1.      Introduction and Background

Cervical cancer is one of the most preventable cancers because of its slowprogression,cytologically identifiable precursors and effective treatments. Yet,itremains the third most common gynecological malignancy diagnosed and the fourthleadingcause of cancer deaths among women worldwide [1]. According to the Centers for Disease Control and Prevention, the most recent statisticsindicatethat 11,955 women were diagnosed with cervical cancer in 2013 and 4,217 died.  Whendiagnosedearly, the likelihood of survival is close to 100% [2]. A key reason for the high number of deaths caused by this preventable cancer isfailureto obtain follow-up care after an abnormal screening with the Pap smear. The rates of losstofollow-up for abnormal Pap smears have been found to range from 30% to 50% [3]. The purpose of this EBP project was to ascertain thebestevidence on ways to increase adherence to follow-up care recommendations and suggestpossibleinterventions for a Federally Qualified Health Center (FQHC) in SoutheasternOhio.

2.      Cultivating a Spirit of Inquiry

Within southeastern Ohio there is a federally qualified health center whose mission istoprovide high quality, affordable health care services to medically underservedpopulationsregardless of their ability to pay.  Loss to follow-up care has been recognized as apotentiallylife-threatening consequence for women within this health center. Despite the fact that therearesome interventions in place such as an automated telephone reminder system and in somecasestransportation vouchers, the number of patients with abnormal Pap smears who do notfollow-upin a timely manner or do not follow-up at all remains high. This prompted the author to wanttoobtain evidence that would assist in determining what interventions would help thesewomenkeep their follow-up appointments and could be used to develop a plan for the healthcenter.

3.      PICOTQuestion

A PICOT question (P=Patient Population, I=Issue of Interest, C= ComparisonGroup,O=Outcome, and T=Timing) was developed to guide the literature search and thedevelopmentof the patient and staff questionnaires. For this project, there was not a comparison group.ThePICOT question was “In women receiving gynecological care (P), what interventions (I)willreduce barriers and facilitate adherence to follow-up (O) after abnormal Cervical Cytology(T)?”

4.      Search for the Best Evidence

It is important to focus on barriers that are amenable to intervention; therefore,aliterature search on the best evidence for intervention was conducted. Using thedatabasesPubMed, CINAHL and Cochrane, a search for articles published from 1990-2017wasconducted. The keywords used from the PICOT question in the search process were:barriers facilitators, adherence, Pap smear and follow-up. The search was limited to theEnglishlanguage. This search yielded a total of 25 articles adding to the body of evidence relatedtobarriers and facilitators to adherence to follow recommendations for abnormal Pap smears.The search methods were validated by a Health Sciences Librarian who has expertise inEBP.

