Keywords
discharge planning - patient self-care - home care and e-health - wireless devices
- adverse drug event - medication adherence
Background and Significance
Background and Significance
The period immediately after hospital discharge is an especially vulnerable time for
patients.[1] This transition of care is especially fraught as there is a high risk of postdischarge
adverse drug events (ADEs) or injury due to medications within 30 days of hospital
discharge. Research suggests postdischarge ADEs make up 70% of all postdischarge adverse
events, at a rate of 0.30 ADEs per patient.[2] Further, approximately one-fifth of patients suffer a postdischarge ADE, two-thirds
of which are potentially preventable or mitigatable.[2]
[3]
[4]
[5] These postdischarge ADEs may lead to adverse medication effects, hospital readmission,
or mortality.[6]
[7]
[8]
Health information technology (HIT) interventions hold promise in minimizing medication
discrepancies and ADEs.[9]
[10]
[11] One such class of HIT interventions are “smart pillboxes.” Smart pillboxes are technologically
enabled pillboxes that have a range of capabilities, including the ability to transmit
audible and digital alerts, track patient medication adherence, and generate adherence
reports to clinicians.[12]
[13]
[14] Several studies to date have touted the success of such interventions in reducing
medication discrepancies and, in some cases, improving chronic disease control in
the ambulatory setting for a wide range of conditions such as hypertension,[15]
[16] diabetes,[15]
[17] human immunodeficiency virus (HIV),[12]
[18]
[19]
[20]
[21]
[22]
[23]
[24] tuberculosis (TB),[18]
[25] multiple myeloma,[26] and post–kidney transplantation.[15] Additionally, and importantly given the novelty of smart pillbox devices, several
studies have also explored user perspectives of this technology, the majority of which
have focused on patient[19]
[22]
[27]
[28]
[29]
[30]
[31]
[32]
[33]
[34]
[35]
[36] rather than clinician[32]
[35]
[37] perspectives.
Given the novelty of smart pillbox devices and their potential in reducing medication
discrepancies, it is important to gain a better understanding of their use during
care transitions. Specifically, it is crucial to identify barriers and facilitators
of implementing such an intervention in this unique setting, to guide successful implementation
in the postdischarge care transition.
Objectives
The purpose of this study is to provide patient, patient caregiver, and clinician
perspectives on the implementation of a novel smart pillbox intervention to reduce
medication discrepancies and improve medication adherence after hospital discharge
from an academic medical center. Primary outcomes of the trial reporting the impact
of the smart pillbox on medication adherence and chronic disease control and a report
on the challenges of deploying a complex HIT intervention will be published separately.[38]
Methods
Study Setting
We conducted this qualitative study as a component of the Smart Pillbox Transitions
Study (clinicaltrials.gov identifier: NCT03475030). The Smart Pillbox Transitions
Study was a cluster-randomized clinical trial in which patients were randomized to
receive a technologically enabled pillbox (TowerView Smart Pillbox) or usual care
at discharge from an acute hospitalization. The Smart Pillbox is a technologically
enabled device that houses prefilled weekly medication trays and sends medication
administration reminders via device chimes and illumination, phone, and text and/or
e-mail to patients and caregivers ([Fig. 1]). Additionally, the Smart Pillbox detects if medications are removed from the corresponding
tray and generates adherence reports accessible by patient clinicians via a secure
online platform.
Fig. 1 The TowerView Smart Pillbox. (A) The pill box (note the blue illumination alarm around the device margin). (B) Insertion of the blister pack into the pill box. (C) A patient opening one of the wells. Keys and a smartphone are shown for scale.
The Mass General Brigham Institutional Review Board approved this study.
Study Participants
Eligible patients for the Smart Pillbox Transitions Study included hospitalized patients
with a plan of discharge home from the medical, cardiology, or oncology services at
Brigham and Women's Hospital, a 793-bed tertiary academic medical center in Boston,
MA. Other inclusion criteria included being prescribed five or more chronic medications,
having a primary care provider at a hospital-affiliated clinic, and being primarily
English or Spanish speaking. Cluster randomization was performed at the primary care
practice level and completed prior to patient enrollment. The trial was performed
between January 2017 and December 2018.
