Trial record 2 of 9 for:    Open Studies | "Pelvic Inflammatory Disease"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01299259
First received: November 30, 2010
Last updated: August 8, 2014
Last verified: August 2014
  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:


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: November 2014
Estimated Primary Completion Date: November 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:

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: August 8, 2014
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 September 29, 2014