- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299259
Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease
October 27, 2014 updated by: Children's Hospital of Philadelphia
Improving Primary Care Follow-up for Adolescents With PID: A Randomized Controlled Trial Using Text Message Reminders
The investigators hypothesize that text message reminders to girls diagnosed with pelvic inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Centers for Disease Control (CDC) recommends that patients diagnosed with pelvic inflammatory disease (PID) receive follow-up care within 72 hours of diagnosis.
However, recent studies show that the majority of teenage girls diagnosed with PID do not receive this follow-up care within 72 hours.
We hypothesize that text message reminders to girls diagnosed with PID in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Females aged 15 years and older
- New diagnosis of PID, as defined by the 2006 CDC minimum criteria for diagnosis of PID, on current ED encounter
- Determined by attending physician to be appropriate for outpatient treatment
Exclusion Criteria:
- Patient does not have a cell phone that is capable of receiving text messages
- Developmental disability
- Non-English speaking
- Pregnancy
- Patient who was enrolled in this study on a prior ED visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Text Message Reminders
Subjects randomized to the the intervention group will receive a total of 4 text messages on days 2 through 5 to remind them to schedule and attend a PCP follow-up appointment
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Patients in the intervention group will receive text messages on their cell phones following discharge from the emergency department reminding them to make an appointment with their primary care provider.
Text messages will be sent daily for 4 days after discharge from the ED.
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No Intervention: Control Group
The control group will not receive any additional reminders to follow-up with PCP.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PCP follow-up rates will be used to evaluate the efficacy of text message reminders.
Time Frame: PCP follow-up rates will be assessed 7-14 days after discharge from the ED.
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PCP follow-up rates will be assessed 7-14 days after discharge from the ED.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of adolescents who accept text message reminders as an measure of feasibility and acceptability.
Time Frame: 7-14 days after discharge from the ED
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The acceptability among adolescents of using text message reminders after ED discharge in adolescents treated in a pediatric ED.
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7-14 days after discharge from the ED
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Number of adolescents satisfied with ED care between the control group and intervention group as a measure of patient satisfaction.
Time Frame: 7-14 days after ED discharge
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Patient satisfaction of ED care when receiving text message reminders.
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7-14 days after ED discharge
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Type of participant characteristics associated with PCP follow-up as a measure of behavior change, compliance and rate of follow-up care
Time Frame: 7-14 days after ED discharge
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Patient characteristics associated with PCP follow-up
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7-14 days after ED discharge
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Barriers to PCP follow-up from an ED visit to measure use of text message technology and rate of change in follow-up care between groups
Time Frame: 7-14 days after ED visit
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Types of barriers encountered to PCP follow-up from an ED visit for PID care to measure rate of change in follow-up care between groups
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7-14 days after ED visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cynthia Mollen, MD, MSCE, Children's Hospital of Philadelphia
- Study Director: Frances Balamuth, MD, PhD, Children's Hospital of Philadelphia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Miloh T, Annunziato R, Arnon R, Warshaw J, Parkar S, Suchy FJ, Iyer K, Kerkar N. Improved adherence and outcomes for pediatric liver transplant recipients by using text messaging. Pediatrics. 2009 Nov;124(5):e844-50. doi: 10.1542/peds.2009-0415. Epub 2009 Oct 12.
- Armstrong AW, Watson AJ, Makredes M, Frangos JE, Kimball AB, Kvedar JC. Text-message reminders to improve sunscreen use: a randomized, controlled trial using electronic monitoring. Arch Dermatol. 2009 Nov;145(11):1230-6. doi: 10.1001/archdermatol.2009.269.
- Centers for Disease Control and Prevention; Workowski KA, Berman SM. Sexually transmitted diseases treatment guidelines, 2006. MMWR Recomm Rep. 2006 Aug 4;55(RR-11):1-94. Erratum In: MMWR Recomm Rep. 2006 Sep 15;55(36):997.
- Trent M, Ellen JM, Walker A. Pelvic inflammatory disease in adolescents: care delivery in pediatric ambulatory settings. Pediatr Emerg Care. 2005 Jul;21(7):431-6. doi: 10.1097/01.pec.0000169432.14067.eb.
- Trent M, Judy SL, Ellen JM, Walker A. Use of an institutional intervention to improve quality of care for adolescents treated in pediatric ambulatory settings for pelvic inflammatory disease. J Adolesc Health. 2006 Jul;39(1):50-6. doi: 10.1016/j.jadohealth.2005.08.008.
- Engel KG, Heisler M, Smith DM, Robinson CH, Forman JH, Ubel PA. Patient comprehension of emergency department care and instructions: are patients aware of when they do not understand? Ann Emerg Med. 2009 Apr;53(4):454-461.e15. doi: 10.1016/j.annemergmed.2008.05.016. Epub 2008 Jul 10.
- Franklin VL, Greene A, Waller A, Greene SA, Pagliari C. Patients' engagement with "Sweet Talk" - a text messaging support system for young people with diabetes. J Med Internet Res. 2008 Jun 30;10(2):e20. doi: 10.2196/jmir.962.
- Riley W, Obermayer J, Jean-Mary J. Internet and mobile phone text messaging intervention for college smokers. J Am Coll Health. 2008 Sep-Oct;57(2):245-8. doi: 10.3200/JACH.57.2.245-248.
- Wolff M, Balamuth F, Sampayo E, Mollen C. Improving Adolescent Pelvic Inflammatory Disease Follow-up From the Emergency Department: Randomized Controlled Trial With Text Messages. Ann Emerg Med. 2016 May;67(5):602-609.e3. doi: 10.1016/j.annemergmed.2015.10.022. Epub 2015 Dec 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
November 30, 2010
First Submitted That Met QC Criteria
February 17, 2011
First Posted (Estimate)
February 18, 2011
Study Record Updates
Last Update Posted (Estimate)
October 28, 2014
Last Update Submitted That Met QC Criteria
October 27, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-007744
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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