Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

Sponsor
Dartmouth-Hitchcock Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02912806
Collaborator
(none)
545
39

Study Details

Study Description

Brief Summary

Evolving reimbursement policies are driving health systems to improve quality and efficiency. Transitioning to an electronic health record (EHR) provided Dartmouth-Hitchcock Medical Center (DHMC) an opportunity to redesign staff roles and care path for Total Knee Replacement (TKR). The organization implemented a coordinated team-based care delivery model that integrated real-time measurement of: (1) compliance with trusted guidelines, (2) process of Shared Decision-Making (SdM), and (3) use of Patient-Reported Outcomes (PROs). The investigators present the implementation protocol and data.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total Knee Replacement

Detailed Description

Patient-reported outcome measures were completed 1 month preceding TKR and also at 1 and 12 months following surgery. The primary outcome was change in physical function from baseline to 1-year following surgery in the Physical Component Summary (PCS) of the Veterans-Rand (VR-12) Survey. Preoperative measures were: (1) general demographics (patient age, sex, height, weight, body mass index (BMI); (2) treatments tried before surgery; (3) health habits (tobacco use, alcohol use); (4) pre-existing medical conditions (Charlson score); (5) physical exam findings (knee range of motion, knee laxity); (7) lab tests (hemoglobin); and (7) radiographic measures (severity of osteoarthritis on standing x-rays). Secondary outcomes included Physical Score (PS) of the Patient Reported Outcome Measurement Information System Global Survey (PROMIS-10), knee function (Knee Osteoarthritis Outcome Score, KOOS), safety (reoperations, readmissions, emergency visits, and infection) and measures of patient experience (Clinician Group and Hospital Consumer Assessment of Healthcare Providers and Systems).

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
545 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Dartmouth GreenCare Program: Implementation of Shared Decision Making and Patient-reported Outcomes in a Standardized Care Path for Knee Replacement
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
Apr 1, 2016

Outcome Measures

Primary Outcome Measures

  1. Health Gain as measured by the change in Physical Component Summary (PCS) Score [1-year following surgery]

    Health Gain from baseline to 12 months (from 300 to 400 days following the date) following surgery, as measured by the change in Physical Score based on standardized US adult population benchmarks for the VR12 survey

Secondary Outcome Measures

  1. Health Gain as measured by the change in Global Physical Health (GPH) [1-year]

    Health Gain from baseline to 12 months following surgery, as measured by the change in Physical Score based on standardized US adult population benchmarks for the PRIOMIS10 survey

  2. Health Gain as measured by the change in Percentile Rank, TKR age and gender matched [1 year]

    Health Gain from baseline to 12 months following surgery, as measured by the change in Physical Score Percentile Rank based on age and gender-matched beta distributions for the Dartmouth TKR population, for the PRIOMIS10 or VR12 survey

  3. Emotional Health [1 year]

    Mental Component Summary (MCS) Score change from baseline to 12 months following surgery, as measured by the change in Mental Score based on standardized US adult population benchmarks for the PRIOMIS10 or VR12 survey

  4. Knee Osteoarthritis Outcome Score (KOOS) [1 year]

    Change in KOOS score from baseline to 12 months following surgery

  5. Reoperation [3 months]

    From 0 to 90 days following the date of surgery

  6. Readmission [3 months]

    From 0 to 90 days following the date of surgery

  7. ER visits after surgery [3 months]

    From 0 to 90 days following the date of surgery

  8. Infection [3 months]

    From 0 to 90 days following the date of surgery

  9. Patient Satisfaction with Hospital [1 month]

    HCAHPS survey in 10% random subsample completed between 20 to 40 days following the date of surgery

  10. Patient Satisfaction with Surgeon [10 months]

    Clinician Group CAHPS survey in 10% random subsample completed between 300 to 400 days following the date of surgery

  11. Cost of care [3 months]

    Episode-based costs for 0 to 90 days following the date of surgery, and also per visit outpatient costs

  12. Length of hospital stay [Acute hospitalization]

    Number of days between date of admission and date of discharge

  13. Discharge to home [Acute hospitalization]

    Disposition at time of discharge from acute hospitalization

  14. Mortality [1 year]

  15. Range of motion [90 days]

    Knee range of motion measured by a clinician between 60 and 120 days following surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Scheduled TKR

  • Osteoarthritis of the knee

Exclusion Criteria:
  • previous TKR on the affected knee

  • diagnosis other than osteoarthritis

  • age less than 18 years

  • declined consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Sohail K Mirza, MD, MPH, Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT02912806
Other Study ID Numbers:
  • CPHS23310
First Posted:
Sep 23, 2016
Last Update Posted:
Sep 23, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Dartmouth-Hitchcock Medical Center

Study Results

No Results Posted as of Sep 23, 2016