Therapeutic Frontiers Award Lecture—Therapeutic ... · controlled drug trials but will inject...

Annual Meeting

Therapeutic Frontiers Award Lecture—Therapeutic Frontiers In Health Services Research: Methods and Intervention Models Activity No. 0217-0000-11-065-L04-P (Knowledge-Based Activity) Sunday, October 16 10:30 a.m.–11:30 a.m. Convention Center: Spirit of Pittsburgh Ballroom A Moderator: William A. Kehoe, Pharm.D., FCCP, BCPS ACCP President, Professor of Clinical Pharmacy and Psychology; Chair, Department of Pharmacy Practice, University of the Pacific Stockton, California Speaker: Barry L. Carter, Pharm.D., FCCP, BCPS Professor, College of Pharmacy, University of Iowa, Iowa City, Iowa Faculty Conflict of Interest Disclosures Barry L. Carter: no conflicts to disclose. Learning Objectives

1. Briefly review rigorously designed controlled clinical trials on team-based care for the

management of hypertension. 2. Discuss various methodologies for conducting prospective interventional studies. 3. Describe new methodologies to evaluate technology, implementation, dissemination and/or

sustainability.

Self-Assessment Questions Self-assessment questions are available online at www.accp.com/am

Therapeutic Frontiers In Health Services Research: Methods and Intervention Models 1

Therapeutic Frontiers In Health Services Therapeutic Frontiers In Health Services Research: Methods and Intervention Research: Methods and Intervention

ModelsModels

Therapeutic Frontiers In Health Services Therapeutic Frontiers In Health Services Research: Methods and Intervention Research: Methods and Intervention

ModelsModels

Barry L. Carter, Pharm.D., FCCP, FAHA, FASHDepartment of Pharmacy Practice and Science

Patrick E. Keefe Professor in PharmacyCollege of Pharmacy and

Professor and Associate Head for ResearchDepartment of Family Medicine

Roy J. and Lucille A. Carver College of MedicineUniversity of Iowa

Our Research TeamOur Research Team

Thanks to my family…..Thanks to my family…..

1.1. 1990 ACCP1990 ACCP--Mead Johnson Family Medicine Mead Johnson Family Medicine Clinical Pharmacy Research Award. Clinical Pharmacy Research Award.

2. 19972. 1997--1998 ACCP 1998 ACCP -- Merck Merck PharmacoeconomicsPharmacoeconomicsFellowship (Sarah Fellowship (Sarah BillupsBillups).).

3 19993 1999 2000 ACCP2000 ACCP M kM k Ph iPh i

Thank you to the ACCP Research Thank you to the ACCP Research InstituteInstitute

3. 19993. 1999--2000 ACCP 2000 ACCP -- Merck Merck PharmacoeconomicsPharmacoeconomicsFellowship (Sam Ellis).Fellowship (Sam Ellis).

All investigators who have yet to be All investigators who have yet to be federally funded should definitely federally funded should definitely consider applying for the ACCP FIT consider applying for the ACCP FIT program!!!program!!!

1. Briefly review rigorously designed, controlled clinical trials on team-based care for the management of hypertension.

2. Discuss various methodologies for d ti ti i t ti l

ObjectivesObjectives

conducting prospective interventional studies.

3. Describe new methodologies to evaluate technology, implementation, dissemination and/or sustainability.

Important Concepts that Determine Important Concepts that Determine Various Study MethodologiesVarious Study Methodologies

Diffusion: the passive, untargeted, unplanned and uncontrolled spread of new interventions. See later CAPTION study example…..

Implementation: is the process of putting to use or integrating evidence-based interventions within a specific setting. See later CAPTION study…..

Rabin BA et al. A glossary for dissemination and implementation Rabin BA et al. A glossary for dissemination and implementation research in health. J Public Health Management Practice research in health. J Public Health Management Practice 2008;14:1172008;14:117--123.123.

2011 ACCP Annual Meeting


Important Concepts that Determine Important Concepts that Determine Various Study MethodologiesVarious Study Methodologies

Sustainability: describes to what extent an evidence-based intervention can deliver its intended benefits over an extended period of timeintended benefits over an extended period of time after external support from the donor agency is terminated. See two later examples….

