The foundation of our programme theory is self-management theory which in turn draws upon self-efficacy theory—each of these is covered in more detail below. To underpin our programme theory, we developed a logic model that demonstrated the links between the self-management intervention, and hence self-management theory, self-efficacy and quality of life.
Bandura [30] defined self-efficacy as an individual’s beliefs about their capabilities to produce designated levels of performance that exercise influence over events that affect their life [23]. Self-efficacy is important because it determines how individuals feel, think and motivate themselves and how they behave [30]. In terms of health, having a strong sense of self-efficacy motivates an individual to set and meet challenging goals, overcoming obstacles that may arise [30]. Therefore, in order to successfully facilitate an individual to self-manage their condition, it is essential the self-management programme incorporates methods to boost an individual’s perception of self-efficacy to ensure they have the resilience and confidence to utilise the skills and knowledge they have obtained, adapting them as necessary [18].
Lorig and Holman [19] describe three tasks and six skills they believe to be necessary to self-manage a condition. The tasks specified are medical management of the condition, role management and emotional management. The necessary skills are problem-solving, decision-making, resource utilisation, formation of patient-provider partnership role, action planning and self-tailoring. The TOPSY intervention (Appendix) was modelled upon these tasks and skills with the aim of better supporting women who wished to self-manage their pessary to overcome potential barriers.
Medical management
Medical management is about how a person medically manages their health condition. In TOPSY, women were supported to have the skills to medically manage their POP by being taught pessary self-care. To facilitate this, women were given a 30-min support appointment and a 2-week follow-up call. During the support appointment with a healthcare professional, they were provided with information about POP including relevant anatomy and management options with specific emphasis on pessary management including how a pessary works. Women were also provided with an example pessary to handle so they could practice manipulating the pessary as necessary to insert and remove it. Once comfortable with handling and compressing the pessary, the woman was encouraged to practise removing and inserting it. Whilst there is no specific evidence to inform practice in pessary self-management support, there is literature about how to support the effective learning of other similar skills such as intermittent self-catheterisation (ISC). Individuals taught ISC emphasised the importance of effective communication from the healthcare professional, good interpersonal skills to provide reassurance and overcome embarrassment, a private environment, both written and oral information and at least one practical demonstration, with some participants stating a preference for more than one practical demonstration [31]. The findings of another qualitative study exploring the experience of being taught ISC demonstrate that performing the skill under supervision to be determined as competent resulted in women feeling under pressure to ‘pass’ a test [32]. This demonstrates the importance of an individualised approach to supporting the learning of a new healthcare skill, in this instance, pessary self-management. In view of this, as part of the TOPSY intervention, women were supported to practice repeated insertion and removal of the pessary under the supervision of the healthcare professional providing the support. However, should the woman be unable or not feel sufficiently comfortable to practice this skill during the appointment, she was encouraged to do this at home instead, and this was followed up during the 2-week follow-up phone call. All women who were randomised into the self-management group and received the intervention accordingly were contacted by telephone after 2 weeks to check whether they had been able to remove and insert the pessary independently at home and whether they had experienced any difficulties or required further support. Complications such as discharge, discomfort or pain and bleeding are common amongst pessary users [33]. However, when supported to manage these issues, this need not result in pessary discontinuation [33]. Details regarding how we facilitated women to problem solve are reported below.
Role management
There may be a complex relationship between a healthcare professional and patients learning to self-manage their condition [34]. Patients may be used to deferring to the healthcare professional providing their care, due to their academic expertise within the area, despite this minimising the value of the patient’s lived experience of their condition [34]. To suddenly change the relationship and ask a patient to take responsibility for their own care is argued to require sensitivity and support to ensure the patient is not confused about the abrupt change in the power dynamics of clinician and patient roles [34]. Lawn et al. [34] suggest a patient’s role in self-management is undertaking and being engaged in self-management activities whilst also accepting support from healthcare professionals as required. Therefore, the healthcare professional and patient share responsibility for the management of the condition [34]. In this instance of pessary self-management, women were encouraged to take ownership of their role in managing their pessary. Rather than clinician-led follow-up at pre-determined intervals, this was instead guided by the woman depending on her needs. It is helpful to emphasise the value of the woman’s experience as a pessary user and the benefits this offers during pessary insertion and removal. For example, whilst determining the correct size and type of pessary requires clinical knowledge and experience [35], the process of removing and inserting a pessary does not. As the woman inserting her own pessary is able to feel whether the pessary is positioned comfortably and effectively to reduce the prolapse, this is a pragmatic benefit a healthcare professional inserting a woman’s pessary does not have. This demonstrates the valuable contribution that both the healthcare professional and woman bring to the pessary self-management relationship. Following the intervention, women should feel empowered with the additional knowledge and confidence provided to undertake the self-management role, whilst still feeling supported by a healthcare professional in case of any concerns or issues.
