Transcript Resource - The Center for Care Innovations

November 10th, 2015
Barry L. Carter Pharm.D., FCCP, FAHA, FASH, FAPHA
The Patrick E. Keefe Professor in Pharmacy
University of Iowa
Moderated By:
J. Nwando Olayiwola, MD, MPH, FAAFP
Tem Woldeyesus, BS
Kira Levy, MS
Center for Excellence in Primary Care
Webinar sponsored by:
The Center for Excellence in Primary Care and the Center for Care Innovations
2
Care Integration Resource Center
Team-based Care for Hypertension in the
Age of Healthcare Reform
Barry L. Carter, Pharm.D., FCCP, FAHA, FASH, FAPHA
The Patrick E. Keefe Professor in Pharmacy
Department of Pharmacy Practice and Science
College of Pharmacy and
Professor
Department of Family Medicine
Roy J. and Lucille A. Carver College of Medicine
University of Iowa
Disclosure of Relationships
• Grant Support: NIH, AHRQ, VA HSR&D.
• Member of the JNC 5, 6, 7 and 8
committees
• I have had NONE of the following in
the past 18 years: Consultant, Speakers
Bureau, Major Stock Shareholder, or Other
Support from Industry.
Objectives
1. To discuss evidence-based strategies
for implementing team-based care
for the management of
hypertension.
2. To describe components and results
of the CAPTION Trial.
Limitations with many studies
evaluating team-based care
Small sample sizes (low power or limited
generalizability)
Single site and single intervention pharmacist
or nurse
Bias in BP measurement
Lack of control groups (pre- post- design only)
No evaluation of key covariates
Few were intention-to-treat analyses
Carter BL, Bosworth HB, Green BB. State of the Art Review: The
Hypertension Team: The role of the pharmacist, nurse and
teamwork in hypertension therapy. J Clin Hypertens 2012;14:51-65
Cluster, Randomized Efficacy Trial
OriginalPaper
A Cluster Randomized Trial to Evaluate
Physician/Pharmacist Collaboration to
Improve Blood Pressure Control
Barry 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 HL69801
Journal of Clinical Hypertension 2008;10:260-271
Physician/Pharmacist
Collaborative Management
Collaborative Management of
Hypertension Study: 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.
Research BP at 0, 2, 4, 6, 8, 9 months
24-hour BP at baseline and 9 months
Journal of Clinical Hypertension 2008;10:260-271
Intervention
• 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 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 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,
race, 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.
Baseline Demographics
Control (n=78)
Age
BP meds
Baseline med
adherence
# co-existing DX
Diabetes
BMI (kg/m2)
* p < 0.001
61.0 + 11.3
Intervention
(n=101)
59.6 + 13.7*
1.4 + 1.0
1.5 + 1.0
88.6%
71.1%*
0.46 + 0.78
0.47 + 0.81
24.4%
24.8%
31.8 (+14.7)
32.3 (+7.7)
Results: BP Control Rates
Main Finding: The major reason for the high control
was due to intensification of medications.
Control
Interven- Adjusted
tion
OR
CI;
p value
All
patients
52.9%
89.1%
8.9
3.8-20.7
P<0.001
Diabetes
23.5%
81.8%
40.1
4.1-394.7
P=0.002
- Carter BL, Bergus GR, Dawson et al. Journal of Clinical
Hypertension 2008;10:260-271.
- Von Muenster SJ, et al. Pharmacy World & Science
2008:30:128-135.
Physicians accepted 95.8% of 267 pharmacist recommendations
Recommendation
Frequency by Visit
0 Mo
Opt
Added Thiazide n=45
40
2
3
0
0
0
NA
Added Other Drug n=79
30
13
18
9
6
3
NA
Increased Dose n=89
28
21
14
9
9
8
NA
Changed Dose Frequency n=7
2
0
1
3
1
0
NA
Switch Within Class n=15
6
3
1
3
2
0
NA
Decreased Dose n=14
3
3
3
2
3
0
NA
Drug Discontinued n=18
2
4
8
3
1
0
NA
111
46
48
29
22
11
NA
0
-
Total n=267
BP Control Rate n=101
2 Mo 4 Mo 6 Mo 8 Mo 9 Mo
52% 67% 73% 84%
89%
• Von Muenster SJ, Carter BL, Weber CA et al. Description of pharmacist
interventions during physician-pharmacist co-management of hypertension.
