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The objectives of this research are to:
Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" post discharge management of patients undergoing TKA. The intervention will focus on the challenging process of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and from inpatient rehabilitation to home.
The principal goals of the trial are:
The investigators hypothesize that:
The "Post-TKA Care Navigator" proof of concept intervention will be implemented as a randomized controlled trial. The investigators aim to identify and enroll a cohort of up to 300 subjects who have decided to undergo total knee replacement (TKA) at BWH. Subjects will be patients of the five orthopedic surgeons at Brigham and Women's Hospital who perform the most TKAs: Drs. Wright, Brick, Ready, Martin and Thornhill. Subjects will be followed from about two weeks prior to the operation to six months after discharge.
The investigators will assign patients into two groups, at random: 1) receiving current standard of post-operative care and 2) adding "Post-TKA Care Navigator". The role of the Care Navigator will be to follow up with patients via frequent telephone conversations, ranging from weekly during the first month to bi-weekly for the next 6 weeks to monthly by the 14th week post op. subjects assigned to the care navigator will receive up to 10 telephone calls over a period of 5 months. The goal of the Care Navigator would be to ensure or encourage compliance with physical therapy, triage patient concerns, questions and complaints, and identify those patients that require a call from a clinician to address a problem in the recovery process. For those issues that can be resolved easily at home the navigator would suggest strategies. The value of the post-TKA Care Navigator will be assessed by comparing functional status, satisfaction with surgery, utilization of health care, adherence to physical therapy, range of knee motion and intervention costs across the two randomized groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Care Navigator Intervention Group | Active Comparator | Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively |
|
| Usual Care Group | Active Comparator | Subjects in the Usual Care group receive the current standard post-operative TKA care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care Navigator | Behavioral | Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharge from the hospital for 5 months after their total knee replacement. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC Physical Function | The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months | Change in functional status from baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction | Percentage of patients in each study arm who reported being very satisfied with the results of TKA | Measured at 6 months post TKA |
| Range of Motion | Percentage of participants able to bend knee at least 120 degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Losina, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24119081 | Background | Losina E, Collins JE, Daigle ME, Donnell-Fink LA, Prokopetz JJ, Strnad D, Lerner V, Rome BN, Ghazinouri R, Skoniecki DJ, Katz JN, Wright J. The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features. BMC Musculoskelet Disord. 2013 Oct 12;14:290. doi: 10.1186/1471-2474-14-290. | |
| 26714179 |
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Subjects were recruited from a tertiary academic medical center in Boston, MA
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| ID | Title | Description |
|---|---|---|
| FG000 | Care Navigator Intervention Group | Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care |
| FG001 | Usual Care Group | Subjects in the Usual Care group receive the current standard post-operative TKA care Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Care Navigator Intervention Group | Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in WOMAC Physical Function | The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months | The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline | Posted | Mean | 95% Confidence Interval | units on a scale | Change in functional status from baseline to 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Care Navigator Intervention Group | Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elena Losina, PhD | Brigham and Women's Hospital | 617-732-6928 | elosina@partners.org |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Standard Post-Operative TKA Care | Other | Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care |
|
| 6 months after TKA |
| Losina E, Collins JE, Wright J, Daigle ME, Donnell-Fink LA, Strnad D, Usiskin IM, Yang HY, Lerner V, Katz JN. Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2016 Sep;68(9):1252-9. doi: 10.1002/acr.22829. Epub 2016 Jul 28. |
| BG001 | Usual Care Group | Subjects in the Usual Care group receive the current standard post-operative TKA care Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| WOMAC Physical Function score | The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst | Mean | Standard Deviation | units on a scale |
|
| WOMAC Pain score | The WOMAC Pain scale is scaled from 0 to 100, with 100 worst | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care Group | Subjects in the Usual Care group receive the current standard post-operative TKA care Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care |
|
|
| Secondary | Satisfaction | Percentage of patients in each study arm who reported being very satisfied with the results of TKA | The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire | Posted | Number | percentage of participants | Measured at 6 months post TKA |
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| Secondary | Range of Motion | Percentage of participants able to bend knee at least 120 degrees | Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees | Posted | Number | percentage of participants | 6 months after TKA |
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| 154 |
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| 154 |
| EG001 | Usual Care Group | Subjects in the Usual Care group receive the current standard post-operative TKA care Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement. Subjects assigned to the usual Care group will receive current standard of post-operative care | 1 | 154 | 0 | 154 |
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