Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care
Formerly:
Improving HIV Prevention and Treatment Outcomes Among HIV-Infected
Persons by Integrating Community Pharmacists and Clinical Sites into
a Model of Patient-Centered HIV Care
(60 day published under
the longer title)
OMB No. 0920-NEW
Supporting Statement B
January 17, 2014
Kathy Byrd, MD, MPH, Project Officer
Centers of Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division
of HIV/ AIDS Prevention- Surveillance and Epidemiology
HIV
Epidemiology Branch
1600 Clifton Rd., MS E-45
Atlanta, GA 30333
Phone: 404-639-3083
Fax: 404-639-6127
Email: [email protected]
TABLE OF CONTENTS
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
1. Respondent Universe and Sampling Methods
2. Procedures for the Collection of Information
3. Methods to Maximize Response Rates and Deal with Nonresponse
4. Tests of Procedures or Methods to be Undertaken
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
References
Project overview
To address these problems, CDC has entered into a partnership with Walgreen Company (a.k.a Walgreens pharmacies, a national retail pharmacy chain)and the University of North Texas Health Science Center (UNTHSC) to develop and implement a model of HIV care that integrates community pharmacists with primary medical providers for patient-centered HIV care. The model program will include the core elements of MTM which include: Medication Therapy Review, Personal Medication Record, Medication-related action plan, Intervention and/or referral and Documentation and follow-up.(8) In addition, project pharmacists will perform additional services such as individualized medication adherence counseling, active monitoring of prescription refills and active collaboration with medical clinic providers to identify and resolve medication related treatment problems such as treatment effectiveness, adverse events and poor adherence.
The service model will be developed by CDC in collaboration with Walgreens pharmacies and UNTHSC. The University of North Texas Health Science Center is a CDC grantee funded through a co-operative agreement who will manage and coordinate project sites, collect data from the project sites and transmit the data to CDC.
The pilot program will be conducted in ten project sites. Each project site will be made up of at least one Walgreens pharmacy and one medical clinic with which the pharmacy will partner. Each project pharmacy will be a Walgreens HIV Center of Excellence (COE). Walgreens COEs are pharmacies that are staffed with specially-trained pharmacists who work closely with HIV patients to offer guidance and support with their medication therapy. A total of 1000 HIV-infected persons (~100 patients per site) will be enrolled in the patient-centered HIV care pilot project. The project sites will enroll minority populations disproportionately affected by HIV. Walgreens will provide expanded MTM services to participants of the pilot program and will work with medical clinic providers to implement the service model.
The project clinics will be funded to participate in the project through a sub-contract of the co-operative agreement. Walgreens is donating its time and resources in-kind. Project staff at project clinics and pharmacies will collect data from their respective clinics and pharmacies. Most data collected from the project clinics and pharmacies are routinely collected as part of normal patient care. Program data will then be sent to the grantee (UNTHSC) who will clean the data and resolve any data discrepancies before sending the data to CDC.
The patient-centered HIV care model program is a 3 year pilot project. No statistical sampling will be used to identify or enroll project participants. Project outcomes will be compared within the project cohort (i.e. outcomes pre- and post-intervention) and are not meant to be generalizable to the general public. Rather, the purpose of the project is to develop a patient-centered HIV care model to increase clinic and pharmacy collaboration and to determine the service model’s performance within the project cohort. The expected outcomes, of the model program, are improved retention in care, adherence to medication therapy and viral load suppression, among the project cohort. The project has been determined to not be human subjects research.
B. Collections of Information employing statistical methods
1. Respondent Universe and Sampling Methods
Our sample will be a non-probability based convenience sample. The respondent universe is HIV-infected persons, from targeted minority populations, receiving HIV medical care at one of the 10 project sites. Targeted minority populations include Black, Latino and American Indian/Alaska Native populations. A project site will contain one or more Walgreens pharmacy and one or more medical clinic. Each project site will enroll 100 patients for a total of 1000 patients.
