Nonarthritic Hip Disease Evaluation And Treatment

Clinical Decision Making Clinical Trial

— NEAT  

Official title:

Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03519087
• Other study ID #: 2017H0340
• Status: Terminated
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. All participants will proceed with their scheduled, standard-care physician evaluation. Participants without NAHD will be excluded. Participants will then be randomized to receive a same-day physical therapist (PT) evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added for research. All participants will complete expectation surveys before and after their evaluation(s). The clinicians will discuss their recommended plan with the patient and the patient will record a final treatment decision and outcome expectations. Participants will then be randomized to either receive posture and movement training (PMT) for 3 weeks or undergo a 3-week wait period. All participants will be required to withhold any treatment during this 3-week period (except PMT in the PMT group). The 3-week wait period for the no-PMT group is aligned with current clinical processes for time from physician evaluation to start of treatment. All participants may proceed with any further interventions (including PMT) after the 3-week period, but none will be provided/required as part of research. Patient-reported outcomes and clinical tests will be recorded before and after the 3-week period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no additional risk because the PT evaluation includes similar clinical tests to the physician and movement analysis during tasks participants complete during daily life. Clinical tests before/after the 3-week intervention period may produce muscle soreness that should resolve within 2 days. Understanding how interdisciplinary care influences expectations and outcomes can inform clinicians regarding the effectiveness of interdisciplinary collaboration.

Description:

The clinical evaluation by the physician is standard-of-care and performed as part of potential participants' scheduled appointment. Participants in this study will complete a HIPAA authorization to allow data from their clinical evaluation by the physician to be utilized for this study, including any imaging the physician used in their clinical evaluation and the evaluation note entered into the participant's electronic health record. The physician notes are standardized, allowing streamlined data analysis from the electronic health record.

Research activities to occur the same day as the informed consent process include randomization to receive or not receive a clinical evaluation by a physical therapist along with surveys for treatment decisions, expected outcomes, and patient-reported function. A small sub-group of patients will also complete interviews to identify how they felt about their evaluation that day. The HIPAA authorization will also allow the data from the physical therapy evaluation and any subsequent posture and movement training at OSUWMC to be utilized for this study.

Regardless of randomization to receive or not receive a same-day physical therapy evaluation in the physician clinic, all participants will be randomized to receive posture and movement training (PMT) or undergo a 3-week wait period. Participants who are randomized to receive PMT as part of this research study will schedule based on their availability, twice weekly for 3 weeks with an OSUWMC Sports Medicine physical therapist who also hold IRB-approved status as research personnel. Participants will be made aware during the informed consent process that any PMT they receive as part of this study will be their responsibility to pay for using either self-pay or insurance-based methods.

Participants who refuse randomization to receive PMT will be offered to participate in the observational group. These participants proceed with the same baseline and follow-up testing, but continue with their treatment-of-choice rather than an assigned treatment during the 3-week intervention period.

All participants will complete baseline and follow-up biomechanical and clinical follow-up testing in the Motion Analysis and Performance Laboratory. Biomechanical testing involves using 3-dimensional motion capture techniques to analyze movement during 3 functional tasks including walking, sit-to-stand, and a forward tap-down. Clinical testing involves obtaining anthropometric measures, hip strength, patient-reported function, and planned treatment decisions with respective expected outcomes. A small sub-group of patients will also complete interviews at these testing sessions to identify how they feel about the intervention (wait or posture & movement training).

Posture and movement training involves the physical therapist prescribing therapeutic exercises and activities to improve posture and movement (Harris-Hayes 2016), focusing heavily on extrinsic cueing (Benjaminse 2015). Therapeutic exercises and activities will be individualized based on the participant's presentation and will progress according to pain and quality of movement from double-leg to single-leg activities and from functional to more dynamic tasks.

Participants who are randomized to undergo a 3-week wait period will be required to withhold any treatment during the 3-week wait period. These participants will complete the same testing as the participants in the PMT group (see next paragraph). These participants will not receive any intervention during the 3-week wait period; however, after their first follow-up testing session (within 1 week of completing the 3-week wait period), these participants may proceed with any intervention of their choice. The participants in the PMT group may also proceed with any intervention after their first follow-up testing session. These follow-up interventions will not be provided or required as part of the research study, but participants will be asked to report if they completed any follow-up interventions between their first follow-up testing session and their 3month and 6month follow-up testing sessions.

Follow-up testing will occur within 1-week of completing the 3-week intervention period. At this point, participants in both the PMT and no-PMT groups may proceed with any intervention (i.e. surgery, injection, physical therapy). All participants will perform additional follow-up testing at 3- and 6-months post-intervention.

Qualitative interviews will be conducted to evaluate how physicians and physical therapists involved in the study feel about the evaluation and treatment protocols.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Over 18 years old NAHD diagnosis

Exclusion Criteria:

• Osteoporosis or rheumatoid arthritis

• Systemic health condition

• Legal representative required for treatment decisions

• Bilateral symptoms

• Current spine, hip, knee, or ankle surgery or major injury*

• Pregnancy

• Total hip arthroplasty candidate (Tönnis grade > 2)

• Periacetabular osteotomy candidate (lateral center edge angle<20, anterior center edge angle<18, acetabular index >10)

• Participants with history of spine, hip, knee, or ankle surgery or major injury will be evaluated by the physician to determine appropriateness for evaluation (and treatment) by a physical therapist

Related Conditions & MeSH terms

• Clinical Decision Making
• Nonarthritic Hip Disease

Intervention

Other:
• Interdisciplinary Evaluation for Nonarthritic Hip Disease
The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.
• Posture and Movement Training
Physical therapists will lead participants through an intervention protocol to normalize seated and standing posture and function movement. Verbal, visual, and tactile cues, along with strengthening exercises will be provided to train posture and movement.
• Treatment-of-choice
Participants may proceed with any treatment-of-choice, which may or may not have been recommended by their health care provider(s). Treatments will be recorded, but not controlled.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	Foundation for Physical Therapy, Inc., Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decisional Regret	Participants will report decision regret related to their treatment plans	Day of enrollment, after all evaluations are complete
Other	Decisional Regret	Participants will report decision regret related to their treatment plans	4 weeks
Other	Changes in Hip Strength	Strength of hip abductors, adductors, flexors, extenders, internal and external rotators will be collected during maximal voluntary isometric contractions	4 weeks
Primary	Treatment Plan	Participants will indicate their planned treatment(s)	Post-evaluation, same-day (approximately 5-10min after evaluation)
Primary	Decisional Conflict	Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).	Pre-evaluation, 10min Post-evaluation
Secondary	Themes From Provider Interviews	Qualitative interviews will be conducted with study providers both before patient participant enrollment and after study completion to collect information on how they feel about the evaluation protocols. Qualitative analysis of this data will count responses based on themes. Data for this report will be provided as the total number of responses (across all providers) that fell within each theme at both time points. Each provider could provide multiple responses.	Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)
Secondary	Participant Protocol Opinions	Participants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols.	20min post-evaluation, 4 weeks post-evaluation
Secondary	Decisional Conflict	Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).	10min post-evaluation, 4-week laboratory visit
Secondary	Patient-reported Hip Function	Participants will complete validated, reliable surveys for hip function (the Hip Outcome Score Activities of Daily Living [HOSADL] was used and is scored from 0-100 with 0 representing the worst function and 100 representing the best function). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).	10min post-evaluation, 4-week laboratory visit
Secondary	Movement Mechanics	3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair	Baseline laboratory visit, 4-week laboratory visit