Research

PAMFRI Study on Diabetes Management Programs for Economically Disadvantaged Patients Published

October 11, 2011

Dominick Frosch, Ph.D., associate investigator at PAMF Research Institute

The Archives of Internal Medicine have published three randomized controlled trials which examine the effectiveness of behavioral and educational interventions for patients with poorly controlled diabetes. One of the three research trials was directed by Dominick Frosch, Ph.D., associate investigator with the Palo Alto Medical Foundation’s (PAMF) Research Institute (PAMFRI).

The study conducted by Dr. Frosch, with colleagues from the University of California, Los Angeles, examined the effectiveness of a disease management program among socially and economically disadvantaged patients with poorly controlled diabetes.

The study included 201 patients (72 percent African American or Latino; 74 percent with annual incomes of less than or equal to $15,000) with poorly controlled diabetes. Participants were randomized to receive either an intervention package consisting of a 24-minute video behavior support intervention with a workbook and five sessions of telephone coaching by a trained diabetes nurse (treatment group), or a 20-page brochure developed by the National Diabetes Education Program (control group).

Dr. Frosch and his colleagues found that most participants in both the treatment group (94.3 percent) and control group (93.5 percent) had reviewed the assigned treatment materials and the majority (88.5 percent in the treatment group and 89.8 percent in the control group) rated the clarity of the information presented as good, very good, or excellent at the one-month follow-up.

Across treatment groups there was a significant overall reduction in average glycated hemoglobin (HbA1c) levels from study initiation to six-month follow-up, but differences between the groups were not significant.

The study also found that differences in other clinical measures (including blood lipid levels and blood pressure) and measures of diabetes knowledge and self-care behaviors were also not significant.

“More intensive and therefore more expensive interventions may be a worthwhile investment to lower the high costs associated with poorly managed diabetes in the long term. However, larger structural interventions also may be necessary to overcome the many challenges faced by these severely disadvantaged patients,” Dr. Frosch concluded.

The study, which was initiated by Dr. Frosch at University of California, Los Angeles before joining the Palo Alto Medical Foundation Research Institute in 2009, took place during one of the worst economic recessions since the Great Depression.

Dr. Frosch describes the premise and hypothesis of the study:

The costs of diabetes to society have grown enormously in recent years, owing to an increase in the incidence of the disease, driven in large part by the obesity epidemic, and the potentially severe medical complications that can result from diabetes. There is increasing interest in using disease management programs with telephone support to help patients with diabetes achieve better control of their condition and to reduce complications and suffering caused by the disease. We conducted a study to evaluate whether a video behavior support intervention combined with 5 sessions of telephone coaching could help patients from economically disadvantaged backgrounds, who were struggling to control their condition, achieve better outcomes.  The comparison group received a standardized printed brochure about diabetes management, but no telephone coaching.

Our results showed that all patients who participated in the study improved their diabetes control, but contrary to our expectations, patients who received telephone coaching did not do better than patients who did not.

 Many of the patients who enrolled in the study had lost their jobs and were struggling for basic survival. We concluded that for the most economically disadvantaged patients, who face enormous daily challenges, a modest intervention such as the one we tested may not be sufficient and that more intensive interventions appear necessary.

Even though it yielded positive insights, Dr. Frosch’s study is considered a “negative” study because the outcomes did not align with the original hypothesis that the experimental intervention would lead to more  improved health outcomes.

All three reports, including Frosch’s, are part of the journal’s Health Care Reform series. In another report, Katie Weinger, Ed.D., of the Joslin Diabetes Center, Boston, and colleagues, evaluated the efficacy of a behavioral intervention for improving glycemic control among patients with long-duration poorly controlled diabetes. In a third report, JoAnn Sperl-Hillen, M.D., of HealthPartners Research Foundation and HealthPartners Medical Group, Minneapolis, and colleagues evaluated a total of 623 adults from Minnesota and New Mexico with type 2 diabetes and glycosylated hemoglobin (HbA1c) concentrations of seven percent or higher. The authors found that individual education resulted in better glucose control in patients with established sub-optimally controlled diabetes than did group education.

