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

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
  • Study Primary Completion Date: October 2014

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • 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
  • No Intervention: Control Group
    • The control group will not receive any additional reminders to follow-up with PCP.

Outcome Measures for this Clinical Trial

Primary 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.
      Safety Issue?: No

Secondary 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Children’s Hospital of Philadelphia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cynthia Mollen, MD, MSCE, Principal Investigator, Children’s Hospital of Philadelphia
    • Frances Balamuth, MD, PhD, Study Director, Children’s Hospital of Philadelphia

References

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.

Source

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01299259