Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease - Full Text View

Purpose

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.

Condition	Intervention
Pelvic Inflammatory Disease	Behavioral: Text Message Reminders

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment
Official Title:	Improving Primary Care Follow-up for Adolescents With PID: A Randomized Controlled Trial Using Text Message Reminders

Resource links provided by NLM:

MedlinePlus related topics: Pelvic Inflammatory Disease

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The acceptability among adolescents of using text message reminders after ED discharge in adolescents treated in a pediatric ED.
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 ] [ Designated as safety issue: No ]
Patient satisfaction of ED care when receiving text message reminders.
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 ] [ Designated as safety issue: No ]
Patient characteristics associated with PCP follow-up
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 ] [ Designated as safety issue: No ]
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

Estimated Enrollment:	94
Study Start Date:	February 2011
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Behavioral: Text Message Reminders 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. Other Name: Text message reminders
No Intervention: Control Group The control group will not receive any additional reminders to follow-up with PCP.

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299259

Contacts

Contact: Frances Balamuth, MD, PhD		balamuthf@email.chop.edu
Contact: Cynthia Mollen, MD		mollenc@email.chop.edu

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Margaret Wolff, MD meg.s.wolff@gmail.com
Contact: Steve Yakscoe yakscoes@email.chop.edu
Sub-Investigator: Margaret Wolff, MD
Sub-Investigator: Esther Sampayo, MD, MPH
Principal Investigator: Cynthia Mollen, MD, MSCE
Sub-Investigator: Frances Balamuth, MD, PhD

Sponsors and Collaborators

Children's Hospital of Philadelphia

Investigators

Principal Investigator:	Cynthia Mollen, MD, MSCE	Children's Hospital of Philadelphia
Study Director:	Frances Balamuth, MD, PhD	Children's Hospital of Philadelphia

More Information

Additional Information:

Pew Internet & American Life Project This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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. Epub 2008 Jul 10.

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.

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.

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. Epub 2009 Oct 12.

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.

Responsible Party:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT01299259 History of Changes
Other Study ID Numbers:	10-007744
Study First Received:	November 30, 2010
Last Updated:	December 14, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

Text message reminders
Pelvic inflammatory disease
PID

Primary care follow-up
Emergency department care
Discharge instructions

Additional relevant MeSH terms:

Pelvic Inflammatory Disease
Pelvic Infection
Infection
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013