Adherence, PatientNCT03710213
Automated Navigation to Improve Outpatient Colonoscopy Adherence
A study testing Text Message-based Intervention in people with Adherence, Patient and Colonoscopy, run by University of Pennsylvania at 1 site in United States.
Trial summary
Outpatient colonoscopy adherence is negatively impacted by poor communication and challenges with bowel preparation. We plan to perform a randomized controlled trial at the Pennsylvania Presbyterian Medical Center to (1) provide text message-based educational and reminder messages to patients regarding a scheduled… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Adherence, Patient, Colonoscopy, Text Messaging
- What is being tested?
- Text Message-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 18 Sep 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for outpatient colonoscopy at Pennsylvania Presbyterian Medical Center
- Subject has a cell phone with enabled text messaging capability
Who cannot join
- Fewer than 14 days between the time of enrollment and time of scheduled colonoscopy
- Subject is non-English speaking requiring a translator
- Subject is not the primary individual receiving the text messages
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Hospital System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation
Outpatient colonoscopy adherence is negatively impacted by poor communication and challenges with bowel preparation. We plan to perform a randomized controlled trial at the Pennsylvania Presbyterian Medical Center to (1) provide text message-based educational and reminder messages to patients regarding a scheduled colonoscopy, and (2) evaluate the impact of the texting intervention on colonoscopy show rate and bowel preparation.
Read the detailed description
Colorectal cancer (CRC) is the second leading cause of cancer death in the US, yet there are effective screening and treatment strategies that allow for early detection and treatment. CRC screening is recommended for all individuals aged 50-75, which could include stool testing or colonoscopy, but national rates are still suboptimal at 59-65%. Colonoscopy is an essential component of CRC screening, as it is also required if stool testing is positive. However, colonoscopy requires a complex process to identify an escort, purchase the preparation, take a day off from work, adhere to a clear liquid diet, and complete the split-dose preparation as recommended. This results in a significant no-show and cancellation rate, along with suboptimal preparation quality, which can lead to non-adherence and incomplete screening.
Current approaches to engaging patients include having nurses call patients before the procedure or patient navigators. However, it is often difficult to get patients on the phone, and these interventions can be costly, making it less scalable for clinical practices. Other interventions such as videos or mobile apps have been limited by poor user experience or limited engagement with the patient. There is an opportunity to leverage an automated text message navigation intervention using the Way to Health (WTH) platform to improve patient engagement prior to colonoscopy completion. The WTH platform is a Penn Medicine platform that is hosted on site at the University of Pennsylvania. The platform allows custom text messages to automatically be sent to patients, in addition to bidirectional message capabilities. WTH is protected by a secure firewall and is a HIPAA compliant platform.
In the past year, our team conducted a quality improvement pilot initiative using WTH that tested the feasibility and impact of a one-week text messaging protocol for patients who were scheduled for outpatient colonoscopy. The text messages sent to patients contained information about the preparation process and instructions, expectations about the procedure, and reminders about location and timing. Among the 21 patients enrolled in the pilot, we found high user acceptability and higher colonoscopy show rates as compared to baseline values at Pennsylvania Presbyterian Medical Center. As such we believe that the texting intervention is feasible for testing in the context of a randomized controlled trial.
- Conditions
- Adherence, Patient, Colonoscopy, Text Messaging
- Being tested
- Text Message-based Intervention
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message-based InterventionBehavioural
The intervention consists of a series of educational and reminder text messages that a patient will receive in the week prior to a scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual care includes (1) bowel preparation instructions that are delivered via mail or through a secure online messaging portal, (2) a phone call from the endoscopy staff in the week prior to colonoscopy, and (3) the option to call the endoscopy staff during business hours to have any questions answered on demand. |
| Text Message-based Intervention | Experimental | In addition to usual care, the text message-based intervention consists of the subject receiving text messages per a pre-determined protocol starting 7 days prior to the date of scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program. Of note, if a patient in the intervention arm cancels or reschedules their colonoscopy after randomization, they will not receive any additional protocol text messages as part of this trial. Receives: Behavioral: Text Message-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonoscopy show rate with good or excellent bowel prep
The proportion of patients who show up to their scheduled colonoscopy appointment and have a good or excellent prep
Measured: Assessed on day of colonoscopy
Secondary outcomes (6)
Colonoscopy show rate
The proportion of patients who show up to their scheduled colonoscopy appointment
Measured: Assessed on day of colonoscopy
Bowel preparation quality
The grading of bowel preparation quality (poor, fair, adequate, good, excellent) among those patients who show to their scheduled colonoscopy
Measured: Assessed on day of originally-scheduled colonoscopy
Colonoscopy cancellation rate
The proportion of patients who cancel their originally scheduled colonoscopy appointment
Measured: Assessed on day of originally-scheduled colonoscopy
Colonoscopy reschedule rate
The proportion of patients who cancel and reschedule (for a future date) on the same day, at least one day prior to the originally scheduled colonoscopy appointment date
Measured: Assessed on day of originally-scheduled colonoscopy
Colonoscopy no-show rate
The proportion of patients who do not show for their scheduled colonoscopy appointment and who have not canceled
Measured: Assessed on day of originally-scheduled colonoscopy
Timing of advance cancellation notification (in days)
The number of days in advance that a patient cancels their scheduled colonoscopy
Measured: Assessed on day of originally-scheduled colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start26 Nov 2018
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
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 Adherence, PatientStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shivan J Mehta, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710213
- Sponsor's protocol ID
- 831701
- Status last verified
- Jan 2020
- First submitted
- 15 Oct 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mahmud N, Asch DA, Sung J, Reitz C, Coniglio MS, McDonald C, Bernard D, Mehta SJ. Effect of Text Messaging on Bowel Preparation and Appointment Attendance for Outpatient Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2034553. doi: 10.1001/jamanetworkopen.2020.34553.
