SuRxgWell: Study Protocol for a Randomized Controlled Trial of Telemedicine-based digital Cognitive Behavioral Intervention for high Anxiety and Depression Among Patients Undergoing Elective Hip and Knee Replacement surgery

doi:10.21203/rs.3.rs-2728996/v1

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Research Article

SuRxgWell: Study Protocol for a Randomized Controlled Trial of Telemedicine-based digital Cognitive Behavioral Intervention for high Anxiety and Depression Among Patients Undergoing Elective Hip and Knee Replacement surgery

https://doi.org/10.21203/rs.3.rs-2728996/v1

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Journal Publication

published 09 Nov, 2023

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Background

Mood disorders (anxiety, depression) and catastrophizing, lead to increased post-operative pain perception, decreased engagement with physical activity, and increased resource utilization. Studies on perioperative psychological assessment and treatment are scarce. Digital cognitive behavioral intervention (dCBI) such as RxWelläreduces depression in patients with inflammatory bowel disease. We hypothesize that SuRxgWell, the surgical adaptation of RxWellä, can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients undergoing primary total hip and knee arthroplasty (THA, TKA).

Methods

This randomized, controlled trial will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell. After an informed consent, subjects will be screened using the PROMIS Anxiety/Depression questionnaires. Subjects with a T-score of ≥ 60 will be randomized to either usual care (control group) or SuRxgWell dCBI pre- and perioperative cognitive behavioral intervention via RxWell plus usual care (intervention group). Control group will receive information on how to locate tools to address mood disorders, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months thereafter. The allocation will be 3:1 (intervention: control). Investigators will be blinded, but research coordinators and subjects will not.

The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Anxiety/Depression, GAD-7, and PHQ-8. Secondary endpoints include sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function as well as preoperative and postoperative pain scores, pain medication usage, orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery. Subjects will complete a GAD-7 and PHQ-8 questionnaires bi-weekly. Data about RxWell usage and engagement, postsurgical complications, and resource utilization will be recorded. The primary outcome will be analyzed with intention-to-treat estimates and tested using independent two sample t-tests.

Discussion

We will evaluate dCBI as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery. If effective, this might have important clinical implications towards improving outcomes.

Trial Registration

clinicaltrials.gov, NCT05658796. Registered 21 December 2022. https://clinicaltrials.gov/ct2/show/NCT05658796

The optimization of perioperative care reduces postoperative complications and undesirable sequelae of surgery such as pain, fatigue, depression, resource utilization, and prolonged convalescence(1–3). Patients scheduled for surgery often present with co-occurring mood disorders, such as generalized anxiety, major depression, and/or high levels of pain catastrophizing(4). These are particularly salient amongst patients scheduled for primary total hip and knee arthroplasty (THA, TKA), procedures that are expected to increase by 71%, to 635,000 procedures, by 2030 (THA) and by 85%, to 1.26 million procedures, by 2030 (TKA)(5).

Almost 30% of patients undergoing a TKA surgery experience psychological distresses preoperatively(6). These emotional conditions negatively impact postoperative pain and opioid consumption, post-surgical complications rate, recovery time and re-hospitalization rate(7–16). Although preliminary data demonstrate that advances in perioperative medicine such as the use of multimodal and multidisciplinary interventions appear to control perioperative surgical stress response and improve postoperative outcomes, this is insufficient. Optimization of physiology, such glycemic control in diabetic patients or blood pressure management in patients with hypertension is systematically performed and yet surgical outcomes can be improved. An often-overlooked opportunity for improving surgical care is optimizing a patient’s preoperative emotional condition. The pathophysiological link between psychological factors and surgical outcomes has been widely described(17). Unfortunately, studies focusing on perioperative psychological assessment and treatment are lacking. Non-physical preoperative patient factors may directly influence the neuroendocrine and inflammatory response to surgical stress, impacting on immune function and healing, the development of cardiovascular diseases and neurological events (18–21).

Surgical patients with mood disorders result in longer in-hospital length of stays, higher incidence and odds of readmission, higher rate of medical and implant-related complications, and higher day of surgery and 90-day peri-surgical costs(22, 23). Mood disorders also increase peri-operative pain, opioid requirement, and delay recovery. The high prevalence of anxiety and depression in patients undergoing total hip and knee makes mood disorders meaningful potential targets for preoperative patient optimization(24). However, studies analyzing the impact of a preoperative psychological assessment and intervention in orthopedic surgery are missing. Mood disorders can be efficiently assessed using brief screening methods such as the Hospital Anxiety and Depression Scoring (HADS) or PROMIS (Patient-Reported Outcomes Measurement Information System). The PROMIS library has short forms for depression and anxiety and has the added advantage of being validated across different patient populations. Interventions focusing on managing mood disorders could be implemented to improve perioperative outcomes. The FDA recommends cognitive-behavioral intervention (CBI) as a first line treatment for the non-pharmacologic treatment of depression and anxiety, and this could be a potential intervention for reducing mood disorders and pain levels in surgical patients(25–27). In-person CBI has been described as an effective tool for reducing the Pain Catastrophizing Scale score and Postoperative General Anxiety Disorder-7 scores; decreasing postoperative pain, opioid use and length-of-stay at the hospital; and increasing functionality based on Knee Outcome Survey – Activities of Daily Living scale (KOS-ADL) in patients undergoing TKA(28–30). However, multiple barriers exist preventing surgical patients from accessing CBI, such as high costs and lack of accessibility in remote areas(31).