Eligible participants for the qualitative aspect of the study included patients enrolled
in the intervention from the primary study (i.e., patients who had received the smart
pillbox intervention). We contacted all patients who received the intervention (n = 24) via phone. If patients were interested in participating (n = 6), we obtained verbal consent and scheduled the interview. If a patient also had
a caregiver actively involved with medication management, we then asked if the caregiver
would be willing to be scheduled for a separate interview. To identify potential clinician
participants, we identified the discharging interns/physician assistants (PAs), inpatient
attendings, and outpatient attendings of patients who received the intervention. We
then used a random number generator to randomly identify 10 discharging interns/PAs,
5 inpatient attendings, and 5 outpatient attendings. These clinicians were then e-mailed
inviting them to participate in an interview. Clinicians who replied were then scheduled
for interviews.
Study Design
We developed an interview guide ([Supplementary Appendix 1], available in the online version) based on the Systems Engineering Initiative for
Patient Safety (SEIPS) framework, which is a theoretical model from the human factors
and systems engineering fields that expands upon the Donebedian structure-process-outcome
model to depict how the health care environment work system affects processes and
patient outcomes.[39]
[40] The work system is further comprised of several components, including interactions
between person, organization, technologies and tools, tasks, and environment.
We framed the interview guide based on three a priori domains:
-
Barriers to implementation.
-
Facilitators/points of success of the intervention.
-
General feedback on the intervention.
Within these domains, we ensured the interview guide targeted additional themes within
components of the SEIPS model work system, including environment and organization,
logistics and tasks, personnel and patients, and technology and tools ([Fig. 2]). Additional subthemes within these themes are listed in [Supplementary Appendix 2] (available in the online version). We collected additional participant responses
within the domain of general feedback and impressions on the intervention, which included
asking participants about potential barriers identified by the research team during
the development of the interview guide, and suggestions for improvement. Within this
domain, general feedback impressions of intervention components were categorized as
“positive,” “neutral,” and “negative.”
Fig. 2 Adaptation of Systems Engineering Initiative for Patient Safety (SEIPS) model.[39]
[40] The interview guide targeted themes within adapted components of the SEIPS model
work system, including environment and organization, logistics and tasks, personnel
and patients, and technology and tools. Components of the original SEIPS model work
system include organization, physical environment, tasks, person, and technology and
tools. (Reproduced with permission of Carayon et al.[39])
Data Collection
All interviews were conducted by phone by one of two experienced study team members
(EMS or JLS) between May 2018 and January 2019. The interviews were 15 to 45 minutes
in length. All interviews were audio-recorded, transcribed, and uploaded to NVivo
v12 (QSR International, Doncaster, Australia) for analysis and retrieval.
Data Analysis
Study team members met regularly following data collection to review transcripts.
Interview transcripts were independently coded by two study team members (EMS and
JLS) using the analytic framework based on the domains from the interview guide, and
content analysis to interpret findings within the SEIPS-based themes. We used a combination
of inductive and deductive approaches, starting with the SEIPS-based themes (deductive),
and then using an inductive approach to draw on emerging subthemes from the interviews.
Following independent coding, we met for comparative reflection and discussion to
identify emerging themes and resolve discrepancies through consensus. Through this
iterative process, themes and subthemes were refined and redundancies were reconciled.
Results
Fifteen participants were interviewed, including 6 patients, 2 patient caregivers,
and 7 clinicians (2 inpatient attendings, 2 outpatient attendings, 2 inpatient interns,
and 1 inpatient PA). Characteristics of the patient and clinician participants are
summarized in [Table 1].
Table 1
Characteristics of interview patient and clinician interview participants
Characteristic
|
Number (%)
|
Patients
|
6
|
Female
|
5 (83)
|
Age, (y) median (range)
|
63.5 (26–88)
|
Race/ethnicity
|
Hispanic Black
|
1 (17)
|
Non-Hispanic White
|
5 (83)
|
Highest educational attainment
|
Graduate school
|
1 (17)
|
College
|
4 (67)
|
High school/GED
|
1 (17)
|
Employment status
|
Employed full time
|
1 (17)
|
Retired
|
4 (67)
|
On disability
|
1 (17)
|
Marital status
|
Married
|
3 (50)
|
Widowed
|
1 (17)
|
Single/never married
|
2 (33)
|
Lives alone
|
3 (50)
|
Caregiver helps with ADLs/IADLS[a]
|
1 (20)
|
Someone helps with medications
|
3 (50)
|
Cell phone access
|
5 (83)
|
Daily Internet use
|
6 (100)
|
Pillbox use prestudy
|
4 (67)
|
Morisky scale[b]
|
High (>8)
|
2 (33)
|
Medium (6–8)
|
3 (50)
|
Low (<6)
|
1 (17)
|
sTOFHLA score[b]
|
Adequate (23–36)
|
5 (83)
|
Inadequate (0–16)
|
1 (17)
|
Clinicians
|
7
|
Medical resident
|
2 (29)
|
Physician assistant
|
1 (14)
|
Inpatient attending
|
2 (29)
|
Outpatient attending
|
2 (29)
|
Female
|
5 (71)
|
Years in practice, median (range)
|
9 (1–21)
|
Abbreviations: ADL, activity of daily living; GED, general educational development;
IADL, instrumental activity of daily living; sTOFHLA, short test of functional health
literacy in adults.
a Data missing for 1 respondent.
b The Morisky scale is a score of medication adherence; sTOFHLA is a score of patient
health literacy.
The qualitative results are presented in the following sections under each domain,
theme, and subtheme, as well as summarized in [Tables 2] and [3].
Table 2
Domains, themes, and additional illustrative examples from participant experience
with the Smart Pillbox intervention
Domain
|
Theme
|
Illustrative example (subtheme in parentheses)
|
Barriers to implementation
|
Environment and organization
|
“The next competing new thing, right? Like do you need to learn about it or to integrate
it into your practice? Like are we doing virtual visits or annual wellness visits
or do we need to increase like the number of whatever X things that we bill for it's
just like, that checklist of new things…” (competing priorities)—Outpatient clinician
|
Logistics and task
|
“I mean I don't know anything about what the patient is seeing or handling” (insufficient training)—Inpatient clinician
|
Personnel and patients
|
“I'm hearing impaired and I never seemed to be handy when they [alarms] went off”
(patient poor fit due to physical limitations)—Patient
|
Technology and tools
|
“…[it] went a little bit haywire at one point where I would take my medication and
it would constantly be texting me and alerting me that I need to take my medication”
(false-positive/false-negative alarms)—Patient
|
Facilitators/points of success of intervention
|
Environment and organization
|
“All of my doctors were very supportive when I got set up” (sufficient institutional engagement)—Patient
|
Logistics and task
|
“You know the thing is everyone was very cooperative, and I found everyone was working
toward the same goal, which was getting the pillbox filled correctly and getting it
out to me and making sure that the medication was correct. So, I had a good experience
with it” (interdisciplinary communication between pharmacy and patient)—Patient
|
Personnel and patients
|
“To me it seems like an excellent intervention for people who have a hard time with
medications, like remembering to take them, who have complicated regimens, and need
help sticking to it” (positive outcome expectancy)—Outpatient clinician
|
Technology and tools
|
“If I took my medication, I was fine, and if I didn't, I knew the lights were on and
it's time for me to go grab them” (useful alarms)—Patient
|
General feedback on the intervention
|
Suggestions for improvement
|
“If someone wanted to do like a 20-minute teaching or in-service on it, I think it'd
be really an eye-opener, to kind of know what's going on in people's homes with this
and know how we could even recommend it” (changes to training)—Inpatient clinician
|
“Maybe a way to make like a travel size version or something easier to take with you”
(changes to pillbox and technology)—Patient
|
Table 3
General feedback and impressions of intervention component illustrative examples,
categorized as positive, neutral, or negative, from patients/caregivers and clinicians
General feedback sentiment
|
Patient/caregiver
|
Clinician
|
Positive
|
“To keep track of everything rather than having a lot of different, individual medicine
bottles around, so, that's kind of what I thought it would be the benefit, just organizing
the pills”
|
“I think it was just great knowing that my patient is leaving with their meds in their
hands… with an intervention that would help them actually take them”
|
Neutral
|
“I would say no, I thought it [would work] pretty well”
|
“The clinical concerns, I didn't really have any. I, you know, was thinking sort of
through logistically, how is this going to get implemented? How are the people going
to get set up with it in the right time frame?”
|
Negative
|
“I guess I thought that it was, you know, clever but unnecessary”
|
“I mean thinking about the amount of medications as people who have advanced age,
medical complexity, not only do they have so many pills, there are sometimes TID or
QID, so the frequencies and like drug interactions, like not to take one when the
other one is being administered”
|
Abbreviations: QID, quater in die (four times daily); TID, ter in die (three times
daily).
