operatively. |
| Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 30 days post-operatively | To evaluate the difference in adverse events between each study arm up to 30 days post-operatively. |
| Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively | 30 days post-operatively | To evaluate the difference in nursing phone calls between each study arm up to 30 days post-operatively. |
| Differences in Patient Engagement Between Cohorts at 14 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score | 14 days post-operatively | To evaluate the difference in patient engagement between each study arm at 14 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. Participants who answered the survey were included in this analysis. 560 patients were analyzed in the Team Monitoring Arm and 541 were analyzed in the Enhanced Feedback Arm. |
| Differences in Patient Engagement Between Team Monitoring and Enhanced Feedback Cohorts at 60 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score | 60 days post-operatively | To evaluate the difference in patient engagement between each study arm 60 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. 465 participants form the Team Monitoring Arm and 460 participants from the Enhanced Feedback arm were analyzed who answered the Patient Activation Measure at POD 60. |
| Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | 14 days post-operatively | To evaluate the difference in caregiver burden between each study arm at two timepoints: 14 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute. |
| Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | 10 days post-operatively | This analysis utilized 3 anxiety items from the PRO-CTCAE survey. The responses were defined on a scale of 0-4 with higher scores representing stronger agreement with the item (higher anxiety). The 3 items were summed to generate an overall score ranging from 0-12. 139 patients responded to only some of the 3 items and were counted as a missing value for the overall sum score. As the surveys were repeated daily, longitudinal mixed effects regression was used to test the association between the anxiety sum score and randomization arm after adjusting for time, randomization strata, and an interaction between randomization arm and time with a random intercept for patient. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Team Monitoring Team monitoring is the current standard of care for patients at the Josie Robertson Surgical Center (JRSC) at Memorial Sloan Kettering Cancer Center (MSK). Patients report their symptoms via an electronic questionnaire called the Recovery Tracker, delivered through an in-house informatics platform known as the ambulatory cancer care electronic symptom self-reporting (ACCESS) system. The healthcare team receives portal-secure message alerts if patients report symptoms above a specified threshold and contact the patient by phone during business hours. Given the need for real-time feedback for some symptoms, patients who report very severe symptoms receive a bold red alert instructing them to immediately contact their care team or seek medical attention. | 1 |
| Enhanced Feedback In the enhanced feedback cohort, the ACCESS system provides tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The feedback report consists of periodically updated PRO data from previous patients that are stratified by surgical procedure and postoperative date. As a result, patients can see their recovery trajectories relative to others who have undergone the same procedure. Care is 'patient-activated', in that patients use the information about expected symptoms to decide whether they should call the care team, for instance, if they experience symptoms that are more severe or more prolonged than expected. Similar to the team monitoring cohort, patients who report very severe symptoms are instructed to immediately contact their physician's office, and the care team receives an alert. | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Procedure Ineligible Post-Operatively/Pr | 47 | 46 |
| Overall Study | Surgery Cancelled/Relocated | 34 | 30 |
| Overall Study | Withdrawal by Subject | 5 | 7 |
Baseline characteristics
| Characteristic | Team Monitoring | Total | Enhanced Feedback |
|---|---|---|---|
| Age, Continuous | 54 years | 54 years | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 80 Participants | 166 Participants | 86 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1146 Participants | 2309 Participants | 1163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 84 Participants | 149 Participants | 65 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 80 Participants | 158 Participants | 78 Participants |
| Race (NIH/OMB) Black or African American | 74 Participants | 170 Participants | 96 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 81 Participants | 172 Participants | 91 Participants |
| Race (NIH/OMB) White | 1073 Participants | 2118 Participants | 1045 Participants |
| Region of Enrollment United States | 1310 Participants | 2624 Participants | 1314 Participants |
| Sex: Female, Male Female | 948 Participants | 1881 Participants | 933 Participants |
| Sex: Female, Male Male | 362 Participants | 743 Participants | 381 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,310 | 0 / 1,314 |
| other Total, other adverse events | 0 / 1,310 | 0 / 1,314 |
| serious Total, serious adverse events | 0 / 1,310 | 0 / 1,314 |
Outcome results
Primary
Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively
To compare the effectiveness of Team Monitoring and Enhanced Feedback with regard to urgent care, emergency department visits, and readmissions up to 30 days post-operatively.
Time frame: 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Team Monitoring | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | UCC with Readmission within 30 days | 31 Participants |
| Team Monitoring | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | UCC without Readmission within 30 days | 44 Participants |
| Team Monitoring | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | Readmission within 30 days | 32 Participants |
| Team Monitoring | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | No UCC or Readmissions within 30 days | 1203 Participants |
| Enhanced Feedback | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | No UCC or Readmissions within 30 days | 1177 Participants |
| Enhanced Feedback | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | UCC with Readmission within 30 days | 38 Participants |
| Enhanced Feedback | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | Readmission within 30 days | 39 Participants |
| Enhanced Feedback | Rates of UCC Visits and Readmissions Between the Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-operatively | UCC without Readmission within 30 days | 60 Participants |
Secondary
Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively
To evaluate the difference in nursing phone calls between each study arm up to 30 days post-operatively.