NOTE: JAMA & the Archives Journals are subscription-based, but you can read the full text of the article online for free.

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PAMF Announces Opportunity to Participate in Novel Study

June 29, 2011

Study May Make Research More Convenient and Lower the Cost of Developing New Treatments

Clinical trials are expensive, which drives up the price of drugs and limits the number of new treatments that can be developed. Current trial methods are also inconvenient for participating patients. Researchers at the Palo Alto Medical Foundation (PAMF) believe that conducting trials from home, via a secure system, could lower this cost and make participation in clinical trials easier for patients.

“Because of concerns about patient privacy, nearly all clinical trials require patients to come in and meet with researchers face-to-face for follow-up assessments,” says Hal Luft, Ph.D., director of PAMF’s Research Institute and Caldwell B. Esselstyn, professor emeritus of health economics and health policy at the University of California, San Francisco (UCSF).

“Regular email is not secure enough to replace these in-person appointments, which are costly and often inconvenient for study participants. However, a secure electronic messaging and data collection system—such as the one PAMF uses to communicate with its patients—is safe, private and may work for some research studies,” Dr. Luft says. Investigators at UCSF and Mytrus, a firm that conducts clinical trials, are studying this new approach to undertaking trials.  The PAMF Research Institute is testing whether patients volunteering for this trial are representative of all patients with the problem.

The current study is of a treatment for overactive bladder symptoms. After a first visit, women will communicate with the researchers through a secure password-protected website. The 14-week study is approved by UCSF.

“If the results of the study show that this is an effective way for researchers and study participants to communicate, it could make developing new drugs much less costly in the future and help many patients,” Dr. Luft says.

Interested in Participating in the Study?

The study is seeking women age 21 or older who have symptoms of overactive bladder—feeling the urge to urinate at least eight times a day and sometimes at night, and occasionally leaking urine if unable to get to the bathroom quickly.

If this describes your symptoms, learn more about this innovative study or call 877-448-6987 for more information.

Additional coverage of this innovative, new clinical trial method and study has been featured in the following news outlets. A few of them are listed below:

Wall Street Journal

Reuters

ABC News

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Shared Medical Appointments Help Promote Weight Loss, PAMF Research Shows

January 24, 2011

Latha Palaniappan, M.D., M.S., Principal Investigator, PAMF Research Institute

Obesity is a growing problem in the United States.  Two out of every three adults are either overweight or obese, and would greatly benefit from weight loss to prevent chronic disease, like diabetes.  In order to address this critical issue, the Palo Alto Medical Foundation (PAMF) has piloted an innovative program using Shared Medical Appointments to promote weight loss.

Shared Medical Appointments (SMAs) are group appointments for patients with similar medical concerns.  SMAs include components of a regular office visit, but provide increased time with the physician and allow patients to learn from others.  SMAs provide patients with high-quality medical care and the support of a group environment.

In a specialized SMA designed for weight loss, Amy Muzaffar, M.D., a PAMF Los Altos Center Internal Medicine physician, adapted the Lifestyle Balance Program for PAMF patients.  The Lifestyle Balance Program was developed by the Diabetes Prevention Program Research Group and is supported by the National Institutes of Health (NIH).

Latha Palaniappan, M.D., M.S., an associate investigator at the PAMF Research Institute and her research team, carefully studied the specialized SMAs for more than two years and found that the SMAs were successful in promoting weight loss.  In addition, the more SMAs a patient attended, the more weight was lost.  The findings from this study were accepted in December 2010 for publication by the Journal of the American Board of Family Medicine.  Studies have shown that weight loss can prevent and treat diabetes. 

