Division of General Internal Medicine

Inactive Studies

Last updated 9/10/07

Name of Project:
Intimate Partner Violence, Lifetime Trauma Exposure, PTSD & Symptoms

Investigators.
Janice Humphreys, UCSF School of Nursing
Chris Miaskowski, UCSF School of Nursing
Bruce Cooper, UCSF School of Nursing

PI & primary contact:
Janice Humphreys, Janice.humphreys@nursing.ucsf.edu

Research question(s):

What is the nature of the relationships between and among general health, intimate partner violence (IPV), lifetime trauma exposure, Posttraumatic Stress Disorder (PTSD), resilience, and the symptoms of chronic pain and depression in a community-based sample of formerly abused women?

The specific aims of this study are to:
1) determine the type, frequency, severity, and timing of IPV,
2) describe the type, timing, and number of their lifetime trauma exposures,
3) determine the frequency of posttraumatic stress disorder (PTSD),
4) determine the severity of depressive symptoms,
5) determine the contribution of the number of lifetime traumatic exposures and the presence of PTSD to severity of depressive symptoms,
6) determine the frequency of chronic pain,
7) examine the characteristics and severity of chronic pain symptoms,
8) determine the contribution of the number of lifetime traumatic exposures and the presence of PTSD to severity of chronic pain, and 9) determine the influence of resilience on these symptoms.

Brief Background/Significance:

Intimate partner violence (IPV) disproportionately affects women and numerous studies have concluded that women who experience IPV have poorer overall health and more symptoms than women who have not experienced IPV. Among the most commonly reported symptoms are chronic pain and depression. Some researchers have concluded that women who experience IPV are at high risk for PTSD. Others suggest that PTSD alone does not explain the full range of women's responses to trauma exposure. Another body of literature suggests that personal resilience is associated with fewer and less distressing symptoms. A substantial body of research with veterans, victims of violent crime, and survivors of natural disasters has found that exposure to other traumatic events is associated with poorer health and more symptoms. However, to date no research has examined women's responses to IPV and other trauma using a community-based sample of women. We propose to explore the relationships between and among IPV, lifetime trauma exposure, PTSD, and chronic pain and depressive symptoms in a community-based sample of women with a history of IPV. This pilot study will increase our understanding of life experiences that predict chronic pain and depression in women who experience IPV. In addition, the findings should lead to the development of focused interventions to reduce abused women's chronic pain and depressive symptoms. Humphreys, Lee, Neylan, and Marmar conducted symptom research with 50 abused women residing in emergency shelters who had experienced multiple traumatic exposures (8.1 + 4.6) as measured by the Trauma History Questionnaire (THQ), 19 (38.8%) of these women PTSD. The abused women had more severe and distressing symptoms on each of the three global indices of the Brief Symptom Inventory than a normative sample of female nonpatients14. However, in this study only sleep disturbances were examined in-depth. Neither chronic pain, depression, nor resilience was measured, and using the THQ, only the number of trauma exposures was determined. Results indicated that IPV was only one type of lifetime trauma exposure experienced by these women, and their associated symptoms were severe and distressing. The study also suggested the need for better instrumentation to examine lifetime trauma exposures, and that multiple, in-depth measures were needed to adequately measure symptoms. The proposed study will use instrumentation that better measures the type, timing and number of lifetime trauma exposures as well as measures of resilience, chronic pain and depressive symptoms.

Inclusion/exclusion criteria

Inclusion Criteria

Any English-speaking woman with a history of IPV who presents at one of three primary care clinics and who self-refers to the study or voices interest in the study to a staff member at the clinic. Participants are women over the age of 18 who can speak and read English, who have a history of ever experiencing IPV as an adult (at age 16 years old or older), and who agree to participate in the study.

Exclusion Criteria - Women who cannot speak or read English, with no history of IPV since age 16, or who have obvious alterations in cognitive functioning will be excluded from the study.

Method of contact/recruitment

A member of the research team will recruit women who come to the UCSF Division of General Internal Medicine (DGIM). Notices about the study with eligibility criteria will be posted where appropriate around the clinic and clinicians will be informed of the study. A member of the research team will be present during selected clinic hours and all women who voice interest in the study will be approached by the research team member. Information about the location of the research team member will also be posted so that women can self-refer. Potential participants will be seen in a private waiting area and provided additional information about the study. If still interested, an information sheet will be provided and reviewed with the women. We have been granted a waiver of signed consent in order to protect the confidentiality of all participants. Women will again be self-screened by completing three questions adapted from the Abuse Assessment Screen; "Since the age of 16, have you ever been physically or emotionally abused by your partner or someone important to you?, Ever been hit, slapped, kicked, or otherwise physically hurt by someone?, or Has anyone forced you to have sexual activities?". Women who indicate experience with any of this abuse will be asked to continue completing the remainder of the questionnaires. All other women are asked to return the questionnaires to the secured research questionnaire container. Study questionnaires will be completed by the participant in a quiet location in the clinic and a research team member will be nearby to answer any questions. If a woman would prefer to participate in the study at another time, mutually agreeable arrangements will be sought. All women will also be offered information about local IPV survivor assistance programs, and staff clinicians will be available to support participants who request help.

Benefits/burden for participants

There are no direct benefits to the study participants. [All participants who complete the questionnaire packet will receive $20.00 in cash at the time of the completion.] Potential burdens include that the research team is mandated to report any women who volunteer that they are currently in an abusive relationship to the San Francisco Domestic Violence unit. Also, it is possible that completing questionnaires about IPV and other traumatic exposures could be distressing. Participation in research also runs the risk of loss of confidentiality and privacy.

