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Addressing Gaps in the Management of Chlamydia trachomatis and Neisseria gonorrhoeae in Primary Care

Lessons Learned in a Pilot Intervention Study

Rose, Sally B. PhD*; Garrett, Susan M. MPH*; Hutchings, Deborah RGN, GradDipCouns; Lund, Kim BAN, ANP-BC, CNS; Kennedy, Jane FAChSHM (RACP), MBChB; Pullon, Susan R.H. MPHC, MBChB, FRNZCGP*

Sexually Transmitted Diseases: July 2019 - Volume 46 - Issue 7 - p 480–486
doi: 10.1097/OLQ.0000000000001005
The Real World of STD Prevention
Free

Background We aimed to test the acceptability and utility of strategies designed to facilitate the delivery of clinical best practice for patients diagnosed with chlamydia or gonorrhea in primary care.

Methods A nonrandomized pilot intervention study with a historic control period was run over 9 months in six primary health care clinics (2 youth services, 3 low-fee clinics, and 1 student health service) in Wellington, New Zealand. “Study nurses” in participating clinics oversaw the implementation of strategies designed to facilitate partner notification and follow-up for patients diagnosed with chlamydia or gonorrhea. Clinics chose which of 2 approaches they wished to trial—either managing all study processes themselves or drawing on the assistance of an external specialist sexual health advisor. Outcome measures included acceptability and utility of study processes ascertained via structured interviews with study nurses and collection of clinical data.

Results Outcomes for 287 patients seen during the intervention were compared with 240 historic controls. Participant views on study processes were positive overall, and all clinics intended to continue all or most of the study processes implemented. During the intervention, substantial improvements were observed in documented patient management (sexual history, partner notification, and outcomes, P < 0.05). Increases were observed in percentages of patients reached for follow-up (74% vs. 26% at baseline, P < 0.05) and partners reported to have been notified (79% vs. 23%, P < 0.05).

Conclusions Nurse-led strategies implemented were deemed acceptable and appeared to facilitate delivery of best practice care for patients diagnosed with bacterial sexually transmitted infections in participating primary care practices.

Nurse-led strategies designed to facilitate best practice sexual health care were deemed acceptable by participating clinicians, integrated into routine care and appeared to improve documented sexually transmitted infection patient management.

From the *Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand, and

Wellington Sexual Health Service, Wellington, New Zealand

Acknowledgements: The authors thank all those primary care teams who participated in this research, particularly the nurses who fulfilled the role of “study nurse” during the intervention phase, and also the 2 staff from the local Sexual Health Service who provided support to primary care teams in their role as health advisors.

Conflicts of Interest: None declared.

Sources of Funding. This project was funded by a 2015 Lottery Health Research grant (Application number 353074) and a 2016 University of Otago Dean's Grant. The funding bodies played no role in the design, implementation or interpretation of the research.

Correspondence: Sally B Rose, Department of Primary Health Care and General Practice, University of Otago, Wellington, PO Box 7343, Wellington South 6242, New Zealand. E-mail: sally.rose@otago.ac.nz.

Received for publication November 14, 2018, and accepted March 25, 2019.

Online date: April 4, 2019

Sexually transmitted infections (STIs) constitute a significant health and economic burden globally.1 A key component of effective STI control is the provision of accessible, quality health care.2 Bacterial STIs, such as Chlamydia trachomatis and Neisseria gonorrhoeae, are frequently diagnosed in primary care settings, so primary care clinicians have an important role to play not only in the diagnosis and treatment of STIs but also in the prevention of onward transmission and reinfection. Best practice guidelines for the management of STIs provide clinicians with an evidence-based reference detailing appropriate sampling and antimicrobial treatments, and the broader aspects of patient management including partner notification and follow-up.3–5 Partner notification is a key component of STI control that helps to reduce onward transmission and prevent reinfection.6 It involves a discussion of recent sexual history to identify at-risk sexual contacts, making a plan to inform contacts of their risk of infection, and offering testing and treatment. This discussion is also an opportunity to provide risk reduction advice.7 Follow-up with the index patient is key to checking on treatment compliance, risk of reinfection and completion of partner notification.3–5 Reinfection from an untreated partner or an infected new partner is common,8,9 and can result in more serious long-term reproductive health complications than an initial infection.9,10 Although a “test of cure” is now advised only in very limited circumstances, guidelines recommend testing for reinfection around 3 to 6 months posttreatment for chlamydia or gonorrhea as an important step in the management pathway.3–5