Rabin BA et al. A glossary for dissemination and implementation Rabin BA et al. A glossary for dissemination and implementation research in health. J Public Health Management Practice research in health. J Public Health Management Practice 2008;14:1172008;14:117--123.123.

Types of Designs:Types of Designs:

Efficacy trial: conducted under ideal circumstances with tight inclusion criteria. Good internal validity but low external validity (generalization). Example outcome measure: multiple BPs measured frequently (e.g. monthly) by a blinded research nurse.

Effectiveness trial: conducted under usual practice conditions and often using databases or retrospective designs. Prospective trials have few exclusions and less internal validity but high external validity. Example outcome measure: routine office-measured BPs measured whenever…..

Types of Designs Continued:Types of Designs Continued:

Combination trial: attempts to use features of both efficacy and effectiveness trials. Example outcome measure: research measured BP but limit the frequency to reduce the effect on patient behavior.

Typical Method of Randomization:Typical Method of Randomization:

• By Patient: typical approach for randomized controlled drug trials but will inject contamination for a behavioral intervention at MD l lMD level.

Gold Standard for HSR: Gold Standard for HSR: Cluster Randomized DesignsCluster Randomized Designs

• By Physician (MD clusters): reduces contamination since a given MD only has patients in one group. However, if MDs cover for one another or interact, then contamination still occurscontamination still occurs.

• By Clinic or Hospital (cluster randomized trial): The strongest design for behavioral interventions but requires many clinics or hospitals (usually no less than 10 for 2-arm study).

Limitations with many studies evaluating team-based care

Small sample sizes (low power or limited generalizability)Single site and single intervention pharmacist or nurseBias in BP measurementLack of control groups (pre- post- design only)No evaluation of key covariatesNo evaluation of key covariatesFew were intention-to-treat analysesDid not adequately evaluate missing data (last value

carried forward versus more sophisticated modeling or sensitivity analysis).

Carter BL, Bosworth HB, Green BB. State of the Art Review: The Carter BL, Bosworth HB, Green BB. State of the Art Review: The Hypertension Team: The role of the pharmacist, nurse and Hypertension Team: The role of the pharmacist, nurse and teamwork in hypertension therapy. J Clin teamwork in hypertension therapy. J Clin HypertensHypertens (in press).(in press).



Examples of Clinical Trials with Different Methodologies and

Interventions

Contemporary and rigorously p y g ydesigned trials

Federal Study of Adherence to Medications in the Elderly

(FAME)

Efficacy study that evaluates sustainabilityEfficacy study that evaluates sustainability

•Clinical pharmacist evaluation and education:Medication names indications doses

LLee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication ee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and lowadherence and persistence, blood pressure, and low--density lipoprotein density lipoprotein cholesterol: a randomized controlled trial. JAMAcholesterol: a randomized controlled trial. JAMA DeDec 6 2006;296(21):2563c 6 2006;296(21):2563--2571.2571.

Medication names, indications, doses, frequency, side effects, and proper medication-taking behavior

•Convenience aide:Custom blister-packed medications

Run-in (Baseline)

Phase 1:Comprehensive Pharmacy Care Intervention (Adherence)

Phase 2: Continued Pharmacy Care (Persistence)

FAME Study DesignFAME Study Design

Months

Usual Care (Persistence)

0 1 8 10 12 142 4 6

Randomization

Adherence:

• Baseline• 61.2 ± 13.5%

• End phase 1

96.9 ± 5.2%

Run-in Phase 1: Pharmacy care

FAME Phase 1: Primary endpointFAME Phase 1: Primary endpoint

16-fold in participants ≥ 80% adherent to all medications

P < .001

LLee JK, Grace KA, Taylor AJ. JAMAee JK, Grace KA, Taylor AJ. JAMA DeDec 6 2006;296(21):2563c 6 2006;296(21):2563--2571.2571.

