Pelvic Inflammatory DiseaseNCT01299259
Improving Primary Care Follow-up for Patients With Pelvic Inflammatory Disease
A study testing Text Message Reminders in people with Pelvic Inflammatory Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Text Message Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Text Message Reminders
- Keywords
- Text message reminders, Pelvic inflammatory disease, PID, Primary care follow-up, Emergency department care, Discharge instructions
- Medical subject headings
- Pelvic Inflammatory Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Message RemindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Text Message Reminders |
| Control Group | No intervention | The control group will not receive any additional reminders to follow-up with PCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCP follow-up rates will be used to evaluate the efficacy of text message reminders.
Measured: 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.
The acceptability among adolescents of using text message reminders after ED discharge in adolescents treated in a pediatric ED.
Measured: 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.
Patient satisfaction of ED care when receiving text message reminders.
Measured: 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
Patient characteristics associated with PCP follow-up
Measured: 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
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
Measured: 7-14 days after ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Mollen, MD, MSCE, Principal investigator, Children's Hospital of PhiladelphiaFrances Balamuth, MD, PhD, Study director, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299259
- Sponsor's protocol ID
- 10-007744
- Status last verified
- Oct 2014
- First submitted
- 30 Nov 2010
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16888612Trent 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.
PubMed 16027575Trent 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.
PubMed 16781961Engel 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.
PubMed 18619710Armstrong 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.
PubMed 19917951Franklin 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.
PubMed 18653444Miloh 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.
PubMed 19822583Riley 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.
PubMed 18809542Wolff 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.
PubMed 26686262
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Primary Care Follow-up for Adolescents With PID: A Randomized Controlled Trial Using Text Message Reminders
- ClinicalTrials.gov ID
- NCT01299259
- Acronym / sponsor ID
- 10-007744
- Conditions
- Pelvic Inflammatory Disease
- Keywords
- Text message reminders, Pelvic inflammatory disease, PID, Primary care follow-up, Emergency department care, Discharge instructions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text Message Reminders | Experimental | Behavioral: Text Message RemindersSubjects 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 |
| Control Group | No intervention | –The control group will not receive any additional reminders to follow-up with PCP. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Message RemindersPatients 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. | Behavioural | Text Message Reminders |
Primary outcome
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.
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Background: PubMed 16888612Centers 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.
- Background: PubMed 16027575Trent 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.
- Background: PubMed 16781961Trent 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.
- Background: PubMed 18619710Engel 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.
- Background: PubMed 19917951Armstrong 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.
- Background: PubMed 18653444Franklin 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.
- Background: PubMed 19822583Miloh 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.
- Background: PubMed 18809542Riley 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.
- Derived from this study: PubMed 26686262Wolff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Mollen, MD, MSCE principal investigator
Children's Hospital of Philadelphia
Frances Balamuth, MD, PhD study director
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message Reminders in people with Pelvic Inflammatory Disease, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01299259, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.