Telemedicine represents increasingly common strategies for patient care. Similarly, digital Cognitive Behavioral Intervention (dCBI) could be an effective strategy for overcoming some of these barriers. There is preliminary data suggesting that dCBI could be an effective treatment for depression and anxiety in primary care(32). However, the implementation of dCBI for reducing perioperative psychological and psychosomatic conditions is limited. RxWell™ is a dCBI platform and can be used remotely to teach techniques and coping strategies based on CBI and has proven to successfully help patients with inflammatory bowel disease(33).

We hypothesize that SuRxgWell, the surgical adaptation of RxWell™, will reduce the deleterious impact of established mood disorders on recovery following primary total hip and total knee replacements by improving the following postoperative outcomes:

pain and opioid requirement,
improved functional recovery,
decrease complications, and
reduce resource utilization such as hospital length of stay, postoperative need for visits, and the use of rehabilitation.

Accordingly, we will do the following in this study:

Determine the adherence of using RxWell™, for patients undergoing elective surgery, who have mood disorder symptoms identified either at the time of in-person visit to the Center for Perioperative Care (CPC) in the Department of Anesthesiology and Perioperative Medicine or to the orthopedic clinic,
Evaluate the efficacy of RxWell™, in improving anxiety and depression over a 4-month period compared to treatment as usual, and
Explore the impact of RxWell™, - associated improvements in anxiety, depression, catastrophizing, resource utilization, and postoperative outcomes

This trial that intends to use SuRxgWell, strives to answer a central question: Can digital cognitive behavioral intervention be effectively delivered in the surgical population, and would it improve the deleterious impact of mood disorders on peri-operative recovery?

Ethical principles

The trial was approved by the institutional review board (IRB) PittPRO (University of Pittsburgh) on 06/10/2022 (STUDY21120053) and registered to the clinicaltrials.gov database (NCT05658796). This study is supported by the Department of Anesthesiology and Perioperative Medicine and UPMC Health Plan.

Study design

The dCBI is a mobile application that guides patients through a series of cognitive behavioral intervention learnings and techniques such as, relaxation, cognitive reframing, exposure, and mindfulness. The RxWell™ digital behavioral tool offers a patient access to a live coach via an asynchronous text messaging component within the application. This personalized experience helps guide and motivate the patient through the program, and to apply the techniques into everyday life situations. The application provides feedback and progress to the patient. Feedback includes tracking depression and anxiety from Generalized Anxiety Disorder Scale (GAD) and Patient Health Questionnaire (PHQ) measures that are completed within the app. Coaches review messages and scores within 2 business days. In the event of a risk escalation, coaches will email the coach supervisor and include “urgent” in the subject line to notify the supervisor of a high-risk situation, or of an interaction with a user where they encounter concerning symptoms. Concerning symptoms may be exhibited either within the context of a message sent to the coach or free text responses within techniques.

This is a prospective, randomized, controlled clinical trial in a multi-hospital health care system among patients with high levels of anxiety with an indication for primary total hip or knee arthroplasty. We will be comparing two groups: one that receives access to RxWell™ and usual care and one that only receives the usual care. Figure 1 and Table 1 show the study design, timing of pre- and postoperative use of RxWell™, and follow-up evaluations. We will recruit patients from 4 hospitals within the UPMC system (UPMC Shadyside, Magee, East, and Passavant hospitals). In this randomized trial, we will prospectively allocate 34 subjects in the control group and using a 1:3 allocation, we will have 102 in the intervention group (two-sided t-test with alpha of .05, power of .8, with a 3:1 ratio and a 50% drop out rate for a Cohen’s d of .8). A block randomization schedule generated using R software (version 4.2.1, R Core Team, 2022) will be used to allocate the participants to either dCBI plus usual care (intervention) or usual care (control) with a 3:1 allocation (Table 2). Investigators will be blinded for group assignment in the REDCap and they will also be blinded for the monthly reports. Research coordinators and subjects will not be blinded. To make sure investigators are blinded to the intervention, investigators will not have access to the randomization table and surveys on REDCap. Investigators will only be able to access the eligibility checklist and informed consent surveys on REDCap. Patients will be randomized immediately after the PROMIS Anxiety 4a and the PROMIS Depression 4a patient assessment by a research coordinator using REDCap.