Associated changes in BP and LDL-C among patients with drug-t t d HTN

FAME Phase 1: Secondary endpointFAME Phase 1: Secondary endpoint

treated HTN or HLD

N Baseline End phase 1 P

Systolic BP (mm Hg) 142 133.2 ± 14.9 129.9 ± 16.0 .02

Diastolic BP (mm Hg) 142 70.5 ± 9.2 69.7 ± 10.5 .30

LDL‐C (mg/dL) 122 91.7 ± 26.1 86.8 ± 23.4 .001

Pre-specified analysesSystolic BP Change SBP 95% CI P (within

group)P (between

group)

Usual care -1.0 mm Hg -5.9 to 3.9 .69 .04

Pharmacy care -6.9 mm Hg -10.7 to -3.1 .001

FAME Phase 2: BP and LDLFAME Phase 2: BP and LDL--CC



O r i g i n a l P a p e r

A Cluster Randomized Trial to Evaluate Physician/Pharmacist Collaboration to

Cluster, Randomized Efficacy Trial

Physician/Pharmacist Collaboration toImprove Blood Pressure ControlBarry L. Carter, PharmD; George R. Bergus, MD; Jeffrey D. Dawson, ScD;

Karen B. Farris, PhD; William R. Doucette, PhD; Elizabeth A. Chrischilles, PhD; Arthur J. Hartz, MD, PhD

Funded by NHLBI: RO1 HL69801Funded by NHLBI: RO1 HL69801Journal of Clinical Hypertension 2008;10:260Journal of Clinical Hypertension 2008;10:260--271271

Collaborative Management of Collaborative Management of Hypertension Hypertension StudyStudy: Efficacy Trial: Efficacy Trial

• Only faculty / private physicians involved in the study.• Patients 21-85 years with diagnosis of hypertension.• Baseline BP: 145-179 SBP or 95-109 DBP for uncomplicated.

• 135-179 SBP or 85-109 DBP for diabetes.• Clinic BP at 0, 2, 4, 6, 8, 9 monthsClinic BP at 0, 2, 4, 6, 8, 9 months• 24-hour BP at baseline and 9 months

Journal of Clinical Hypertension 2008;10:260Journal of Clinical Hypertension 2008;10:260--271271

Physician/PharmacistPhysician/PharmacistCollaborative ManagementCollaborative Management InterventionIntervention

• Pharmacist conducted interview and assessed patient for strategies to improve BP control.

• Pharmacist made recommendations to MD and patient to improve BP control.

• Pharmacists and physicians worked toPharmacists and physicians worked to overcome/prevent sub-optimal treatment, clinical inertia, poor adherence, adverse reactions, drug interactions

• Pharmacists saw patients at least every 2 months x 9 months.

NHLBI: RO1 HL69801

Data AnalysisData Analysis

• Continuous variables – likelihood-based mixed models with random patient effects fit to SAS Proc Mixed in an intention-to-treat analysis.

• Models adjusted for baseline BP, age, gender, d ti i t t h h ldrace, education, insurance status, household

income, marital status, smoking status, alcohol intake, BMI, number of co-existing conditions, baseline medication adherence and total number of visits during the study.

Dealing with Missing DataDealing with Missing Data

• Common methods are to use the baseline BP or the last value carried forward, these are now considered inferior approaches.

• We used statistical modeling for missing data.• We then performed as sensitivity analysis

d t i t d t t thunder worst-case scenario to demonstrate the effect was robust:– Missing data for subjects in the control group all

assumed to have controlled BP– Missing data for subjects in the intervention groups

assumed to have uncontrolled BP



Baseline Demographics

Control (n=78) Intervention (n=101)

Age 61.0 + 11.3 59.6 + 13.7*

BP meds 1.4 + 1.0 1.5 + 1.0

Baseline med 88 6% 71 1%*Baseline med adherence

88.6% 71.1%*

# co-existing DX 0.46 + 0.78 0.47 + 0.81Diabetes 24.4% 24.8%

BMI (kg/m2) 31.8 (+14.7) 32.3 (+7.7)

* * -- p < 0.001p < 0.001

Evaluating Clustering EffectsEvaluating Clustering Effects

• When adjusting for the intervention effect, the within-clinic Intercluster Correlation Coefficient (ICC) is needed to determine the variability within office or within physician cluster.t o ce o t p ys c a c uste

• Measuring patient level data without accounting for clustering will potentially bias the results.

Results of Clustering AnalysesResults of Clustering Analyses

• ICC for SBP at 9 months was 0.0084 (<1%). The within clinic variance was 139 and between clinic variance of 1.2 (NS). When adjusting for all relevant baseline covariates, ICC dropped to 0.0010.ICC dropped to 0.0010.

• Within-physician ICC was 0.0097 (NS), within-physician variance was 138.4, between-physician variance was 1.4. When adjusting for covariates, ICC dropped to 0.0005.