Any benefits or burden to DGIM practitioners?

Burdens to DGIM practitioner are minimal. On the selected days that a research team member is present, she will be occupying clinic space. Clients may have questions for the practitioners about the study or ask to be referred to the research team. Benefits include the opportunity to be involved, in the project if so desired.

Timeline for recruitment

Data collection is currently underway via advertisements and public notices. Once approved by the DGIM, data collection will commence at the clinics. Data collection will end when a sufficient number of participants have been recruited, approximately July 2008.

Funding source:

This project is funded by the PI, Janice Humphreys.

Potential for DGIM collaborators?

We would be happy to collaborate with anyone who is interested in the project.

Do you agree to notify us when recruitment is completed?

Yes

Date form completed:

July 1, 2007

Name of Project:
Perceptions of Breast Cancer Risk in Chinese American and Filipina American Women

Investigators:
Primary contact/Co-PI: Melinda Chen, mchen2@itsa.ucsf.edu
PI: Tung Nguyen, 415-502-1539, tung@itsa.ucsf.edu

Research question:

How do English speaking Chinese American and Filipina American women perceive their own breast cancer risk in relation to American women of other ethnicities as well as to women in Asia?
Which factors influence the formation of persona breast cancer risk perception?
How does an individual's risk perception influence breast cancer prevention practices?

Brief Background/Significance:
It has been historically well documented that breast cancer incidence is 4-7 times lower in Asian countries than in the United States. Much of the research exploring this lower incidence focuses on possible environmental differences between women living in Asia versus the United States. In part because of the publicity surrounding this lower incidence, studies have indicated that Asian females perceive themselves to be at lower risk. Asian American women too have a lower incidence of breast cancer compared to other US ethnic groups. However, the incidence of breast cancer in Asian American women is increasing, arousing concern that the protective environment enjoyed by Asian women may not continue once these women leave their native lands for America. In fact, in a study of the association between migratory patterns and breast cancer risk, it was found that Asian women who have lived in the US for greater or equal to ten years have an overall 80% higher risk than more recent immigrants.

This finding leads us to question whether Asian American womens' perceptions of their own risk of developing breast cancer differ from women in Asian countries.

Inclusion/exclusion criteria

Subjects must be:

Chinese American or Filipina American women
Between the ages of 18-40
Lived in the US for greater than or equal to ten years
Speak English

Subjects must not:

Be of any ethnicity other than Chinese American or Filipina American
Be a man
Have lived in the US for less than ten years
Be outside the ages of 18-40
Be unable to speak English

Method of contact/recruitment
Recruitment flyers will be posted at UCSF General Medicine clinics at Parnassus and Mount Zion with prior permission of clinic managers. Additional flyers will also be displayed at local libraries, Asian and American grocery stores, laundromats, churches, bookstores, and cafes with prior permission of business owners.

Benefits/burden for participants
The risks associated with this study are minimal, not exceeding those associated with daily living or routine interaction with community members and health care professionals. On the other hand, the data generated by this project may produce a larger questionnaire to further assess breast cancer risk perception in Asian American women. Through administration of the questionnaire, health professionals may reinforce the need for increased outreach to particular groups of Asian American women.

Any benefits or burden to DGIM practitioners?
Benefits are that through the feedback and educational component of the study, participants may be better educated about breast cancer risk and screening and more able to discuss and interact with their practitioner.

Timeline for recruitment (projected start and stop dates)
Recruitment to start 12/05-2/06

Funding source
UCSF U-56 Cancer Awareness Minigrant (PI: Tung Nguyen)

Potential for DGIM collaborators?
Dr. Chen is a DGIM Internal Medicine resident and Dr. Nguyen is a DGIM faculty member.

Do you agree to notify us when recruitment is completed?
Yes

Date form completed:
12/7/05

Name of Project:
Improving Rates of Colorectal Cancer Screening in Primary Care Practice: Quality Improvement in Partnership With The American Cancer Society

Investigators:
PI: Judith M.E. Walsh, M.D., M.P.H.
jmwalsh@itsa.ucsf.edu

Co-PI: Michael Potter, M.D.
potterm@fcm.ucsf.edu

Research question(s):
Will an intervention targeting patients increase rates of colorectal cancer screening? It will be important to determine whether directly targeting patients using innovative educational interventions can increase rates of screening.

Brief Background/Significance:
Colorectal cancer is the third most common form of cancer in the U.S. and has the third highest mortality rate, and screening clearly reduces mortality [1-3]. The United States Preventative Services Task Force (USPSTF) recommends screening for colorectal cancer for all persons over fifty, but does not recommend a preferred screening strategy [4]. The U.S. Multisociety Task Force on Colorectal Cancer also recommends presenting multiple options, including annual FOBT, sigmoidoscopy every 5 years, combined FOBT and sigmoidoscopy, barium enema every 5 years or colonoscopy every 10 years [5]. Despite publication of these screening guidelines, they have not been widely implemented by physicians. Recent data from the Morbidity and Mortality Weekly Report (MMWR) reveal that only 44% of U.S. adults >50 have been recently screened with FOBT or sigmoidoscopy. In 2001, only 23.5% of eligible participants had undergone FOBT within the preceding year, and only 38.7 of eligible participants had undergone sigmoidoscopy/colonoscopy in the preceding 5 years, rates which have not significantly improved since 1997 [6]. In a study of over 6,000 participants in the UCSF General Internal Medicine Clinics, 85% of eligible women had received mammography in the preceding 2 years, whereas only 53# had received any colon cancer screening (FOBT in the past 2 years OR sigmoidoscopy or colonoscopy in the past 10 years) [7]. Improving rates of colorectal cancer screening is an important quality improvement goal. Interventions to increase rates of CRC screening are needed. Recent public health campaigns sponsored by the CDC and the American Cancer Society have focused on colorectal cancer screening. Many efforts are focusing on increasing public awareness of the importance of colorectal cancer screening, yet the effects of these efforts targeting the public have not been measured.

