Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the biopsychosocial impact of caregivers in patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability to provide care following surgery on a loved one.

Detailed Description
-----------------
This is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical subgroup, with a total of 150 subjects. Caregivers for patients undergoing the above surgeries will be administered Patient Reported Outcome Measurement Information System (PROMIS) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1 month postoperatively. PROMIS item banks will include Global Health, Anxiety, Fatigue, Depression, Self Efficacy, Social Satisfaction, and Sleep Disturbance. If the caregiver reports the presence of persistent pain, Pain Interference and Physical Function will be administered.

Official Title
-----------------
Characterizing the Biopsychosocial Impact on Caregivers in Patients Undergoing Joint Replacement and Cervical/Thoracic/Lumbar Spine Surgery: A Pilot Study

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Other: No specific treatment based intervention-health measurement instrument


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older Are the primary person helping in the recovery of a patient undergoing one of the following surgeries below with in the first 30 days after surgery Total knee arthroplasty Total hip arthroplasty Cervical/Thoracic/Lumbar spine surgery Able to understand English and can verbalize their pain level Exclusion Criteria: Younger than 18 years old Refuse participation Cannot understand English Has cognitive deficiencies (subject unable to provide consent for the study, subject unable to complete initial post consent measures)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee group<br>Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing total knee arthroplasty. | Other: No specific treatment based intervention-health measurement instrument<br>* Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)<br>|
| Hip group<br>Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing total hip arthroplasty. | Other: No specific treatment based intervention-health measurement instrument<br>* Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)<br>|
| Spine group<br>Caregivers who will be the primary source of assistance (medical, rehabilitative, daily living, etc) after surgery for patients undergoing Cervical/Thoracic Lumbar Spine Surgery (Discectomy, Foraminotomy, Laminectomy, Fusion, Nerve Root Decompression) | Other: No specific treatment based intervention-health measurement instrument<br>* Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Natural history of biopsychosocial impact of Caregivers | To describe the natural history of the biopsychosocial impact of Caregivers for patients undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar spinal surgery. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of biopsychosocial measures over time | To assess the biopsychosocial measure over time from the following time points: Preoperative, 7 days, 14 days postoperatively, and 1 month postoperatively. | 1 month |