The sample size is based on the maximum number of patients to which Walgreens Company is willing to provide in-kind services. Because project clinics must be chosen in concert with Walgreens project pharmacies (who will ultimately decide which pharmacies will participate), no sampling methods will be employed to choose project sites. Both the project sites and project participants will represent convenience samples.
Participant eligibility includes HIV patients 18 years of age and older who receive medical care at one of the project clinics. CDC will work with Walgreens and the University of North Texas Health Science Center to define additional eligibility criteria. Participants will be enrolled into the project on a rolling basis until each project site has enrolled the targeted number of participants.
2. Procedures for the Collection of Information
Data collection methods
Project clinics and pharmacies are the sites for the data collection. Most data will be abstracted from the clinics’ and pharmacies’ archived patient medical and pharmacy records by project clinic and pharmacy staff. Data collected from participants’ medical and pharmacy records are routinely collected and stored information used by participants’ providers for routine medical care. Medical record data will be abstracted at the baseline of the study and quarterly thereafter. Pharmacy record data will be abstracted quarterly. In addition, baseline descriptive data on the characteristics of the project sites will be collected at the beginning of the project by project staff and annually thereafter.
Data Transmittal
The project clinics and pharmacies will send data to the grantee who will clean the data, resolve data discrepancies and then transmit the data to CDC. Data will be electronically transmitted to CDC through the CDC Secure Data Network (SDN). All data transmissions are automatically encrypted by the software that generates the transfer files. Security certificates are used to control access to the SDN.
Sample Size Justification
This
project has a fixed maximum sample size of m
= 10 sites and 100 participants per site, giving a total of
= 1000 participants. We account for the group structure of this
non-randomized trial by assuming a standard intraclass
correlation
of
=
5%. We also account for the potential loss of retention by assuming
that
= 20% of
participants will be lost to follow-up over the course of the
project. We
thus obtain an effective sample size of
= 441. See Table 1 for the effective sample sizes (ESSs) for
various intraclass correlations (
and
proportions of loss-to-follow-up (
).
The
primary outcomes are the binomial proportions of participants with a
HIV diagnosis who (a) are retained in care (b) are virally suppressed
(c) are adherent to HIV medication therapy. Retention in care will
be defined as the percentage of patients who had at least one medical
visit in each 6-month period of the measurement period with a minimum
of 60 days between medical visits. A medical visit is any visit at
the project clinic with a physician, nurse practitioner and/or a
physician assistant. HIV viral load suppression will be defined as
the proportion of participants with HIV viral loads < 200
copies/ml at the end of the project period. The Proportion
of Days Covered
(PDC) will be used to calculate adherence to HIV medication therapy.
The PDC is defined as the total number of days a patient was in
possession of a medication divided by the number of days between
the patient’s last fill date and last fill date plus the days’
supply of the last fill. These outcomes will be measured for
all participants both at baseline (BL) and 24 months follow-up (FU).
Thus, the data will be paired on each participant. Improvements
(changes) in these outcomes will be tested using McNemar’s test
with a two-sided significance level of
= 5%.