Inclusion Criteria
Patients being seen at the following 5 primary care clinics:
3 General Internal Medicine Clinics at UCSF

GMA
GMB
Mount Zion

UCSF Women's Health Internal Medicine Primary Care Clinic
Lakeshore Family Practice Clinic
Patients aged 50-79 whose physician has just recommended screenings

Exclusion Criteria
Patients under the age of 50
Anyone for whom CRC screening is not recommended

Method of contact/recruitment (be specific)

For patients in the control clinics, there will be no special contact or recruitment procedures. Patients in the intervention clinics will only be actively recruited by their own physician/nursing staff if they are in the reminder call arm of the study. For the reminder intervention clinics, after a patient has a colon cancer screening test recommended, the physician will ask him/her if it is OK for someone from the American Cancer Society (ACS) to call and remind the patients about what he/she agreed to do. If the patient agrees, he/she will sign the reminder postcard (which will serve as implied informed consent) and it will be mailed to the ACS. A trained ACS volunteer will call the patient to remind the patient to be screened and to ask if he/she has completed or scheduled the tests. All ACS volunteers are trained not to give medical information. A script for the ACS volunteer phone call and a copy of the postcard are attached. For patients in the patient education only intervention clinic, posters will be placed on the walls and if patients wish to, they may take information sheets as well, however these patients will not be contacted or actively recruited.

Benefits/burden for participants

Benefits:
If the intervention works, more patients could undergo screening for CRC which is currently recommended. Early detection of CRC can save lives. Also, if the intervention has an impact, it can be applied in other settings to increase awareness.

Burden:
Since the tests that are being promoted are all within the standard of care, the only risk to the patient is loss of confidentiality. To maintain patient confidentiality, no copies of the signed postcard will be maintained in the clinic setting. Once the phone calls have been made by the ACS volunteer(s), the postcards will be returned to study investigators and all will be maintained in a safe locked office.

Any benefits or burden to DGIM practitioners?
We want to minimize any burden to DGIM practitioners. The only change that the study requires is the time needed for physicians/clinic staff to have patients sign the ACS postcards.

Timeline for recruitment
Start date: As soon as approved
Stop date: 3 months from start date

Funding source
American Cancer Society

Potential for DGIM collaborators?
If any residents or fellows are interested in the study, we would be excited to have them as collaborators.

Do you agree to notify us when recruitment is completed?
Yes

Name of Project: Computer-based Preventive Health Education for Women of Reproductive Age

Investigator(s).

PI and primary contact Eleanor Bimla Schwarz, MD, MS
Schwarz@medicine.ucsf.edu

(PI for CHR purposes) Barbara Gerbert, PhD.
gerbert@itsa.ucsf.edu

Research question(s):

Can a computer-(kiosk) based module effectively deliver preventive health education to women of reproductive age who are waiting for urgent care services?
Specifically, using an RCT design, Is an educational module about emergency contraception effective in increasing women's knowledge and appropriate use of emergency contraception (when evaluated by phone follow up, 6 months after the educational intervention), and
Is an educational module about the importance of folate supplementation effective in increasing women's knowledge and use of folate supplements (when evaluated by phone follow up, 6 months after the educational intervention)

Brief Background/Significance:
Reaching women of reproductive age with preventive health messages is challenging, as healthy women frequently do not establish a relationship with a primary care provider. Many, especially those of lower socio-economic status, find urgent care settings an efficient way to obtain needed health care, despite the fact that these settings often require a significant amount of time spent in a waiting area. The development of computer- aided health education technology has created the possibility of introducing interactive sources of health education to waiting areas without increasing staffing needs. The development of computer-aided health education technology has created the possibility of introducing interactive sources of health education to urgent care settings without increasing staffing needs.i Computer-aided health technology has been shown to be effective in addressing sensitive topics such as sexual practicesii,iii and in providing contraceptive education.iv,v With the use of audio headsets, this technology can be private and meet low-literacy needs.

Inclusion/exclusion criteria

Inclusion:
Fertile women (18-45 years old) waiting in urgent care waiting rooms

Exclusion:
Women who do not speak English
Have been surgically sterilized
Are using an IUD
Do not have a telephone
Or plan to move in the next 6 months

Method of contact/recruitment (be specific)
Subjects will be approached by a research assistant in urgent care waiting rooms using the attached script.

Benefits/burden for participants (clearly identify potential for harm)
Benefits to participants include providing the opportunity for participants to learn things that will help them to have healthy babies when they desire to do so. This project will provide information about how to effectively expand women's knowledge of folate and emergency contraception. The benefits of increased knowledge of the importance of regular folate intake and timely use of available contraceptive options outweighs the risk of discomfort when discussing personal behaviors.

Potential for harm
During the interviews women will be asked questions about behaviors that can affect their health. They may feel uncomfortable discussing personal issues such as their sexual history. However, they will be free to refuse to answer any questions they find too uncomfortable, and are free to stop the interview at any time. In addition, participation in research may involve a loss of privacy; however, records will be handled as confidentially as possible. Only Dr. Schwarz, Dr. Gerbert, and their assistant will have access to study records. No individual identities will be used in any reports or publications that may result from this study.

Any benefits or burden to DGIM practitioners?
This intervention is designed to provide women with health information they might otherwise seek from a DGIM practitioner.