DOMAIN 1: Barriers to Implementation
Theme 1: Environment and Organization
We identified several environmental and organizational barriers to implementation
of the Smart Pillbox at both the hospital and pharmacy levels. Hospital-related barriers,
endorsed solely by clinicians, were mostly related to competing priorities, such as
early discharge, which could potentially reduce institutional commitment to this intervention.
Pharmacy-related barriers that impacted clinician participants pertained to the pharmacy's
hours of availability and insurance coverage issues. Patient participants also experienced
delays in medications when the contracted pharmacy for this study transitioned to
a different pharmacy.
Theme 2: Logistics and Tasks
Within the theme of logistics and tasks, we identified several subthemes including
insufficient training, device setup at discharge, interdisciplinary communication,
and availability of assistance. Several clinicians and patients/caregivers identified
that they did not receive sufficient training, had unclear goals and expectations
regarding the intervention, or were unaware of several of the core features of the
Smart Pillbox.
The greatest reported barrier endorsed by inpatient clinicians pertained to elements
regarding the setup at discharge. Specifically, all the interviewed inpatient clinicians
relayed the rushed nature and timing of discharge as a significant barrier to implementing
the Smart Pillbox. Additionally, the fact that use of the Smart Pillbox required earlier
discharge medication reconciliation in combination with unpredictability of final
discharge prescriptions contributed to barriers related to setup at discharge. As
one inpatient attending stated:
“…that lag time between knowing that the patient is being discharged and then… getting
the patient the box, I think is probably the biggest barrier.”
There were fewer reported barriers related to the subthemes of interdisciplinary communication
and availability of assistance, but these subthemes were still observed: one patient
reported difficulties in reaching the product support line; another patient and his
caregiver reported difficulties communicating with pharmacy staff members.
Theme 3: Personnel and Patients
Within the theme of personnel and patients, one concentrated subtheme for clinicians
was a lack of, or negative, outcome expectancy (i.e., not expecting the intervention
to work, including not being able to see if it was successful). As one inpatient PA
explained:
“I never get to see the follow-up to see how it would have impacted her adherence,
or did it save her from missing doses she should have received.”
“Poor fit” was likewise identified within the theme of personnel and patients as a
barrier among some patients; examples of poor fit included frequent travel, functional
limitations (physical and cognitive), language barriers, medication regimen complexity,
having medications outside the pillbox, poor adherence and follow-up, resistance to
accepting help, and periods of illness and hospitalizations. One caregiver's response
was particularly illustrative:
“I would say, another issue that she had is because she was taking them (medications)
at four different times a day. The first pill would be before she got out of bed and
then her 10 a.m. say and her 5 p.m. would be on the first floor and her bedroom was
on the second floor and then her bedtime pills, she preferred to take them upstairs
getting ready for bed on the second floor, so she would have to take them out of the
container and bring some of them upstairs with her…and sometimes she didn't hear the
phone ring”
Theme 4: Technology and Tools
Barriers within the theme of technology and tools were reported primarily among patients
and caregivers and included false-positive/false-negative or annoying alarms, signal
issues, and the number and size of wells. One patient had difficulty finding a location
in their home with adequate signal:
“Well, I guess my original pillbox they thought something was wrong with it…we tested
it and said it had moved to a new location in my apartment and it looked like it wasn't
getting a good signal.”
DOMAIN 2: Facilitators/Points of Success of the Intervention
Theme 1: Environment and Organization
Within the theme of environment and organization, clinicians commented on there being
adequate support from the hospital and that the intervention aligned with other hospital
priorities. Some clinicians stated that the hospital outpatient pharmacy was generally
available when necessary, in contrast to others who noted pharmacy availability as
a barrier (as above). Patients endorsed that their outpatient clinicians were supportive
of their involvement in the study and were pleased that multiple clinicians across
the health care system were able to monitor their progress.