All patients will be assessed either in person at the initial visit or via telemedicine technologies (text or video) at baseline, on the day of surgery, and 1, 2 and 3 months after the surgery. We will evaluate how patients comply with and respond to RxWell together with weekly supports. We will then determine the program's efficacy in ameliorating symptoms.

Outcome measures

We will assess:

RxWell™’s acceptance by practitioners and patients will be measured by qualitative interviews among all practitioners and randomly selected patients.
workflow changes brought on by the implementation of RxWell™, and
impact of RxWell™, on mood disorders (anxiety, depression, pain catastrophizing) in the immediate pre- and post-operative periods.

We will also test the impact of RxWell™, on

Sleep disorders
Fatigue
Ability to Participate in Social Roles
Pain Interference
Cognitive Function
Perioperative pain
Opioid requirements and Opioid Morphine Equivalents,
Functional recovery, and
Resource utilization associated with the surgery and recovery (hospital length of stay, duration of physical therapy).

Ultimately, our outcome is to determine if RxWell™ can improve surgical outcomes.

Primary and secondary outcomes will be measured at baseline preoperatively, on the day of the surgery and 1, 2, and 3 months after surgery (Table 1). Preoperative data will be collected virtually via REDCap surveys by investigators. Postoperative data collection will be performed via email surveys and telephone calls by investigators. Research coordinators collecting outcomes will not be blinded to group assignment. Patients will not be blinded and will be informed that the study aims to study the effect of dCBI in addition to usual care compared to usual care on surgical patients.

Primary outcomes

The primary outcome is the patient’s score on the PROMIS Anxiety 4a Questionnaire and on the PROMIS Depression 4a Questionnaire, as well as on the GAD-7 and PHQ-8 scales 1 month before surgery, on the day of the surgery and 1, 2 and 3 months after surgery, to assess the severity of the patient anxiety and depression levels and the potential effect of RxWell™ on these conditions. (Table 1).

The short PROMIS 4a questionnaires are 4-item forms with five-response options per question ranging in value from one to five. The lowest possible raw score is 4 and the highest possible raw score is 20. In both cases, a higher score indicates worse status, and both assess the condition over the past 7 days. The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness) and somatic symptoms related to arousal (racing heart, dizziness). The PROMIS Depression instrument measures self-reported negative mood (sadness, guilt), views of self (self-criticism, worthlessness), social cognition (loneliness, interpersonal alienation), decreased positive effect and engagement (loss of interest, meaning and purpose). The PROMIS scores are centered with a mean of 50 and standard deviation of 10. The T-score range for Severe Anxiety is > 70, Moderate 60–69 Mild 55–59, and < 55 is none to less anxiety. Based on our prior work, we chose a baseline anxiety and depression mean T-score of 60, with a standard deviation of 10.

The GAD-7 Scale is a 7-question instrument that measures self-reported anxiety, worry, trouble relaxing, restlessness, irritability, and fear in the last 2 weeks. The PHQ-8 Scale is an 8-question instrument that measures self-reported interest and pleasure, irritability and depressed mood, problems with sleep, appetite and concentration, lack of energy, changes in the speed of movement and speech and low self-esteem, over the last 2 weeks. In both cases, both questionnaires have 4 options, ranging from 0 to 3 and in all cases, and a higher score indicates a worse status. The possible lower score is 0 and the highest total score is 21 for GAD-7 and 24 for PHQ-8.

Secondary outcomes

Pain Catastrophizing
Sleep disorders
Fatigue
Ability to Participate in Social Roles
Pain Interference
Perioperative pain at rest and during movement
Opioid requirements and Opioid Morphine Equivalents,
Functional recovery, and
Resource utilization associated with surgery and recovery (hospital length of stay, duration of physical therapy). We will adjust for surgical decision during the resource utilization modeling as surgeons vary in their decision algorithms for patient discharge timing.

In addition, as part of secondary outcomes, we will record participants’ usage of RxWell, adherence, use frequency, number of techniques completed and the path in the RxWell platform (anxiety vs. depression) patient is utilizing. Participants will also complete a Satisfaction Survey at the end of their participation. The instruments and specific timepoints at which these outcomes are measured are collected in Table 1. The study team will receive monthly reports measuring the time spent and adherence to the platform, number of techniques completed, the path in RxWell (anxiety vs. depression) used and engagement with coach and with the program.