All research and educational activity will be conducted in the SACC and MZ Urgent Care waiting rooms. If a clinician is ready to see a subject, the survey or educational module will be interrupted and the subject will be offered the opportunity to complete the module when they are finished seeing a clinician.

Timeline for recruitment (projected start and stop dates)
March 1, 2005-July 1, 2005

Name of Project:

Improving Antibiotic Use For Acute Treatment ((IMPAACT) Project

Investigator(s):
Ralph Gonzales, MD, MSPH
Chrissie Baker, RN

Research question(s):
1. What are current levels of knowledge, attitudes, and behavior related to appropriate antibiotic use for acute respiratory tract infections, and how do these levels differ between VA and non-VA patient populations?
2. What is the credibility of various health information sources, and does the credibility vary between VA and non-VA patient populations.

Rationale:
The response patterns we observe in VA and non-VA patient populations will help inform specific patient education strategies that we will employ in our multicenter randomized trial of a quality improvement strategy to improve antibiotic use in VA and non-VA emergency department settings.

Methods:
We will conduct a cross-sectional survey of adults seeking care at SACC (and the VA E&A) clinics. The knowledge and attitudes survey we will administer has previously been used by Dr Gonzales and colleagues at University of Colorado, Denver as part of the Minimizing Antibiotic Resistance in Colorado Project. We have added several questions on the trustworthiness of various health information sources, and the convenience of obtaining information from those sources.

Sample Size: In order to detect a minimum difference of 10% in dichotomized response patterns related to knowledge, attitudes or awareness, we will require approximately 400 persons from each clinical site (setting alpha=0.05 and beta=0.80). Since this survey will be performed in parallel with colleagues at the University of Pennsylvania, we will only recruit 50% of the final sample size in San Francisco.

Brief Background/Significance:
The response patterns we observe in VA and non-VA patient populations will help inform specific patient education strategies that we will employ in our multicenter randomized trial of a quality improvement strategy to improve antibiotic use in VA and non-VA emergency department settings.

Inclusion/exclusion criteria:
Inclusion:
English-speaking, adults (age > 18 years) seeking care at SACC

Exclusion:
Exclusion criteria include those unable to provide reliable responses (intoxicated, mental illness, non-English-speaking, severe pain or illness)

Method of contact/recruitment

Prospective participants will be approached by a trained research assistant in the waiting area of each facility immediately after seeing the triage nurse. If they express interest, they will be escorted to a semi-private room for the purposes of obtaining informed consent, and administering the survey.

Benefits/burden for participants
No direct benefit to participants
No direct harm to patients, except for burden of 15-20 minutes it takes to complete survey. Survey can be completed after the visit if the patient is called to be seen by a provider.

Any benefits or burden to DGIM practitioners?
No

Timeline for recruitment
July 26 - August 15, 2004

Name of Project:

Self Management Groups for Treating Depression in Primary Care Settings

Investigator(s):

PI: Sara Swenson, M.D.
Email: swenson@medicine.ucsf.edu

Co-PI: Mitchell Feldman, M.D., M.Phil.
Email: mfeldman@medicine.ucsf.edu

Research question(s): Is a group self-management intervention for treating older patients with depression feasible in academic general internal medicine clinics?

Objectives include:

To demonstrate the feasibility of a depression group visit program in community- and hospital-based academic general internal medicine practices
To ascertain patient attitudes toward this form of depression management
To explore whether depression group visits affect depression outcomes
To investigate the relationship between participants' perceived self-efficacy and depression severity and outcomes

Brief Background/Significance:

Reviews of interventions in the management of depression reveal that successful interventions require alterations in delivery system or practice organization and a strong component of patient-oriented self-management activities.1-4 However, the specific content and process of patient self-activation and its relationship to patient preferences and disease severity have received less attention. Thus, a key requirement for optimizing depression management involves developing patient self-management strategies that are effective and acceptable to patients and can be integrated into a range of primary care settings.

Interdisciplinary group visits for patients with depression constitute a promising delivery systems innovation that can accomplish these objectives. Lorig and colleagues have demonstrated the effectiveness and acceptability of delivering self-management training in a group format for patients with a variety of chronic diseases, including arthritis, heart disease, and diabetes.5, 6 Chronic disease self-management groups have been validated in several patient populations in the US and UK.7, 8 Participation in such groups has been associated with improvements in patient emotional distress and functional health status. To date, however, their effectiveness among patients with major depression and dysthymia has not been specifically evaluated. Moreover, coupling chronic disease self-management groups to other aspects of medical care for persons with depression (e.g., medication management) has not been studied.

Inclusion/exclusion criteria:

We will recruit approximately 30 patients to attend 3 sets of depression group visits (8-12 participants/group).

Inclusion Criteria:

Age 50 or greater
English-speaking
Continuity patients (have PCP in target practice with at least one PCP visit in past 12 months
PHQ-9 score of 10 or more

Exclusion Criteria:

Require acute psychiatric hospitalization
Chronic psychotic disorders
Moderate to severe dementia
Alcohol or drug abuse
Borderline personality disorder

Method of contact/recruitment:

Recruitment will occur via referral by primary care providers and clinic advertisements (Appendix I). Dr. Swenson will contact primary care clinicians in the UCSF Mt. Zion and Parnassus general medicine clinics and selected medical subspecialty clinics to ask them to refer patients who have current major depression or dysthymia to the study. She will ask clinicians to limit referrals to those patients who are aware of their diagnosis of depression and who have addressed issues of depression with their primary care clinician in the context of a prior office visit. To refer patients, primary care clinicians can either (1) refer to the intervention using a standard "ACC" referral form; (2) contact Dr. Swenson via telephone (502-1542); or (3) ask patients themselves to contact Dr. Swenson. Alternatively, patients who respond to posted notices regarding the study can self-refer by calling the same number. Using a telephone protocol (Appendix I), Dr. Swenson will then contact patients and schedule an intake interview to determine eligibility and explain the study.