“This study suggests that for doctors who want their patients to lose weight, it may be better to offer longer group visits than short visits with each patient,” said Dr. Palaniappan.  ”The group visit offers additional benefits of social support and interaction which have been shown to be helpful for weight loss. Shared Medical Appointments are a new and valuable opportunity for patients who want to lose weight and prevent chronic disease.”

Shared Medical Appointments (SMAs) at PAMF

PAMF offers several SMA groups, covering a wide range of health care issues. Related SMA groups are currently offered in the areas of diabetes, nutrition, and cardiology.  Each SMA group is an appointment with a physician which is additionally supported by a multi-dimensional health care team, such as nurses, medical assistants, and behavioral therapists.  For more information about SMAs at PAMF’s Fremont, Los Altos, and Palo Alto Centers, call 650-853-2283.

Learn more:

PAMF Shared Medical Appointment (SMA) study

Diabetes Prevention Program materials (including weight loss and lifestyle changes)

Shared Medical Appointments allow patients to maximize their time and learn from others.  

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PAMF Researchers Awarded AHRQ Grant to Study PAMF as a Patient Centered Medical Home

November 22, 2010

Ming Tai-Seale, Ph.D., MPH, Senior Investigator, Health Policy Research, PAMFRI

Transforming Primary Care Practice

Although leading medical professional societies have identified Patient Centered Medical Homes (PCMH) as a key to revive primary care in the United States, the PCMH model remains largely an aspiration nationwide. Based on the Palo Alto Medical Foundation’s (PAMF) years of experience in implementation of components of the Patient Centered Medical Home and a winning research proposal, researchers at the PAMF Research Institute (PAMFRI) have been awarded a competitive grant from the U.S. Department of Health and Human Service’s Agency for Healthcare Research and Quality (AHRQ) to conduct a study of PAMF as a Patient Centered Medical Home. 

Researchers will gather qualitative (studying interviews) and quantitative (studying measures) information about the actual primary care transformation processes and outcomes. “Insights learned from the study will inform future PCMHs elsewhere and policymakers in need of empirical evidence in developing PCMH payment and administrative policies,” said Principal Investigator Ming Tai-Seale, Ph.D., MPH, Senior Investigator, Health Policy Research at PAMFRI.  “Lessons learned from the transformation process, including understanding critical drivers; costs involved; and impact on frontline staff, physicians, and patients, will be informative to other primary care settings undergoing or thinking of undergoing transformation to PCMHs.”

PAMF Experience with Patient Centered Medical Homes

  • PAMF has been implementing components of PCMH since 1999, and each PAMF division was certified by NCQA’s Physician Practice Connection as a Patient Centered Medical Home in 2006.
  • As a large multispecialty practice, PAMF’s experience is applicable to a wide range of health care delivery settings.
  • The diversity of PAMF’s practice size (from a few physicians to a few hundred physicians), culture, location, heterogeneous patient population and payer mix provide the variability needed to assess the effects of interventions.
  • All PAMF clinics use the same EpicCare Electronic Health Record (EHR) system, allowing uniform assessments across sites.
  • The PAMF Research Institute has a team of experienced investigators with direct access to data, medical leadership and patients, yet remains as an independent research institute to publish all findings.

Aims of the Patient Centered Medical Home Study

  • Describe methods used to transform practices, with attention to the organizational context and culture and conditions within which changes have occurred.
  • Assess the changes in processes, intermediate clinical outcomes, and costs and efficiency of care. Empirical approaches range from key informant interviews, focus group, to a retrospective quantitative quasi-experimental study with data drawn from EpicCare EHR, IDX scheduling, and billings data.
  • Determine the impact of the transformative processes on the actual experiences and satisfaction of doctors, patients and staff. Key informant interviews and focus groups data will be collected for the study and leveraged with routinely collected past and ongoing surveys undertaken by the organization.

Learn more about the PAMF Research Institute.

Learn more about the Agency for Healthcare Research and Quality (AHRQ).

Learn more about Patient Centered Medical Homes.