Theme 2: Logistics and Tasks
In contrast to the barriers mentioned earlier, within the theme of logistics and tasks,
some clinicians felt that their training on intervention implementation and understanding
of the goals and expectations was adequate. Additionally, interdisciplinary communication
and availability for assistance was regarded favorably, especially communication between
patients and the pharmacy and communication between study staff and the inpatient
team. One patient's caregiver was especially praiseful of pharmacy staff members:
“I talked several times with people on the phone there, the pharmacy… there was a
pharmacist … she was just, stellar in what she did.”
Although inpatient clinicians rarely commented that the discharge medication setup
process was easy, one resident stated:
“…in some ways, it also saved time the next day because it, the meds were already
sent, and then also you didn't have to spend time like calling the pharmacy and making
sure like all the medications were there and available.”
Theme 3: Personnel and Patients
Within the theme of personnel and patients, while some patients and clinicians expressed
barriers related to a pessimistic outcome expectancy (as above), many interviewees
endorsed a positive outcome expectancy, that is, belief that this intervention would
end up being effective. One outpatient attending stated:
“My impression was that it would be a great tool for some patients.”
Similarly, in contrast to the barriers outlined earlier, patients and clinicians also
identified that a patient being a “good fit” for the intervention was a facilitator.
Additional subthemes that emerged included patients having adequate support from family
and home services, patients having few or no medications outside the pillbox (such
as inhalers or insulin), and patients having a language difference that could be bridged
by the technology. Regarding language differences, one outpatient attending commented:
“You know she has limited English proficiency, so you know the visual acuity, like
the visual cues and the sound cues help when there's a language barrier right?”
Theme 4: Technology and Tools
Within the theme of technology and tools, patients generally expressed high regard
for many of the technological aspects of the Smart Pillbox. In particular, all of
the patients and their caregivers stated that they found the alarms to be useful.
As one patient commented:
“I would forget, and then I hear, I'd have my phone and I would hear the alert or
I would be in my room and I would see the lights flashing, so I know, “Wait a minute,
I gotta [sic] go take my medications,” and you open the pillbox and there you are,
you know exactly what you're taking…there's no way you can make a mistake, with your,
when you have that pillbox. There's no way.”
Other aspects of the technology and tools that patients positively endorsed included
ease of use, portability, lack of obtrusiveness, and lack of signal issues.
DOMAIN 3: General Feedback on the Intervention
General impressions of intervention components that were considered “positive,” “neutral,”
or “negative” are summarized in [Table 3]. Most general impressions were positive and were related to the perceived usefulness
of having medications prepackaged and of the alerts. The research team also asked
patients about several potential barriers developed a priori by the research team; all of these were ultimately not endorsed by the patients,
including potential confusion around having as-needed medication outside of the pillbox
or concern about having young children who might try to access it.
Both patients and clinicians also offered suggestions for improvement in different
aspects of the intervention, including the themes of environment/organization, logistics/task,
personnel/patients, and technology/tools. For example, regarding suggestions for improvement
for the organization, one inpatient PA suggested incorporating discussion about setting
up the device as part of morning interdisciplinary rounds and care coordination. Clinicians
also suggested more careful consideration of which patients would benefit the most
from and should receive the intervention. Patients also offered suggestions for improving
the pillbox, such as first doing a home signal test, making the device less bulky,
incorporating a password or lock device, and developing an associated smartphone application.
Discussion
In our SEIPS-informed qualitative analysis of patient, patient caregiver, and clinician
experience with the implementation of a novel smart pillbox intervention to reduce
medication discrepancies and improve medication adherence after hospital discharge,
we were able to identify key barriers and facilitators of successful intervention
as well as several suggestions for improvement. Patients and their caregivers identified
barriers related to the technology, including inappropriate alarms, connectivity,
and portability issues, in addition to issues with logistics and task as they related
to contacting the pharmacy and ensuring medications were accurate and delivered in
a timely manner. Clinicians endorsed key barriers, mostly pertaining to the hospital
environment and organization and logistics and tasks, especially the rushed nature,
competing priorities, and unpredictability of the discharge process that conflicted
with the additional time required to set up the pillbox for use. Overall, these findings
provide a useful assessment for barriers and facilitators of a technologically enabled
pillbox to improve medication adherence at discharge, many of which likely apply to
similar HIT interventions during this crucial transition of care.