Pharmacy World & Science 2008:30:128-135.
“Mixed” Efficacy-Effectiveness trial
ORIGINAL INVESTIGATION
HEALTH CARE REFORM
Physician and Pharmacist Collaboration
to Improve Blood Pressure Control
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:
NCT00201019
Arch Intern Med. 2009;169(21):1996-2002
Guideline Adherence Study:
Combination of Efficacy 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.
Intervention
• 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 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).
Research BP Measurement
• Automated Omron Device
• Measure 1 BP, record but do not use for
research value
• Measure 2 BP values and average them if
less than 4 mm Hg apart.
• If more than 4 mm different, measure a
4th BP and average the 2 closest BP
values (from the 2nd to 4th BP
measurements).
*
Systolic Blood Pressure
160
Systolic Blood Pressure (mmHg)
150
*
140
**
130
120
Prospective study ended
Intervention stopped
Retrospective evaluation of sustainability…
110
100
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
Time
(months)
15
16
•- p<0.001; **- p=0.0015; *** - p=0.0023
Arch Intern Med. 2009;169(21):1996-2002
Journal of Clinical Hypertension 2011;13:431-437.
17
18
19
20
21
22
23
24
Meta-Analysis: Potency of individual components of teambased care (n=37 controlled trials)
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
Counseling on lifestyle modification
-7.59
Nurse did the intervention
-4.8*
*- statistically significant
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,
21
Contract No. 290-02-0017). AHRQ publication No. 04-0051-3, Rockville, MD. January 2005.
Meta-analysis of Potency of individual components of teambased 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
physician offices or clinics
2.48 (2.05-2.99)
[148% increased chance]
Studies done in community
pharmacies
2.89 (1.83-4.55)
[189% increased chance]
Conclusion: All were effective but interventions by
pharmacists appear to be more potent than by
nurses.
Carter BL, et al. Archives of Internal Medicine 2009; 169:1748-1755.
22
Collaboration Among Pharmacists and
Physicians To Improve Outcomes Now
(CAPTION)
Barry L. Carter, Pharm.D.
Principal Investigator, CCC
Department of Pharmacy Practice and Science,
College of Pharmacy and
Professor
Department of Family Medicine
Roy J. and Lucille A. Carver College of
Medicine
Christopher Coffey, Ph.D.
Principal Investigator, DCC
Professor and Director, Clinical Trials Data
Management Center
College of Public Health
• Funded by NHLBI/NIH, R01 HL091841
Carter et al. A Cluster-randomized Trial of
a Physician/Pharmacist Collaborative Model
to Improve Blood Pressure Control.
Circulation: Cardiovascular Quality and
Outcomes. 2015; 8:235-43.
CAPTION Study Outcomes
Primary outcome = BP control @ 9 months
BP control defined as:
• < 140/90 for patients with uncomplicated
hypertension
• < 130/80 for patients with diabetes or
chronic kidney disease**
Secondary endpoints:
• Mean BP @ 12, 18, 24 months
CAPTION
Offices Stratified on:
1. Pharmacy Structure Score (high vs. low)
2. Percent minorities (<44% vs. >44%)
32 offices randomized to:
1. Usual care group
2. 9-month pharmacist intervention
3. 24-month pharmacist intervention.
Subjects followed for 24 months to determine:
1. What happens when the intervention is
stopped?
2. Does the intervention benefit patients from
minority groups?
