mhealth enabled patient & provider centered medical ...reduced work force productivity ... life...
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mHealth Enabled Patient & Provider Centered Medical
Regimen Adherence Solutions for Uncontrolled Hypertension
Frank Treiber, PhD.
Professor of Nursing & Psychiatry
Director, Technology Applications Center
for Healthful Lifestyles (TACHL)
Medical University of South Carolina
Presented at: Society of Behavioral Medicine Conference
Washington, D.C. 3/31/16
HL118447 UL1 RR029882 KL2 &
DK103839
SC Telemedicine Initiative & UL1
RR029882
Objectives
1. Brief overview of medication nonadherence
2. Rationale for using mHealth
3. Rationale for user patient centered, theory
guided , iterative design process
4. Provide example of this process with 4 patient
populations with uncontrolled EH:
Kidney transplant patients
FQHC Hispanic migrant farmers
FQHC African Americans
Post stroke patients
Obj.#1: Patient Nonadherence to Medication Regimens
Leading obstacle in chronic disease management 25% of initial scripts never filled ~ 50% of patients with chronic disease(s) adhere to med regimens
Med nonadherence responsible for : 10% of hospitalizations reduced work force productivity suboptimal clinical outcomes (~125,000 deaths/yr ) increased healthcare costs $100- 300 B/yr
Obj.#2: Why use mHealth in Tackling Patient Nonadherence to Med Regimens ?
Ubiquity of Mobile Phones: ~93% of Americans have cell phones ~63% own Smart Phones ~64% use phone to access health info
mHealth solutions: increase quality, reach & personalization of care available 24/7; provide timely access to therapeutic support “snap shot clinic visit” issue addressed –HCPs know how
patient is functioning & can address needs quicker
Obj.#3: Why Use Theory Guided, User Centered, Iterative Design Process?
Insurers, Hospital & health plan execs & HCPs need:
Evidence based, empirically validated, sustainable & cost effective solutions;
ACCOMPLISHED using: iterative design process guided by patient & provider input
behavioral & tech. application theories ( foster self efficacy & intrinsic motivation to sustain adherence to medical regimen )
Empirical evaluations & repeated refinements establishing usability, efficacy, effectiveness & sustainability
Development of personalized, sustainable, effective solutions
4. Usability Testing
5. Further Development
6. User Surveys
7. Refine prototype
1. User Needs Content/Function
• Focus groups
• Interviews
2. Qualitative Analysis
3. Prototype Development
Users
ResearchersDesign Team
Clinical Trials
Proof of Concept
Efficacy/ Effectiveness
Dissemination
Post Trial Focus
Groups
Iterative Design ProcessEngages all stakeholders from
generation of clinical need
through all iterative
design phases
Obj.#4a: Development of mHealth Medication Adherence & BP Control Program Among Kidney Transplant
Recipients (KTRs)
UL 1 RR029882KL2 10/11-9/14
RO1 DK103839
10/15-9/19
Rationale
ESRD afflicts >500,000/yr in USA EH is the #1 cause of ESRD
Transplantation is treatment of choice Despite advances, graft survival stagnant: M=9 yrs (S.C. 4.5 yrs)
Medication nonadherence: Key cause of premature graft loss (35-45%) Fosters immune mediated rejection &
deleterious effects of uncontrolled EH & DM
Iterative Design Process of Prototype System
Individual interviews conducted to determine: healthcare providers’ needs for following KDIGO & MUSC
stepped care guidelines & perspectives on premature graft loss
patients’ functional health literacy, attitudes toward, willingness and ability to use mHealth
Iterative Development of mHealth Prototype System cond.
Prototype mHealth system developed (SMASH)& usability tested
99 KTRs surveyed after demo of SMASH mHealth system
Further SMASH Refinement Feasibility trial conducted Post trial interviews & further refinement Efficacy RCT underway
Survey Results of mHealth prototype: SMASH
90% cell phones; 52 % had smart phone access
61% texted; 34% downloaded apps
7% had heard of mHealth/Telehealth
79% very willing to use mHealth
87% very confident mHealth would increase communication with physician
84% felt doctor would make quicker med changes
McGillicuddy et al. (2014) Journal Medical Internet Research
TACHL Prototype
SMASH SystemMedication Reminder
Devices
AND Monitor
Time Stamped Events
Identification of Tailored Motivational Message Content
Yes
Yes
Yes
Tailored Motivational MessageExample
Background: 55 yr.-old single with EH & T2D. Family history: parents with EH,
T2D & ESRD.
