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eHealth Partnered Evaluation Initiative

eHealth Partnered Evaluation Initiative (PEC 15-470)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02665468
Acronym
eHealth PEI
Enrollment
1196
Registered
2016-01-27
Start date
2016-02-01
Completion date
2017-09-30
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-secure Message Senders

Keywords

Supported adoption, Secure messaging, Patient aligned care team (PACT), My HealtheVet Coordinator

Brief summary

On October 1, 2016, the VHA Office of Telehealth and the Connected Health Office will merge to create a single entity that will be responsible for the implementation and evaluation of eHealth technologies across the healthcare system. In an effort to successfully fulfill its mission, the new combined Connected Health/Telehealth Office is pledging $1,100,000 for an eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of eHealth technologies across VHA, and to measure their impacts on dimensions of access and other outcomes. Developed in close consultation with leadership of the new office, the proposed objectives of the eHealth PEI are to (1) implement a patient-level supported adoption intervention for secure messaging and evaluate the impact of secure messaging use through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA's automated telehealth text messaging system to Veterans and clinical team members.

Detailed description

eHealth is a model for the delivery and receipt of healthcare services with an expanding evidence base that suggests great potential to increase access and support the transition from episodic to continuous care. In this model, patients, their families, and clinical team members use eHealth technologies that support functions (e.g., communication, behavior support, transactions) that are critical to disease prevention and health management which in turn influences behaviors, processes and outcomes. In October 2016, the existing Office of Telehealth and the Connected Health Office will merge to create a single Office to oversee the implementation and evaluation of eHealth technologies across VHA. The new combined Connected Health/Telehealth Office will manage the full spectrum of technologies included in the current Offices of Telehealth (e.g., clinical video telehealth, home telehealth, tele-ICU) and Connected Health (e.g., patient portal, secure messaging, mobile apps), as well as new technologies that span these offices (such as the new Automated Telehealth Texting System). Recognizing the importance of rigorous evaluation to its mission, the Connected Health/Telehealth Office is pledging funds for an eHealth Partnered Evaluation Initiative (PEI) to support the further implementation of eHealth technologies across VHA, and to measure their impacts on dimensions of access, as well as Veteran and clinical team experiences, healthcare processes, and Veteran health outcomes. Developed in close consultation with Connected Health/Telehealth Office leadership, the proposed objectives of the eHealth PEI are to (1) implement a patient-level supported adoption intervention for secure messaging and evaluate the impact of secure messaging use through a rapid, one-year randomized trial; and (2) evaluate the initial rollout of VHA's automated telehealth text messaging system to Veterans and clinical team members. The evaluation work associated with each of these two objectives will be guided by the Practical, Robust Implementation and Sustainability Model (PRISM). The implementation and evaluation of eHealth technologies is not just the mission of the new Connected Health/Telehealth Office, it is also the vision of VHA. In addition to addressing the needs of the investigators' operational partner, the aforementioned objectives map to key strategies and transformational actions detailed in the Blueprint for Excellence, and align with a recently developed Virtual Access Strategy Document intended to guide the efforts of the Connected Health/Telehealth Office. The proposed eHealth PEI team includes leadership and investigators from the eHealth Quality Enhancement Research Initiative (QUERI) who are recognized authorities in informatics, implementation science, and mixed methods evaluation, and have longstanding, collaborative relationships with constituents in the Connected Health/Telehealth Office.

Interventions

BEHAVIORALSupported adoption intervention

An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)

The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Authenticated My HealtheVet users who have not sent a secure message * Active patients who have an appointment scheduled in the following year

Exclusion criteria

* Authenticated My HealtheVet users who have sent a secure message * Inactive patients (who do not have an appointment scheduled in the following year)

Design outcomes

Primary

MeasureTime frameDescription
Change in Rate of UseBaseline and Six monthsMeasure the change in rate of use of secure messaging in intervention versus control Veterans, reported as participants in each arm that sent a secure message during study period.

Secondary

MeasureTime frameDescription
Patient Self-reported Access to CommunicationSix month follow-upTo explore the impact of secure messaging use on healthcare encounters, the investigators will compare the responses of each arm at 6-month follow-up assessment for Patient Self-reported Access to communication using 2 Questions adapted from the Survey of Healthcare Experience of Patients Scale which inquires, How easy is it for you to communicate with your doctor when you need to? and, How easy is it for you to get to see your nurse when you need to? Responses to scale were 1= Never, 2= Sometimes, 3= Usually, 4= Always; where Always was the best score.
Care Coordination: Patient Assessment of Chronic Illness CareSix month follow-upTo explore the impact of secure messaging use on healthcare encounters, the investigators will use the Patient Assessment of Chronic Illness Care (PACIC) designed to assess patients' perceptions of the degree to which their care experiences are consistent with the chronic care model and includes subscale scores for patient activation, goal setting/tailoring, and follow-up/coordination. Investigators compared arms at 6-month follow-up using scale 0 (not a problem) - 4 (very big problem), where 0 indicates the desired response.
Physician Accessibility and EngagementSix monthsTo explore the impact of secure messaging use on healthcare encounters, the investigators will compare each arm at 6-month follow-up assessment with responses from Health Care Climate Questionnaire (HCCQ), a 15-item scale adapted to assess the degree to which patient healthcare provider is accessible and supportive (taking the participant's perspective, encouraging and answering questions, supporting their plans) This is a Likert scale ranging from 1 = Strongly Disagree to 7 = Strongly Agree; where in all but one question - 1 = Strongly Agree is the desired response. Responses were totaled, inverting the one question and mean was determined.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1: Supported Adoption Intervention
Supported adoption intervention Supported adoption intervention: An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)
595
Arm 2: General Wellness Information
General wellness information Active comparator control: The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention
601
Total1,196

Baseline characteristics

CharacteristicArm 2: General Wellness InformationTotalArm 1: Supported Adoption Intervention
Age, Continuous53.8 years
STANDARD_DEVIATION 13.4
54.3 years
STANDARD_DEVIATION 13.4
54.7 years
STANDARD_DEVIATION 13.5
Race/Ethnicity, Customized
African-American
37 Participants70 Participants33 Participants
Race/Ethnicity, Customized
MIssing
144 Participants280 Participants136 Participants
Race/Ethnicity, Customized
Other Race
5 Participants11 Participants6 Participants
Race/Ethnicity, Customized
White
415 Participants835 Participants420 Participants
Sex: Female, Male
Female
62 Participants122 Participants60 Participants
Sex: Female, Male
Male
539 Participants1074 Participants535 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 5950 / 601
serious
Total, serious adverse events
0 / 5950 / 601

Outcome results

Primary

Change in Rate of Use

Measure the change in rate of use of secure messaging in intervention versus control Veterans, reported as participants in each arm that sent a secure message during study period.

Time frame: Baseline and Six months

Population: The number of participants who received the Supported Adoption Intervention as analyzed was 2 less (these materials were returned/wrong address) than initially randomized and baseline characteristics are presented for.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Arm 1: Supported Adoption InterventionChange in Rate of Use85 Participants
Arm 2: Usual CareChange in Rate of Use28 Participants
p-value: 0.01Chi-squared
Secondary

Care Coordination: Patient Assessment of Chronic Illness Care

To explore the impact of secure messaging use on healthcare encounters, the investigators will use the Patient Assessment of Chronic Illness Care (PACIC) designed to assess patients' perceptions of the degree to which their care experiences are consistent with the chronic care model and includes subscale scores for patient activation, goal setting/tailoring, and follow-up/coordination. Investigators compared arms at 6-month follow-up using scale 0 (not a problem) - 4 (very big problem), where 0 indicates the desired response.

Time frame: Six month follow-up

Population: Participants who completed 6-month follow-up assessment

ArmMeasureValue (MEAN)Dispersion
Arm 1: Supported Adoption InterventionCare Coordination: Patient Assessment of Chronic Illness Care2.12 units on a scaleStandard Deviation 2.98
Arm 2: Usual CareCare Coordination: Patient Assessment of Chronic Illness Care2.06 units on a scaleStandard Deviation 2.92
Secondary

Patient Self-reported Access to Communication

To explore the impact of secure messaging use on healthcare encounters, the investigators will compare the responses of each arm at 6-month follow-up assessment for Patient Self-reported Access to communication using 2 Questions adapted from the Survey of Healthcare Experience of Patients Scale which inquires, How easy is it for you to communicate with your doctor when you need to? and, How easy is it for you to get to see your nurse when you need to? Responses to scale were 1= Never, 2= Sometimes, 3= Usually, 4= Always; where Always was the best score.

Time frame: Six month follow-up

Population: Participants who completed the 6-month follow-up survey

ArmMeasureValue (MEAN)Dispersion
Arm 1: Supported Adoption InterventionPatient Self-reported Access to Communication3.70 units on a scaleStandard Deviation 1.11
Arm 2: Usual CarePatient Self-reported Access to Communication3.52 units on a scaleStandard Deviation 1.21
Secondary

Physician Accessibility and Engagement

To explore the impact of secure messaging use on healthcare encounters, the investigators will compare each arm at 6-month follow-up assessment with responses from Health Care Climate Questionnaire (HCCQ), a 15-item scale adapted to assess the degree to which patient healthcare provider is accessible and supportive (taking the participant's perspective, encouraging and answering questions, supporting their plans) This is a Likert scale ranging from 1 = Strongly Disagree to 7 = Strongly Agree; where in all but one question - 1 = Strongly Agree is the desired response. Responses were totaled, inverting the one question and mean was determined.

Time frame: Six months

Population: Participants who completed 6-month follow-up survey

ArmMeasureValue (MEAN)Dispersion
Arm 1: Supported Adoption InterventionPhysician Accessibility and Engagement6.24 units on a scaleStandard Deviation 1.12
Arm 2: Usual CarePhysician Accessibility and Engagement5.97 units on a scaleStandard Deviation 1.33

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026