Other variables of interest

At baseline, participants will also complete a demographic, lifestyle, and diagnostic survey, consisting of age, gender, ethnicity, race, height, weight, smoking and alcohol use, medical history, ongoing treatments, and comorbidities.

The following medical data will be gathered: type of operation, surgical indication and American Society of Anesthesiologists (ASA) classification, and if the patient received a nerve block before the surgery.

Participants and recruitment

Participants

The target population is patients undergoing elective primary total hip or primary total knee replacements at UPMC (Shadyside, Magee, Passavant, and East) and are found to have high levels of anxiety and/or depression using validated surveys. We will use the Patient-Reported Outcomes Measurement Information System (PROMIS) scales for the assessment of anxiety and depression.

Inclusion criteria

Eligible participants will be adult patients undergoing primary total hip or knee arthroplasty for a degenerative condition, who can read and speak English, with access to a smart phone or tablet and with a T-score ≥ 60 in short PROMIS Anxiety and/or Depression short forms 4a.

Exclusion criteria

Patients will be excluded from the study if they meet any of the following criteria: plans to undergo a non-elective surgery or secondary arthroplasty; profound mood disorder that requires emergent care, defined as a T-score > 70 in PROMIS Anxiety 4a and/or Depression 4a forms, neurocognitive impairment, dementia or active delirium, or severe intellectual disability; and no access to a smartphone or tablet.

Recruitment

Patients scheduled for their pre-operative evaluation at the Center for Perioperative Care clinics or at the orthopedic clinic will be screened for eligibility and those deemed eligible will be approached by the study coordinators for recruitment or given a flyer by nurse practitioners or physician assistants. Patients who are interested will be able to consent with an investigator or a research coordinator in person, reach out to the research team, use the QR code that appears on the flyer to give their contact information, or they will be called by an investigator.

Participants will be able to sign the informed consent via REDCap through a virtual interview with the Principal Investigator or in person with an investigator or research coordinator. In the case of the e-consent, virtual interviews will be conducted remotely using HIPAA-compliant Zoom and following a semi-structured format to ensure a systematic yet flexible approach. Once patients provide consent, we will use the PROMIS questionnaires to assess their mood condition and identify those with high levels of anxiety and depression. They will be eligible if they have a T-score ≥ 60 on the PROMIS Anxiety Short Form 4a v1.0 questionnaire and/or PROMIS Depression 4a Short Form v1.0 - questionnaire. Participants who meet this criterion will be enrolled and randomized into perioperative treatment with a RxWell™ and usual care or only usual care.

Surveys employed:

The full survey, including the four questionnaires, is expected to be completed in no more than 15 minutes. REDCap will host all surveys.

Study procedure:

Initially, participants will complete a demographic, lifestyle, and diagnostic survey, consisting of age, gender, ethnicity, race, height, weight, smoking/alcohol use, medical history, ongoing treatments, and comorbidities.

At the baseline, participants from both groups (intervention and education group) will also complete the PROMIS 29 + 2 v2.0 form, except the Anxiety and Depression subsection since it will have been already completed during the eligibility assessment, the GAD-7 and PHQ-8 scales, the Pain Catastrophizing Scale (PCS), the Knee injury and Osteoarthritis Outcome Score (KOOS) and Hip injury and Osteoarthritis Outcome Score (HOOS) and the Pain Medications Survey and Pain Scores Survey created in REDCap. (Table 1)

Participants will be assessed with the same instruments on the day of surgery. In addition, participants allocated in the intervention group will be assessed bi-weekly through the RxWell™ application during its use.

Long Term Follow up: Both groups will be assessed at 1, 2 and 3 months after the surgery, which corresponds to 2, 3, and 4 months after the enrollment. Participants from both groups will have to complete the same instruments described above and the Post-Surgical Survey created in REDCap, which records potential post-surgical complications and additional measures like the length of stay in the hospital, the time to ambulation and the use of physiotherapy. In addition, participants will also have to complete a satisfaction survey about RxWell™ at the 3-month timepoint, corresponding to the last interaction with the participants. The purpose of this follow up is to collect data on long-term effects of the interventions and document any changes that might take place in the participant’s disease condition, their frequency of CBI intervention practice and other additional changes noted.

Users will complete GAD-7/PHQ-8 bi-weekly to monitor their behavioral health over time and coaches will review the scores and personal messages every two business days. In the event of a risk escalation, coaches will contact the coach supervisor to notify a high-risk situation or an interaction with a user where they encounter concerning symptoms, that may be exhibited either within the context of a message sent to the coach or free text within a technique.

As for behavioral studies, trials are commonly designed with a waitlist control group. This approach would allow that all participants have an opportunity to utilize the intervention, however in the current trial, we will use the randomized approach and plan the waitlisted approach for a larger clinical trial.

