NCT01299259

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 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

November 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

3.7 years

First QC Date

November 30, 2010

Last Update Submit

October 27, 2014

Conditions

Keywords

Text message remindersPelvic inflammatory diseasePIDPrimary care follow-upEmergency department careDischarge instructions

Outcome Measures

Primary Outcomes (1)

  • PCP follow-up rates will be used to evaluate the efficacy of text message reminders.

    PCP follow-up rates will be assessed 7-14 days after discharge from the ED.

Secondary Outcomes (4)

  • Number of adolescents who accept text message reminders as an measure of feasibility and acceptability.

    7-14 days after discharge from the ED

  • Number of adolescents satisfied with ED care between the control group and intervention group as a measure of patient satisfaction.

    7-14 days after ED discharge

  • Type of participant characteristics associated with PCP follow-up as a measure of behavior change, compliance and rate of follow-up care

    7-14 days after ED discharge

  • 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

    7-14 days after ED visit

Study Arms (2)

Text Message Reminders

EXPERIMENTAL

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

Behavioral: Text Message Reminders

Control Group

NO INTERVENTION

The control group will not receive any additional reminders to follow-up with PCP.

Interventions

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.

Text Message Reminders

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (9)

  • 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.

    PMID: 16888612BACKGROUND
  • 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.

    PMID: 16027575BACKGROUND
  • 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.

    PMID: 16781961BACKGROUND
  • 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.

    PMID: 18619710BACKGROUND
  • 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.

    PMID: 19917951BACKGROUND
  • 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.

    PMID: 18653444BACKGROUND
  • 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.

    PMID: 19822583BACKGROUND
  • 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.

    PMID: 18809542BACKGROUND
  • 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.

MeSH Terms

Conditions

Pelvic Inflammatory Disease

Condition Hierarchy (Ancestors)

Pelvic InfectionInfectionsAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Cynthia Mollen, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Frances Balamuth, MD, PhD

    Children's Hospital of Philadelphia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations