 |
 |
|
Building a Better Physician - The Case for the New MCAT
April 5, 2012
Applications are being accepted for Physician with Behavioral and Social Science Expertise position. Deadline: 05-14-2012
May 4, 2012
The New Journal Supplement on Racial/Ethnic Discrimination and Health
April 23, 2012
U.S. Cancer Rates Could Be Cut in Half Today Based on What's Already Known
March 29, 2012
More News >>
|
 |
|
June 10 - 15, 2012
Washington University, St. Louis
2012 Institute on Systems Science and Health (ISSH)
 Add Event to your Calendar
July 9 - 12, 2012
San Jose, CA
Training Institute for Dissemination and Implementation Research in Health
Add Event to your Calendar
July 9 - 13, 2012
New York, NY
2012 NIH Summer Institute on Social and Behavioral Intervention Research
Add Event to your Calendar
More Events >>
|
|
|
 |
|
 |
|
|
Home > Grants > Requests For Applications > AdherenceAwards
|
Adherence Awards |
Testing Interventions to Improve Adherence to Pharmacological Treatment Regimens
RFA OD-00-006
Background
With the participation of 12 NIH Institutes and Centers, OBSSR initiated, coordinated,
and released this call for research on January 19, 2000. Applications in response proposed
research where (1) the therapeutic regimen includes a pharmacological treatment; (2) the
therapeutic regimen must be for an existing illness or condition, whether acute or chronic,
as opposed to a health promotion regimen; (3) the adherence intervention has been (a)
demonstrated to be efficacious in controlled settings (e.g., laboratories, clinical trials),
(b) tested only with limited populations (e.g., small samples or samples from
restricted populations) or with short periods of follow-up, or (c) researched on a health condition or
treatment regimen different from that in the proposed research; (4) the adherence
intervention targets individuals, formal or informal health-care providers, and/or the social or
institutional environment; and (5) there are measurements of (a) the delivery of
the specified therapeutic regimen and adherence intervention (i.e., treatment fidelity) and of (b)
adherence to the regimen. The participating NIH Institutes made seven awards
in September 2000, using $3,000,000 provided by OBSSR and, in some cases, supplemented by their own
funds.
Meeting of Grantees, October 2003
Research Grants Awarded
Improving Adherence to Pharmacological Treatment
Ira S. Ockene, M.D.
University of Massachusetts Medical School
Worcester, MA
R01 HL066786
The overall goal of this study is to implement and evaluate the effects of a systems-based
and pharmacist-mediated program designed to improve adherence to lipid-lowering pharmacologic
therapy for patients with known coronary heart disease (CHD) and of their physicians/nurse
practitioners (MD/NPs) to the National Cholesterol Education Program Guidelines. The program
to be tested will intervene on three levels: the patient, the provider, and the system.
In this two-condition randomized clinical trial the Intervention condition will include: (1) a
computer-based tracking system designed to facilitate follow-up of patients who were
initially seen for a coronary clinical event at the University hospital of UMass Memorial Health-Care,
Inc.; and (2) an initial inpatient contact and a series of coordinated follow-up patient
telephone counseling sessions carried out by pharmacists using a patient-centered approach to improve
adherence. The pharmacists will utilize pharmacy refill records to obtain medication
adherence information, and will provide feedback and recommendations to the patients and MD/NPs.
The study population will consist of 800 patients admitted for a clinical CHD event and
recruited from the cardiac catheterization laboratories. Patients will be randomly assigned to a
control (usual care) condition (UC) that will consist of patients provided with usual
care only, or to the adherence-enhancing Special Intervention condition (SI). The patient is the unit
of randomization and analysis. SI will be implemented and coordinated by pharmacists,
who will utilize the Lotus Notes-based tracking system that we have developed and used successfully in
a number of previous projects.
The primary outcomes which will be evaluated at one year are the following:
- Percentage of patients with an LDL level < 100 mg per dl;
- Proportion of prescribed lipid-lowering medication taken by patients as
measured by a continuous multiple-interval
availability (CMA) measure based on pharmacy records (ratio of days
supply obtained to total days in the observation period).
Secondary outcomes will include:
- Percentage of patients on pharmacologic lipid lowering therapy
- Proportion of selected non-lipid-towering prescribed medication taken by patients as measured by CMA; and
- Percentage of patients with an LDL level <130 mg per dl
Increasing Treatment Adherence through Social Engagement
Larry Davidson, Ph.D.