Participating Locations
Demographics
Variable
9 Month
(N=194)
N (%)
119 (61.3)
24 Month
(N=207)
N (%)
125 (60.4)
Control
(N=224)
N (%)
133 (59.4)
Total
(N=625)
N (%)
377 (60.3)
p-value
Age (SD) 60.6 (12.4)
56.7 (11.8)
60.5 (13.8)
59.3 (12.8)
0.055
BMI (SD)
33.8 (8.5)
35.2 (9.0)
32.9 (7.7)
33.9 (8.5)
0.090
DM or
CKD *
SBP
(SD)
102
(52.6%)
109
(52.7%)
103
(46.0%)
314
(50.2%)
0.5995
147.6
(13.7)
149.8
(15.6)
149.6
(15.3)
149.1
(15.0)
0.458
Female
0.938
* lower treatment goal (<130/80) making it more difficult to
achieve control
Carter et al. Circulation: Cardiovascular
Quality and Outcomes. 2015; 8:235-43.
Primary Outcome 9-Month BP Control
Variable
BP
Control
All
subjects
BP
Control
Minorities
Intervention
Groups
(N = 401)
(N=226
minorities)
Control
Group
(N = 224)
(N=111
minorities)
Model-Adjusted
Difference –
Intervention vs.
Control
(95% CI)
p-value
43%
34%
1.57
( 0.99 , 2.50 )
0.059
37%
28%
1.54
( 0.83 , 2.86 )
0.17
* Defined as <140/90 for uncomplicated BP, <130/80 for diabetes or CKD
Carter et al. Circulation: Cardiovascular
Quality and Outcomes. 2015; 8:235-43.
9 – month BP- All subjects
Intervention Control
Variable
Groups
Group
(N = 401)
(N = 224)
ModelAdjusted
Difference –
Intervention
vs. Control
(95% CI)
p-value
SBP
Mean
(SD)
131.6
(15.8)
138.2
(19.7)
-6.1
( -9.75, -2.39 )
0.002
DBP
Mean
(SD)
76.3
(11.1)
78.0
(14.5)
-2.9
( -4.85, -0.93 )
0.005
Carter et al. Circulation: Cardiovascular
Quality and Outcomes. 2015; 8:235-43.
Results – Minority subjects
Intervention Control
Variable
Groups
Group
(N = 226)
(N = 111)
Model
Adjusted
Difference –
Intervention
vs. Control
(95% CI)
pvalue
SBP
Mean
(SD)
133.0
(16.3)
140.3
(21.4)
-6.4
( -11.16, -1.68 )
0.009
DBP
Mean
(SD)
77.9
(10.7)
78.8
(15.9)
-2.9
( -5.88, -0.08 )
0.044
Pharmacist Visits/Contacts
Group
9 –Month
Group
24 – Month
Group
First 9 Months
(rate/month)
9-24 Months
(rate/month)
0.58
0.07
0.50
0.26
Dose Increase or Medication
Addition at 9 months
Time
Period
Usual Care
0 to 9
Months
0.7 + 1.0*
* p<0.001
9-month
24-month
intervention intervention
3.1 + 3.2
2.7 + 3.1
Systolic BP Results
2014 Evidence-Based Guideline for
the Management of High Blood
Pressure in Adults
Report from the Panel Members Appointed to
the Eighth Joint National Committee (JNC 8)
James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb
C, Handler J, Lackland DT, Lefevre ML, Mackenzie TD, Ogedegbe
O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr,
Narva AS, Ortiz E
James PA, Oparil S, Carter BL et al. JAMA. 2014; 311 (February 5):507-520.
Sensitivity Analysis Using JNC-8
• If we exclude 138 subjects who would not
have qualified because their BP would have
been considered controlled by JNC-8, 9month BP Control:
Intervention
BP Control
Usual Care
BP Control
61%
45%
OR
(95% CI)
p-value
2.03
0.003
(1.29, 3.22)
Carter et al. Circulation: Cardiovascular
Quality and Outcomes. 2015; 8:235-43.
