Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH

April 19, 2021 updated by: The Cleveland Clinic

Improvement of Patient Satisfaction and Clinical Outcomes Using JointCOACH to Manage the Episode of Care for THA and TKA Bundles

JointCOACH is a web-based communication platform that enables joint replacement patients to communicate with their care team via computer or smartphone throughout their episode of care, from the time that surgery is scheduled until at least 90 days postoperatively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will receive the following information at key intervals: 1) instructions about how to prepare for surgery, 2) information about the procedure, 3) information about medications and pain control, 4) information about postoperative recovery and rehabilitation. In addition, several surveys will be distributed using JointCOACH to keep patients involved in their own recovery and to keep the surgical team informed of their progress. The proposed research will help determine if JointCOACH can improve patient satisfaction and clinical outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
446

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing primary total hip or primary total knee arthroplasty
  • Willing to sign an IRB approved informed consent form
  • Have internet access or mobile access with a valid email address at the time of enrollment
  • Above the age of 18 years

Exclusion Criteria:

  • Staged arthroplasty procedure within 6 months of the index procedure
  • Abandoned email address of record (e.g. bounce of email from clinic)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Standard of Care Group
The Standard of Care Group will receive standard, routine medical care and will communicate with their surgeon and clinical care team through conventional methods such as phone.
EXPERIMENTAL: Experimental (JointCOACH) Group
The Experimental Group will receive standard, routine medical care and utilize a web-based communication platform called JointCOACH to communicate with their care team via computer or smartphone throughout their episode of care. They will also receive information personalized to their treatment plan and will be asked to complete online questionnaires.
Other: JointCOACH
Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Picker Patient Experience (PPE-15) Questionnaire
Time Frame: 30 and 90 days after index surgery
It is a 15-item patient experience questionnaire. Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.
30 and 90 days after index surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) for Patient Satisfaction
Time Frame: 30 and 90 days after index surgery
It is a satisfaction measurement tool using a scale from 0-100, where 0 = completely dissatisfied and 100 = completely satisfied.
30 and 90 days after index surgery
Length of Hospital Stay
Time Frame: 90 days after index surgery
It is a count of the number of days the patient was admitted to the hospital after the index procedure prior to being discharged (measured in days)
90 days after index surgery
Discharge Disposition
Time Frame: 90 days after index surgery
Number of patient routinely discharged to home
90 days after index surgery
Number of Participants With Readmissions
Time Frame: 30 and 90 days after index surgery
It is a count of the number patients with hospital readmissions related to the index procedure within 30 and 90 days after the index procedure.
30 and 90 days after index surgery
Number of Participants With Reoperations
Time Frame: 30 and 90 days after index surgery
It is a count of the number of reoperations related to the index procedure within 30 and 90 days after the index procedure.
30 and 90 days after index surgery
Number of Subjects With Emergency Department Visits
Time Frame: 30 and 90 days after index surgery
It is a count of the number of subjects with emergency department visits related to the index procedure within 30 and 90 days after the index procedure.
30 and 90 days after index surgery
Number of Outpatient Follow-Up Visits
Time Frame: 30 and 90 days after index surgery
It is a count of the number of outpatient follow-up visits with the surgical team related to the index procedure within 30 and 90 days after the index procedure.
30 and 90 days after index surgery
Number of Telephone Calls
Time Frame: 30 and 90 days after index surgery
It is a count of the number of telephone calls with the surgical team related to the index procedure within 30 and 90 days after the index procedure.
30 and 90 days after index surgery
Provider Satisfaction Survey- JointCOACH Satisfaction
Time Frame: 90 days after the last patient enrolled has had surgery. approximately 22 months after the first patient enrolled. All study-related intervention is complete at this time.
It is a 2 question survey regarding provider experience using JointCOACH measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied.
90 days after the last patient enrolled has had surgery. approximately 22 months after the first patient enrolled. All study-related intervention is complete at this time.
Provider Satisfaction Survey- JointCOACH Recommendation
Time Frame: 90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time.
It is a 2 question survey regarding provider experience using JointCOACH measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied.
90 days after the last patient enrolled has had surgery. All study-related intervention is complete at this time.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Cleveland Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stryker Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-063

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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