5.      Presentation and Critical Appraisal of the Evidence

The 25 articles found were examined for validity (whether or not the results of thestudywere obtained from sound scientific methods), reliability (whether or not the effects fromthestudy have sufficient influence on practice) and applicability (whether or not the effects ofthestudy are appropriate for a particular patient situation). Of the articles that focusedonintervention studies, five were systematic reviews or meta-analysis. The systematicreviewsyielded results of studies related to barriers to follow-up care and improving adherence tofollow-up care after an abnormal Pap smear during a span from 1966-2014. There are multiplefactorsassociated with adherence to follow-up recommendations, including both demographicandpsychosocial patient factors as well as healthcare system influences [2].Demographic barriers include younger or older age, nonwhite race, and lowereducationallevel. Financial barriers include lack of insurance or ability to pay for care. Psychologicalissue includes fear and beliefs about health and cancer. Accessibility to care is demonstratedby individuals not having the time to attend multiple appointments, transportation issues and lackofchildcare.  Other barriers found to affect adherence include forgetting the follow-upappointment being asymptomatic and not having follow-up recommendations from health care providers.Insome instances, there are administrative problems such as incorrect patient addresses andphonenumbers making it difficult contactpatients.Five systematic reviews indicate that effective strategies to improve patient adherencetofollow-up recommendations include: (a) structured educational/counseling phone calls,(b)transportation and financial incentives, (c) office-based reminder calls and letters, (d)educationalbrochures and handouts regarding abnormal Pap smears, (e) slide-taped presentations, (f)andcase managementtracking Seven randomized control studies and one quasi-experimental intervention studywasreviewed. One study was conducted using patients from 12 different primary health careclinics.Seven studies were conducted in various units of a hospital or medical center, all of whichwerelocated in the United States. The majority of the intervention studies used samplepopulationspredominantly including minority women of African American (ranging from 13%-86% ofthetotal number of participants) or Hispanic descent (ranging from 17% to 80.6% of thetotalnumber of participants). Those that were Caucasian in the studies ranged from 6%-24% ofthetotal number of participants representing a much smaller portion of the total. Thelargerproportion of participants was uninsured or relied on public assistance for medicalexpenses. The participants were relatively young in age with most under age 35 years.  Oneinterventionstudy used a sample of predominately white women with an average age of 31 years,welleducated, and in the middle and upper social classes. Sample sizes for all the interventionstudiesranged from 108 to 4,488 participants. Intervention study times ranged from 6 months to 3½years following abnormal Papsmears.Results from these studies revealed that single or a combination of interventionsiseffective in improving patient adherence rates.  Two studies found that telephone counselingismore effective than standard care for improving adherence to follow-up [4,5]. Two studies describe the effectiveness ofacomputerized tracking system [6,7]. In astudyinvolving a combination of interventions including a personalized follow-up letterandeducational pamphlet and a slide taped program describing Pap smears and the importanceoffollow-up compared to transportation incentives alone, transportation incentives were foundtobe the most effective at improving adherence rates [8]. A second studythatinvolved transportation incentives along with two other interventions found similar ratesofreceipt of follow-up care but did not find strong evidence for intervention effects [9]. Interventions supported in other studies which have been shown to improve adherenceto follow-up care are: (a) educational pamphlets, (b) notification letters, (c) financial incentives,(d)telephone reminders, (e) and slide-tapededucation.Young Suk &Jeong Sook, 2014 found the main reason that patients follow upforabnormal pap smear is receiving recommendations from health care providers. They alsofoundthat almost half the patients in their study returned for follow up when they had doubts about the progress of cervical cancer.  Other factors included symptoms of disease such asvaginalbleeding and discharge, recommendations from female friends and family anddiscountedexpenses.Limitations of the studies include a lack of consensus on the definition of“Adherence”.Some studies refer to adherence as a patient who completed all recommendedfollow-upappointments. Others defined adherence as a patient that presented for at least onefollow-upappointment.   Another limitation to the studies is that all but one of the studies used a sampleofpredominately minority women of African American or Asian descent which may limitthegeneralizability to white women. Although each intervention study had limitations,alldocumented some improvement in adherence to follow-up with intervention.  In addition,eachstudy provides and supports the development of futureinterventions.

6.      Qualitative Studies

The purpose of the single qualitative meta-analysis was to determine the effectivenessofinterventions designed to improve follow-up after abnormal Pap smear. The criteria fortheanalysis included: randomized or concurrently controlled study design, defined outcomes,anddata available for abstraction. Interventions were classified as behavioral, cognitive,sociologic,or combined strategies. Twenty-two interventions in ten studies were reviewed. Themosteffective cognitive intervention included telephone counseling, improving adherence by24-31%.Behavioral interventions such as patient reminders increase adherence by 18%.Video-tapedpeer discussions were found to be the only sociologic intervention and were not found tobeassociated with an improvement in follow-up. There were eight distinct interventions inthreestudies that used a combination of strategies.  Most of the behavioral and cognitivecombinationsyielded an improvement in compliance by 7-13%. Varying effectiveness was found inthebehavioral and sociologic or the behavioral, sociologic and cognitivecombinations.Limitations of the studies included a varying definition of abnormal Pap smear,follow-upoutcome measurement and time frame used to assess follow-up. Variability in thepatientpopulations studied could also have an effect on the interpretation of theresults.The samples of the remaining 11 studies were varied. The sample sizes ranged from40-1216 participants. In the studies, most participants were under age 35, had completedhighschool, and were uninsured or covered by public assistance. The majority of studiesobtainedinformation from women of racial or ethnic minorities. The literature indicates thatfacilitatorsto follow-up care include reminders, transportation and financial incentives, andeducationalmaterials help to facilitate adherence to follow-uprecommendations.

