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Purpose

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.

Condition	Intervention
Internal Medicine Patients Participating Staff	Other: Re-designed room Other: Control room

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment
Official Title:	SIT Trial: The Effect of Clinical Room Design on the Quality of the Clinical Encounter

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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). [ Time Frame: Immediately post clinical visit (survey) ] [ Designated as safety issue: No ]
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. [ Time Frame: Immediately post visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	February 2009
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual room: Active Comparator Patients in this arm will see their clinician in the usual clinical exam room	Other: Control room This is the usual clinical room for a clinical visit, with physician at desk and chairs along the wall for patient/family.
Re-designed room: Experimental Patients assigned to this arm will see the physician in a redesigned clinical exam room	Other: Re-designed room 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Eligible Clinicians:

In the Department of GIM or Preventive Medicine
Able and Willing to participate in research study.

Eligible patients:

Patient of a clinician participating in the study
18 years or older
Seeing clinician for return/summary visit.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806559

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Steelcase

Investigators

Principal Investigator:

Victor M. Montori, M.D., MSc

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic ( Victor Montori, M.D. )
Study ID Numbers:	07-000135
Study First Received:	December 10, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00806559 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

effects clinical space
follow-up appointments

ClinicalTrials.gov processed this record on May 07, 2009