Emotional management
POP significantly affects a woman’s emotional well-being [36]. Furthermore, the treatment of POP can have either a positive or negative impact on emotions [36]. Therefore, women being taught to self-manage their pessary may feel positive about the process as their pessary is working well, but they desire more autonomy in how they use their pessary. Conversely, other women may have negative emotions about the process as they have had a recurrence of POP following surgery, wanted surgical management but were unsuitable or are having to learn to self-manage their pessary because it is continually expelled and therefore will need to be reinserted frequently by the woman. Taking the range of emotions women may be experiencing into consideration may facilitate a healthcare professional to better meet her needs [36]. To facilitate the woman to overcome the negative emotions she may experience related to living with POP or self-managing her pessary, the healthcare professional reinforced the benefits of pessary self-management and spoke positively about pessaries as an effective POP management option which may not be inferior to surgery [10].
At present, there is a lack of evidence exploring the barriers to pessary self-management. However, an exploratory study of the barriers to the use of vaginal dilators identified women had concerns of pushing the dilator in too far, hurting themselves or breaking the dilator [37]. It is acknowledged there are differences in the use of vaginal pessaries and dilators; however, consensus between clinical co-applicants suggested the fears women have about using vaginal dilators are shared by many women learning how to self-manage their pessary. Therefore, the healthcare professional also discussed common concerns women using or self-managing pessaries may have, for example, the risk of infection, or that a pessary could be inserted incorrectly. The ability to self-manage a pessary means that if desired, a woman can remove her pessary to be sexually active. Meriwether et al. [38] reported 70% of sexually active pessary using women regularly removed their pessary before sexual activity, usually due to concerns expressed by their partner. Therefore, this is clearly an important aspect of pessary self-management for women who are, or wish to be, sexually active. A discussion about how POP or pessary management has affected the woman’s sexual function and the emotional impact of this is indicated. The woman was also given the opportunity to ask any questions they may have or express if anything was worrying them.
Problem-solving
Hill-Briggs devised an applied model of problem-solving in chronic illness self-management which details four key components [39]. These are disease-specific knowledge, transfer of past experience, problem-solving skills and process and problem-solving orientation [39]. In relation to pessary self-management, women were supported to problem solve by ensuring they had sufficient disease-specific knowledge through the provision of written and verbal information including POP, pelvic anatomy and how a pessary works. The woman’s prior experience of pessary use could be used to demonstrate effective self-management problem-solving by ensuring women understand potential causes for problems and appropriate responses [39]. For example, if a woman previously sought assistance from a healthcare professional for reinsertion of a pessary due to pessary expulsion caused by excessive straining, the woman can be encouraged to instead reinsert the pessary herself and take measures to avoid excessive straining in future, as this prior experience makes the problem-solving behaviour more relatable. Ensuring a woman had a positive problem-solving orientation was achieved by ensuring the woman has sufficient self-efficacy to feel confident enough to resolve unexpected issues or to seek clinician support if necessary. The intervention therefore aimed to ensure women felt self-efficacious and viewed pessary self-management as a solvable challenge through positive reinforcement and encouragement during the session.
Decision-making
To facilitate day-to-day decision-making managing a chronic condition, individuals require sufficient and relevant information [19]. Providing women with an understanding of potential issues and when to seek clinician advice or assistance if necessary, enables women to make decisions about how to deal with any concerns or problems with the pessary knowing there is support at hand if required. For example, if informed vaginal discharge is a common side effect for women using pessaries, whether self-managing or not, they may be less likely to be concerned if they experience non-bothersome discharge and instead decide to remove and wash the pessary more frequently.
