Patient PortalsNCT03242070
A Theory-Based Patient Portal eLearning Program for Older Adults With Chronic Illnesses
A study testing Theory-based PP eLearning Program(T-PeP) in people with Patient Portals and Chronic Disease, run by University of Maryland, Baltimore at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Portals, Chronic Disease, Older Adults
- What is being tested?
- Theory-based PP eLearning Program(T-PeP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being age ≥50
- having been diagnosed with at least one chronic disease* (e.g., heart disease, diabetes, cancer)
- having access to the Internet/e-mail
- being able to use the Internet/e-mail independently
- currently residing in the U.S.
- being able to read/write English.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Patient Portals, Chronic Disease, Older Adults
- Being tested
- Theory-based PP eLearning Program(T-PeP)
- Keywords
- Patient Portals, Chronic Disease, Older Adults
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory-based PP eLearning Program(T-PeP)Other
Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 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.
| Study group | Role | What they receive |
|---|---|---|
| Theory-based PP eLearning Program(T-PeP) | Experimental | Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 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. Receives: Other: Theory-based PP eLearning Program(T-PeP) |
| Control Group | No intervention | No specific intervention will be provided to the control group participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
PP knowledge
An 8-item questionnaire developed by experts and tested in preliminary studies (α=.50).40,41
Measured: Change from baseline knowledge at 3 week and 4 months
Self-efficacy for using PPs
a modified 4-item Self-Efficacy for Computer-Based PHR Scale100 (α=.97; criterion validity), which was successfully used in our preliminary studies.40,41
Measured: Change from baseline knowledge at 3 week and 4 months
Self-efficacy for health decision making
Decision Self-Efficacy Scale, including 11 items on a 5-point Likert scale. The scale assesses the person's ability to obtain information, ask questions, and make a choice.136-138 It was tested for older adults in an eHealth study (α=.83; criterion validity).139
Measured: Change from baseline knowledge at 3 week and 4 months
Patient-provider communication
14 items of the Components of Primary Care Instrument140,141 that assesses the following 3 areas: interpersonal communication, physician's knowledge of the patient, coordination of care. This tool has been tested in our prior study40 (α=.89; factor analysis141).
Measured: Change from baseline knowledge at 3 week and 4 months
PP use
The number of newly activated account(s) and the frequency of PP usage per function; lab results, medications, and health summaries; and other functions as reported in the scheduled surveys.
Measured: Change from baseline knowledge at 3 week and 4 months
Secondary outcomes (1)
Medication reconciliation
The frequency of comparing all medications that participants are taking with all medications listed on their PP142 as reported in the scheduled surveys.
Measured: Change from baseline knowledge at 3 week and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start17 Jan 2017
- Primary completion31 Dec 2017
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient PortalsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel-group RCT
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Eun-Shim Nahm, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242070
- Sponsor's protocol ID
- HP-00069040
- Status last verified
- May 2022
- First submitted
- 2 Aug 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-Based Patient Portal eLearning Program for Older Adults With Chronic Illnesses
- ClinicalTrials.gov ID
- NCT03242070
- Acronym / sponsor ID
- HP-00069040
- Conditions
- Patient Portals, Chronic Disease, Older Adults
- Keywords
- Patient Portals, Chronic Disease, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm parallel-group RCT
| Arm | Type | Receives |
|---|---|---|
| Theory-based PP eLearning Program(T-PeP) | Experimental | Other: Theory-based PP eLearning Program(T-PeP)Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 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. |
| Control Group | No intervention | –No specific intervention will be provided to the control group participants |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being age ≥50
- having been diagnosed with at least one chronic disease* (e.g., heart disease, diabetes, cancer)
- having access to the Internet/e-mail
- being able to use the Internet/e-mail independently
- currently residing in the U.S.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theory-based PP eLearning Program(T-PeP)Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 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. | Other | Theory-based PP eLearning Program(T-PeP) |
Primary outcome
PP knowledge
Time frame: Change from baseline knowledge at 3 week and 4 months
An 8-item questionnaire developed by experts and tested in preliminary studies (α=.50).40,41
Self-efficacy for using PPs
Time frame: Change from baseline knowledge at 3 week and 4 months
a modified 4-item Self-Efficacy for Computer-Based PHR Scale100 (α=.97; criterion validity), which was successfully used in our preliminary studies.40,41
Self-efficacy for health decision making
Time frame: Change from baseline knowledge at 3 week and 4 months
Decision Self-Efficacy Scale, including 11 items on a 5-point Likert scale. The scale assesses the person's ability to obtain information, ask questions, and make a choice.136-138 It was tested for older adults in an eHealth study (α=.83; criterion validity).139
Patient-provider communication
Time frame: Change from baseline knowledge at 3 week and 4 months
14 items of the Components of Primary Care Instrument140,141 that assesses the following 3 areas: interpersonal communication, physician's knowledge of the patient, coordination of care. This tool has been tested in our prior study40 (α=.89; factor analysis141).
PP use
Time frame: Change from baseline knowledge at 3 week and 4 months
The number of newly activated account(s) and the frequency of PP usage per function; lab results, medications, and health summaries; and other functions as reported in the scheduled surveys.
1 secondary outcome
Medication reconciliation
Time frame: Change from baseline knowledge at 3 week and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory-based PP eLearning Program(T-PeP) in people with Patient Portals and Chronic Disease, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PP knowledge (time frame: Change from baseline knowledge at 3 week and 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.