Comparators

RxWell™, – digital Cognitive Behavioral Intervention

This application guides patients through a series of CBT learnings and techniques such as relaxation, cognitive reframing, problem solving skills, distress tolerance, and mindfulness. These techniques are brief and interactive with easy-to-use material presented as audio, video, and interactive text content. The application includes two different pathways, one focuses on anxiety and one on depression management. The participant will receive a program based on one depending on the initial psychological assessment. If participants score ≥ 60 on the PROMIS Anxiety questionnaire, they will follow the Anxiety Pathway and if participants score ≥ 60 on the PROMIS Depression questionnaire, they will follow the Depression Pathway. Participants who score ≥ 60 on both questionnaires, will be indicated to follow the Anxiety Pathway and the health coaches will personalize their care by using some depression management techniques at their discretion.

Participants will also have access to a live coach via an asynchronous text messaging component within the application, receiving patient-centered and personalized support. The main goal of the coach is to help guide the participant through the application to apply the techniques into everyday life situations, and especially into the perioperative context. Coaches can also personalize the program the participant receives and add techniques from the other pathway if needed.

Although participants can text the coach anytime, the application is not designed to be a crisis management tool. In case of emergency, participants can use a button available within the app which will direct them to contact ReSolve or 911. ReSolve is a crisis-management hotline and walk-in clinic as part of the UPMC.

Usual care

The control intervention consists of the usual care of a patient undergoing primary total hip or knee replacement, which includes a surgery-specific education session before surgery. This pre-surgical visit provides a detailed verbal information on the preparation for surgery in terms of nutrition, expectations, breathing exercises and usual workflow until the day of surgery; surgery itself and materials used for the replacement and recovery from surgery. Questions and concerns raised by patients are also answered and discussed by the orthopedic surgery nurse coordinator. Patients will also be educated about the potential resources for anxiety and depression management by the SuRxgWell coaches.

Sample size calculation

Our primary analysis, comparing PROMIS T scores, GAD-7 and PHQ-8 between groups on day of surgery, will determine clinically meaningful differences using a Cohen’s D of 0.8 or more. Therefore, with 95% confidence, 80% power, using two sided tests and assuming a 50% retention rate, our desired sample size is 136. We will utilize 1:3 allocation, randomizing 34 to the control group and 102 to the intervention group. We are allocating 1:3 to get more accurate estimates around within treatment group improvements as well as to increase the number of patients we can potentially aid by supplying them with the low-risk treatment. The 1:3 allocation was chosen based on the study design and the nature of the intervention. In addition, our target subjects are patients with a moderate level of anxiety and/or depression and, we consider it is more ethical to offer a treatment to as many subjects as possible.

Data analysis

The primary hypotheses and all other comparisons will be assessed with intention to treat estimates. Between group differences in primary outcomes, PROMIS anxiety and depression scores, PHQ-8, and GAD-7 scores, will be tested using independent two sample t-tests on day of surgery. Two-sided tests using p values of < 0.05 will be considered statistically significant. Differences of tests showing Cohen’s D of > = 0.8 will be considered clinically significant. Participants with missing primary timepoint data will be excluded from testing. For secondary outcomes, we will calculate descriptive statistics i.e., usage of RxWell™, adherence, use frequency etc. Testing of treatment and control group differences in secondary outcomes will be applied to appropriate variables i.e., participant perioperative pain, opioid equivalent requirement, functional recovery, etc. for time points baseline, day of surgery and 1 month follow-up. Continuous variables will be described using means and standard deviations. Categorical variables will be described using frequencies/proportions. We will use independent sample t-tests and chi-squared analyses to examine between group differences. Fisher’s exact tests and Mann Whitney U tests will be performed in replacement of their counterpart parametric tests where appropriate. Missing data will be removed from denominators, proportions, distributions and testing of their differences. We will use longitudinal mixed effect models to account for within person variance across all time points as a secondary analysis. Baseline patient comorbidities and procedure details will be stratified by group and described, however testing of differences will not be performed (Table 1).

We estimated that 50% or more of eligible patients will be enrolled, and as for the proportion of engagement, we are targeting 70% or more of the enrolled patients attending the first SuRxgWell orientation class and 50% or more of the follow-up weekly. The proportion of compliance, targeting 60% or more of the enrolled participants completing the questionnaires; the proportion of adherence, targeting 60% or more adherent participants who complete CBT practices daily.

Compliance & adherence:

Bi-weekly surveys will obtain compliance and adherence data on the use of RxWell™ platform.