ResultsResults• Mean difference (control group minus the

intervention group) in SBP was -8.7 (95% CI: -4.4, -12.9) mm Hg

• Mean difference in DBP was 5 4 (CI: 2 8• Mean difference in DBP was -5.4 (CI: -2.8, -8.0) mm Hg.

• 24-hour BP levels mean difference in SBP of -8.8 (CI: -5.0, -12.6) mm Hg -4.6(CI: -2.4, -6.8) mm Hg for DBP.

Results

135

140

145

150

155

160

P m

m H

g)

Systolic BP vs. Time

Intervention - CMH (n=101)

Control - CMH (n=78)

Intervention - post-study (n=64)

Control - post-study (n=39)

Sustainability

* p<0.05, ** p<0.01, *** p<0.001, * p<0.05, ** p<0.01, *** p<0.001,

******

******

** **

110

115

120

125

130

0 2 4 6 8 10 12 14 16 18 20 22 24 26

SB

Time in Months

**********

*** *****

****

Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260--271.271.Carter BL, Doucette WR. Franciscus CL, et al. Pharmacotherapy 2010;30:228Carter BL, Doucette WR. Franciscus CL, et al. Pharmacotherapy 2010;30:228--235.235.

Results: BP Control RatesResults: BP Control Rates

Control Interven-tion

Adjusted OR

CI; p value

All 52 9% 89 1% 8 9 3 8-20 7

Main Finding: The major reason for the high control was due to intensification of medications.

All patients

52.9% 89.1% 8.9 3.8 20.7P<0.001

Diabetes 23.5% 81.8% 40.1 4.1-394.7P=0.002

-- Carter BL, Bergus GR, Dawson et al. Journal of Clinical Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260Hypertension 2008;10:260--271.271.

-- Von Muenster SJ, et al. Pharmacy World & Science Von Muenster SJ, et al. Pharmacy World & Science 2008:30:1282008:30:128--135.135.



ORIGINAL INVESTIGATIONORIGINAL INVESTIGATION

Physician and Pharmacist Collaboration to Improve Blood Pressure Control

HEALTH CARE REFORMHEALTH CARE REFORM

“Mixed” Efficacy“Mixed” Efficacy--Effectiveness trialEffectiveness trial

Barry L. Carter, PharmD; Gail Ardery, PhD; Jeffrey D. Dawson, ScD; Paul A. James, MD; George R. Bergus, MD; William R. Doucette, PhD; Elizabeth A. Chrischilles, PhD; Carrie L. Franciscus, MA; Yinghui Xu, MS

Trial Registration: clinicaltrials.gov Identifier:Trial Registration: clinicaltrials.gov Identifier:NCT00201019NCT00201019

Arch Intern Med. 2009;169(21):1996Arch Intern Med. 2009;169(21):1996--20022002

Adherence Study: Combination of Adherence Study: Combination of Efficacy and EffectivenessEfficacy and Effectiveness

Adherence Study: Combination of Adherence Study: Combination of Efficacy and EffectivenessEfficacy and Effectiveness

• Prospective, cluster-randomized controlled trial in 6 community-based family medicine residency clinics all with clinical pharmacist faculty in the medical office.

• Research nurse in each clinic measured BP at baseline, 3 and 6 months and 24-hour BP at baseline and 6 months.

InterventionIntervention

• Pharmacist conducted interview and assessed patient for strategies to improve BP control.

• Pharmacist made recommendations to MD and patient to improve BP control.

• Pharmacists and physicians worked toPharmacists and physicians worked to overcome/prevent sub-optimal treatment, clinical inertia, poor adherence

• Pharmacists only encouraged to see patients at baseline and 1 month with a telephone call at 3 months with a goal to achieve BP control by 6 months (but they could see patients more often).

Danger of Cluster Randomized Designs With Small Number of Clinics

Control(n=210)

Intervention (n=192)

P-value

Caucasian 163 (77.6%) 165 (85.9%) 0.039Married 91 (43.3%) 130 (67.7%) <0.001Income 109 (51.9%) 41 (21.4%) <0.001<$25,000

( ) ( )

BMI 34.2 (+8.7) 32.1 (+6.8) 0.010DM 80 (38.1%) 38 (19.8%) <0.001Co-existing DX 3.6 (+2.2) 2.8 (+1.8) <0.001BP medications

1.9 (+1.0) 1.3 (+1.2) <0.001

Carter et al. Archives of Internal Medicine 2009; 169:1996Carter et al. Archives of Internal Medicine 2009; 169:1996--2002.2002.