Our study is a novel contribution to the literature as it is the first, to our knowledge,
that provides qualitative insight into the barriers and facilitators of the implementation
of a HIT intervention for medication safety at hospital discharge. Further, it is
among the first that purposefully integrates a patient safety framework (SEIPS) to
develop an interview guide and identify themes and subthemes. This process will help
facilitate the incorporation of lessons learned from this intervention to other similar
interventions.
Our study's focus on implementation of technologically enabled pillboxes at the time
of hospital discharge adds to existing qualitative studies in the ambulatory setting.[19]
[22]
[27]
[28]
[29]
[30]
[31]
[32]
[33]
[34]
[35]
[36] These studies have examined the use of a smart pillbox in a variety of geographic
locations (e.g., U.S. academic medical centers, clinics in sub-Saharan Africa, urban
clinics in India) for a variety of conditions. Similar to what we found in our study,
these studies also identified technology and tools as a prominent barrier to implementation.
Patients identified issues with device connectivity[19]
[31] and with alarms being either inappropriate or obtrusive.[27]
[35]
[37] Other qualitative studies also highlight patient-reported issues with device portability
during commuting or travel.[22]
[27]
[30]
[32]
[33]
[35]
[36] Our study adds barriers not previously noted in the literature, including patient
concerns regarding medication complexity and having multiple medications in the pillbox
wells given multiple medical conditions, different from other studies that were largely
disease specific. This feedback is particularly important when considering utilization
of the smart pillbox technology within a more complex clinical setting involving a
broader cohort of patients.
Our study adds insight into barriers of implementation from clinician perspectives
during challenging workflows in the hospitalization-to-home transition of care, which
also involves a transition of patient responsibility from the inpatient to outpatient
clinician. The limited existing data on clinician perspectives largely support our
findings, including lack of available personnel to implement the device,[37] insufficient training, medication dispensing, and communication with pharmacists
and product support[35] as major barriers to implementation.
As with identified barriers, many of the facilitators that patients identified for
the smart pillbox intervention were similar to other qualitative research of technologically
enabled pillboxes in the outpatient setting. This was especially true within the theme
of technology and tools, where our study supported the findings of other studies that
found the pillbox was easy to use,[19]
[27]
[31]
[35]
[36]
[41] that the alarms were useful,[19]
[27]
[31]
[35]
[36]
[41] and there were limited signal issues.[31] Other literature also identified that having family members available to help in
medication management facilitated the intervention.[27]
[32]
[33]
[35] Although fewer existing studies examined the domain of logistics and task (specifically
patient communication with pharmacists, product support, or clinician staff members),
one international study did find that patients appreciated having health care clinicians
contacting them in the case of missed medication doses.[35] Within the theme of personnel and patients, several studies highlight clinicians'
positive outcome expectancy as a facilitator of implementation,[35]
[37] supported by our findings. Our study adds to this existing literature as it evaluates
facilitators to implementation within the unique setting of transition from hospital
to home, which necessitates involvement and collaboration between multiple types of
personnel, including product support, pharmacists, inpatient and outpatient clinicians,
and study staff members.
Some comments we received from patients and clinicians were contradictory (e.g., some
patients found device portability to be problematic, while others found it sufficiently
portable; some clinicians believed training was inadequate, while others thought training
was sufficient), likely due to natural differences in opinions and lack of standardized
training on device implementation. Given this, future attempts to incorporate such
a device into the hospitalization-to-home care transition should include more robust
early-stage input from various stakeholders, including patients, caregivers, clinicians,
pharmacists, staff, and hospital administrators, to ensure these perspectives are
integrated into implementation planning.
