Medical CareNCT01353560
Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study 1-Survey
An observational study of Medical Care, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Despite widespread and growing popularity of complementary and alternative medicine (CAM) in the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical effectiveness, safety and cost- effectiveness. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Care
- How many people
- 1,509 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2014
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. All new patients coming into the Osher Clinical Center (OCC) for any medical reason. 2. All physicians in the 5 included departments/divisions (Women's Health, Orthopedics, Obstetrics and Gynecology, General Medicine, and Rheumatology) are eligible to participate in the survey. Other BWH physicians whom OCC patients have identified as their referring doctors and given us permission to contact, will also be eligible to participate in the survey.
Who may be able to join
- New patient coming into Osher Clinical Center for any medical reason.
- Physician affiliated with any of included division/department (see above).
Who cannot join
- Patient has been seen at Osher Clinical Center within past 3 months for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Clinical Center at Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
Despite widespread and growing popularity of complementary and alternative medicine (CAM) in the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the Harvard Medical School (HMS) Osher Research Center established and trained a multidisciplinary integrative team of CAM and conventional providers to work collaboratively to provide state-of-the-art "integrative care" in a coordinated and individualized fashion. The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making process of both patients and conventional providers with respect to communication about and referral to an integrative care team in an academic hospital outpatient setting.
- Conditions
- Medical Care
- Keywords
- integrative medicine, barriers to utilization, communication
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| New patients of Osher Clinical Center | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of decision-making process for patients of CAM therapies and conventional providers
Surveys will be sent to: 1) 1500 consecutive new patients seen at the OCC over 3.5 years, to characterize the chief complaints; their medical history; referral sources; communication with their physicians; barriers to use of CAM; views regarding and previous use of CAM; and expectations for CAM therapy as adjuncts to their conventional care; 2) 300 BWH physicians from five divisions (Women's Health, Orthopedics, Obstetrics and Gynecology, General Medicine, and Rheumatology) most likely to refer to the OCC, to assess their use of, feelings about, and knowledge of CAM.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical CareStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Julie E. Buring, Brigham and Women's Hospital
- Investigators
- Julie E Buring, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353560
- Sponsor's protocol ID
- 1R01AT005065-01A1-1
- Other IDs
- 1R01AT005065-01A1
- Status last verified
- Jun 2017
- First submitted
- 12 May 2011
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study 1-Survey
- ClinicalTrials.gov ID
- NCT01353560
- Acronym / sponsor ID
- 1R01AT005065-01A1-1
- Conditions
- Medical Care
- Keywords
- integrative medicine, barriers to utilization, communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,509 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center
- Study start
- May 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 May 2011 (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.
Despite widespread and growing popularity of complementary and alternative medicine (CAM) in the US, there currently exist significant gaps in our knowledge regarding CAM use, clinical effectiveness, safety and cost- effectiveness. With previous funding support from NCCAM, the Harvard Medical School (HMS) Osher Research Center established and trained a multidisciplinary integrative team of CAM and conventional providers to work collaboratively to provide state-of-the-art "integrative care" in a coordinated and individualized fashion. The Osher Integrative Care Center (OCC) was opened in fall 2007, physically located within the Ambulatory Care Center of the Brigham and Women's Hospital (BWH) at 850 Boylston Street in Chestnut Hill, MA. The focus of this survey study is to characterize the decision-making process of both patients and conventional providers with respect to communication about and referral to an integrative care team in an academic hospital outpatient setting.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New patients of Osher Clinical Center | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. All new patients coming into the Osher Clinical Center (OCC) for any medical reason. 2. All physicians in the 5 included departments/divisions (Women's Health, Orthopedics, Obstetrics and Gynecology, General Medicine, and Rheumatology) are eligible to participate in the survey. Other BWH physicians whom OCC patients have identified as their referring doctors and given us permission to contact, will also be eligible to participate in the survey.
Key inclusion criteria (2 listed)
- New patient coming into Osher Clinical Center for any medical reason.
- Physician affiliated with any of included division/department (see above).
Key exclusion criteria (1 listed)
- Patient has been seen at Osher Clinical Center within past 3 months for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of decision-making process for patients of CAM therapies and conventional providers
Time frame: 3.5 years
Surveys will be sent to: 1) 1500 consecutive new patients seen at the OCC over 3.5 years, to characterize the chief complaints; their medical history; referral sources; communication with their physicians; barriers to use of CAM; views regarding and previous use of CAM; and expectations for CAM therapy as adjuncts to their conventional care; 2) 300 BWH physicians from five divisions (Women's Health, Orthopedics, Obstetrics and Gynecology, General Medicine, and Rheumatology) most likely to refer to the OCC, to assess their use of, feelings about, and knowledge of CAM.
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 Jun 2017.
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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.
Julie E Buring, ScD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Care, run by Brigham and Women's Hospital 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 2 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 Jun 2017. 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?
Characterization of decision-making process for patients of CAM therapies and conventional providers (time frame: 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2017.