We
assume that the BL proportions for each of these three outcomes are
(a)
= 45%, [1] (b)
= 75% [2] and (c)
= 69% [3] respectively. For the above effective sample size of
= 441, we
have 80% power to reject the null hypothesis of no change when the
absolute increases in these proportions at FU for each of these three
outcomes are at least (a)
= 10%,
(b)
= 8%, and (c)
= 9%, respectively. For
the above effective sample size of
= 441, we
have 90% power to reject the null hypothesis of no change when the
absolute increases in these proportions at FU for each of these three
outcomes are at least (a)
= 11%,
(b)
= 9%, and (c)
= 10%, respectively. Tables 2 and 3
Table
1: Effective sample sizes for
various intraclass correlations (
)
and
proportions of loss to follow-up (LTFU,
)
|
intraclass
correlation ( |
||||||||||
LTFU ( |
0.00 |
0.01 |
0.02 |
0.03 |
0.04 |
0.05 |
0.06 |
0.07 |
0.08 |
0.09 |
0.10 |
0.00 |
1000 |
917 |
847 |
787 |
735 |
689 |
649 |
613 |
581 |
552 |
526 |
0.05 |
902 |
827 |
764 |
710 |
663 |
622 |
586 |
553 |
524 |
498 |
475 |
0.10 |
810 |
743 |
686 |
637 |
595 |
558 |
525 |
496 |
470 |
447 |
426 |
0.15 |
722 |
662 |
612 |
568 |
531 |
498 |
469 |
443 |
420 |
399 |
380 |
0.20 |
640 |
587 |
542 |
503 |
470 |
441 |
415 |
392 |
372 |
353 |
336 |
0.25 |
562 |
516 |
476 |
442 |
413 |
387 |
365 |
345 |
327 |
310 |
296 |
0.30 |
490 |
449 |
415 |
385 |
360 |
337 |
318 |
300 |
284 |
270 |
257 |
0.35 |
422 |
387 |
358 |
332 |
310 |
291 |
274 |
259 |
245 |
233 |
222 |
0.40 |
360 |
330 |
305 |
283 |
264 |
248 |
233 |
220 |
209 |
198 |
189 |
Table
2: Sample sizes required to have 80% power to reject the null
hypothesis of no change from baseline to follow-up using McNemar’s
test with two-sided significance level of
= 0.05.*
|
absolute
increase from BL to FU ( |
||||||||
BL
% ( |
0.05 |
0.06 |
0.07 |
0.08 |
0.09 |
0.10 |
0.11 |
0.15 |
0.20 |
0.35 |
1474 |
1029 |
761 |
586 |
465 |
379 |
315 |
173 |
99 |
0.40 |
1537 |
1071 |
789 |
606 |
481 |
391 |
324 |
176 |
100 |
0.45 |
1568 |
1090 |
802 |
615 |
487 |
395 |
326 |
176 |
99 |
0.50 |
1568 |
1088 |
799 |
611 |
483 |
391 |
322 |
173 |
96 |
0.55 |
1537 |
1064 |
780 |
595 |
469 |
379 |
312 |
166 |
91 |
0.60 |
1474 |
1018 |
745 |
567 |
446 |
359 |
295 |
155 |
84 |
0.65 |
1380 |
951 |
693 |
527 |
413 |
332 |
272 |
141 |
76 |
0.70 |
1254 |
862 |
626 |
474 |
370 |
296 |
242 |
124 |
65 |
0.75 |
1097 |
750 |
543 |
409 |
318 |
253 |
206 |
103 |
52 |
0.80 |
909 |
617 |
443 |
332 |
256 |
202 |
163 |
78 |
-- |
0.85 |
689 |
463 |
328 |
242 |
184 |
143 |
114 |
-- |
-- |
*Assuming
a minimal within-participant correlation of
= 0.
Table
3: Sample sizes required to have 90% power to reject the null
hypothesis of no change from baseline to follow-up using McNemar’s
test with two-sided significance level of
= 0.05.*
|
absolute
increase from BL to FU ( |
||||||||
BL
% ( |
0.05 |
0.06 |
0.07 |
0.08 |
0.09 |
0.10 |
0.11 |
0.15 |
0.20 |
0.35 |
1972 |
1377 |
1017 |
783 |
622 |
506 |
420 |
230 |
132 |
0.40 |
2056 |
1432 |
1056 |
811 |
642 |
522 |
432 |
234 |
133 |
0.45 |
2098 |
1459 |
1073 |
822 |
650 |
527 |
436 |
234 |
132 |
0.50 |
2098 |
1456 |
1069 |
817 |
645 |
522 |
431 |
230 |
128 |
0.55 |
2056 |
1424 |
1043 |
796 |
627 |
506 |
417 |
220 |
121 |
0.60 |
1972 |
1362 |
996 |
758 |
596 |
480 |
394 |
206 |
112 |
0.65 |
1846 |
1272 |
927 |
704 |
552 |
443 |
363 |
188 |
100 |
0.70 |
1678 |
1152 |
837 |
633 |
494 |
396 |
323 |
164 |
86 |
0.75 |
1467 |
1003 |
725 |
546 |
424 |
338 |
274 |
136 |
68 |
0.80 |
1215 |
825 |
592 |
443 |
341 |
270 |
217 |
104 |
-- |
0.85 |
921 |
618 |
438 |
323 |
245 |
191 |
151 |
-- |
-- |
*Assuming
a minimal within-participant correlation of
= 0.