Current limitations in these broader aspects of patient management may be contributing to persistently high rates of chlamydia and increasing rates of gonorrhea in New Zealand where youth, Māori (the indigenous people of Aotearoa/New Zealand) and Pasifika people are overrepresented among those diagnosed.11 Research in New Zealand has shown clear evidence of gaps in effective partner notification, follow-up and testing for reinfection,12–16 and a recognition by primary care clinicians that implementing practical strategies could help to facilitate these essential aspects of best practice care.14 Without practice-wide strategies and resources in place to support the implementation of best practice sexual health care, it is perhaps no surprise that service delivery sometimes falls short in this area. Furthermore, chlamydia is not a notifiable disease in New Zealand and contact tracing/partner notification are not legislatively prescribed but occur on a voluntary, informed consent basis.17 Gonorrhea became notifiable (in a nonidentifying manner) to a Medical Officer of Health under changes to the Health Act 1956 and Health (Infectious and Notifiable Diseases) Regulations that came into effect in January 2017 (but were not implemented in clinical practice until late 2018, ie, after this study was completed).17

Before seeking funds for a larger scale intervention study, we undertook this pilot study to assess the acceptability and utility of nurse-led processes designed to enable routine delivery of best practice sexual health care (including partner notification and follow-up). Baseline data have already been reported12; here we describe the intervention processes trialed in the pilot study together with lessons learnt.

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MATERIALS AND METHODS

Participants and Setting

Six primary health care clinics in the greater Wellington region served as participants, including 2 Youth Health clinics, 1 University Student Health service, 3 low-fee clinics providing accessible health care to low income and vulnerable populations (including a Māori health provider). Clinics were recruited from those diagnosing the highest caseloads of chlamydia in the region in the 12 months to June 2015 identified from laboratory testing data. Ten clinics selected to include a range of clinic types with a diversity of patient populations including high proportions of at-risk youth, indigenous Māori and Pasifika populations were approached for participation in the baseline phase. Eight agreed to take part, 2 declined citing “lack of time.” Of these, 6 went on to take part in the intervention phase (funding constraints prohibited inclusion of all 8 clinics).

Ethical approval for baseline data collection was granted by the Southern Health and Disability Ethics Committee on 16 July 16, 2015 (Ref 15/STH/109). Approval for the intervention study was granted by the Central Health and Disability Ethics Committee (Ref 16/CEN/38) on 1 April 2016. This study was registered at: http://www.anzctr.org.au (Trial number: ACTRN12616000837426).

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Study Processes

Phase 1: Baseline Data Collection

In 2016, the case notes for 40 patients diagnosed with chlamydia or gonorrhea were retrospectively reviewed at each participating clinic to establish the extent to which partner notification, follow-up and testing for reinfection were undertaken and documented before the intervention.12 Ethical approval was granted for clinical members of the research team to review patient records within clinics, but no names or contact details were recorded on data collection forms received for analysis.

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Phase 2: Pilot Intervention Study