7.      Integration ofEvidence

It is unknown whether women at a federally qualified health center have similarbarriersand facilitators to adherence to follow-up recommendations after an abnormal Pap smearaswomen studied in the literature. To assess this, patient data was obtained from women inthehealth center and compared to the data found in the literature. To add to the evidence, datawasalso obtained from clinicians who provide care to the women at the healthcenter.

8.      Project Procedure

Patients were conveniently chosen based on their presence at the health center foranappointment in the gynecological service line.The investigator felt that trying toobtaininformation strictly from patients who did not ever return for a follow-up appointment due toanabnormal Pap smear would be difficult. This was concluded because many patients do nothavecurrent contact information available and have not been seen at the health center for more thanayear.  However, within the data collected, it is likely that there would be some patients thathavehad an abnormal Pap smear in the past but did not follow-up in a timely manner or hadmissed

one or more scheduled appointments prior to being seen for follow-up care. It is essentialtoidentify what barriers prohibited them from following the recommendations provided bytheirhealth care provider. For the patients that have not missed any appointments, theirperspectiveon facilitators to follow-up isimportant.Since the health center where the data was collected is not governed by anInstitutionalReview Board (IRB), approval was sought and obtained from The Ohio StateUniversity’sInstitutional Review Board.  Since the health center does not have its own reviewboard,appropriate approvals from administration were obtained. After IRB approval, packetsweredistributed to patients presenting to the gynecological service line who met inclusioncriteria.Inclusion criteria included: the participant was at least 18 years of age, was a patient inthegynecological service line at the FQHC, and was able to read and write. Exclusioncriteriaincluded the patient who was under age 18 years, failed to consent, and/or could not readandwrite. The packets were distributed by trained staff members. The packet consisted of a copyofthe informed consent accompanied with a cover letter explaining the purpose ofthequestionnaire, the questionnaire and an envelope. The participant completed the questionnaireinthe exam room while waiting to be seen by the provider. After completing the questionnaire,itwas placed into the enclosed envelope and sealed by the participant. Following theparticipant’soffice visit, the sealed envelope was collected by a staff member and returned to theinvestigator.Staff members providing Pap smears to patients at the health center were provided withapacket. Their packet consisted of a cover letter explaining the purpose of the questionnaire,aninformed consent, the questionnaire and an envelope marked with staff. Staff who consentedtoparticipate completed the questionnaire and then placed into the envelope.  They wereinstructedto seal the envelope and return it to theinvestigator.

9.      Questionnaires

 The patient questionnaires were formatted in a check box format for quick,easyresponses as well as open-ended questions that allowed the participant to providemoreexpressive answers. The patient questionnaire included demographic information includingage,race, education level, income, work status, marital status, number of children andinsurancecoverage. There were questions which helped determine the patient’s history of abnormalPapsmears, education received regarding their abnormal Pap and information aboutscheduling.Staff questionnaires were used to obtain data about their perceptions ofpatient’sresponses to follow-up care, perceptions of patient knowledge of the Pap smearresults,perceptions of the patient’s own health and perception of the patient’s ease of accessibilitytocare. These were written as open-ended questions. There was one check-box questionwhichasked for the staff member to identify their role as a staffmember.

10.  Data Analysis

Descriptive data analysis was used to analyze closed-ended questions. Openendedresponses were analyzed using McLaughlin and Marascuilo’s (1990) three-phasecontentanalysis technique. The first phase of the content analysis was to identify individual unitsofanalysis, (i.e. a thought or a theme that appeared in the response). Each thought or themewasbracketed on copies of raw, de-identified data, independently by two trained coders. Unitsofanalysis were compared between members, and an Interrater Reliability (IRR) percentagreementwas calculated using the following formula: IRR = (NA –N8)/Total where NA = numberofagreements, N8 = number of disagreements, and the Total = the total number ofbracketedthoughts/themes.  The investigators determined that an adequate IRR is 0.90 agreement.  Iftherewas disagreement on any unit, it was discussed until a consensus was reached. All unitscodedwere > 98% prior to discussion.  The second phase of the content analysis required a codertocreate mutually exclusive and exhaustive categories that incorporated all of the thoughtsorthemes (i.e. units), then develop names and definitions for each category. A priori level of90%agreement was determined as acceptable for interrater reliability.  For the third phase, allunitswere > 90% prior to discussion. Frequencies and percentages for each category werecalculated.