PubMed 33492374
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Text Message Navigation to Improve Outpatient Colonoscopy Show Rate and Bowel Preparation
- ClinicalTrials.gov ID
- NCT03710213
- Acronym / sponsor ID
- 831701
- Conditions
- Adherence, Patient, Colonoscopy, Text Messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 18 Oct 2018 (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.
Outpatient colonoscopy adherence is negatively impacted by poor communication and challenges with bowel preparation. We plan to perform a randomized controlled trial at the Pennsylvania Presbyterian Medical Center to (1) provide text message-based educational and reminder messages to patients regarding a scheduled colonoscopy, and (2) evaluate the impact of the texting intervention on colonoscopy show rate and bowel preparation.
Detailed description
Colorectal cancer (CRC) is the second leading cause of cancer death in the US, yet there are effective screening and treatment strategies that allow for early detection and treatment. CRC screening is recommended for all individuals aged 50-75, which could include stool testing or colonoscopy, but national rates are still suboptimal at 59-65%. Colonoscopy is an essential component of CRC screening, as it is also required if stool testing is positive. However, colonoscopy requires a complex process to identify an escort, purchase the preparation, take a day off from work, adhere to a clear liquid diet, and complete the split-dose preparation as recommended. This results in a significant no-show and cancellation rate, along with suboptimal preparation quality, which can lead to non-adherence and incomplete screening.
Current approaches to engaging patients include having nurses call patients before the procedure or patient navigators. However, it is often difficult to get patients on the phone, and these interventions can be costly, making it less scalable for clinical practices. Other interventions such as videos or mobile apps have been limited by poor user experience or limited engagement with the patient. There is an opportunity to leverage an automated text message navigation intervention using the Way to Health (WTH) platform to improve patient engagement prior to colonoscopy completion. The WTH platform is a Penn Medicine platform that is hosted on site at the University of Pennsylvania. The platform allows custom text messages to automatically be sent to patients, in addition to bidirectional message capabilities. WTH is protected by a secure firewall and is a HIPAA compliant platform.
In the past year, our team conducted a quality improvement pilot initiative using WTH that tested the feasibility and impact of a one-week text messaging protocol for patients who were scheduled for outpatient colonoscopy. The text messages sent to patients contained information about the preparation process and instructions, expectations about the procedure, and reminders about location and timing. Among the 21 patients enrolled in the pilot, we found high user acceptability and higher colonoscopy show rates as compared to baseline values at Pennsylvania Presbyterian Medical Center. As such we believe that the texting intervention is feasible for testing in the context of a randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual care includes (1) bowel preparation instructions that are delivered via mail or through a secure online messaging portal, (2) a phone call from the endoscopy staff in the week prior to colonoscopy, and (3) the option to call the endoscopy staff during business hours to have any questions answered on demand. |
| Text Message-based Intervention | Experimental | Behavioral: Text Message-based InterventionIn addition to usual care, the text message-based intervention consists of the subject receiving text messages per a pre-determined protocol starting 7 days prior to the date of scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program. Of note, if a patient in the intervention arm cancels or reschedules their colonoscopy after randomization, they will not receive any additional protocol text messages as part of this trial. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for outpatient colonoscopy at Pennsylvania Presbyterian Medical Center
- Subject has a cell phone with enabled text messaging capability
Key exclusion criteria (3 listed)
- Fewer than 14 days between the time of enrollment and time of scheduled colonoscopy
- Subject is non-English speaking requiring a translator
- Subject is not the primary individual receiving the text messages
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 |
|---|---|---|
| Text Message-based InterventionThe intervention consists of a series of educational and reminder text messages that a patient will receive in the week prior to a scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program. | Behavioural | Text Message-based Intervention |
Primary outcome
Colonoscopy show rate with good or excellent bowel prep
Time frame: Assessed on day of colonoscopy
The proportion of patients who show up to their scheduled colonoscopy appointment and have a good or excellent prep
6 secondary outcomes
Colonoscopy show rate
Time frame: Assessed on day of colonoscopy
Bowel preparation quality
Time frame: Assessed on day of originally-scheduled colonoscopy
Colonoscopy cancellation rate
Time frame: Assessed on day of originally-scheduled colonoscopy
Colonoscopy reschedule rate
Time frame: Assessed on day of originally-scheduled colonoscopy
Colonoscopy no-show rate
Time frame: Assessed on day of originally-scheduled colonoscopy
Timing of advance cancellation notification (in days)
Time frame: Assessed on day of originally-scheduled colonoscopy
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 6 Jan 2020.
- Derived from this study: PubMed 33492374Mahmud N, Asch DA, Sung J, Reitz C, Coniglio MS, McDonald C, Bernard D, Mehta SJ. Effect of Text Messaging on Bowel Preparation and Appointment Attendance for Outpatient Colonoscopy: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2034553. doi: 10.1001/jamanetworkopen.2020.34553.
- 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 Text Message-based Intervention in people with Adherence, Patient and Colonoscopy, run by University of Pennsylvania 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 2 inclusion and 3 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 6 Jan 2020. 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?
Colonoscopy show rate with good or excellent bowel prep (time frame: Assessed on day of colonoscopy). 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 NCT03710213, 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 6 Jan 2020.