The pilot study ran for 9 months in each clinic (from July 2016 to March 2017) to ensure a minimum of 240 cases would be diagnosed across all clinics combined (to match the baseline sample size). Allocation to the intervention was nonrandomized. Clinics were able to choose which of 2 groups they wanted to participate in, based on their preference to train, upskill, and manage all study processes in-house (practice-led [PL] group) or to draw on the assistance of a specialist sexual health advisor (HA group). The HA was employed at the local specialist Sexual Health Service to provide information, advice and counseling to clients diagnosed with an STI at the service, focusing on partner notification and reinfection risk-reduction—based on the HA model utilized in Genitourinary Medicine (GUM Clinics) in the United Kingdom (http://ssha.info/). In this study, the HA was considered part of the primary care clinic team (in the same way Diabetes Nurse specialists provide care across a number of practices in a region in New Zealand) taking responsibility for phone follow-up of patients diagnosed with chlamydia or gonorrhea in HA group clinics. The HA was also available by phone to provide expert advice to all participating clinicians and played a key role in the provision of educational training to study nurses. The HA was supported by a sexual health nurse from the local specialist Sexual Health Service to ensure there was cover for this role at all times.

Intervention strategies focused on partner notification, follow-up and retesting (STI testing and treatment took place as per usual care) and followed the principles of best practice outlined in New Zealand Sexual Health Society STI management guidelines for primary care.4 Components were selected from a range of strategies ranked most favorably by clinicians in the region who were surveyed prior.14Table 1 describes the intervention processes adopted by each study group (3 clinics per group).

TABLE 1

TABLE 1

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Outcome Measures and Analyses

To assess the acceptability of each of the study processes, we used a structured interview process to seek participant views in a face-to-face discussion at the end of the intervention period. Interviews were conducted by an experienced member of the research team and responses were recorded on the interview schedule questionnaire. When considering strengths and weaknesses of the study, we also reflected on researcher field notes gathered during researcher-participant interactions throughout the course of the study. Interactions occurred via phone, email, and face-to-face meetings and were initiated by both researchers and participants to address queries, provide advice, collect datasheets and check on progress.

Patient outcome data were collected via customized paper forms prospectively completed by study nurses for all patients diagnosed with chlamydia or gonorrhea during the study period. We assessed completeness of clinical documentation (information that would be required to assess clinical outcomes in a full-scale intervention trial) and assessed the likely magnitude of improvement in patient outcomes including: the proportion of clinic patients with whom follow-up contact was made within 1 month of STI treatment; the proportion of patients self-reporting at least 1 partner was notified (at follow-up contact); the proportion of patients reporting at least 1 partner was treated (at follow-up contact). Attendance rates for a test of reinfection within 6 months of treatment were also assessed but will be reported separately in a companion paper.

We compared outcomes before and after the implementation of the intervention (ie, baseline vs. intervention) and between intervention groups (PL vs. HA). χ2 Tests (performed using Openepi.com) were used to test for statistical significance between baseline and intervention phases and between the 2 intervention groups, and P were values reported.

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RESULTS

Acceptability of Study Processes

Interviews with six study nurses conducted at the end of the intervention phase provided valuable insight into the strengths and weaknesses of the study components. Table 2 presents the key findings from these interviews together with participant comments and lessons learnt. Overall, participants viewed the study as being extremely valuable, with comments highlighting the benefits of having an overall framework for the provision of best practice. Time (especially for completion of follow-up phone calls) was cited as the main drawback of participating. Although well received in general, resources developed for the study (training, sexual health template and patient resources) had both strengths and limitations, which are highlighted in detail in Table 2.

TABLE 2

TABLE 2

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Before and After Comparison

During the intervention phase, 287 individuals were diagnosed with chlamydia or gonorrhea; 133 in the PL group and 154 in the HA group. Demographic characteristics of those diagnosed during the intervention and baseline period differed with a higher proportion of females and patients younger than 25 years in the intervention cohort. Table 3 presents the demographic characteristics of the study populations at each period with a comparison of outcomes related to documentation, follow-up and partner notification outcomes for the 2 periods. During the intervention phase, 83% had a record of recent sexual partners (51% at baseline, P < 0.05), 83% had a record that partner notification was discussed (74% at baseline, P < 0.05), and 78% had a documented plan for notifying partners (65% at baseline, P < 0.05). Follow-up successfully reached 74% of patients during the intervention (vs. 26% at baseline, P < 0.05). In the intervention phase, significantly higher proportions of patients reported that all or some partners had been told, tested, and treated.