Based on the findings from this study, when taken in the context of limited existing
literature on this topic, there are several key recommendations within the SEIPS-based
themes that we present to optimize the likelihood for a smart pillbox intervention
to be successfully implemented at the hospitalization-to-home care transition. Within
the theme of environment and organization, the hospital system and associated pharmacies
should have sufficient awareness and sponsorship of the intervention to ensure that
sufficient resources are devoted to support the intervention's infrastructure. Within
the theme of logistics and tasks, clinicians should have adequate training about the
device and its potential to improve patient care, to improve clinician adherence and
buy-in. A standardized and internally validated training about the device and its
capabilities for all clinicians and supporting staff could be considered to improve
clinician buy-in. Given the logistic complexity of patient discharge for inpatient
clinicians who are often overloaded with other tasks, there may be a role for dedicated
discharge coordinators or pharmacists to ensure that device setup is completed in
a thorough and timely manner. Within the theme of personnel and patients, when considering
which patients have the highest likelihood of benefit from such an intervention, we
would recommend selecting patients with medical complexity (i.e., multiple comorbidities),
but with relatively stable medication regimens and dosages, with a limited number
of medications outside the pillbox (e.g., as needed medication, insulin, inhalers,
controlled substances), who have caregivers invested in their successful medication
management and with limited cognitive or functional limitations. It is crucially important
to monitor the sociodemographic profile of patients who receive a smart pillbox and
compare this to the general profile of a health care system to ensure that the intervention
does not exacerbate a “digital divide.”[42] Finally, within the theme of technology and tools, the smart pillbox itself must
be user-friendly, portable, unobtrusive, safe, and have robust connectivity capabilities.
We recommend that developers of similar devices particularly focus on device portability.
We believe if these critical themes and subthemes are addressed, HIT interventions
such as this have a reasonable possibility of being successfully implemented.[43]
Limitations
We acknowledge several limitations of this study that should be considered. First,
we hoped to achieve theme saturation after completion of the participant interviews,
but it is unclear if this was achieved. This was in part due to the relatively low
number of subjects enrolled in the trial and low number of clinicians who responded
to requests for interview. While we did not include pharmacists in this qualitative
study, perspectives from this key group are shared in an accompanying manuscript.[38] Second, our study was performed at a single, well-resourced academic medical center
in the Northeast United States as part of a randomized trial. Additionally, the majority
of patients included were Whites and college educated with high medical literacy.
Some of our findings may not therefore be generalizable, especially in lower-resource
settings that may lack the infrastructure, personnel, and funding to support this
intervention. However, we are reassured that many of the themes identified were shared
with studies performed in different clinical (i.e., ambulatory) and geographic (i.e.,
international, urban/rural) settings. Third, although we purposefully chose a validated
framework for understanding how the health care environment work system affected processes
and patient outcomes in the SEIPS model, it is possible that by using this framework
we did not identify other important domains. There is also some overlap between our
identified themes and subthemes, which is a consequence of the SEIPS framework's emphasis
on interactions between its components. However, we are reassured that while ours
is the first to purposefully use the SEIPS framework in this context, many of the
domains and themes we identified were shared with other studies. Fourth, we did not
include a formal test of interrater concordance. Finally, our study is subject to
the same biases as other qualitative research, including selection, acquiescence,
and confirmation bias. Selection bias derives from selecting our patient sample from
the pool of participants who completed the intervention arm of the study. Thus, the
opinions expressed may not be representative of all smart pillbox users. We purposefully
conducted the interviews to avoid sources of interviewer biases.
Conclusion
In this qualitative study based on the SEIPS framework on the implementation of a
novel smart pillbox intervention to reduce medication discrepancies and improve medication
adherence after hospital discharge, we identified key barriers and facilitators to
intervention implementation endorsed by patients and clinicians. Whereas patients
and their caregivers generally appreciated the smart pillbox and its technological
capabilities as well as support from study staff, inpatient and outpatient clinicians
endorsed key barriers, mostly within the theme of logistics and tasks. Reconciliation
of perspectives from key stakeholders is crucial for a smart pillbox or similar HIT
interventions to be successful.
Clinical Relevance Statement
Clinical Relevance Statement
Technologically enabled pillboxes are generally well-received by patients and have
the potential to reduce posthospital discharge ADEs. It is important to ensure that
the technology is functioning appropriately and that workflows to provide patients
with such a device during the discharge process are streamlined if such an intervention
is to be successfully implemented.