Up to 43% of post-TKA patients report persistent pain, functional limitations, and poor quality of life despite clinical and radiological indicators of surgical success(34, 35). Greater symptom intensity and movement intolerance after surgery is usually attributed to surgical technique or implant design(36, 37). However, the evidence suggests these aspects have minimal influence and that inadequately addressed mental and social health distresses could be important factors(38). Giesinger et al. documented that psychological and demographic factors accounted for more variance in patient reported outcomes than surgical factors after hip and knee arthroplasty(39). Depressed patients remain up to a 6-times-higher risk for dissatisfaction after primary TKA than patients who are not depressed independent of surgical recovery and anxiety has demonstrated to increase pain and postsurgical complications(40–42).

The prevalence of clinically meaningful anxiety or depression symptoms is 6–7% in the USA but in patients undergoing TKA these values increase up to 20%(43, 44). The current practice in elective orthopedics does not involve routine psychological interventions but, given the high prevalence of psychological distresses in patients undergoing arthroplasty and the impact of these factors in its outcomes and patient perception, there is a need for an increased understanding and perioperative assessment of the psychological condition in these patients(45, 46).

Cognitive behavioral intervention is an effective psychological treatment for depression and anxiety. It carries the potential of reducing depression, anxiety, pain catastrophizing and postsurgical pain in patients undergoing total arthroplasty(29, 47, 48).

Similar to our proposal, das Nair determined the role of conducting a trial of home-based, in-person, pre-surgical psychological intervention based on CBT and its effect in terms of mood, pain and function in patients undergoing TKA and at 6-month follow-up, the patients allocated to the intervention group showed a significant benefit in mood, pain and functionality(49).

There is preliminary work assessing the role of telemedicine in perioperative care of surgical patients^55–57 but the evidence for orthopedic surgery, and especially incorporating a psychological intervention, is limited(50–52). Buvadendran and his colleagues studied the effect of CBI in patients undergoing TKA and proved that its use prior to surgery, both in person or via telehealth, lead to reduced Pain Catastrophizing Scores in postsurgical stages³⁰, supporting the results found in previous literature(25, 27, 28, 53, 54). Rognsvåg et al developed an internet-delivered cognitive behavioral therapy program for use in combination with exercise and education in patients at increased risk of chronic pain following total knee arthroplasty(55). Antony et al. also conducted a randomized clinical trial to evaluate of the effectiveness of acceptance and commitment therapy delivered via a mobile phone messaging robot to patients who had their THA or TKA postponed due to COVID-19 pandemic, showing better surgical outcomes in participants from the intervention group(56).

To the best of our knowledge, our current proposal is the first randomized controlled trial using dCBI before, during and after surgery in patients undergoing both THR and TKR. Studies demonstrated the role of telemedicine to provide orthopedic consultations to patients living in remote areas safely without serious adverse events increase patient satisfaction, reduce travel, time, and costs(57–65). Interestingly, during COVID-19 pandemic, patients with anxiety or depression were more likely to have a telehealth encounter than an in-person encounter(66). However, telehealth has the risk of perpetuating socioeconomic disparities if patients do not have access to the required technology and those living in rural and underserved areas are less likely to use telehealth, emphasizing the need for attention to at-risk underserved areas(51, 67–69). As we incorporate dCBI into our practice, we envision embedding dCBI into surgical care models.

Trial Status

The current protocol version is #6 and the first patient was recruited on 1/27/2023. The expected day for study completion is 7/31/2024.

CIPC

The Center for Innovation in Pain Care

CRISMA

The Clinical Research, Investigation, and Systems Modeling of Acute Illness

dCBI

Digital cognitive behavioral intervention

THA

Total hip arthroplasty

TKA

Total knee arthroplasty

HADS

Hospital Anxiety and Depression Scoring

PROMIS

Patient-Reported Outcomes Measurement Information System

PCS

Pain Catastrophizing Scale

KOOS

The Knee injury and Osteoarthritis Outcome Score (KOOS)

HOOS

The Hip injury and Osteoarthritis Outcome Score (HOOS)

KOS-ADL

Knee Outcome Survey – Activities of Daily Living scale

CPC

Center for Perioperative Care

GAD

Generalized Anxiety Disorder Scale

PHQ

Patient Health Questionnaire

UPMC

University of Pittsburgh Medical Center

ASA

American Society of Anesthesiologists

Ethics approval and consent to participate:

University of Pittsburgh Institutional Review Board – Office of Research Protection: STUDY21120053. Written, informed consent to participate will be obtained from all participants.

Consent for publication

The authors are willing to provide a model consent form on request.

Availability of data and materials

The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from the corresponding author upon reasonable request. Data are in controlled access data storage at The University of Pittsburgh.

Competing interests

The authors declare that they have no competing interests.