Yale School of Medicine
New Haven, CT
R01 DA013856
Lack of adherence to medication and outpatient treatment along with
substance abuse are two of the most troubling factors to emerge as
persons with psychotic disorders have returned to the
community. These factors have combined to produce a new cohort of
patients who experience poor clinical and functional outcomes and a
revolving door cycle of
recurrent inpatient and detoxification admissions followed by continued
drug use. Primarily young and in urban settings, these patients are more likely to be
from ethnic minority communities and to be disaffiliated from traditional
mental health services. This study evaluates the effectiveness of an innovative approach
to increasing medication and outpatient treatment adherence among this
population that combines a peer-run engagement program with intensive community-based clinical
care. Based on input from dually diagnosed patients, including those
of African-American and Latino origin, this approach is informed by a theoretical model in which
adherence is hypothesized to be mediated by social support, self-efficacy,
and degree of collaboration and cultural sensitivity present in treatment relationships
between patients and their mental health providers. Aims include evaluations
of this theoretical model and of the effectiveness of the social engagement intervention
as compared to standard care with and without a medication compliance skills
training module in increasing medication and outpatient treatment adherence and level of
functioning and decreasing psychiatric symptoms, substance abuse, and the rate
and duration of readmissions in the first 3 and 9 months following hospitalization.
To achieve these aims, a controlled clinical trial will be conducted involving
360 adults with co-occurring psychotic and substance use disorders recruited during
hospitalization over a 36-month period. Process measures will be employed to
ensure fidelity of the interventions in each of the three conditions. The theoretical
model informing the intervention and its effectiveness will be assessed through
interviews at baseline, 12 weeks, and 9 months follow-up post-discharge from index
hospitalization on measures of social support, self-efficacy, degree of collaboration
and cultural sensitivity present in treatment relationships, treatment adherence,
clinical and functional status, substance abuse, and inpatient and detoxification service utilization.
Medication Adherence and Outcomes in Schizophrenia
Dawn I. Velligan, Ph.D.
University of Texas Health Science Center
San Antonio, TX
R01 MH062850
It is well established that poor adherence to antipsychotic medication can lead to relapse
and rehospitalization for schizophrenia patients. Prominent among the many
reasons for non-adherence to pharmacotherapy are cognitive deficits that contribute to
forgetting to take medication and the failure to establish promoting adherence.
In a series of studies, we showed that Cognitive Adaptation Training (CAT)-a manual-driven
set of environmental supports (signs, checklists, electronic devices)
designed to bypass specific neurocognitive deficits-significantly improved symptomatology,
adaptive functioning and rates of relapse in schizophrenia patients compared
to control conditions. One interpretation of these results is that the environmental supports,
established specifically to increase adherence to medications, were
responsible for the better outcomes observed in CAT. We plan to examine this issue in a sample
of 90 schizophrenia patients on atypical antipsychotic medications. After
obtaining blood levels during hospital stay to determine intraindividual variability in plasma
concentration of antipsychotic medication during optimal adherence,
patients will be followed prospectively from the time of discharge for three months. This will
allow us to examine predictors of poor adherence to atypical antipsychotics
in the sample. Next, patients will be randomly assigned for 9 months to one of three treatment groups:
1) Full-CAT, (a comprehensive use of environmental supports to improve multiple areas of adaptive functioning),
2) Pharm-CAT (supports for medication adherence only),
3) Treatment as usual. All patients will be followed for 6 months after CAT treatments have been
discontinued. Primary outcome variables will include medication compliance
(blood levels), and measures of symptomatology, and adaptive functioning obtained at study entrance
and every three months. Analyses of covariance, with pretreatment scores
used as covariates, will be utilized to examine group differences on the outcome variables
at the end of treatment and follow-up. We hypothesize that both Pharm-CAT and Full-CAT
will improve adherence, symptomatology and rates of relapse but that only the comprehensive
Full-CAT program will improve adaptive functioning. Moreover, we hypothesize that
compliance and functioning will return to baseline levels six months after discontinuation of treatment.
Tuberculosis Adherence Partnership Alliance Study
Wafaa El-Sadr, M.D., M.P.H.