Benefits/Burdens for participants:

Risks/Burdens: Much of the scope and content of the DSMG's will resemble interventions that primary care clinicians routinely employ to treat depression. Consequently, the most significant risks entail (1) discomfort with discussing depression symptoms or other aspects of their health or personal background and (2) potential loss of participant confidentiality due both to participation in a group and in the evaluation. An additional risk involves potential costs and inconveniences of lost time from work, parking, and other transportation costs.

Benefits: This study may benefit participants in the following ways. (1) They will receive free care for their depression that may supplement routine depression management by their primary care clinician. (2) The DSMG's may enhance depression outcomes, self-efficacy, and functional status. (3) The DSMG's may help coordinate depression management and facilitate mental health specialist referral. (4) Participants may benefit psychologically from contributing to a quality improvement project aimed at improving depression care.

Benefits/Burdens to DGIM practitioners?

Risks/Burdens: As with any referral, referring patients to the depression groups could conceivably lengthen visit length for primary care clinicians. DGIM clinicians will also receive feedback regarding the intervention and may be contacted by the intervention's facilitators regarding management issues for their participating patients.

Benefits: DGIM practitioners with participating patients will receive feedback regarding their patient's level of depression, self-management action plans, medication adherence and mental health specialty referrals (if relevant), and other relevant issues. The additional patient support and self-management skills teaching may improve patient self-activation as well as the quality of patient care and ease the burdens of caring for these patients.

Timeline for recruitment (projected start and stop dates)
Start date: 8/2/04
Stop date: 1/1/05

Name of Project:

Chinese Community Smoking Cessation Project

Investigator(s):

PI: Candance Wong MD, PhD
Email: ccwong@itsa.ucsf.edu

Sharon Hall, PhD
Email: smh@itsa.ucsf.edu

Neal Benowitz, MD
Email: nbeno@itsa.ucsf.edu

Virginia Carrier-Kohlman, PhD
Email: ginger.carrieri@nursing.ucsf.edu

Janice Tsoh, Ph.D
Email: jtsoh@itsa.ucsf.edu

Inclusion/exclusion criteria (list):
Inclusion: self-identified Chinese, adult, current smoker (within last 90 days), has cardiovascular risk factors or pulmonary disease or diabetes, willing to quit smoking
Exclusion: former or non-smoker, cognitively impaired, medically unstable, advanced or metastatic cancer, current history of substance abuse, pregnant women Timeline for recruitment:

- Start: Winter 2004
- End: Winter 2005

Pneumococcal Vaccination Acceptance and Standing Order Study

Investigator(s).

Nicholas A. Daniels, MD, MPH
Email: ndanlels@medicine.ucsf.edu

Inclusion/exclusion criteria:

The study nurse will first consent patient (if eligible). Patients will receive an introductory letter upon checking in for their clinic appointment. The introductory letter (Appendix A) will be accompanied by a self-identification (Appendix B) form (pre-tested CDC forin) for patient's to complete to assess their need for pneumococcal vaccination. After completion of form and nurse's review of form, take vital signs, and triage for administration of pneumococcal standing order vaccination

Timeline for recruitment:
Start date: February 04
End date: June04

Approved: Winter 04

Consumer influences on practice studies.

Investigator(s).

Mitchell D. Feldman, MD, M.Phil, UCSF site PI.
E-mail: mfeldman@medicine.ucsf.edu

Richard L. Kravitz, MD, MSPH, Principal Investigator of the overall project.
E-mail: rkravitz@blue.ucdavis.edu

Lesley Sept, PhD, Project Manager - primary contact.
E-mail: lesley@medicine.ucsf.edu

Inclusion/exclusion criteria:

Forty-eight adult primary care physicians (internists and family physicians) will be recruited from each of the 3 cities (n=144 physicians total). In Sacramento, we will recruit physicians from the Kaiser Permanente Medical Group (a large staff/group model HMO) and from the UC Davis Primary Care Network (a large primary care oriented medical group with private offices and clinics scattered throughout the greater Sacramento region). In San Francisco, we have obtained the cooperation of Brown & Toland, a large independent practice association. In Rochester, we will recruit physicians from the largest local managed care organization (MCO). Approximately 500,000 persons (over 50% of the local population) are enrolled in the MCO.

Timeline for recruitment:
Start date: June 2003
End date: June 2004

Approved: Summer 03

PSA Screening Practices (CHR # H11678-23979-01)

Investigator(s)
June M. Chan, ScD, (PI)
Email: jmlchan@itsa.ucsf.edu

Peter Carroll, MD, (Co-PI)
Email: pcarroll@urol.ucsf.edu

Nicholas A. Daniels, MD, MPH, (Primary study contact)
Email: ndaniels@medicine.ucsf.edu

Inclusion/exclusion criteria:
All physicians practicing internal medicine or family medicine at UCSF, SFGH, and SFVA will be recruited (approx. 200).

Timeline for recruitment:

Start date for recruitment is within week following DGIM approval to compile mass mailing of surveys. We plan to send out one-time mass mailing of this survey via campus mail to 200 physicians. If we receive no response to initial mailing as specified in the study protocol, we have allocated sending two email reminders (over two-four week time period). Thus approximate stop date of recruitment is within one and three month(s) after initial mailing depending on the number & dates of email reminders with large group of participants.