Funding

The study is funded by the University of Pittsburgh, Department of Anesthesiology and Perioperative Medicine, the Center for Innovation in Pain Care, and University of Pittsburgh Medical Center Health Plan. The funding sources did not have any influence on the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

Authors' contributions

AMK has made substantial contributions to the conception of the work, the acquisition, and drafted the work.

CL has made substantial contributions to the conception of the work, the acquisition, and drafted the work.

AGS has made substantial contributions to the conception of the work, the acquisition, and drafted the work.

DRL has made substantial contributions to the conception of the work, the analysis, and drafted the work.

AM has made substantial contributions to the conception of the work and the acquisition.

NZ has made substantial contributions to the acquisition and analysis of data.

MS has made substantial contributions to the conception of the work and substantively revised the draft.

KS has made substantial contributions to the conception of the work and substantively revised the draft.

YJG has made substantial contributions to the conception of the work and substantively revised the draft.

BAK has made substantial contributions to the conception of the work and substantively revised the draft.

MJO has made substantial contributions to the conception of the work and substantively revised the draft.

ES has made substantial contributions to the conception of the work, the acquisition, analysis, and drafted the work.

ADW has made substantial contributions to the conception of the work, the acquisition, analysis, and drafted the work.

JEC has made substantial contributions to the conception of the work, the acquisition, analysis, and drafted the work.

All authors have approved the submitted version and agreed both to be personally accountable for the author's own contributions and to ensure that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and the resolution documented in the literature.

Acknowledgements

The authors acknowledge the efforts by Luke Plizga, MS and Ashley Tasz, MS for their efforts in conducting the trials, including subject recruitment and follow-up.

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Table 1

Outcomes	Instrument	Study period	*Eligibility assessment*	*Enrollment*	*Surgery*	*Post-Surgery*
		Time	After consenting the patient	Baseline (3-4 weeks before surgery)		1M	2M	3M
*Primary outcomes*
Self-reported anxiety	PROMIS 4a anxiety		x	x	x	X	x	x
	GAD-7			x*	x*	x*	x*	x*
Self-reported depression	PROMIS 4a depression		x	x	x	x	x	x
	PHQ-8			x*	x*	x*	x*	x*
*Secondary outcomes*
Sleep disturbances, Fatigue, Ability to Participate in Social Roles,	PROMIS 29+2 (Excepting PROMIS 4a Anxiety and 4a Depression)			x	x	x	x	x
Pain Catastrophizing	Pain Catastrophizing Scale			x	x	x	x	x
Perioperative pain	Pain Scores			x	x	x	x	x
Opioid and non-opioid consumption				x	x	x	x	x
Functionality	HOOS/KOOS			x	x	x	x	x
Post-Surgical complications						x	x	x
Patient Satisfaction								x

*The intervention group will also be assessed bi-weekly with GAD-7 and PHQ-8 through the RxWell app

Table 2

Section	CONSORT Abstract item	Relevant CONSORT-SPI item	Reported on Page #
Title	Identification of the study as randomized		1
Authors	Contact details for the corresponding author		Click here to enter text.
Trial Design	Description of the trial design (e.g. parallel, cluster, noninferiority)	If the unit of random assignment is not the individual, refer to CONSORT for Cluster Randomized Trials and report the items included in its extension for abstracts	3
Methods
Participants	Eligibility criteria for participants and the settings where the data were collected	When applicable, the eligibility criteria for the setting of the intervention delivery and the eligibility criteria for the persons who delivered the interventions	3
Interventions	Interventions intended for each group		3
Objective	Specific objective or hypothesis	If pre-specified, how the intervention was hypothesized to work	3
Outcomes	Clearly defined primary outcome for this report		3
Randomization	How participants were allocated to interventions		3
Awareness of assignment	Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done		3
Results
Number randomly assigned	Number randomized to each group		3
Recruitment	Trial status		4
Interventions		Extent to which interventions were actually delivered by providers and taken up by participants as planned	3
Number Analyzed	Number analyzed in each group		N/A
Outcomes	For the primary outcome, a result for each group and the estimated effect size and its precision		N/A
Harms	Important adverse events or side effects		N/A
Conclusions	General interpretation of the results		N/A
Trial registration	Registration number and name of trial register		4
Funding	Source of funding		4