Economics of Team Care:
Community Preventive Services
Task Force: 2012
• 31 studies total
• Intervention for BP cost $198 per person
per year.
• $87 per mm reduction in SBP.
• 20 year cost per QALY:
– $24,042 for Nurse
– $10,244 for Pharmacist and other
Jacob V et al. Am J Prev Med 2015;49:772-83.
Community Preventive Services Task Force
(30% of studies non-U.S.)
Nurses
(n=16 studies)
Pharmacists
(n=11 studies)
Nurse +
Pharmacist
(4=studies)
Median %
improved BP
control
8.5
Median
reduction SBP
mm HG
5.4
22.0
5.0
16.2
5.6
Proia KK, et al. Am J Prev Med 2014;47:86-99
37
CAPTION Cost and RVU
Analyses
 Included Brian Isetts, Ph.D. and Dan
Buffington, Pharm.D. as consultants to
perform RVU analysis.
 Linnea Polgreen, Ph.D. conducting costeffectiveness analysis.
Manuscript in review
CAPTION Cost and RVU Analyses
(N=390) first 9 months
 Pharmacists made 1,169 recommendations to:
 start a new drug (443)
 discontinue a drug (283)
 increase dose (329)
 decrease dose (94)
 change regimen-same dose (20)
 Physicians accepted 1,153 (98.6%)
CAPTION Pharmacist Time
Activity
Medical record review
prior to patient visit.
Consultation with other
provider or family
Patient
assessment/medication
history
Medical record review
during patient visit
Order laboratory
Minutes to complete activity (circle one)
Order medications/write
prescriptions
Medical education
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
Lifestyle modification
education
Education on BP
measurement
Recommendations to MD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
Documentation in medical
record
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 >30
CAPTION Cost and RVU Analyses
 Drs. Isetts and Buffington consult
directly with CMS and AMA on CPT
coding.
 These data will be used to better
establish relative value units (RVUs) for
pharmacist intervention and reimbursement mechanisms.
Cost-Effectiveness Analysis
 The additional cost of the intervention
was $203 or $33 for each mm Hg
reduction in SBP or $23 for each
percentage point increase in BP control
over 9 months.
 Polgreen LA, Han J, Carter BL et al.
Hypertension 2015 (in press)
Cost-Effectiveness Analysis
Variable
Intervention*
(N=539)
Control *
(N = 194)
P value
Changed BP
Medications
Total cost BP
Medications
Pharmacists
Costs
Physician
Costs
251 (493)
160 (392)
0.028
857 (829)
838 (982)
0.808
144 (102)
0
<0.001
88 (105)
105 (88)
0.055
Total Costs
1340
(1064)
1103
(1118)
0.017
* - Mean (SD) U.S. dollars
CAPTION Conclusions
• Clinic-based pharmacists in primary care
enhance effectiveness for BP control.
• 53% were minorities (2/3 AA, 1/3 Hispanic).
• Many of the subjects in CAPTION had not
had controlled BP for years.
• > 25% - Medicaid/ self-pay, about 50% had
incomes <$25,000/yr, 50% had DM or CKD.
• Cost compared to usual care - $203
($33/mm Hg reduction in SBP), $23 for each
percentage point increase in BP control.
Recommendations of the
Community Preventive Services
Task Force
• Include team-based care to improve BP.
• More research needed on the type of
provider-patient interaction needed.
• More research needed in disadvantaged
populations.
• Need more information on strategies to
develop teams, resources infrastructure and
costs.
Am J Prev Med 2014;47:100-102
Recommendations
• Team-based care should be a critical component
of primary care to improve BP control in African
Americans (SBP reductions of 5-14 mm Hg).
• A pharmacist and nurse should be integrated into
practices to improve BP control.
• Several studies have found that the most potent
strategy appears to be medication intensification.
• The team member (pharmacist or nurse) should
independently implement the intervention as this
is the most effective strategy for rapid
implementation.
Comments and Questions