Approval: Fall 03

Diabetes, Mood, & Management Assessment Project (D-MMAP)

Investigator(s):
Lawrence Fisher, PI;
Email: fisher@itsa.ucsf.edu (primary contact)

Marilyn Skaff PI;
E-mail: merlin@itsa.ucsf.edu

Patricia Arean
Email: areanp@itsa.ucsf.edu

Umesh Masharani
Email: ubm@itsa.ucsf.edu

David Mohr
Email: dmohr@irsa.ucsf.edu

Joseph Mullan
Email: mullan@itsa.ucsf.edu

Inclusion/exclusion criteria:

Patient 21 to 75 years, with diagnosis of type 2 diabetes for more than 12 months, may be obese, on oral medication or insulin, but not blind on dialysis, have major amputations, or be unable to live independently. Patients will be selected from all major ethnic groups, with equal proportions of males an females in each, but be able to read and speak either English or Spanish.

Timeline of recruitment:
Start date: 9/1/03
End date: 8/31/05

Approved: Fall 03

Name of Project:
Yoga for Treatment of Hot Flashes and Menopausal Symptoms

Investigator(s).
PI: Deborah Grady, MD MPH
deborah.grady@ucsf.edu

Investigator: Alka Kanaya, MD
alka.kanaya@ucsf.edu

Sr. Project Director: Judy Macer
judy.macer@ucsf.edu

Jr. Project Director: Ann Chang
ann.chang@ucsfmedctr.org

Research Assistant: Makani da Silva
Makani.DaSilva@ucsfmedctr.org

Research question(s):
1. To determine the feasibility of recruiting women with moderate to severe hot flashes into a clinical trial of yoga.

2. To estimate the efficacy of 8 weeks of training in yoga for treatment of hot flashes.

3. To evaluate the effect of yoga on other menopausal symptoms including sleep and quality of life and on serum lipids, glucose and insulin levels.

4. Explore the role of sympathetic nervous system activity in hot flushes by comparing pre-and post-intervention 24-hour urine epinephrine, norepinephrine and cortisol levels.
The long-range objective of this and similar pilot studies is to develop safe and effective behavioral treatments for menopausal women with moderate to severe vasomotor symptoms. This study will allow us to determine the feasibility of using yoga for this purpose, and provide initial estimates of efficacy to support sample size estimates for a definitive trial. If the results of the pilot trial are encouraging, we plan to submit a proposal for a definitive randomized trial of this therapy to the National Institute of Complementary and Alternative Medicine.

Brief Background/Significance:
Today, there are 36 million American women between the ages of 45-65. About two thirds of these women will experience hot flashes as they traverse the menopause transition and approximately 20% will seek medical relief for debilitating symptoms. Other common menopausal symptoms include night sweats, insomnia, vaginal dryness, and decreased quality of life. Postmenopausal hormone therapy is highly effective treatment for vasomotor symptoms. However, recent large randomized trials have shown that hormone therapy is associated with increased risk of cardiovascular disease, venous thromboembolic events and dementia. Given the increased risks for serious diseases and other common side effects such as uterine bleeding and breast tenderness, many women would like to avoid using hormone therapy for treatment of hot flashes. Several other treatments for hot flashes have been tested in clinical trials, including progestin, clonidine, gabapentin, and SSRIs. However, most are only modestly effective and associated with significant side effects. In summary, an effective and safe alternative to drug treatment of hot flashes would be highly desirable.

No trials specifically examining the use of yoga for the reduction of hot flashes have been reported. However, small trials using relaxation techniques derived from yoga, such as meditation and controlled breathing, have found improvement in hot flashes. In one study, 33 women were randomized to relaxation training, reading group, or control groups. After six weeks, the relaxation group demonstrated significant reductions in hot flash intensity, tension-anxiety, and depression. The control group did not have any significant changes in these measures. In another trial, 14 postmenopausal women who reported at least two hot flashes per day were randomized to a treatment group that received training in controlled breathing and progressive muscle relaxation or to a biofeedback control group. Hot flash frequency was significantly reduced in the treatment group after the training (from 6.6 to 3.0 per day) but unchanged in the control group. This improvement was maintained at 6 month follow up. Given these preliminary data and the studies linking yoga to decreased sympathetic activity, we believe yoga may be an effective behavioral therapy for the treatment of menopausal symptoms.

Inclusion Criteria
1. Women between the ages of 40 to 60.
2.    Self-report ≥4 moderate to severe hot flashes per day or ≥ 30 moderate to severe hot flashes per week.
3.     Successful completion of a Hot Flash Diary.
4.   Able and willing to attend yoga training sessions, maintain yoga logs, and practice yoga at home.

Exclusion Criteria
1. Inability to sign an informed consent or fill out questionnaires.
2. Use of other treatments for hot flashes (estrogens, progestins, clonidine, selective serotonin reuptake inhibitors, relaxation techniques or acupuncture) within 4 weeks of enrollment in the trial and do not agree to refrain from using these therapies for the duration of the trial.
3. Use of raloxifene or tamoxifen within three months of enrollment.
4. Any condition that, in the investigator's opinion, would preclude the participant from being able to understand and follow the yoga training or from completing the trial, including severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia.

Method of contact/recruitment

Participants will be recruited from a database of women maintained by the WHCRC, by the use of flyers and posters, and by seeking referrals from physician's offices (specifically in gynecology, primary care, and geriatric medicine). Providers can refer patients who may be eligible or interested in participation to our study staff.

