NCT02209246

Brief Summary

The investigators of this study would like to see whether providing feedback to patients regarding their illness behavior/coping strategies, using online questionnaires, improves patient-physician communication in orthopaedic surgery. The investigators aim to enroll 128 patients.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

July 29, 2014

Last Update Submit

August 1, 2014

Conditions

Outcome Measures

Primary Outcomes (4)

  • PROMIS CAT Pain Interference

    A computerized assessment of pain interference measured at enrollment

    1 day

  • PROMIS CAT Pain Behavior

    A computerized assessment of pain behavior measured at enrollment

    1 day

  • PROMIS CAT Physical Function

    A computerized assessment of physical function measured at enrollment

    1 day

  • Medical Interview Satisfaction Scale (MISS-21)

    Questionnaire

    1 day

Secondary Outcomes (1)

  • Patient-physician communication

    1 day

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention group will be comprised of patients who will complete the PROMIS- CAT for pain interference, pain behavior and physical function prior to the encounter with the physician and then will complete the MISS-21 after the encounter.

Other: PROMIS CAT Pain InterferenceOther: PROMIS CAT Pain BehaviorOther: PROMIS CAT Physical FunctionOther: MISS-21

Control

EXPERIMENTAL

The control group will complete the PROMIS- CAT for pain interference, pain behavior and physical function after the encounter and after completing a satisfaction questionnaire (MISS-21).

Other: PROMIS CAT Pain InterferenceOther: PROMIS CAT Pain BehaviorOther: PROMIS CAT Physical FunctionOther: MISS-21

Interventions

ControlIntervention
ControlIntervention
ControlIntervention
MISS-21OTHER
ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • All new patients visiting the Orthopaedic Hand and Upper Extremity Service
  • English fluency and literacy
  • Ability to provide informed consent

You may not qualify if:

  • age \< 18
  • Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027.

    PMID: 12479768BACKGROUND
  • Chamie K, Sadetsky N, Litwin MS. Physician assessment of pretreatment functional status: a process-outcomes link. J Urol. 2011 Apr;185(4):1229-33. doi: 10.1016/j.juro.2010.11.087. Epub 2011 Feb 22.

    PMID: 21334026BACKGROUND

Study Officials

  • David Ring, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 29, 2014

First Posted

August 5, 2014

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations