Activating Collaborative CIS Support Via Targeted Provider Mailing

Study Overview
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Brief Summary
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RATIONALE: Receiving a reminder letter from their doctor with questions to ask the Cancer Information Service may be more effective than a standard reminder letter in helping patients who have had an abnormal Pap test keep their follow-up colposcopy appointment. PURPOSE: This randomized clinical trial is studying a personalized letter with Cancer Information Service support to see how well it works compared with a standard reminder letter in women scheduled for colposcopy after an abnormal Pap test.

Detailed Description
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OBJECTIVES: Compare the effect of a usual care mailing intervention vs a Cancer Information Service (CIS) support mailing intervention on the likelihood that women with an abnormal Pap test will keep their medical follow-up appointments and be satisfied with how they talk to their provider. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 intervention arms. Arm I (Usual-care mailing intervention): Patients receive a generic letter reminding them of their follow-up colposcopy appointment. Arm II (Cancer Information Service [CIS] support mailing intervention): Patients receive a targeted letter reminding them of their follow-up colposcopy appointment, asking them or someone they designate to call the CIS, and suggesting some questions to ask the CIS about colposcopies and Pap tests. At their follow-up appointments, all patients undergo an exit interview to compare patient satisfaction between the 2 interventions. Patients in arm II also answer questions about their CIS experience, and if the intervention made their follow-up visit less difficult.

Official Title
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Activating Collaborative CIS Support Via Targeted Provider Mailing

Conditions
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Precancerous Condition

Intervention / Treatment
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* Other: Usual care mailing intervention
* Other: CIS support mailing intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: DISEASE CHARACTERISTICS: Received an abnormal Pap test result Scheduled for a colposcopy within 6 months of their Pap test at either the Erie Family Health Center or the Prentice Ambulatory Clinic PATIENT CHARACTERISTICS: Female Able to communicate in either English or Spanish Clinic staff will review patient charts to determine eligibility PRIOR CONCURRENT THERAPY: Not specified Exclusion criteria: <18 years unable to communicate in English or Spanish no address to which a letter can be mailed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care mailing intervention<br>routine colposcopy reminder letter mailed | Other: Usual care mailing intervention<br>* routine colposcopy reminder letter<br>|
| Experimental: CIS support mailing intervention<br>Mailed reminder plus provider recommendation to call CIS and sample questions to ask | Other: CIS support mailing intervention<br>* Mailed reminder plus provider recommendation to call CIS and sample questions to ask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction in the 2 Interventions | Patient satisfaction with provider-patient communication was assessed via administration of the Consumer Assessment of Health Plans Study (CAHPS) satisfaction questionnaire which rates satisfaction on a 1 to 3 scale. Scores are added together, with minimum score being 4 and the maximum score being 12, with a higher score indicating greater satisfaction. | within 6 months of PAP | 
| CIS Experience of Patients in Arm II and the Effect of the Intervention on Their Follow-up Colposcopy |  | within 6 months of PAP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance at a Follow-up Colposcopy Appointment Within 6 Months of Their Pap Test |  | within 6 months of PAP | 
| Latency Between the Pap Test and the Colposcopy Appointment |  | within 6 months of PAP | 
| Number of CIS Callers Who Provided the Specific Codes Listed in the Intervention Letter |  | WITHIN 6 MONTHS OF PAP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical intraepithelial neoplasia, atypical squamous cells of undetermined significance, high-grade squamous intraepithelial lesion, low-grade squamous intraepithelial lesion