Video-based Consensus Opinion for Hand and Upper Extremity Problems

Pain Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02204605
• Other study ID #: 2014P000132
• Status: Withdrawn
• Phase: N/A
• First received: July 29, 2014
• Last updated: December 20, 2016
• Start date: May 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators would like to determine if there is a difference in patient satisfaction among patients who have puzzling pain conditions and receive one evaluation from their treating physician, and those that receive an evaluation from their treating physician and from a group of consulting physicians by video. The investigators expect to enroll 128 patients at Massachusetts General Hospital.

Description:

Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.

Primary study question:

1. Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.

Secondary study questions:

2. Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.

3. There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients (>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).

• English fluency and literacy

• Able to provide informed consent

Exclusion Criteria:

• Pregnant Women

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Video-based Consensus Opinion

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Likert Scale for Satisfaction		At enrollment	No
Primary	Likert Scale for Satisfaction		4-6 weeks	No
Secondary	Patient Self-Efficacy Questionnaire (PSEQ-2)		At enrollment	No
Secondary	Patient Self-Efficacy Questionnaire (PSEQ-2)		4-6 weeks	No
Secondary	Patient Health Questionnaire (PHQ-2)		at enrollment	No
Secondary	Patient Health Questionnaire (PHQ-2)		4-6 weeks	No
Secondary	QuickDASH (Disabilities of the Arm, Shoulder, and Hand)		At enrollment	No
Secondary	QuickDASH (Disabilities of the Arm, Shoulder, and Hand)		4-6 weeks	No
Secondary	Numerical Rating Scale for Pain		at enrollment	No
Secondary	Numerical Rating Scale for Pain		4-6 weeks	No