Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03242070 |
Other study ID # |
HP-00069040 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 17, 2017 |
Est. completion date |
June 30, 2019 |
Study information
Verified date |
May 2022 |
Source |
University of Maryland, Baltimore |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The high prevalence of chronic illnesses is a serious public health problem in the U.S., and
more than 70 million adults age ≥50 have at least one chronic illness. Management of chronic
conditions requires long-term use of complex treatment plans and can cause unintended
consequences, such as increased risk of medication errors. Patient portals (PPs), a federally
supported health information technology (IT), can be especially helpful for patients with
chronic illnesses. Patients can now access their own health records and directly communicate
with care providers through PPs. Prior findings suggest a great potential for using PPs to
improve care quality, and the federal government funds healthcare organizations to implement
this tool nationwide. Despite the potential benefits, the overall PP adoption rate in the
U.S. is low. A lack of PP use among older adults has been addressed as a particular concern.
When only older adults who use the Internet are considered, however, their proportion of PP
use is similar to other age groups. A few studies also reported that older adults are
receptive to PPs. In general, older adults need additional support for learning to use PPs,
as they tend to be less familiar with technology. Currently, most older adults receive little
or no PP support from their providers. This is an important gap in the nation's health IT
initiative because without appropriate support, older adults will not be able to use this
robust health tool, missing an important opportunity to improve their health outcomes. In an
effort to fill this gap, the investigators developed and tested an older adult friendly
Theory-based Patient portal eLearning Program (T-PeP) to support older adults in using PPs
for their care. In the proposed feasibility study, the investigators plan to (Aim 1) optimize
and implement a vendor-agnostic T-PeP and conduct formative and process evaluations; and (Aim
2) assess the preliminary impact of T-PeP on PP use and selected outcomes (PP knowledge,
self-efficacy for PP use and health decision making, health communication, and medication
reconciliation). If successful, this study could directly affect quality of care provided to
older adults and the success of the national health IT initiative. Findings from this study
will also provide hospitals, vendors, and policymakers with in-depth information on older
adults' current PP usage patterns and other challenges in using various types of PPs at the
national level.
Description:
The high prevalence of chronic illnesses is a serious public health problem in the United
States, accounting for 70% of all deaths. Older adults are especially vulnerable; more than
70 million adults age ≥50 have at least one chronic illness (e.g., heart disease, diabetes).
Management of chronic conditions requires long-term use of multiple medications and complex
treatment plans, which can cause unintended consequences, such as increased risk of
medication errors. Engaging patients in their care and health decision-making processes is
vital for the provision of high quality care to people with chronic conditions. Until
recently, however, patients were not given access to their own health records and had to call
their providers' offices to communicate with them. In the past few years, the nation has made
unprecedented efforts to transform health care using information technology (IT). Through
secure patient portals (PPs), patients now can access their electronic health records (EHRs),
directly send eMessages to their providers, and request medication renewals online. They can
also involve their family caregivers in their care more efficiently. PPs are especially
helpful for patients with chronic illnesses, as they offer tools to manage health conditions.
With the Meaningful Use (MU) incentive payment program by the Centers for Medicare and
Medicaid Services (CMS), healthcare organizations nationwide are implementing PPs and making
them available to the public.
Prior findings demonstrated positive impacts of PPs on management of chronic conditions,
adherence to treatment, and patient-provider communication. Currently, PP adoption rates vary
depending on care organizations, but the overall nationwide adoption rate has been low
(26.8%). A lack of PP use among older adults has been addressed as a particular concern.
Based on 2014 national survey data, however, when only online users were considered, the
proportion of PP use in older adults was similar to other age groups (≥18 yrs, 32.2%; 50-64,
34.1%; ≥65, 29.8%). In a 2015 SeniorNet34 member survey (N=553; mean age, 73.6 yrs), 60.6%
(n=327) reported having at least one PP account. These findings indicate an excellent
potential for using PPs for the care of older adults (AHRQ's priority population36). Many
older adults, however, are not technologically savvy and need additional support. Currently,
most older adults receive little or no PP training support from their providers. This is a
critical gap in the nation's health IT initiative because without appropriate support, older
adults will not be able to use this robust health tool, missing an important opportunity to
improve their health-related outcomes.
In an effort to fill this gap, in our previous studies the investigators developed and tested
the older adult friendly Theory-based PP eLearning Program (T-PeP) to provide older adults
necessary support for using PPs. In the proposed feasibility study, the investigators will
optimize and implement the program in a large older adult online community, conduct
formative/process evaluation, and assess its preliminary impact on PP use and selected
health-related outcomes. T-PeP was developed based on self-efficacy theory to improve older
adults' use of PPs for managing their care and includes learning modules, discussion boards,
and other resources. Considering variations in the types and usability of PPs used by
patients nationwide, T-PeP was developed as a vendor-agnostic ("not tied to a specific
vendor") program. The specific aims of the study are to:
Aim 1: Optimize and implement T-PeP in an older adult online community and conduct formative
and process evaluations (e.g., usability problems, barriers and facilitators for PP use, and
other practical issues).
Aim 2: Assess the preliminary impact of T-PeP on older adults' PP use and selected
health-related outcomes using a two-arm randomized controlled trial (RCT). Older adult online
users with chronic conditions (N=242, age ≥50) will be recruited from a large older adult
online community (SeniorNet.org).
H1. The intervention group participants will demonstrate greater improvement than the control
group at the end of T-PeP (3 weeks) and at 4 months in PP knowledge, self-efficacy for using
PPs and making health decisions, perceived patient-provider communication, and PP use
(enrollment, usage frequency).
H2. More participants in the intervention group than the control group will reconcile the
medications they are taking with the medications listed in their PP at 4 months.
This study could directly impact quality of care provided to older adults and the success of
a national health IT initiative by offering a critically missing component in the current PP
implementation process-patient support for the health IT (PP) designed for patients. Findings
from the study will also provide hospitals, vendors, and policymakers in-depth information on
older adults' current PP usage patterns and other challenges in using various PPs at the
national level, contributing to the improvement of PP technology and clinical practices. Once
the feasibility of the study is demonstrated, the vendor-agnostic T-PeP could be used widely
and incorporated into busy practices. The next R01 study will test its long-term effects on
health behavior and clinical outcomes, as well as care cost, using more diverse samples,
including practice settings and underserved populations.