Benefits/burden for participants
Yoga has not been studied specifically for menopausal hot flashes, however, it is reported to have overall health benefits, including reduction in blood pressure and improvement in dyslipidemia. Yoga may also have additional benefits as a method of exercise and relaxation.

The potential benefit of this study is the development of a behavioral method that will provide women relief from menopausal symptoms without exposing them to the side effects of pharmacologic treatment.

There are no known significant risks associated with the study procedures. Thus, the potential benefits of yoga outweigh the potential risks.

Any benefits or burden to DGIM practitioners?

To refer patients they may see in practice to our study if they feel they qualify. We know that this is not the most effective method of recruitment, but may be enough for a small pilot study.

Timeline for recruitment

Recruitment started on August 1, 2005 and will continue through October 15, 2005.

Funding source: Investigator initiated study.

Potential for DGIM collaborators?
Dr. Alka Kanaya is an Investigator in the study. Other fellows, residents, faculty interested, are welcome to get involved in the study group.

Name of Project:
Benefits of Ambulatory Oxygen in Hypoxic COPD Patients

Investigators:
Primary Investigator: Stephen C. Lazarus,
Investigators:
Prescott Woodruff,M.D.,MPH
Homer A Boushey, M.D.
John V. Fahy, M.D.
Steven R. Hays, M.D.
Audrey Plough, BSN
Primary contact:
Martha Birch martha.birch@ucsf.edu

Research question(s):
To compare the physiologic and clinical benefits to hypoxemic COPD patients of utilizing lightweight ambulatory oxygen systems versus portable E-cylinder systems. Our hypotheses are that, in comparison with a group of hypoxemic COPD patients receiving long-term oxygen therapy (LTOT) who are assigned to portable oxygen delivered by E-cylinders, patients assigned to receive lightweight ambulatory oxygen: 1) will use oxygen for more hours per day (this will be the primary outcome measure), 2) will use ambulatory oxygen for more hours of the day, and 3) will have increased activities of daily life, as objectively measured by triaxial accelerometry.

Brief Background/Significance:
This is the first study to be proposed by the newly-established COPD Clinical Research Network (CCRN). Many studies are underway to define the pathogenesis of disease and to discover new treatments. Unfortunately, to date, the only interventions shown to significantly change the natural history of COPD are smoking cessation and oxygen therapy.

COPD patients who experience chronic hypoxemia have an especially poor prognosis. More than 20 years ago, two randomized multicenter clinical trials (one NIH supported) clearly demonstrated that chronic provision of supplemental oxygen to these patients provides dramatic benefits, including markedly improved survival. As a result of these studies, provision of long-term oxygen therapy (LTOT) to hypoxemic COPD patients is considered to be the standard of care. Today, roughly 750,000 patients in the United States receive LTOT (82% have COPD), at a cost of roughly $1.8 billion annually - largely supported by Medicare funds. Yet, the lack of subsequent clinical investigations that further delineate these benefits and clarify their physiologic mechanisms leaves substantial uncertainty regarding LTOT policy. Specifically, expert opinion posits that ambulatory oxygen therapy is of benefit to the patient and, indeed, units easily carried by patients (weighing less than 5 lb) are commercially available. Yet the substantial majority of hypoxemic patients able to be ambulatory are supplied only with pressurized oxygen in E-cylinders weighing 22 lb. We therefore propose a multicenter randomized trial in 100 (14 at UCSF) hypoxemic COPD patients comparing the physiologic and clinical benefits of utilizing lightweight ambulatory oxygen systems versus portable E-cylinder systems. The results of this investigation will provide a scientific foundation for the clinical management of hypoxemic COPD patients. It will also clarify the need for more expensive ambulatory oxygen therapy and provide incentive for technologic developments that will inevitably reduce the cost of this therapy.

Inclusion/exclusion criteria (list):
Inclusion:
a. Men or women 40 or more years of age, in a stable phase of their disease, defined as having had no disease exacerbation within the prior 4 weeks.
b. Able to give informed consent.
c. Participants must be ambulatory.
d. Spirometry demonstrating FEV1²60% predicted and FEV1/FVC²65% on screening evaluation.
e. Receiving long term oxygen therapy (LTOT)
f. Patients proceeding to randomization must demonstrate on screening resting arterial blood gas (ABG): PaO2<60 torr. (Note: Currently Medicare regulations specify that patients with PaO2 55-59 torr only be started on oxygen therapy in the presence of one or more of the following, a) dependent edema suggesting congestive heart failure, b) P-pulmonale on resting ECG (P wave greater than 3mm in leads II, III or AVF), erythrocythemia (hematocrit>56%). It was decided to include all patients in this PaO2 range, since it seemed possible that 6 months or more of oxygen therapy might well have, in itself, lead to resolution of some of these consequences of chronic hypoxemia, e.g., dependent edema and erythrocythemia.)

Exclusion:
a. Clinically significant cardiovascular disease, e.g., uncontrolled hypertension, left-sided heart failure, peripheral vascular disease, exertional angina, complex arrhythmias, severe dependent edema, ischemic changes on stress ECG which would be contraindications for ad lib ambulation or the 6 minute walk test.
b. Orthopedic impairments that would limit ambulation.
c. Participation in the active phase of pulmonary rehabilitation within the past three months.
d. Neurologic impairments (e.g., Parkinson's disease, stroke) or with mental states that would limit independent ambulation (e.g., senile dementia).
e. Neoplastic disease that is anticipated to influence survival.
f. Those currently receiving lightweight ambulatory oxygen therapy.
g. Inability to maintain an oxygen saturation of 92% at rest with 4 L/min of continuous oxygen flow and during exercise with a oxygen conserver setting of 6 utilizing a nasal cannula.
h. Those currently smoking.
i. Those with central sleep apnea (treated or not) and those with untreated obstructive sleep apnea.