11.  Results

11.1.   Results of Patient Surveys

Fifty women completed the questionnaires. Demographic information for the patientsisincluded in (Table 1). The women ranged in age from 18 to 66 years-old (M = 35; SD =11.54).One participant was excluded because she did not meet inclusion criteria, making the finaltotal49. All participants reported that their primary language was English. The majoritywasCaucasian (86.7%), single/divorced /separated (63.3%), insured by public assistance orwithoutinsurance (83.4%), and had completed at least nine to twelve years of education (98%).Seventy-one percent of the participants reported that they presented for a Pap smear. Oftheparticipants, approximately 43% percent indicated that they have had an abnormal Pap smearinthe past and more than half (60.2%) of these patients did not follow up according totherecommendations of their health careprovider.Patient reasons that prevent them from returning for follow-up visitsincludedtransportation issues/distance to travel (15.0%), negative experiences (13.8%), financialbarriers(13.8%), and fear (7.5%) (see Table 2).  Patients reported that having a positiveexperience(23.1%), motivation by health (i.e. patient is not sick, is in good health) (13.5%),financialassistance (11.5%), and flexible scheduling (11.5%) would help them keep theirfollow-upappointments (see Table3).

11.2.   Results of Staff Surveys 

There was a total of seven staff members that completed questionnaires;threephysicians, three nurse practitioners/physician assistants, and one social worker.  Staffresults(see Table 4) revealed that 26.1% believed that transportation was a reason thatpreventspatients from returning for follow-up appointments.  The next most frequently reportedreasonwas health literacy issues (17.4%) and the third most commonly reported reason wasfinancialbarriers.  The three most commonly reported responses from staff for things that couldhelppatients keep their appointments were transportation assistance (25.0%), reminders (20.0%),andimproving health literacy (15.0%) (see Table5).

12.  Discussion

The women from the FQHC who participated in this EBP project hadsimilardemographic characteristics as those in the literature [2,4,6,8]. These similarities maketheinformation obtained from the literature more appropriate for developing interventions toassistwomen at the FQHC.  The average age of the participants was mid-thirties. Most of thewomenhad completed high school and were unemployed or employed part-time. The majority oftheparticipants were uninsured or insured by public assistance. Many were single, divorcedorseparated and had at least onechild.There were also some differences between the sample of women at the FQHC andthepublished literature with the biggest difference being race. Most of the evidence fromtheliterature is based on samples of predominately African American or Hispanicwomen[4,6,7]. The majority ofthewomenfrom the FQHC wereCaucasian.Commonly reported FQHC patient responses that prevented them from returningforfollow-up care were transportation, finances and fear. Similar barriers were found intheliterature. Patients at the FQHC frequently reported that having a negative experience, definedasa bad or negative experience with staff, less than optimal condition of the environment(i.e.cleanliness) or lack of tending from care providers were all important reasons for notreturningfor follow up care.  This is unique to this sample and was not found to be a dominant barrierinthe literature. It is interesting that the study revealed that only two participants reportedthatforgetting the appointment was a reason for not returning for follow-up but the literaturesupportsthat reminders significantly increased the rate of follow-upcare.Patients at the FQHC believe that one of the most important facilitators includes havingapositive experience. Having a good experience was described as being treated withrespect,having friendly staff, the facility being clean and being seen by the provider on time. Otherreported facilitators were financial assistance, flexible scheduling and reminders. Theyalsoreported that returning for appointments is facilitated by being in good health, meaning thattheyare more likely to return if they are notsick.