Systolic Blood Pressure

130

140

150

160

Blo

od P

ress

ure

(m

mH

g) *

*

**

100

110

120

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Syst

olic

B

Time (months)

Prospective study ended Intervention stopped

••-- p<0.001; **p<0.001; **-- p=0.0015; *** p=0.0015; *** -- p=0.0023p=0.0023Arch Intern Med. 2009;169(21):1996Arch Intern Med. 2009;169(21):1996--20022002Journal of Clinical Hypertension 2011;13:431Journal of Clinical Hypertension 2011;13:431--437.437.

Retrospective evaluation of sustainability…

Implementation Trial (can the model work in typical busy

practices?):AdoptionDiffusion

Sustainability



Collaboration Among Pharmacists and

Physicians To Improve Outcomes Now

(CAPTION)

Collaboration Among Pharmacists and

Physicians To Improve Outcomes Now

(CAPTION)

Barry L. Carter, Barry L. Carter, Pharm.DPharm.D..Principal Investigator, CCCPrincipal Investigator, CCCDepartment of Pharmacy Practice and Science, Department of Pharmacy Practice and Science,

College of Pharmacy andCollege of Pharmacy andProfessor and Associate Head for ResearchProfessor and Associate Head for Research

Department of Family MedicineDepartment of Family MedicineRoy J. and Lucille A. Carver College of Roy J. and Lucille A. Carver College of MedicineMedicine

Christopher Coffey, Ph.D.Christopher Coffey, Ph.D.Principal Investigator, DCCPrincipal Investigator, DCCProfessor and Director, Clinical Trials DataProfessor and Director, Clinical Trials Data

Management CenterManagement Center

College of Public HealthCollege of Public Health

* The study is being funded by NHLBI/NIH, R01 HL091841-01A1.

Participating Locations

CAPTION Study Design: Cluster Randomized Trial

1.1. One goal is to determine if the intervention One goal is to determine if the intervention is effective in minorities so goal is to enroll is effective in minorities so goal is to enroll 40% minorities.40% minorities.40% minorities.40% minorities.

2.2. Clinics stratified based on the percent Clinics stratified based on the percent African Americans or Hispanics (high or African Americans or Hispanics (high or low), and the score of a pharmacy services low), and the score of a pharmacy services provided by the clinical pharmacists (high or provided by the clinical pharmacists (high or low).low).

3.3. DCC then randomized the medical offices.DCC then randomized the medical offices.

Site Randomization to 3 Arms

Active Observation Group 1 9 month BP intervention (n=24/site)

Active Observation Group 2 24 month BP intervention (n=24/site)

Usual Care/Practice Diversion Group Control arm for the hypertension study

(n=24/site)

Diversion asthma intervention

Passive Observation Groups: Diffusion

Every site will also identify 18 patients with uncontrolled HTN who are not consented into the study (passive observation BP group) who will undergo med recordgroup) who will undergo med record review to test whether the effect of the intervention diffuses throughout the medical office.

32 clinics stratified

BP Control Group: (n=216)

BP 9 month Intervention

Group: (9 clinics, n=216)

BP 24 month Intervention

Group: (9 clinics, n=216)

9 month Intervention

9-month asthma

intervention (n=100)

BP Usual Care/ Asthma PPCM

(9 clinics)

BP Observational Cohort: 3 BP Arms (n=486)

32 clinics randomized

Intervention, then stopped

for 24 months

24-month evaluation of BP and covariates (all HTN patients)

BP at baseline, 6, 9, 12, 18, 24

mos.

BP at baseline, 6, 9, 12, 18, 24 mos.

BP at baseline, 6, 9, 12, 18, 24

mos.

Clinic BPs via chart review

for Observational

Cohort



The Electronic Communications and Home Blood Pressure

Monitoring Trial (e-BP)Comparison of 2 Interventions to Usual Care:• Home BP monitor and use of an existing patient Web site

• This plus pharmacist care management (delivered via the patient Web site)

Green BB, Cook AJ, Ralston JD, et al. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. Jun 25 2008;299(24):2857-2867.