Method of contact/recruitment (be specific)
Study investigators send a CHR-approved letter to colleagues asking for referrals of eligible patients interested in the study. The investigators will provide the referring physicians a CHR-approved Information Sheet about the study to give to the patients. If interested, the patient will contact one of the investigators. Or, with documented permission from the patient, the one of the investigator may be allowed to talk directly with patients about enrollment.

Benefits/burden for participants (clearly identify potential for harm)

The potential benefits of this study include improved oxygen utilization, which we expect could improve mortality from this disease, and increased activity, which we expect could improve exercise capacity and quality of life over time. We do not anticipate any risks from the major intervention, which is the provision, on a randomized basis, of a lighter, more portable form of oxygen delivery. There will be minor risks to the subjects during certain procedures performed at study visits that relate to arterial and venous blood sampling and monitored exertion during exercise tests and pulmonary function tests. As these procedures are performed commonly in clinical practice, and will take place in a setting monitored by experienced personnel, we feel that these risks are outweighed by the potential benefits. There may be an increased risk of accidental injury due to possible increased ambulation.

Any benefits or burden to DGIM practitioners?

The DGIM practioner may find it helpful to offer their patients an opportunity to participate in research studies. It may allow their patients to have a better understanding of the benefits of oxygen use.

The practitioner would expect to spend less than one minute to hand a flyer to their patient and/ or inform the study investigator about a potential subject.

Timeline for recruitment (projected start and stop dates)

Presently enrolling
Stop date December 31, 2005 with possible extension

Funding source
National Institute of Health

Potential for DGIM collaborators?
Not at present

Do you agree to notify us when recruitment is completed?
YES

Breath Therapy and Back Pain

Can adult patients with chronic low back pain benefit from a proprioceptive training with breath therapy?

RCT pilot study: 15 patients receiving Breath Therapy compared to 15 patients receiving traditional Physical Therapy.

Breath Therapy is a combination of exercises, skillful touch and body awareness. Breath Therapy is different from traditional Physical Therapy as it uses breath differently. It has been used extensively in Europe, but its application in the United States is limited. Reports from Germany suggest that it is helpful in treating low back pain, but this has not been studied using rigorous design.

Approved: Winter 03

PI: Wolf E Mehling, MD, research fellow in Family Medicine and Osher Center for Integrative Medicine (OCIM, Mount Zion Campus) 353-9506 mehling@itsa.ucsf.edu

alternative contact: program manager Stephanie Maurer 353 7795

Yoga for Back Pain

1. To assess the feasibility of recruitment and adherence to a yoga intervention.

2. To assess the effect size of a yoga intervention for sample size calculations for a full-scale trial.

3. To evaluate evidence for statistical trends (p<0.2) of effectiveness of yoga compared with a minimal educational intervention for function, average pain intensity, range of motion, balance and strength.

4. To evaluate whether biological markers of stress and well-being (cortisol, DHEA, IGF-1, SHBG and B-endorphin) are associated with changes in pain among patients with chronic low back pain undergoing a yoga intervention compared with the minimal educational intervention group.

Approved: Fall 02

PI: Bradly P. Jacobs MD, MPH, jacobsb@ocim.ucsf.edu

Primary Contact: Stephanie Maurer (Project Director) maurers@ocim.ucsf.edu

The Impact of Cultural Competency in Primary Care

David Thom, MD
Associate Professor of Family and Community Medicine SFGH
206-4239 dthom@itsa.ucsf.edu

Approved: Winter 01

This project will enroll 40 physicians and approximately 600 ethnically and linguistically diverse patients to (1) validate cultural competency monitoring tools within four types of health care delivery systems; (2) evaluate the effect of feedback of cultural competency performance on improving cultural competency and quality of care; and (3) develop and evaluate a training program for physicians and staff to improve cultural competency.

Effect of citalopram (Celexa) on clinical symptoms and visceral sensitivity in patients with irritable bowel syndrome

PI: Uri Ladabaum, M.D., M.S., ladabau@itsa.ucsf.edu
Craig Pepin, M.D. cpepin@itsa.ucsf-edu

Approved: Fall 01

Does the selective serotonin reuptake inhibitor (SSRI) citalopram (Celexa) decrease the severity of clinical symptoms and the degree of visceral hypersensitivity compared to placebo in patients with irritable bowel syndrome?

Pilot Trial of the Vegan Healthy Eating Program for Obese Adults

1. Can exposure to vegan environmental, health and food-production issues influence a short-term change in dietary pattern in obese adults, when delivered in the context of personal health promotion, through a group-based, educational nutrition program (a vegan healthy eating program)?
2. Can participation in a vegan healthy eating program facilitate weight loss, a change in blood pressure, glycemic control or lipids, or help maintain recent weight loss in obese adults over a 3 month period?
3. Can patients from a university medical clinic be recruited to participate in a vegan healthy eating program?

Approved: in review

PI: Robert Baron, MD
Medical Director, Weight Management & Risk Factor Reduction Program, UCSF
400 Parnassus Ave; SF CA 94143-0320
UCSF Box 0320

Co- Investigators
Mark Berman (Primary Contact)
Doris Duke Clinical Research Fellow
900 Bridgeway, Sausalito, CA 94965 mark.berman@yale.edu

Ruth Marlin, MD
Medical Director, Preventive Medicine Research Institute
900 Bridgeway, Sausalito, CA 94965

Dean Ornish, MD
President and Director, Preventive Medicine Research Institute
900 Bridgeway, Sausalito, CA 94965