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