TABLE 3

TABLE 3

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Between-Group Comparison

At baseline, the demographic characteristics of patients differed between the PL and HA groups. In the PL group, 86.7% of the cases reviewed were younger than 25 years (compared with 68.3% in the HA group), and a lower proportion were of Māori (27% vs. 47%) or Pasifika (34% vs. 46%) ethnicities than in the HA group. During the intervention phase, demographic characteristics of patients in each group were more broadly comparable but with a younger overall patient population in the PL group (due to inclusion of Youth and Student health clinics in this group).

Table 4 presents a comparison of documented outcomes for the 2 study groups during the intervention phase. Documentation about the number of recent partners taken as part of a sexual history was more often complete in the HA group (89.6% vs. 74.4%). On average 1.6 recent partners (within the past 2 months) were reported for patients in the PL group and 1.5 per patient in the HA group. No significant differences were observed between intervention groups on the primary outcome measures for self-reported partner notification. The majority of patients (65%) reported only 1 recent partner (155 of 237 index cases for whom partner numbers were recorded), 23% had documentation of 2 recent partners (56 of 237) and 10% (25 of 37) had 3 or more recent partners documented. A total of 369 partners were reported for 237 index cases, of whom 266 were reported to have been notified (72%), and 129 reported to have been treated (48% of those notified, based on index patient self-report). Follow-up calls reached 76.3% of patients in the HA group and 87.6% in the PL group (P < 0.05), but few patients were contacted within 1 week (25% of the cohort). Rates of patient contact varied between clinics supported by the HA (83% of the Youth service patients were contacted but only 60% and 72% from the low-fee clinics). Patients in the HA group more often had documentation that further advice was given (regarding treatment, partner notification, reinfection and condom use) during the phone follow-up than those in the PL group. In most of the clinics time was only set aside for phone calls once a week (or in 1 clinic—once a fortnight).

TABLE 4

TABLE 4

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DISCUSSION

The strategies trialed in this study were integrated into routine patient care, deemed acceptable by participating clinics and clinical data collected were suggestive of improved patient management. Both intervention approaches resulted in significant improvements in documented STI management, more frequent follow-up and documentation of self-reported partner notification outcomes than were observed in the baseline phase. Because this was a pilot study, it was not powered to detect statistically significant differences in clinical outcomes such as partner treatment or patient reinfection rates. Before investigating the impact of an intervention on such outcomes, we first needed to trial processes by which these outcomes might be routinely assessed and documented. Lack of adequate documentation of patient care provided in cases reviewed during the historic control period made before/after comparisons difficult to interpret particularly with respect to partner notification. Lack of documentation on recent sexual contacts and partner notification outcomes does not necessarily reflect fewer partners being told, tested or treated—we simply do not know in the absence of clinical documentation. Furthermore, we were limited in our reliance on patient self-reported partner notification outcomes. In the absence of any formal process by which the names of sexual contacts/partners could be acquired and clinic attendance or testing followed-up, we had no alternative means by which to assess partner treatment rates. We chose not to randomize clinics to intervention groups in this small pilot so the differences observed between intervention groups might have been attributable to factors other than the study variables, including differences in the patient populations served by clinics, and within and between staff differences in approaches to patient management and documentation.

This study has some similarities with past research. A study undertaken in the South Auckland region of New Zealand primarily aimed to increase opportunistic screening for chlamydia in 10 primary care practices, but also sought to improve follow-up and documentation of partner notification. Intervention components included involvement of the practice team in identifying and addressing gaps in the service pathway, including the provision of a continuing medical education session for clinicians, and installation of customized software in the patient management system.18,19 Before the study, there had been no documentation on partner notification follow-up, but during the study 64% of index cases were reported to have notified their partner(s).18 This finding was similar to ours (70% of index cases in the current study reported they had notified their partners). The authors noted that a number of difficulties were encountered during the study and concluded that ‘a strong emphasis on follow-up, partner notification and retesting tasks is recommended for future programs.’18 To our knowledge, our study is the first in New Zealand to place strong emphasis on these aspects of care.

