Feasibility, Acceptability and Cost of Video Directly Observed Therapy in Maryland

Samuel Holzman, MD

Johns Hopkins University School of Medicine Baltimore, Maryland

April 21, 2017

Disclosures

Financial Disclosures: None Funding: National Institutes of Health Small Business Innovation Research Grant Note: emocha Mobile Health Inc. is a privately owned and operated company

New guidelines prioritize daily therapy

DOT  remains  the  preferred  standard  

Key principles: “To be consistent with principles of patient-centered care, decisions regarding use of DOT must be made in concert with the patient”  

“Implementation of DOT may not be readily feasible when resources are limited”

The “least restrictive public health interventions that are effective are used to achieve adherence”

“DOT has expanded to other modalities such as web-based video and mobile phones which have been well received by both patients and health dept staff”

 

DOT Benefits DOT Challenges

+ High cost

+ Time intensive  

+ Logistical limitations (patient travel +work obligations, holidays, etc.)

+ Increased patient support

+ Early identification of poor clinical response  + Early detection of side effects  

miDOT

miDOT

miDOT

Data Management & Security

Maryland Geography

<3.7/100,000

>3.7 /100,000

No reported cases

Funding: Design:

NIH Small Business and Innovation Research Grant (SBIR)

Pragmatic, prospective implementation study

Timeline: July 2016 - ongoing

Inclusion Criteria: Adult TB patients in Baltimore City, Montgomery Country and Anne Arundel County

Enrollment at the discretion of non-conflicted TB clinician/staff NO exclusion based on resistance pattern (ex. MDR), past adherence or English proficiency

Mixed Methods: Quantitative analysis

Feasibility

Outcome

Adherence +

Observed fraction

Metric  

Study Design

Qualitative analysis

Pre/post surveys and interview (Patients + Staff)

Acceptability Cost analysis

“Ingredients” based approach with time-

motions studies

Cost

miDOT  interven2on  (n=20)  Age,  yr  (median,  IQR)   32  (22-­‐48)  Female,  n  (%)   12  (60)  Origin,  n  (%)            United  States            Foreign-­‐born            Unknown  

   2  (10)  16  (80)  2  (10)  

Time  in  US,  yr  (median,  IQR)   11  (4-­‐19)  Known  TB  contact,  n  (%)   0  (0)  History  of  incarcera2on,  n  (%)   0  (0)  Comorbidi2es,  n  (%)            HIV  infected            Hypertension            Diabetes            History  of  malignancy  

   0  (0)  1  (6)  1  (6)  0  (0)  

Tuberculosis  type,  n  (%)            Pulmonary                      Smear  posi2ve                      Smear  nega2ve            Exclusively  extrapulmonary            Latent  

       

7  (35.0)  2  (10.0)  8  (40.0)  3  (15.0)  

Baseline Characteristics

Variable   In-­‐person  DOT  

miDOT   Pvalue  

Adherence,  median  (IQR)     92    (88-­‐100)  

92    (83-­‐99)  

0.41  

DOT  as  %  of  observable  doses,  median  (IQR)              Observed  fracHon  

   65    

(62-­‐71)  

   73    

(63-­‐92)  

   0.11  

Self administration: Dose NOT taken under observation.

Feasibility

0  

20  

40  

60  

80  

100  

Pre-miDOT Post-miDOT

Perc

ent (

%)

Video DOT is effective

Disagree Agree

*

*

0  

20  

40  

60  

80  

100  

Pre-miDOT Post-miDOT

Perc

ent (

%)

Video DOT improves treatment adherence

(vs self-administration)

Disagree Agree

Staff opinions on impact of video DOT

Surveys collected on a 5-point Likert scale, dichotomized for analysis Analysis by McNemars test for paired proportions

Acceptability  

Qualitative themes arising from pre/post interviews

“…sometimes they meet me … at work … I’m afraid ill be seen.”  

patient privacy Patient

“… the fact that someone in a county car [is] not coming up to their house or their job in the community, [video DOT] definitely increases privacy for patients.”

“It was as least invasive possible, I'd say. That was probably the best part [of miDOT].”

miDOT improves patient privacy

Patient

Provider

“I'm about to start a [school] … [and] the schedule doesn't really match … I won't be able to do the class, and I need class more than I need this.”

 

In-person DOT is limited by logistical constraints

Patient

Acceptability Theme

DOT strategy Equipment Consumables Labor Total Incremental

In-person DOT (range)

$1751 ($69-$562)

$522 ($17-$141)

$1,8383 ($521-$6,169)

$2,065 ($608-$6,872)

Reference

miDOT (range)

$464 ($2-$136)

$4685 ($0-$1,200)

$131 ($37-$578)

$645 ($39-$1,914)

-$1,420

‘Ingredients’ approach: multiply quantity of consumables/labor utilized by unit costs Time motion studies at each site, and obtained local costing information from clinics/clinic managers Divide costs by category:

Labor Consumables (e.g. supplies) Equipment (e.g. vehicles, computers, etc)

‘Sensitivity analysis’ to examine different methods of implementation and different program structures  

Costs

✶ Patients on miDOT maintained a high (and comparable) level of adherence.

✶ “Observed fraction” was increased on miDOT, though trend was not statistically significant.

✶ Both patients and staff felt miDOT was less burdensome and more private than in-person DOT ✶ Concern among some DOT workers that video DOT would replace them

✶ Cost estimates varied significantly

✶ Only at extreme estimates was miDOT more expensive, more miDOT lead to cost savings.

Conclusions and Considerations

Feasibility Acceptability Costs

✶ Patients were not randomized to miDOT, study participants represents a select subsample of TB clinic population

Patients selected for miDOT tended to be those unable to effectively participate in in-person DOT (conflict with work, school, travel, etc). May have lead to MORE CONSERVATIVE estimates. ✶ Pilot study with small sample size Will need larger follow-up study to improve generalizability

Implementation Considerations  ✶ Video DOT may free-up time to intensify in-person care to those in need of such services

There will be ongoing need for in-person DOT. Patient-centered care is about building treatment around individual patient needs. Some will favor social support > flexibility.

✶ Opens the possibility for 7x per week DOT. Now shift towards daily therapy. Improvements in care may be seen with DOT extended to 7 days per week

Limitations  

Special thanks to the DOT workers and nurse case managers at the following health departments: •  Baltimore City Health Department •  Montgomery County Health

Department •  Ann Arundel Country Health

Department

emocha Mobile Health, Inc. •  Katrina Rios, BA •  Sebastian Seiguer, JD, MBA

Johns Hopkins •  Maunank Shah, MD, PhD •  Avi Zenilman

Acknowledgements