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PAMF Researchers to Present Findings at American College of Epidemiology Annual Meeting

August 20, 2010

Findings Highlight Need for Intervention Programs Emphasizing Fitness, Nutrition

Lead researcher, Latha Palaniappan, M.D., M.S., and her team at the Palo Alto Medical Foundation Research Institute (PAMFRI) will present their most recent findings from three separate studies at the American College of Epidemiology  Annual Meeting in San Francisco, California, on September 11-14, 2010.

Each year, the American College of Epidemiology invites submission of research topics for their annual meeting from different areas, such as medicine, statistics, sociology, genetics, and biology. Dr. Palaniappan and her research team will deliver three poster presentations on the following topics: 1) methods for overcoming partially missing data, 2) colon cancer screening rates, and 3) cardiovascular disease prevalence rates.

PAMF is one of the nation’s earliest adopters and leaders in the use of electronic health records  (EHRs). Dr. Palaniappan and her team use de-identified data from the EHRs at PAMF to study trends in and risk factors for obesity, type 2 diabetes and cardiovascular disease.

Study investigates risk factors for and incidence of diabetes in Asian American subgroups.

Dr. Palaniappan is the primary investigator of the Pan Asian Cohort Study (PACS), a study funded by the National Institute of Diabetes, Digestive, and Kidney Disease to investigate risk factors for and incidence of diabetes in Asian American subgroups. Obesity, a major risk factor for diabetes, is most often defined by body mass index (kg/m2), and is calculated using measured height and weight. Body mass index is an important tool used by physicians to calculate risk for chronic diseases, such as diabetes and cardiovascular disease. For a variety of reasons, body mass index is sometimes partially missing within the EHR. Dr. Palaniappan and colleagues compared methods for overcoming partially missing body mass index data in the EHR. These findings will be applicable to researchers across the nation who study obesity as a risk factor.

Study uses EHRs to compare colorectal cancer screening rates at PAMF to statewide self-report survey data from the California Health Interview Survey (CHIS), the largest state health survey in the U.S.

While missing data is one limitation of  an EHR, EHRs also provides a great deal of information, such as the number of patients with up-to-date colorectal cancer screenings. Colorectal cancer is the second leading cause of death in the U.S., and routine screening is recommended for patients ages 50-75. Several national and state surveys collect self-reported information on colorectal screening use. However, survey data are thought to overestimate receipt of screening tests. Dr. Palaniappan collaborated with Dr. Annette Maxwell, a researcher at UCLA, to compare colorectal cancer screening rates at PAMF to statewide self-report survey data from the California Health Interview Survey (CHIS), the largest state health survey in the U.S. The colorectal cancer screening rates from CHIS self-report data were higher than screening rates at PAMF, suggesting that there is over-reporting in colorectal cancer screening utilization in self-reported survey data.

Study investigates prevalence of stroke, coronary heart disease, peripheral vascular disease (PVD) in Asian American and Non-Hispanic White (NHW) patients at PAMF.

Cardiovascular disease is the leading cause of death in California and the United States. Dr. Palaniappan received a grant from the American Heart Association to investigate the prevalence of stroke, coronary heart disease (CHD) and peripheral vascular disease (PVD) in Asian American and Non-Hispanic White (NHW) patients at PAMF. There are considerable differences in Asian American subgroups with regard to stroke, CHD and PVD. Filipinos and Asian Indians are much more likely to develop CHD than other Asian subgroups and NHWs. While high rates of CHD among Asian Indians are increasingly recognized, Filipinos are less well studied. Dr. Palaniappan believes that future research should study Asian subgroups separately to better understand variation in disease patterns.

The American College of Epidemiology’s annual meeting will provide an important opportunity to present PAMFRI’s research findings and to raise awareness of health issues affecting patients.

Dr. Palaniappan was supported in part by a grant from the American Heart Association (0885049N ) and a grant from the National Institutes of Health  (5R01DK081371-02).

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