3. Methods to Maximize Response Rate and Deal with Nonresponse
Most of the data collected for this project is routinely collected and archived by the project clinics and pharmacies and does not involve participant response to any surveys. A data manager at each clinic will collect the data and send the data to the grantee. The clinics will be funded to participate in the project and will be required to submit data as a condition of funding. Submission of data by the clinics is, therefore, expected to be high. The grantee will work with the project sites to address any problems with data collection and to resolve data discrepancies. The grantee will electronically transmit the data to CDC.
4. Tests of Procedures or Methods to be Undertaken
Data collection for this project does not involve participant response to any surveys. Most data will be abstracted from the clinics’ and pharmacies’ archived patient medical and pharmacy records by project clinic and pharmacy staff. The data collection forms have been reviewed by project team members from CDC, Walgreens and the University of North Texas Health Science Center. In addition, input was received from clinicians at one large HIV-care clinic and from staff from the Health Resources and Services Administration and the National Minority AIDS Council.
5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data
The following individuals were consulted on the statistical aspects of the project:
Craig Borkowf PhD,
Mathematical Statistician
Quantitative Sciences and Data Management Branch,
Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, MS E48
Atlanta, GA 30333
T: 404.639.5235
Email: [email protected]
Yi Pan PhD,
Mathematical Statistician
Quantitative Sciences and Data Management Branch, Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, MS E48
Atlanta, GA 30333
T: 404.639.0960
Email: [email protected]
The following CDC staff will analyze project data:
Kathy Byrd MD, MPH
Medical Epidemiologist
Epidemiology Branch, Division of HIV/AIDS Prevention
1600 Clifton Rd. NE, MS E45
Atlanta, GA 30333
T: 404.639.3083
Email: [email protected]
Craig Borkowf PhD
Mathematical Statistician
Quantitative Sciences and Data Management Branch,
Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, MS E48
Atlanta, GA 30333
T: 404.639.5235
Email: [email protected]
Yi Pan PhD
Mathematical Statistician
Quantitative Sciences and Data Management Branch,
Division of HIV/AIDS Prevention
Centers for Disease Control and Prevention
1600 Clifton Rd. NE, MS E48
Atlanta, GA 30333
T: 404.639.0960
Email: [email protected]
The following contracted staff will analyze project data:
Stacy Muckelroy MPH
Public Health Analyst
Epidemiology Branch, Division of HIV/AIDS Prevention
1600 Clifton Rd. NE, MS E45
Atlanta, GA 30333
T: 404.639.6374
Email: [email protected]
CDC personnel responsible for receiving and approving contract deliverables:
LaShonda Billingsley
Public Health Analyst
Epidemiology Branch, Division of HIV/AIDS Prevention
1600 Clifton Rd. NE, MS E07
Atlanta, GA 30333
T: 404.639.6047
Email: [email protected]
Data will be collected form the project sites by the University of North Texas Health Science Center through a co-operative agreement.
References
1. Gardner, L, Giordano T, Marks G, Wilson T, Craw J, Drainoni M, Keruly J, Rodriguez A, Malitz F, Moore R, Bradley-Springer L, Holman S, Rose, Girde S, Sullivan M, Moore R, Metsch L, Saag M, Mugavero M. Enhanced personal contact with HIV patients across time improves retention in primary care: a randomized trial in six U.S. HIV clinics (unpublished data, under review in 2014)
2. CDC. Vital Signs: HIV Prevention Through Care and Treatment — United States. MMWR 2011; vol 60 (47): 1618-1623.
3. Murphy P, Cocohoba J, Tang A, Pietrandoni G, Hou J, Guglielmo BJ. Impact of HIV-specialized pharmacies on adherence and persistence with antiretroviral therapy. AIDS Patient Care STDS. 2012; 26(9): 526-31
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