Table 3

SECTION	ITEM #	CONSORT-SPI 2010	CONSORT-SPI 2018	REPORTED ON PAGE #
TITLE AND ABSTRACT
	1a	Identification as a randomized trial in the title^§		1
	1b	Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for Abstracts)^§	Refer to CONSORT extension for social and psychological intervention trial abstracts	2
INTRODUCTION
Background and Objectives	2a	Scientific background and explanation of rationale^§		5-7
Background and Objectives	2b	Specific objectives or hypotheses^§	If pre-specified, how the intervention was hypothesized to work	5-7
METHODS
Trial Design	3a	Describe of trial design (such as parallel, factorial), including allocation ratio ^§	If the unit of random assignment is not the individual, please refer to CONSORT for Cluster Randomized Trials	8
Trial Design	3b	Important changes to methods after trial commencement (such as eligibility criteria), with reasons		N/A
Participants	4a	Eligibility criteria for participants^§	When applicable, eligibility criteria for settings and those delivering the interventions	13
Participants	4b	Settings and locations where the data were collected		13
Interventions	5	The interventions for each group with sufficient details to allow replication, including how and when they are actually administered ^§		8-9 and 14-17
	5a		Extent to which interventions were actually delivered by providers and taken up by participants as planned	N/A
	5b		Where other informational materials about delivering the intervention can be accessed	Click here to enter text.
	5c		When applicable, how intervention providers were assigned to each group	Click here to enter text.
Outcomes	6a	Completely defined pre-specified outcomes, including how and when they were assessed^§		11-12
Outcomes	6b	Any changes to trial outcomes after the trial commenced, with reasons		N/A
Sample Size	7a	How sample size was determined^§		17-18
Sample Size	7b	When applicable, explanation of any interim analyses and stopping guidelines		N/A
RANDOMISATION
Sequence generation	8a	Method used to generate the random allocation sequence		17
Sequence generation	8b	Type of randomization; detail of any restriction (such as blocking and block size)^§		17
Allocation concealment mechanism	9	Mechanism used to implement the random allocation sequence, describing any steps taken to conceal the sequence until interventions were assigned^§		9
Implementation	10	Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions^§		DRL generated the random allocation. AMK, CL, AGS, AM, NZ, MS, KS, YJG, BAK, MJO, ES, ADW, and JEC enrolled and assigned participants.
Awareness of assignment	11a	Who was aware of intervention assignment after allocation (for example, participants, providers, those assessing outcomes), and how any masking was done		DRL, AGS, AM, NZ, MS, and KS.
Awareness of assignment	11b	If relevant, description of the similarity of interventions		N/A
Analytical methods	12a	Statistical methods used to compare group outcomes^§	How missing data were handled, with details of any imputation method	18
Analytical methods	12b	Methods for additional analyses, such as subgroup analyses, adjusted analyses, and process evaluations		18
RESULTS
Participant flow (a diagram is strongly recommended)	13a	For each group, the numbers randomly assigned, receiving the intended intervention, and analyzed for the outcomes^§	Where possible, the number approached, screened, and eligible prior to random assignment, with reasons for non-enrolment	21
Participant flow (a diagram is strongly recommended)	13b	For each group, losses and exclusions after randomization, together with reasons^§		22
Recruitment	14a	Dates defining the periods of recruitment and follow-up		N/A
Recruitment	14b	Why the trial ended or was stopped		N/A
Baseline data	15	A table showing baseline characteristics for each group^§	Include socioeconomic variables where applicable	N/A
Numbers analysed	16	For each group, number included in each analysis and whether the analysis was by original assigned groups^§		N/A
Outcomes and estimation	17a	For each outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)^§	Indicate availability of trial data	N/A
Outcomes and estimation	17b	For binary outcomes, the presentation of both absolute and relative effect sizes is recommended		N/A
Ancillary analyses	18	Results of any other analyses performed, including subgroup analyses, adjusted analyses, and process evaluations, distinguishing pre-specified from exploratory		N/A
Harms	19	All important harms or unintended effects in each group (for specific guidance see CONSORT for Harms)		N/A
DISCUSSION
Limitations	20	Summarize the main results (including an overview of concepts, themes, and types of evidence available), link to the review questions and objectives, and consider the relevance to key groups.	Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses	N/A
Generalisability	21	Discuss the limitations of the scoping review process.	Generalizability (external validity, applicability) of the trial findings^§	N/A
Interpretation	22	Provide a general interpretation of the results with respect to the review questions and objectives, as well as potential implications and/or next steps.	Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence	N/A
IMPORTANT INFORMATION
Registration	23	Registration number and name of trial registry		8
Protocol	24	Where the full trial protocol can be accessed, if available		8
Declaration of Interests	25	Sources of funding and other support; role of funders	Declaration of any other potential interests	8
Stakeholder investments	26a		Any involvement of the intervention developer in the design, conduct, analysis, or reporting of the trial	N/A
	26b		Other stakeholder involvement in trial design, conduct, or analyses	N/A
	26c		Incentives offered as part of the trial	N/A

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SuRxgWell: Study Protocol for a Randomized Controlled Trial of Telemedicine-based digital Cognitive Behavioral Intervention for high Anxiety and Depression Among Patients Undergoing Elective Hip and Knee Replacement surgery

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RxWell™, – digital Cognitive Behavioral Intervention

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