Time frame: 30 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Team Monitoring | Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively | 3.79 Nursing Calls | Standard Deviation 3.14 |
| Enhanced Feedback | Difference in Total Number of Nursing Follow-up Calls Between Team Monitoring and Enhanced Feedback Cohorts up to 30 Days Post-Operatively | 3.40 Nursing Calls | Standard Deviation 2.71 |
Secondary
Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
To evaluate the difference in adverse events between each study arm up to 30 days post-operatively.
Time frame: 30 days post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Team Monitoring | Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 1 Adverse Event | 47 Participants |
| Team Monitoring | Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 0 Adverse Events | 1260 Participants |
| Team Monitoring | Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 2 Adverse Events | 3 Participants |
| Enhanced Feedback | Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 1 Adverse Event | 56 Participants |
| Enhanced Feedback | Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 0 Adverse Events | 1258 Participants |
| Enhanced Feedback | Differences in Adverse Events Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 2 Adverse Events | 0 Participants |
95% CI: [0.6, 1.32]
Secondary
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
To evaluate the difference in caregiver burden between each study arm at two timepoints: 60 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute.
Time frame: 60 days post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Financial Problems | 1.93 score on CRA | Standard Deviation 0.91 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Disrupted Schedule | 2.43 score on CRA | Standard Deviation 0.93 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Lack of Family Support | 1.71 score on CRA | Standard Deviation 0.65 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Self Esteem | 4.45 score on CRA | Standard Deviation 0.36 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Health Problems | 2.34 score on CRA | Standard Deviation 0.47 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Self Esteem | 4.42 score on CRA | Standard Deviation 0.41 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Health Problems | 2.44 score on CRA | Standard Deviation 0.5 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Financial Problems | 1.90 score on CRA | Standard Deviation 0.9 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Lack of Family Support | 1.76 score on CRA | Standard Deviation 0.73 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Disrupted Schedule | 2.43 score on CRA | Standard Deviation 0.87 |
Secondary
Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA).
To evaluate the difference in caregiver burden between each study arm at two timepoints: 14 days post-operatively. Scoring information for the CRA: The Caregiver Reaction Assessment involved 24 items given at 14 days and repeated at 60 days with the following potential responses: strongly disagree, disagree, undecided, agree, and strongly agree which we defined on a scale of 1-5 with higher scores representing stronger agreement with the item. These items are combined into 5 subscales: health problems, financial problems, lack of family support, disrupted schedule, and self-esteem. For each subscale, a total score was computed as the average of the subsequent item scores, with a range between 1 and 5. A higher score represented a stronger agreement with the attribute.
Time frame: 14 days post-operatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Financial Problems | 1.76 score on CRA | Standard Deviation 0.85 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Disrupted Schedule | 2.72 score on CRA | Standard Deviation 0.88 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Lack of Family Support | 1.59 score on CRA | Standard Deviation 0.61 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Self Esteem | 4.52 score on CRA | Standard Deviation 0.35 |
| Team Monitoring | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Health Problems | 2.40 score on CRA | Standard Deviation 0.46 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Self Esteem | 4.47 score on CRA | Standard Deviation 0.35 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Health Problems | 2.45 score on CRA | Standard Deviation 0.52 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Financial Problems | 1.78 score on CRA | Standard Deviation 0.88 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Lack of Family Support | 1.75 score on CRA | Standard Deviation 0.66 |
| Enhanced Feedback | Differences in Caregiver Burden Between Team Monitoring and Enhanced Feedback Cohorts Utilizing the Caregiver Reaction Assessment (CRA). | Disrupted Schedule | 2.70 score on CRA | Standard Deviation 0.86 |
Secondary
Differences in Patient Engagement Between Cohorts at 14 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score
To evaluate the difference in patient engagement between each study arm at 14 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. Participants who answered the survey were included in this analysis. 560 patients were analyzed in the Team Monitoring Arm and 541 were analyzed in the Enhanced Feedback Arm.
