This ICR is
approved consistent with memos of 8-29-07, 10-2-07, and 10-22-07.
As per 10-22-07 memo, AHRQ will disclose all study limitations
whenever results from this study are made public. To the extent
that this study might include patients in the control group who
have some level of MTM/MR already but which is not detected through
this study screening mechanism, this will also be disclosed as a
study limitation. Finally, even though the supporting statement
discusses the need for effective approaches to MTM that address
cultural, linguistic, or other communication barriers, AHRQ should
clarify that this study will be limited in its ability to address
cultural/ethnic/linguistic barriers since the intervention will be
conducted in English only and non-English speakers will be excluded
from the study.
Inventory as of this Action
Requested
Previously Approved
11/30/2010
36 Months From Approved
3,800
0
0
2,286
0
0
0
0
0
The Medicare Modernization Act of 2003
(MMA) requires Medicare prescription drug plans to have a MTMP that
is developed in cooperation with licensed and practicing
pharmacists and physicians for targeted beneficiaries. MTMP is
defined in the MMA as a program of drug therapy management that is
designed to assure, with respect to targeted beneficiaries, that
covered part D drugs are appropriately used to optimize therapeutic
outcomes through improved medication use, and to reduce the risk of
adverse events, including adverse drug interactions. The proposed
MTMP research project will prospectively evaluate the effects of a
specific drug therapy management program on health outcomes and
patient safety in a group of research subjects aged 65 or older,
living with multiple chronic health conditions and taking multiple
Part D medications. The evaluation will be designed as a
randomized, controlled study with subjects recruited from multiple
ambulatory care or family practice medical clinics in the states of
Illinois, North Carolina, and Texas. The study will be coordinated
by clinical scientists, physicians, and pharmacists affiliated with
AHRQ, Baylor Health Care System, Duke University, RTI
International, and the University of Illinois at Chicago. The study
protocol and data collection procedures for the MTMP research
evaluation will be reviewed by the official Institutional Review
Boards at each participating study site. The study will be
conducted in accordance with the Privacy and Security regulations
of the Health Insurance Protection and Portability Act, 45 CFR
Parts 160, 162 and 164 and with 45 CFR part 46, the ``Common rule''
regarding the Conduct of Research Involving Human Subjects. An
informed consent with be obtained (see Table below) prior to
subject enrollment in the study. For individuals who consent to
participate, confidential identifiable information will be
collected as described in the informed consent document. Subjects
will be asked to provide information about medication use, health
service use, health status, adverse drug events, satisfaction with
the MTMP, and demographics. Study pharmacists will assess subject's
medication use, the appropriateness of each prescribed medication
using a validated scale, and will provide information about their
own satisfactions with the MTMP. All study information will be
entered and maintained in a secure, password-protected database and
will be protected in accordance with AHRQ's confidentiality
statute, Section 934(c) of the Public Health Service Act (42 U.S.C.
299 c-3(c)).
US Code:
9 USC
580 Name of Law: Agency for Healthcare Research and Quality
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
OMB_Review_Responses_2_070910.doc
Evaluation of a Medication Therapy Management Program to Improve Patient Safety in Medicare Beneficiaries