Clinical trial NCT02656277: Efficacy of First Time Anterior Shoulder Decision Tool
Official title: Efficacy of First Time Anterior Shoulder Decision Tool in a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a randomized controlled trial using Duke patients to test, compared to the standard of care, a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention.

Phase 1 of this study is the initial testing of the instrument and involves a small group of up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized to receive either the Decision Tool or the standard Information on Shoulder Dislocation

Detailed description: An anterior shoulder dislocation is a common problem for people between the ages of 15 to 35. Recurrent instability is common and dependent on age and gender. Treatment options include surgical intervention and repair or non-surgical options that include intensive rehabilitation. Level I evidence suggests early surgical repair can significantly reduce the risk of recurrent instability. The risk of arthritis is increased with multiple dislocation episodes.

Traditionally, the combination of 1) history and physical exam performed by the provider, 2) clinical and diagnostic tools to assess the extent of injury and impact on physical activity, and 3) patient-voiced preference has guided the selection of an optimal solution for an individual patient. When providing a recommendation to individual patients and their unique circumstances, the health care provider may gather patient preferences on factors such as desire to avoid pain, chance of recurrent shoulder dislocation, time needed for rehabilitation and physical therapy, and operative versus non-operative costs. Surgical and non-surgical options have distinct differences in these outcomes. When combined, the interaction between these variables creates important tradeoffs of risks and benefits for each option.

No studies have been conducted to determine the objective weight of these different dimensions of patient preferences and how they might guide the provider-patient conversation. Conjoint analysis is a statistical method that seeks to quantify the relative importance of various aspects of the decision-making process, such as cost or probability of repeat injury as described above. Combined with a validated survey tool, conjoint analysis of patient preferences in shoulder repair can assist the physician in recommending a patient-centered option.

Eligibility criteria: Inclusion Criteria:

- Shoulder dislocation

Exclusion Criteria:

* Prior surgery for shoulder stabilization
* Inability to complete enrollment forms

Primary outcomes:
measure: Patient Preference Survey
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Sports Science Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard Mather, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hutyra CA, Smiley S, Taylor DC, Orlando LA, Mather RC 3rd. Efficacy of a Preference-Based Decision Tool on Treatment Decisions for a First-Time Anterior Shoulder Dislocation: A Randomized Controlled Trial of At-Risk Patients. Med Decis Making. 2019 Apr;39(3):253-263. doi: 10.1177/0272989X19832915. Epub 2019 Mar 5.