NCT03710213

Brief 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 colonoscopy, and (2) evaluate the impact of the texting intervention on colonoscopy show rate and bowel preparation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
752

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

October 15, 2018

Last Update Submit

January 3, 2020

Conditions

Adherence, PatientColonoscopyText Messaging

Outcome Measures

Primary Outcomes (1)

  • 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

    Assessed on day of colonoscopy

Secondary Outcomes (6)

  • Colonoscopy show rate

    Assessed on day of colonoscopy

  • Bowel preparation quality

    Assessed on day of originally-scheduled colonoscopy

  • Colonoscopy cancellation rate

    Assessed on day of originally-scheduled colonoscopy

  • Colonoscopy reschedule rate

    Assessed on day of originally-scheduled colonoscopy

  • Colonoscopy no-show rate

    Assessed on day of originally-scheduled colonoscopy

  • +1 more secondary outcomes

Study Arms (2)

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.

Behavioral: Text Message-based Intervention

Interventions

Text Message-based InterventionBEHAVIORAL

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.

Text Message-based Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for outpatient colonoscopy at Pennsylvania Presbyterian Medical Center
  • Subject has a cell phone with enabled text messaging capability

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Hospital System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 33492374DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 18, 2018

Study Start

November 26, 2018

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)