Harlem Hospital Center
New York, NY
R01 HL066782
Tuberculosis (TB) remains a major health threat in Harlem where TB case rates markedly
exceed national rates. A recent statement by the Advisory Council on the Elimination of
TB highlights the importance of identifying persons with latent TB infection (LTBI),
providing appropriate preventive treatment for those at high risk for progression to TB
disease, and ensuring completion of treatment by at least 80% of those who initiate therapy.
However, completion of LTBI treatrnent is challenging as patients are asymptomatic,
are often unaware of the availability of effective preventive therapy, have unrealistic optimism,
do not appreciate the severity of TB disease and may overestimate the potential
adverse events. In addition, they may have many competing priorities in their lives and few suupport
networks. Finally, they may not have role models who have adopted this
precautionary behavior.
We propose to conduct a randomized clinical trial to compare the efficacy and cost-effectiveness of
an experimental intervention when compared to current clinical practice.
The experimental intervention will utilize key behavior models that are especially suited to LTBI
and its treatment, the Health Belief Model (HBM) and the Precaution Adoption
Process Model (PAPM). The HBM focuses on the patient's perception of susceptibility, severity,
benefits, preservation of health, barriers, and self-efficacy. The PAPM will permit
assessment of the patient's stage in adopting LTBI treatment and facilitate delivery of stage-specific
intervention. Peers, who themselves have been treated for LTBI, will be
utilized to deliver the experimental intervention as they are uniquely equipped to intervene on the
perceptual level and to provide patients with much-needed role models. It is
estimated that the sample size will be 360 participants.
Participants will undergo baseline and regular follow-up assessments to determine adherence with LTBI
treatment via several methods: self-report, computer touch-screen method,
MEMs caps, pharmacy records and provider/peer assessments. In addition, the following data will be
collected: demographic characteristics, PAPM behavior stage, social support,
life stressors, quality of life, substance use, mental illness, literacy, perceived benefit/perceived
barriers, self-efficacy, substance use, TB knowledge and attitudes, and health
care utilization.
It is especially appropriate to conduct this study in the Harlem community where patients with LTBI
are often members of those exact groups recently identified at high risk for
progression to TB disease and who are currently targeted for LTBI treatment.. Additionally, the
recent availability of a two-month short course LTBI treatment regimen offers an
opportunity to assess adherence interventions for this condition with the goal of achieving high
treatment completion rates. The identification of a practical, generalizable,
efficacious as well as cost-effective intervention to enhance adherence with this pharmacologic
therapeutic regimen is likely to have a substantial impact on TB control in this and
other communities.
Improving Medication Adherence in Co-morbid Conditions
Jacqueline Dunbar-Jacob, Ph.D., RN, FAAN
University of Pittsburgh
Pittsburgh, PA
R01 DK059048
Improving Medication Adherence in Comorbid Conditions: Approximately 50 percent of persons
on prescribed pharmacological therapy have difficulty adhering to their regimen. This difficulty
contributes significantly to such adverse outcomes as hospitalization, the development of
complications, disease progression, premature disability or death. The costs of poor adherence have
been estimated to approach $100 billion dollars a year. Little effort, however, has been
directed to the evaluation of adherence intervention strategies and few of those to remedial efforts.
A population at particular risk for poor adherence and resulting untoward outcomes are
those persons with co-morbid chronic conditions. No efforts have been directed to the remediation of
pharmacological adherence problems in this group. It is the aim of this proposed study to evaluate an
intervention developed within a problem-solving framework, which has been shown to be
effective for a single pharmacological regimen for a single chronic disorder, within a sample on
multiple pharmacological therapies for co-morbid conditions. The model for co-morbidity with
multiple therapies that we have chosen is Type 2 diabetes with concurrent hypertension and hyperlipidemia.
This is a prevalent co-morbid condition with high risk for multiple adverse clinical
outcomes. Using a randomized, controlled design, we propose to examine the impact of a telephone delivered
counseling intervention among 198 poor adherers who are being treated with oral
medications for each of these disorders. Subjects receiving adherence counseling will be further randomized
into a maintenance arm and an observation arm for an additional six months. All
subjects will have adherence and clinical outcomes assessed at baseline (t1), the end of the 6-month
intervention (t2), and again after the six-month follow-up period (t3). Potential
predictors of adherence and responsiveness to intervention will be examined, including such factors as
cognitive and physical function, quality of life, social support, and perceived
problem solving ability, and sociodemographic as well as psychosocial factors. Secondarily, we propose
to explore the cost-effectiveness of improving adherence with this intervention. A sample
of approximately 198 good adherers, identified during screening, will also be invited to continue
adherence monitoring for a 12 month period of time to identify the stability of good
adherence levels as well as to identify factors that influence that stability.
