NCT02204605

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2014

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

July 29, 2014

Last Update Submit

December 20, 2016

Conditions

Pain

Keywords

patientspuzzlingconditions

Outcome Measures

Primary Outcomes (2)

  • Likert Scale for Satisfaction

    At enrollment

  • Likert Scale for Satisfaction

    4-6 weeks

Secondary Outcomes (8)

  • Patient Self-Efficacy Questionnaire (PSEQ-2)

    At enrollment

  • Patient Self-Efficacy Questionnaire (PSEQ-2)

    4-6 weeks

  • Patient Health Questionnaire (PHQ-2)

    at enrollment

  • Patient Health Questionnaire (PHQ-2)

    4-6 weeks

  • QuickDASH (Disabilities of the Arm, Shoulder, and Hand)

    At enrollment

  • +3 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Visits are not videotaped

Videoed Patients

EXPERIMENTAL

Patients will have their visit videotaped.

Behavioral: Video-based Consensus Opinion

Interventions

Video-based Consensus OpinionBEHAVIORAL
Videoed Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant Women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

PainDisease

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 30, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

US(1)