Internal Medicine PatientsSITNCT00806559
Space and Interaction Trial: Room Design and Patient-physician Interaction
A study testing Re-designed room in people with Internal Medicine Patients and Participating Staff, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Medicine Patients, Participating Staff
- What is being tested?
- Re-designed room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 1.) Not able to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SIT Trial: The Effect of Clinical Room Design on the Quality of the Clinical Encounter
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.
- Conditions
- Internal Medicine Patients, Participating Staff
- Being tested
- Re-designed room, Control room
- Keywords
- effects clinical space, follow-up appointments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-designed roomOther
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.
Control roomOther
This is the usual clinical room for a clinical visit, with physician at desk and chairs along the wall for patient/family.
| Study group | Role | What they receive |
|---|---|---|
| Usual room | Active comparator | Patients in this arm will see their clinician in the usual clinical exam room Receives: Other: Control room |
| Re-designed room | Experimental | Patients assigned to this arm will see the physician in a redesigned clinical exam room Receives: Other: Re-designed room |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Immediately post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internal Medicine PatientsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Steelcase
- Investigators
- Victor M. Montori, M.D., MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806559
- Sponsor's protocol ID
- 07-000135
- Acronym
- SIT
- Status last verified
- Dec 2011
- First submitted
- 10 Dec 2008
- Last updated
- 14 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21165880
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIT Trial: The Effect of Clinical Room Design on the Quality of the Clinical Encounter
- ClinicalTrials.gov ID
- NCT00806559
- Acronym / sponsor ID
- SIT / 07-000135
- Conditions
- Internal Medicine Patients, Participating Staff
- Keywords
- effects clinical space, follow-up appointments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Steelcase
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual room | Active comparator | Other: Control roomPatients in this arm will see their clinician in the usual clinical exam room |
| Re-designed room | Experimental | Other: Re-designed roomPatients assigned to this arm will see the physician in a redesigned clinical exam room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 1.) Not able to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-designed roomIn 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. | Other | Re-designed room |
| Control roomThis is the usual clinical room for a clinical visit, with physician at desk and chairs along the wall for patient/family. | Other | Usual room |
Primary outcome
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2011.
- Derived from this study: PubMed 21165880Almquist 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor M. Montori, M.D., MSc principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-designed room in people with Internal Medicine Patients and Participating Staff, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2011.