Improving Drug Use for Elderly Heart Failure Patients
Michael D. Murray, PharmD., MPH
Regenstrief Institute for Health Care
Indianapolis, IN
R01 AG019105
Older adults with chronic heart failure need assistance with their medications to facilitate
medication adherence and improve their health outcomes. Adherence
decreases in patients who have complicated medication regimens. Recent expert guidelines for
the treatment of heart failure recommend that patients receive as many as
four to five medications. Furthermore, many older adults with heart failure must regularly
administer and manage additional drugs for their other chronic diseases. Although
medications have been shown to reduce morbidity and mortality of patients with heart failure,
patients must reliably take them to derive any benefits. A particular concern in the
United States is that during the past decade rates of hospitalization and death have
disproportionately increased in elderly patients with heart failure. Recent studies suggest
that the outcomes of patients with heart failure improve when pharmacists provide patients with education and monitoring.
Drawing upon our recent studies of pharmaceutical care for patients with chronic
diseases, we aim to develop and test a multileveled pharmacy-based program to improve the care of
patients with heart failure. The program is built upon two models:
(1) a social-cognitive model for medication adherence, and
(2) a behavioral model of healthcare utilization. We have designed patient education materials
and medication packaging that have been specifically formafted to promote comprehension by older adults.
Using these materials, a schema for instruction for use by a pharmacist and a computer, which is
integrated into an electronic medical record system, we will conduct a randomized controlled trial.
Elderly patients (N=244) with heart failure will be assigned to usual care or to intervention by
a pharmacist equipped with the designed educational support and integrated computer.
The study duration will be 12 months: Nine months of active intervention and three months of
post-intervention follow-up. Adherence will be assessed using electronic monitoring of all medications for
heart failure. Endpoints of the trial will include health-related quality of life, heart failure
exacerbation, patient satisfaction, and health-care costs. We hypothesize that the pharmacy-based
program will result in improved adherence to heart failure medications, which will be accompanied
by improved health-related quality of life, fewer exacerbations of heart failure,.greater
satisfaction with care, and reduced health care costs.
Improving Adherence for Dyslipidemia and Anticoagulation
Peter Rudd, M.D.
Stanford University
Stanford, CA
R01 HL066799
The proposed project seeks to improve the medication adherence and clinical control of
ambulatory patients prescribed treatment for two clinical situations:
(1) Chronic oral administration of 3-hydroxy-3-methylglutaryl coenzyme A reductase
inhibitors (statins) for reducing dyslipidemia and thereby cardiovascular morbidity and mortality, and
(2) Chronic oral anticoagulation therapy with warfarin for dysrhythmias, prosthetic
heart valves, congestive heart failure, and thromboembolism. These situations reflect high prevalence, considerable
long-term risk, well-defined and established therapies, demonstrable benefit exceeding risk
from treatment, but disappointing overall impact in real world settings. Improving adherence
for these situations should translate into better clinical outcomes and provide lessons
useful for other conditions requiring long-term treatment with oral medications without prompts from symptoms.
The project is a randomized controlled trial that
(a) applies adherence -enhancing interventions at the levels of patient, physician,
and medical care system for the two clinical situations;
(b) demonstrates that improved levels of medication adherence occur in the intervention
compared to the usual care groups;
(c) evaluates the potential for dissemination by replicating into community-based practices
the successful interventions from academic clinic settings; and
(d) assesses the cost-effectiveness of the interventions compared to usual care in both
academic and community practice environments.
The primary hypothesis is that the integrated interventions will achieve significantly
higher levels of days with correct dosage for these two treatment conditions compared to usual care.
The interventions reflect both social cognitive and self-determination
theory as well as continuous quality improvement strategies using clinical
process guidelines. Patients' achievements by levels of adherence and clinical control provide
a strategic matrix for feedback that guides actions by the prescribing physician and the project
educator. Electronic medication monitoring allows dynamic and comprehensive assessment of medication adherence by
day as well as by longer interval corresponding to times of clinical visits and evaluation.
Feedback from such monitoring to both patient and physician as well as physicians' adherence to practice guidelines provides
keys to improving overall adherence and outcomes.
|
|
|
|
 |
|
 |
|
|
|