NCT00806559

Brief Summary

The purpose of this study is to improve the clinical encounter through the design of the clinical environment. We will conduct a randomized controlled trial to measure the extent to which a newly designed clinical room, compared to a traditional room, affects the patient-physician interaction. We will judge this outcome by (a) videotaping encounters; and (b) conducting post-visit surveys with patients and an interview with physicians. We will use both qualitative and quantitative tools, including a validated and widely used interaction coding system on the videotapes, to draw inferences from these data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2008

Completed
Last Updated

December 14, 2011

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

December 10, 2008

Last Update Submit

December 13, 2011

Conditions

Keywords

effects clinical spacefollow-up appointments

Outcome Measures

Primary Outcomes (2)

  • Patient and Clinician Interaction variables (duration of the encounter, patient sense of control in encounter, patient's ability to access information from the computer monitor and the quality of the verbal and non-verbal interaction).

    Immediately post clinical visit (survey)

  • Patient experience of the clinical encounter. The following variables will be measured: patient satisfaction with the room, patient satisfaction with the encounter and the quality of the relationship.

    Immediately post visit

Study Arms (2)

Usual room

ACTIVE COMPARATOR

Patients in this arm will see their clinician in the usual clinical exam room

Other: Control room

Re-designed room

EXPERIMENTAL

Patients assigned to this arm will see the physician in a redesigned clinical exam room

Other: Re-designed room

Interventions

In the redesigned room patients and clinicians are sitting at a single table in a different configuration compared to the usual clinical exam room, with the doctor at the computer and two chairs for the patient and family/friends.

Re-designed room

This is the usual clinical room for a clinical visit, with physician at desk and chairs along the wall for patient/family.

Usual room

Eligibility Criteria

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

You may not qualify if:

  • ) Not able to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Almquist JR, Kelly C, Bromberg J, Bryant SC, Christianson TH, Montori VM. Consultation room design and the clinical encounter: the space and interaction randomized trial. HERD. 2009 Fall;3(1):41-78. doi: 10.1177/193758670900300106.

Study Officials

  • Victor M. Montori, M.D., MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2008

First Posted

December 11, 2008

Study Start

July 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

December 14, 2011

Record last verified: 2011-12

Locations