NCT03242070

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 23, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

August 2, 2017

Last Update Submit

May 16, 2022

Conditions

Keywords

Patient PortalsChronic DiseaseOlder Adults

Outcome Measures

Primary Outcomes (5)

  • PP knowledge

    An 8-item questionnaire developed by experts and tested in preliminary studies (α=.50).40,41

    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

    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

    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).

    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.

    Change from baseline knowledge at 3 week and 4 months

Secondary Outcomes (1)

  • Medication reconciliation

    Change from baseline knowledge at 3 week and 4 months

Study Arms (2)

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.

Other: Theory-based PP eLearning Program(T-PeP)

Control Group

NO INTERVENTION

No specific intervention will be provided to the control group participants

Interventions

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.

Theory-based PP eLearning Program(T-PeP)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SeniorNet

Fort Myers, Florida, 33907, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A two-arm parallel-group RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 8, 2017

Study Start

January 17, 2017

Primary Completion

December 31, 2017

Study Completion

June 30, 2019

Last Updated

May 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations