Non-secure Message SenderseHealth PEINCT02665468
eHealth Partnered Evaluation Initiative
A study testing Supported adoption intervention in people with Non-secure Message Senders, run by VA Office of Research and Development at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-secure Message Senders
- What is being tested?
- Supported adoption intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,196 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2016to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Authenticated My HealtheVet users who have not sent a secure message
- Active patients who have an appointment scheduled in the following year
Who cannot join
- Authenticated My HealtheVet users who have sent a secure message
- Inactive patients (who do not have an appointment scheduled in the following year)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: eHealth Partnered Evaluation Initiative (PEC 15-470)
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.
Read the 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.
- Conditions
- Non-secure Message Senders
- Being tested
- Supported adoption intervention, Active comparator control
- Keywords
- Supported adoption, Secure messaging, Patient aligned care team (PACT), My HealtheVet Coordinator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported adoption interventionBehavioural
Also called SAI
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)
Active comparator controlBehavioural
Also called General wellness information
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Supported Adoption Intervention (SAI) | Other | Supported adoption intervention Receives: Behavioral: Supported adoption intervention |
| Arm 2: General wellness information | Active comparator | General wellness information Receives: Behavioral: Active comparator control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Six months
Secondary outcomes (3)
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.
Measured: Six month follow-up
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.
Measured: Six month follow-up
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study start1 Feb 2016
- Primary completion31 Oct 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-secure Message SendersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,196 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy Patrick Hogan, PhD MS BS, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665468
- Sponsor's protocol ID
- PEX 16-001
- Other IDs
- PEC 15-470
- Acronym
- eHealth PEI
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2016
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shimada SL, Zocchi MS, Hogan TP, Kertesz SG, Rotondi AJ, Butler JM, Knight SJ, DeLaughter K, Kleinberg F, Nicklas J, Nazi KM, Houston TK. Impact of Patient-Clinical Team Secure Messaging on Communication Patterns and Patient Experience: Randomized Encouragement Design Trial. J Med Internet Res. 2020 Nov 18;22(11):e22307. doi: 10.2196/22307.
PubMed 33206052
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eHealth Partnered Evaluation Initiative (PEC 15-470)
- ClinicalTrials.gov ID
- NCT02665468
- Acronym / sponsor ID
- eHealth PEI / PEX 16-001
- Conditions
- Non-secure Message Senders
- Keywords
- Supported adoption, Secure messaging, Patient aligned care team (PACT), My HealtheVet Coordinator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,196 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Supported Adoption Intervention (SAI) | Other | Behavioral: Supported adoption interventionSupported adoption intervention |
| Arm 2: General wellness information | Active comparator | Behavioral: Active comparator controlGeneral wellness information |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Authenticated My HealtheVet users who have not sent a secure message
- Active patients who have an appointment scheduled in the following year
Key exclusion criteria (2 listed)
- Authenticated My HealtheVet users who have sent a secure message
- Inactive patients (who do not have an appointment scheduled in the following year)
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 |
|---|---|---|
| Supported adoption interventionAlso: SAIAn 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) | Behavioural | Arm 1: Supported Adoption Intervention (SAI) |
| Active comparator controlAlso: General wellness informationThe 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 | Behavioural | Arm 2: General wellness information |
Primary outcome
Change in Rate of Use
Time frame: Baseline and Six months
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.
3 secondary outcomes
Patient Self-reported Access to Communication
Time frame: Six month follow-up
Care Coordination: Patient Assessment of Chronic Illness Care
Time frame: Six month follow-up
Physician Accessibility and Engagement
Time frame: Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33206052Shimada SL, Zocchi MS, Hogan TP, Kertesz SG, Rotondi AJ, Butler JM, Knight SJ, DeLaughter K, Kleinberg F, Nicklas J, Nazi KM, Houston TK. Impact of Patient-Clinical Team Secure Messaging on Communication Patterns and Patient Experience: Randomized Encouragement Design Trial. J Med Internet Res. 2020 Nov 18;22(11):e22307. doi: 10.2196/22307.
- Click here for more information about this study: eHealth Partnered Evaluation Initiative (PEC 15-470)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Timothy Patrick Hogan, PhD MS BS principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported adoption intervention in people with Non-secure Message Senders, run by VA Office of Research and Development at 4 sites 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 2 inclusion and 2 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 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Rate of Use (time frame: Baseline and Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02665468, which also lists 1 linked publication.
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 18 Feb 2019.