Funded by NHLBI: 5R01HL075263-04

BP control at 12 monthsControl BPM-Web

OnlyBPM-Web-Pharm

All 31% 36% 56%**

Systolic BP at baseline >160 mm

20% 26% 54%**

**P < 0.001 compared to UC and BPM**P < 0.001 compared to UC and BPM--WebWeb

Conclusion: the addition of the pharmacist intervention to the web was necessary to achieve good BP control.Green BB, et al. Green BB, et al. JAMA. JAMA. 2008;299(24):28572008;299(24):2857--2867.2867.

Numerous Meta-analyses of Team-Based Care in BP

1. Walsh JM, et al. Med Care. Jul 2006;44(7):646-657.2. Carter BL, et al. Arch Intern Med. 2009;169(19):1748-

1755.3. Chisholm-Burns MA, et al. Med Care. 2010;48(10):923-

933.4 Machado M et al Ann Pharmacother 2007;41(11):17704. Machado M, et al. Ann Pharmacother. 2007;41(11):1770-

1781.5. Glynn LG, et al. Cochrane Database Syst Rev.

2010(3):CD005182.6. Fahey T, et al.. Cochrane Database Syst Rev.

2006(4):CD005182.7. Clark CE, et al.. BMJ. 2011;341:c3995.

Meta-Analysis: Potency of individual components of team-based care

Median reduction in SBP(mm Hg)

Pharmacist recommended medication to physician -9.3*

Education on BP medications -8.75*

Pharmacist did the intervention -8.44

Assessed medication compliance -7 9

46

Assessed medication compliance -7.9

Counseling on lifestyle modification -7.59

Nurse did the intervention -4.8*

Carter BL, Rogers M, Daly J, Zheng S, James JA. Quality Improvement Strategies for Hypertension: The Potency of Team-based Care Interventions. Archives of Internal Medicine 2009; 169:1748-1755. Adapted from the methods of:Walsh J et al. Hypertension Care. Closing the Quality Gap: A critical analysis of quality improvement strategies. (Prepared by Stanford -UCSF Evidence-based Practice Center, Contract No. 290-02-0017). AHRQ publication No. 04-0051-3, Rockville, MD. January 2005.

**-- statistically significantstatistically significant

Meta-analysis of Potency of individual components of team-based care

Odds that BP was controlled (95% confidence Interval)

Studies involving nurses 1.69 (1.48-1.93)

[69% increased chance]

Studies involving pharmacists within h i i ffi li i

2.48 (2.05-2.99)

47

physician offices or clinics [148% increased chance]

Studies done in community pharmacies

2.89 (1.83-4.55)

[189% increased chance]

Carter BL, et al. Archives of Internal Medicine 2009; 169:1748-1755.

Conclusion: All were effective but interventions by pharmacists appear to be more potent than by nurses.

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research: Health Services Research:

QuestionsQuestions


QuestionsQuestions1.1. TeamTeam--based care interventions have clearly based care interventions have clearly

been shown to be effective for a variety of been shown to be effective for a variety of chronic conditions but many questions remain chronic conditions but many questions remain andand NIH will fund such studiesNIH will fund such studies::and and NIH will fund such studiesNIH will fund such studies::a.a. Can the models be scaled up and Can the models be scaled up and

implemented in large numbers of diverse implemented in large numbers of diverse and very busy practices?and very busy practices?

b.b. Can the effect be sustained in the longCan the effect be sustained in the long--term? Are “booster” interventions needed?term? Are “booster” interventions needed?

c.c. Is there a viable business model for current Is there a viable business model for current and future payment structures?and future payment structures?




Summary of Key PointsSummary of Key Points


Summary of Key PointsSummary of Key Points1. Health-care reform, the patient-centered

medical home and technology will require much more health services research studies in t b dteam-based care.

2. Studies must be rigorously designed, tested and analyzed which will likely require federally funded grants.





3. Clinical pharmacy scientists must have strong training in grant writing. Should attend as many grant writing workshops as possible.many grant writing workshops as possible.

4. You must consider the ACCP FIT program if you are a clinical pharmacy researcher desiring federal funding.

Comments and QuestionsComments and QuestionsComments and QuestionsComments and Questions



Suggested readings:

1. Okonofua EC, Simpson KN, Jesri A, Rehman SU, Durkalski VL, Egan BM. Therapeutic inertia is an impediment to achieving the Healthy People 2010 blood pressure control goals. Hypertension. Mar 2006;47(3):345-351.

2. Walsh JM, McDonald KM, Shojania KG, et al. Quality improvement strategies for hypertension management: a systematic review. Med Care. Jul 2006;44(7):646-657.

3. Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. Oct 26 2009;169(19):1748-1755.

4. Chisholm-Burns MA, Kim Lee J, Spivey CA, et al. US pharmacists' effect as team members on patient care: systematic review and meta-analyses. Med Care. Oct 2010;48(10):923-933.

5. McKenney JM, Slining JM, Henderson HR, Devins D, Barr M. The effect of clinical pharmacy services on patients with essential hypertension. Circulation. Nov 1973;48(5):1104-1111.

6. Bogden PE, Abbott RD, Williamson P, Onopa JK, Koontz LM. Comparing standard care with a physician and pharmacist team approach for uncontrolled hypertension. J Gen Intern Med. Dec 1998;13(11):740-745.

7. Borenstein JE, Graber G, Saltiel E, et al. Physician-pharmacist comanagement of hypertension: a randomized, comparative trial. Pharmacotherapy. Feb 2003;23(2):209-216.

8. Logan AG, Milne BJ, Achber C, Campbell WP, Haynes RB. Work-site treatment of hypertension by specially trained nurses. A controlled trial. Lancet. 1979;2(8153):1175-1178.

9. Rudd P, Miller NH, Kaufman J, et al. Nurse management for hypertension. A systems approach. Am J Hypertens. Oct 2004;17(10):921-927.

10. Machado M, Bajcar J, Guzzo GC, Einarson TR. Sensitivity of patient outcomes to pharmacist interventions. Part II: Systematic review and meta-analysis in hypertension management. Ann Pharmacother. Nov 2007;41(11):1770-1781.

11. Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2010(3):CD005182.

12. Fahey T, Schroeder K, Ebrahim S. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2006(4):CD005182.

13. Clark CE, Smith LF, Taylor RS, Campbell JL. Nurse led interventions to improve control of blood pressure in people with hypertension: systematic review and meta-analysis. Bmj. 2011;341:c3995.

14. Carter BL. Designing quality health services research: why comparative effectiveness studies are needed and why pharmacists should be involved. Pharmacotherapy. Aug 2010;30(8):751-757.

15. Carter BL, Foppe van Mil JW. Comparative Effectiveness Research: Evaluating Pharmacist Interventions and Strategies to Improve Medication Adherence. Am J Hypertens. Jul 22 2010.

16. Lee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication adherence and persistence, blood pressure, and low-density lipoprotein cholesterol: a randomized controlled trial. Jama. Dec 6 2006;296(21):2563-2571.

17. Carter BL, Bergus GR, Dawson JD, et al. A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control. J Clin Hypertens (Greenwich). Apr 2008;10(4):260-271.

18. Von Muenster SJ, Carter BL, Weber CA, et al. Description of pharmacist interventions during physician-pharmacist co-management of hypertension. Pharm World Sci. Jan 2008;30(1):128-135.

19. Carter BL, Doucette WR, Franciscus CL, Ardery G, Kluesner KM, Chrischilles EA. Deterioration of blood pressure control after discontinuation of a physician-pharmacist collaborative intervention. Pharmacotherapy. Mar 2010;30(3):228-235.

20. Carter BL, Ardery G, Dawson JD, et al. Physician and pharmacist collaboration to improve blood pressure control. Arch Intern Med. Nov 23 2009;169(21):1996-2002.

21. Wentzlaff DM, Carter BL, Ardery G, et al. Sustained blood pressure control following discontinuation of a pharmacist intervention. J Clin Hypertens (Greenwich). Jun 2011;13(6):431-437.

22. Allen JK, Dennison CR. Randomized trials of nursing interventions for secondary prevention in patients with coronary artery disease and heart failure: systematic review. J Cardiovasc Nurs. May-Jun 2010;25(3):207-220.



23. Hill MN, Han HR, Dennison CR, et al. Hypertension care and control in underserved urban African American men: behavioral and physiologic outcomes at 36 months. Am J Hypertens. 2003;16(11):906-913.

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