A randomized controlled trial undertaken in the United Kingdom found that patients randomized to receive partner notification advice from a practice nurse with phone follow up from a HA was at least as effective in identifying and treating sexual partners (65% with at least 1 partner treated) as referral to a specialist HA at a GUM clinic for partner notification (57% with at least 1 partner treated).20 In our study, practice nurses in both groups successfully initiated the conversation about partner notification. Follow-up to assess risk of reinfection and partner notification outcomes was similarly effective regardless of whether undertaken by the practice nurse or HA.

Provision of a brief educational training session and use of a nurse-led model to facilitate partner notification and follow-up were strengths of the approach employed in this study. Although doctors were also involved in partner notification discussions, nurses in participating clinics were more often tasked with phoning patients with test results and providing treatment, so it made practical sense to focus on nurses in our provision of partner notification training. Incorporation of a sexual health template and paper checklist to facilitate appropriate documentation in the patient management system appeared to enable more systematic recording of relevant information, and anecdotally served as a reminder to more systematically address all aspects of patient care (including recent sexual history, partner notification, and recall for a test of reinfection). Despite time pressures facing participants, processes implemented to enable routine phone follow-up posttreatment were integrated into routine practice. Although having a designated nurse taking responsibility for overseeing the newly developed processes that spanned the STI care pathway was successful, a limitation of this model was our failure to plan for staff absences. In the future, we would recommend upskilling sufficient numbers of the nursing team to ensure this role is covered at all times. The use of an HA to undertake patient follow-up had pros and cons—the HA was more experienced in discussing partner notification and seizing opportunities for provision of health promotion advice, but the overall follow-up rate was lower than in the ‘in-house’ follow-up by practice nurses, for reasons that are unclear.

Health Advisors are not commonplace in New Zealand, there are currently only 5 individuals working in HA or combined HA/nurse roles so this model could not easily be replicated. There is potential for greater linkage between primary care and sexual health and public health units for assistance with contact tracing when patients have given informed consent for this to occur, but there is currently limited capacity in New Zealand for this to occur. Nurses were the obvious choice to lead the intervention processes in our study because we were simply building on existing skills in our provision of educational training. In other settings, it might make practical sense for other members of the primary care team (such as health care or physician assistants) to take responsibility for some of the intervention tasks. Sufficient and appropriate training would be required with clear guidance for nonclinical staff to ensure referral for clinical assessment when necessary. It is probable that team buy-in, the setup of a framework of care and identification of a designated person(s) to take overall responsibility for ensuring all steps in the management pathway were completed were more important drivers of change than the fact that we used nurses in our study to oversee the STI care pathway. In any future research, it would be important to undertake evaluation of the intervention to more clearly understand the process, environment and personnel factors responsible for driving change.

Specialist sexual health services are becoming increasingly overstretched in the face of funding cuts at a time when sexual health care provision is becoming increasingly complex.21 Syphilis has reached epidemic levels in many countries,21,22 the emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae is becoming an increasing threat,23 and many services face an increasing workload associated with the provision of antiretroviral therapy and HIV preexposure prophylaxis (PrEP).24 It is therefore more critical than ever that primary care clinicians and services are well-equipped to deliver quality sexual health care for common STIs such as uncomplicated chlamydia and gonorrhea. Effective partner notification is an important but often underutilized public health measure for controlling STI prevalence and incidence that can have a direct effect on the health of index cases, their partners, and the wider community.25 This study showed that with clinic buy-in, a short training session, and provision of a framework for STI management, busy primary care settings were able to incorporate practical strategies designed to facilitate partner notification and follow-up, and sustain these changes for a 9-month period. We think the improvements observed in documented case management in the current study are encouraging. Similar strategies could be further investigated in a larger scale trial designed to determine whether widespread adoption of best practice management of patients with STIs in primary care translates into improved health outcomes that can be objectively measured (eg, reduced rates of reinfection). Future research should include careful consideration of comparison groups and suitable outcome measures.

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