Internet-based InterventionNCT05895539
Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool
A study testing An automated patient-reported outcome data collection and adverse event surveillance tool in people with Internet-based Intervention and Web-based Intervention, run by Ro at 1 site in United States.
Trial summary
Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Internet-based Intervention, Web-based Intervention, Online Intervention
- What is being tested?
- An automated patient-reported outcome data collection and adverse event surveillance tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2020to 16 Nov 2020
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients living in the US, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (PDE-5) inhibitors as treatment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Design, Implementation, and Impact of Automated Patient-reported Outcome Data Collection and Adverse Event Surveillance Tool on Treatment Continuation: an Iterative Plan-Do-Study-Act (PDSA) Approach
Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence.
This study evaluated whether implementing a patient-reported outcome data collection and AE surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. We evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. We tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.
- Conditions
- Internet-based Intervention, Web-based Intervention, Online Intervention, Erectile Dysfunction, Telemedicine
- Being tested
- An automated patient-reported outcome data collection and adverse event surveillance tool
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An automated patient-reported outcome data collection and adverse event surveillance toolOther
Patients received a short prompt to provide information on treatment satisfaction and side effects
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Did not receive the tool |
| Intervention | Experimental | Did receive the tool Receives: Other: An automated patient-reported outcome data collection and adverse event surveillance tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month
Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
Measured: 91 days
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 3 months
Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
Measured: 123 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start8 Oct 2020
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Internet-based InterventionStudies 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
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lauren Broffman, PhD, Study director, Ro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895539
- Sponsor's protocol ID
- 21-12-196-599
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not planning to share IPD at this time, due to concerns around patient privacy.
Publications
Zhou MS, Jain T, Hardy N, Perez-Segura A, Hickman J, Leopold L, Qualliotine K, Yedidi RS, Whetsell M, Broffman L. The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial. BMC Health Serv Res. 2023 Nov 20;23(1):1277. doi: 10.1186/s12913-023-10231-1.
PubMed 37986191
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Design, Implementation, and Impact of Automated Patient-reported Outcome Data Collection and Adverse Event Surveillance Tool on Treatment Continuation: an Iterative Plan-Do-Study-Act (PDSA) Approach
- ClinicalTrials.gov ID
- NCT05895539
- Acronym / sponsor ID
- 21-12-196-599
- Conditions
- Internet-based Intervention, Web-based Intervention, Online Intervention, Erectile Dysfunction, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- RoIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 8 Jun 2023 (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.
Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence.
This study evaluated whether implementing a patient-reported outcome data collection and AE surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. We evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. We tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Did not receive the tool |
| Intervention | Experimental | Other: An automated patient-reported outcome data collection and adverse event surveillance toolDid receive the tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients living in the US, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (PDE-5) inhibitors as treatment
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 |
|---|---|---|
| An automated patient-reported outcome data collection and adverse event surveillance toolPatients received a short prompt to provide information on treatment satisfaction and side effects | Other | Intervention |
Primary outcome
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month
Time frame: 91 days
Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 3 months
Time frame: 123 days
Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve)
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 8 Jun 2023.
- Derived from this study: PubMed 37986191Zhou MS, Jain T, Hardy N, Perez-Segura A, Hickman J, Leopold L, Qualliotine K, Yedidi RS, Whetsell M, Broffman L. The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial. BMC Health Serv Res. 2023 Nov 20;23(1):1277. doi: 10.1186/s12913-023-10231-1.
- Individual participant dataSharing planned: No. We are not planning to share IPD at this time, due to concerns around patient privacy.
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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.
Lauren Broffman, PhD study director
Ro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An automated patient-reported outcome data collection and adverse event surveillance tool in people with Internet-based Intervention and Web-based Intervention, run by Ro 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 1 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 8 Jun 2023. 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?
Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month (time frame: 91 days). The study lists 2 primary outcomes in all. 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 NCT05895539, 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 8 Jun 2023.