Time frame: 14 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Team Monitoring | Differences in Patient Engagement Between Cohorts at 14 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score | 3.39 PAM Score at 14 Days | Standard Deviation 0.4 |
| Enhanced Feedback | Differences in Patient Engagement Between Cohorts at 14 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score | 3.37 PAM Score at 14 Days | Standard Deviation 0.43 |
Secondary
Differences in Patient Engagement Between Team Monitoring and Enhanced Feedback Cohorts at 60 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score
To evaluate the difference in patient engagement between each study arm 60 days post-operatively adjusting for strata and preoperative PAM overall score. The survey consists of 10 items with five response options: strongly disagree, disagree, undecided, agree and strongly agree defined on a scale of 1-5 with higher scores representing stronger agreement with the item. The items in the PAM survey were combined to generate an overall mean score at each timepoint - a theoretical score of 0-100. A higher score indicates stronger patient engagement. If a patient is missing a response to an item(s), the overall score is considered missing for that patient/timepoint. 465 participants form the Team Monitoring Arm and 460 participants from the Enhanced Feedback arm were analyzed who answered the Patient Activation Measure at POD 60.
Time frame: 60 days post-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Team Monitoring | Differences in Patient Engagement Between Team Monitoring and Enhanced Feedback Cohorts at 60 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score | 3.47 PAM Score at 60 Days | Standard Deviation 0.4 |
| Enhanced Feedback | Differences in Patient Engagement Between Team Monitoring and Enhanced Feedback Cohorts at 60 Days Post-Operatively Utilizing the Patient Activation Measure (PAM) and Adjusting for Strata and Pre-Operative PAM Score | 3.44 PAM Score at 60 Days | Standard Deviation 0.44 |
Secondary
Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
To evaluate the difference in pain management referrals between each study arm up to 30 days post-operatively.
Time frame: 30 days post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Team Monitoring | Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 0 Clinic Visit | 1299 Participants |
| Team Monitoring | Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 1 Clinic Visit | 10 Participants |
| Team Monitoring | Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 2 Clinic Visits | 1 Participants |
| Enhanced Feedback | Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 0 Clinic Visit | 1302 Participants |
| Enhanced Feedback | Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 1 Clinic Visit | 11 Participants |
| Enhanced Feedback | Differences in Total Number of Pain Management Referrals Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 2 Clinic Visits | 1 Participants |
95% CI: [0.69, 1.31]
Secondary
Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively
To evaluate the difference in unplanned clinic visits and phone referrals to clinic between each study arm up to 30 days post-operatively.
Time frame: 30 days post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 1 Clinic Visit | 467 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 5 Clinic Visits | 9 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 3 Clinic Visits | 129 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 6 Clinic Visits | 5 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 2 Clinic Visits | 301 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 7 Clinic Visits | 0 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 4 Clinic Visits | 49 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 8 Clinic Visits | 1 Participants |
| Team Monitoring | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 0 Clinic Visits | 349 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 8 Clinic Visits | 0 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 0 Clinic Visits | 347 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 1 Clinic Visit | 476 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 2 Clinic Visits | 282 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 3 Clinic Visits | 137 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 4 Clinic Visits | 52 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 5 Clinic Visits | 15 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 6 Clinic Visits | 4 Participants |
| Enhanced Feedback | Differences in Total Number of Unplanned Clinic Visits Between Team Monitoring and Enhanced Feedback Cohorts Up to 30 Days Post-Operatively | 7 Clinic Visits | 1 Participants |
95% CI: [-3.1, 3.6]
Secondary
Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE)
This analysis utilized 3 anxiety items from the PRO-CTCAE survey. The responses were defined on a scale of 0-4 with higher scores representing stronger agreement with the item (higher anxiety). The 3 items were summed to generate an overall score ranging from 0-12. 139 patients responded to only some of the 3 items and were counted as a missing value for the overall sum score. As the surveys were repeated daily, longitudinal mixed effects regression was used to test the association between the anxiety sum score and randomization arm after adjusting for time, randomization strata, and an interaction between randomization arm and time with a random intercept for patient.
Time frame: 10 days post-operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 5 | 2.7 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 10 | 2.3 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 7 | 2.5 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 6 | 2.6 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 2 | 0.03 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 9 | 2.4 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 4 | 2.8 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 3 | 2.9 reduction in anxiety score |
| Team Monitoring | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 8 | 2.5 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 6 | 2.6 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 2 | 3.0 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 3 | 2.9 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 4 | 2.8 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 5 | 2.7 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 7 | 2.5 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 8 | 2.4 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 9 | 2.3 reduction in anxiety score |
| Enhanced Feedback | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 10 | 2.2 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 4 | 0.07 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 2 | 0.15 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 8 | -0.08 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 3 | 0.11 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 10 | -0.16 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 6 | -0.01 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 5 | 0.03 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 9 | -0.12 reduction in anxiety score |
| Difference in Participants Anxiety | Interaction in Participants Anxiety Measured by 3 Items on the Patient Reported Outcome Common Terminology Criteria for Adverse Events Survey (PRO-CTCAE) | Post-Op Day 7 | -0.05 reduction in anxiety score |