12.1.   Recommendations for a Practice Change

TheinformationobtainedfromthisEBPprojectwillbevaluableintailoring,client- centered approaches to follow-up care based on integrating best evidence withprofessionaljudgment and expertise and with client preferences. Given the evidence, women at the FQHCfrequently reported that transportation and financial barriers, fear, and negative experiences mayimpede their ability to return for follow-up appointments. A combination of interventions couldbeincorporatedintothecareofthesepatientsutilizinginformationobtainedfromtheliteratureand feedback provided from the patients and staff at theFQHC.

12.2.   An In-service Conducted by the Director of the Quality Committee

WomenattheFQHCreportedthatapositiveexperiencewouldhelpthemkeeptheirscheduledappointments.Anin-serviceconductedbytheDirectoroftheQualityCommitteecouldbegiventoallemployeesincludingancillarystaffregardingtheprofessionaltreatmentandrespectforpatientsandthingsthatcanbedonetoensurethatpatientshaveapositiveexperiencefromthetime of entry to time of discharge. Included would also be information regardingprofessionalismfor those who talk to patients on thephone.

12.3.   Centralized Computerized Tracking System

Centralized computerized tracking systems could be utilized. The FQHC has recentlychanged from paper charting to an electronic medical record which could possibly meet theneedsof a centralized computerized tracking system. A follow-up coordinator who is a registerednursewouldberesponsibleforusingthetrackingsystemtomonitorthepatientswhoneedfollow-upcare.Utilizingthiscomputerizedtrackingsystemwouldprompttheregisterednursetocontactthepatient via the phone for a one-on-one educational/counselingsession.

12.4.   Telephone Counseling/EducationSession

Patients reported that fear may impede follow-up care.Fear may be caused frommisperceptionsaboutwhattheabnormalPapresultmeans,thattheymaybetreateddifferentlybecauseahighpercentageofabnormalPapsmearresultsarecausedbythehumanpapillomaviruswhich is a sexually transmitted disease, and fear of what the follow-up procedures entail. Thefeelings of fear may be exacerbated when adequate education is not provided to the patient atthetime they are notified of their abnormal Pap smearresult.An automated reminder phone call system is currently in place at the FQHC but aone-on-one education/counseling session conducted by a registered nurse could also be used. Evidenceshows that interactive phone counseling sessions are instrumental in helping patientskeep theirappointments [5,10,11].Thisallowsthenursemakingthecallstoassesstheeducationalandemotionalneedsofthepatientsand to allow the patient to ask questions about the follow-up care. It also provides anopportunityfor rescheduling the appointment if necessary that is convenient for the patient and alsoverifyingthe patient’s current address and updating their contact information in thesystem.

 12.5.   Educational/Reminder Letter and Transportation/Financial Incentives

Following the telephone counseling session, an informational/reminder letter would be mailed to the patient explaining the importance of follow-up and  reminding  them  oftheappointment date and time. As determined during the counseling session, if transportation orfinancialbarrierswereidentifiedasreasonsfornotreturning,atransportationvoucher(gasvoucher or bus/cab pass) would be sent with the letter. The possibility of providing a financialvoucher to those who are without insurance could be discussed with administration. Thevoucherwould offset the required co-pay and decrease the out-of-pocket expense to thepatient.

12.6.   Next Steps

Based on current literature and results of this small study directly related to thepatientpopulation within the FQHC, implementation of the discussed interventions and trackingoffollow-up adherence rates could be implemented as the next step to improving patientadherenceto abnormal pap smear follow-up. This EBP project used data collected from a relativelysmallsample of women and staff members and would provide data that is more generalizable ifalarger sample were used.  In the future, the project could be replicated with a larger sampleofwomen and staff at other similar healthcenters.

13.  Conclusion

Thedeathratefromcervicalcancershouldnotbeashighasitis,however,inordertodecrease these numbers, we must utilize the evidence to decrease barriers and increasefacilitatorstofollow-upcareafteranabnormalPapsmearresult.ThisEBPprojectaddstothebodyof evidenceby providing additional identified barriersand facilitatorsthat are notcurrentlyhighlighted in the literature. Determination of the most frequent barriers to patientfollow-upwithin an agency incorporated with evidence from the literature can help withdevelopment,implementationandevaluationofinterventions.Incorporationoftheevidenceintoclinicalpracticecan lead to better patientoutcomes.

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