Internet Enhanced, Patient-Centered Orthopedic Care: A Prospective, Randomized, Controlled Pilot Trial

Sponsor

Charlotte Sports Medicine Institute, PA (Other)

Overall Status

Completed

CT.gov ID

NCT02025400

Collaborator

Advanced Orthopedic Specialists (Other), The Orthopaedic Center (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators have previously reported on patient utilization of an eRehab patient education web portal that utilizes streaming, clinician prescribed video instruction to motivate and inform patients in self-care of their orthopedic condition, focusing on the importance of a home exercise program. The greatest barrier to patient use of this web-based home exercise treatment plan was the initial access to the program. The purpose of this study is to compare an Internet-based patient education rehab portal (eRehab) to formal physical therapy (PT) in terms of patient costs and outcomes.

Condition or Disease	Intervention/Treatment	Phase
Knee Injuries Shoulder Injuries Rotator Cuff Disease Meniscus Tear Patellofemoral Pain	Other: eRehab Other: Formal Physical Therapy	Phase 1

Detailed Description

This is a prospective, randomized, controlled pilot study. Twenty-four patients who were candidates for a knee or shoulder orthopedic outpatient physical therapy referral were randomized to a 6-week treatment course of either PT or eRehab. Patients were evaluated for outcome scores (KOOS or DASH), pain NRS-11 scores, patient subjective outcomes and cost of treatment.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study Comparing Internet Delivered Home Exercise Programs to Standard Orthopedic Care and Outpatient Physical Therapy.

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Physical Therapy This arm will receive the standard of care for orthopedic patients receiving a diagnosis and then a recommendation for outpatient physical therapy referral. They will follow through on the referral and attend physical therapy.	Other: Formal Physical Therapy This intervention involves referral to a licensed physical therapist or supervised ATC-L.
Experimental: eRehab This group will not go to formal therapy but receive Internet delivered patient education and exercise instruction. This group will then perform those exercises at home.	Other: eRehab Growth in e-Health applications, defined as any computer or Internet application integrated into health services, has resulted in the development of treatment strategies to improve healthcare while reducing costs. The utilization of e-Health to provide a rehabilitative intervention has recently been identified in the cardiac literature as "e-rehabilitation" or "eRehab." This study specifically compares an orthopedic eRehab Internet application to standard outpatient physical therapy as an adjunct in the treatment of non-complicated knee and shoulder disorders.

Arm

Intervention/Treatment

Active Comparator: Physical Therapy

This arm will receive the standard of care for orthopedic patients receiving a diagnosis and then a recommendation for outpatient physical therapy referral. They will follow through on the referral and attend physical therapy.

Other: Formal Physical Therapy

This intervention involves referral to a licensed physical therapist or supervised ATC-L.

Experimental: eRehab

This group will not go to formal therapy but receive Internet delivered patient education and exercise instruction. This group will then perform those exercises at home.

Other: eRehab

Growth in e-Health applications, defined as any computer or Internet application integrated into health services, has resulted in the development of treatment strategies to improve healthcare while reducing costs. The utilization of e-Health to provide a rehabilitative intervention has recently been identified in the cardiac literature as "e-rehabilitation" or "eRehab." This study specifically compares an orthopedic eRehab Internet application to standard outpatient physical therapy as an adjunct in the treatment of non-complicated knee and shoulder disorders.

Outcome Measures

Primary Outcome Measures

Outcome scores for knee (KOOS) and shoulder (DASH) [six weeks]

Secondary Outcome Measures

NRS-11 pain scores [6 weeks]

Other Outcome Measures

Patient utilization of an eRehab portal measured by number of logons and performance of a home exercise program as documented with an exercise log. [6 weeks]
Patient cost of care per episode [6 months]
A patient's insurance explanation of benefits will be reviewed for 6 months from completion of the current episode of care to determine patient out of pocket expenses
Total cost of care per episode [6 months]
Each patient's EOB will be reviewed to determine total cost of care for each episode of care

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patient diagnosed by board certified orthopedic surgeon to be in need of formal physical therapy referral
had the ability to access and use the Internet and email
English-speaking
non-pregnant adults
had not received formal physical therapy for their current diagnosis

Exclusion Criteria:

work-related injuries
pain NRS-11 score greater than or equal to 6

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Orthopaedic Specialists	Prince Frederick	Maryland	United States	20678
2	Charlotte Sports Medicine Institute	Charlotte	North Carolina	United States	28269