Life goals & personal values: religious, desires to spend more time with
family, worries about dying young from kidney disease or a stroke like his parents
Medication dose(s) taken correctly:Great, Frank! You’re taking your meds on time! Your family history does not have to be your future!
Missed medication dose(s):Frank, try and remember to take your meds on time every day! God has blessed you, take care of His gift of life!
Medication Adherence in KTRs
60
89
92 95
50
53
59
56
40
50
60
70
80
90
100
Baseline Month 1 Month 2 Month 3
Pe
rce
nt
Ad
he
ren
ce
mHealth
SOC
McGillicuddy et al.(2013a,b) Journal of Assn. Computing Machinery & Journal of Medical Internet Research
Average of 13.5 different meds/bid-qid
McGillicuddy et al (2013) Journal of Medical Internet Research
BP Changes Among KTRs
138.4
129.3
129.6
121.8
135.1
147.2
138.2
138.8
120
125
130
135
140
145
150
0 1 2 3
Smash
SC
Month
Ave
rage
SBP
Month
Ave
rage
SBP
SC
Month
Ave
rage
SBP
Month
Ave
rage
SBP
SC
Month
Ave
rage
SBP
Month
Ave
rage
SBP
SC
Month
Ave
rage
SBP
Month
Ave
rage
SBP
(m
mH
g)
SC
SMASH
McGillicuddy et al. (2015) Progress in Transplantation
One Year Follow-up Clinic BP Among KTRs
145.38143.88
154.50
135.63
132.25131.13
125
130
135
140
145
150
155
160
End of Trial 6 Month 12 Month
Clin
ic S
BP
(m
mH
g)
Follow Up
SC
SMASK
Obj.#4b: Development of mHealth Medication Adherence & BP Control Program Among
Hispanic Hypertensives
Highest rate of uncontrolled EH in USA
Fastest growing ethnic group
>50% Nonadherent to medication regimen
Obj.#4b: mHealth (SMASH) & Hispanic Uncontrolled Hypertensives
Focus groups & surveys led to SMASH prototype refinement 81% cell phone; 39% smart phone
78% texted; 48% downloaded apps
19% had heard of mHealth
94% very willing to use mHealth
76% had complete trust in privacy of data
85% very confident mHealth would increase communication with physician
Price et al. (2013) Journal Medical Internet Research
HL 118447 4/14-3/17
• SMASH med adherence 96% across 3 mths
SMASH Wake SMASH Sleep SOC Wake SOC Sleep
100
110
120
130
140
150
160
Pre
3mo
156.43
126.61
146.36
117.72
142.72
144.66
132.79
132.42
Ave
rage
SB
P (
mm
Hg)
Ambulatory SBP
Sieverdes et al. (2013) Mobile Health Telecare
BP Changes & Med Adherence Among Hispanic FQHC Uncontrolled Hypertensives
160
123.5120.9
112.8
147.8
138.5 136.5 136.7
100
110
120
130
140
150
160
170
Pre 1 2 3
SBP
(m
mH
g)
Months
Resting SBP
SMASH
SC
Baseline
Obj.#4c: SMASH with African American FQHC Patients & Post Stroke patients Uncontrolled
Hypertensives
163.68163.36
153.00152.77163.25
132.63129.00
125.06
120
130
140
150
160
170
Baseline 1 3
Ave
rage
SB
P (
mm
Hg)
Months
Clinic SBP: AA FQHC patients
SOC
SMASH
Davidson et al. (2015) Journal of Personalized Medicine Ovbiagele et al. (2015) J. of the Neurological Sciences
- 7.7% ED use
- 57% ED use
156.7
151 151.3153.8
136
138.8
130
135
140
145
150
155
160
6 Month Prior 3 Month Program 3 Month Post-Program
Clin
ic S
BP
Interval
MUSC Stroke Quality Improvement Program
SC
mHealth
-20% ED use
-85% ED use
Baseline
Discussion
SMASH has high patient & provider acceptability
Significant & sustained med adherence achieved
Sustained BP control achieved (resting BP <140/90; 24 hrBP < 135/80 mmHg), not typically achieved in previous trials
Indications that SDT constructs enhanced (self-efficacy & intrinsic motivation) based upon 3 & 12 mth follow-ups
Theory guided, iterative patient–provider centered designs useful in mHealth enabled medical regimen self-management programs