Resource utilisation
As with other types of patient education [19], Murray et al. [40] found the provision of an information brochure in addition to verbal information, compared to verbal information alone, for women being taught to self-manage their pessary resulted in women being more satisfied, confident and knowledgeable. With this in mind, the TOPSY intervention included the provision of an information sheet reiterating the self-management information given verbally, so it could be referred to at a later point as desired. Women were also made aware of an online video about pessary self-management created utilising feedback from pessary users for Kearney and Brown [14] service improvement project. To ensure consistency in the information about POP provided to women being taught self-management, it was agreed a copy of the International Urogynaecological Association (IUGA) POP patient information sheet (https://www.yourpelvicfloor.org/media/Pelvic_Organ_Prolapse_RV3.pdf ) be given and utilised during the self-management training. This information sheet includes topics such as the anatomy and physiology of POP, the causes of POP and POP management options. To avoid the suggestion any differences in outcome measures between the two groups could be explained by increased knowledge and understanding of POP, it was agreed all participating women should be provided with the information sheet upon randomisation.
Formation of a patient-provider partnership
In order to facilitate individuals to take responsibility for their condition, it is necessary to ensure they feel in control of their health, rather than simply adhering to their clinician’s instructions [19]. The intervention was designed to encourage women to view the healthcare professional providing self-management training as an equal partner aiming to facilitate best possible pessary care rather than a clinician making decisions about the woman. This was achieved by empowering women with information to ensure they felt sufficiently informed to ask questions and make decisions about their POP and pessary care. Moreover, the intervention was designed to be as pragmatic and unmedicalised as possible. For example, as previously discussed, instead of specifying how to position the pessary in terms of a complex anatomical description, women were advised the pessary was positioned correctly if it was comfortable and the POP was managed.
Action planning
Lorig and Hollman advocate setting individuals a short-term achievable self-management goal to boost self-efficacy [19]. Analysis of action plans suggests they increase feelings of self-efficacy and the likelihood of completing the action plan after 6 months [41]. An action plan should be specific, important to the individual, public and short-term [41]. Lorig et al. [41] also advocate an individual scoring their confidence in successfully completing the action plan to ensure additional targeted support if necessary. For the TOPSY study, the skill to be mastered was independently removing and inserting a pessary. This was therefore specific, important, and public-in terms of being known by the healthcare professional rather than solely the patient and short term as women were asked to practice this skill over the following 2 weeks. After 2 weeks, the healthcare professional arranged to call to answer any questions or concerns the woman might have. After this, women were encouraged to remove their pessary whenever they wished but at least every 6 months.
Self-tailoring
Self-tailoring describes changes made by the individual based on principles they have learnt and self-management skills [19]. Whilst yet unproven, a perceived benefit of pessary self-management is the woman’s ability to make autonomous decisions about how and when to use their pessary [22]. Despite this, a number of publications detailing pessary self-management protocols specify a frequency of pessary removal for the woman to follow [20, 42, 43]. Due to the lack of evidence about the required frequency of pessary removal for self-managing women, it was decided women receiving the TOPSY intervention be advised to remove their pessary at least 6 months [7]. This mirrors the frequency of removal for women receiving clinician-led follow-up in accordance with the NICE guidelines [44]. However, women were encouraged to self-tailor pessary use other than this, removing the pessary as frequently or irregularly as they wished. It was also explained to women that with clinic-based care, women attend a follow-up appointment at a set interval depending upon the agreed schedule at that organisation, typically 3–6 months. For women who were self-managing their pessary, no follow-up appointment was arranged prior to the end of the study at 18 months. However, women could request follow-up at any point and as frequently as they wanted, prior to that. This meant that where they were required, follow-up appointments met the individual needs of the women rather than a local protocol.
Intervention delivery and training
Many different healthcare professional groups provide pessary care in the UK including nurses, medical doctors, physiotherapists, midwifes and clinical support workers [45]. Furthermore, there is extensive variation in training standards for pessary practitioners at different organisations in the UK [45]. This meant a pragmatic approach regarding who delivered the intervention was necessary. In addition to strengthening collective action by ensuring a multidisciplinary approach to intervention delivery which was compatible with existing work practises [23], the findings can also be generalised to a range of healthcare professionals, rather than applicable solely to a specific professional group. It was specified the TOPSY self-management intervention should only be delivered by pessary practitioners already trained to the local specifications at their organisation and providing pessary care as part of their clinical role. Prior to delivering the self-management intervention, pessary practitioners received intervention delivery training provided by a clinical member of the TOPSY team at a site visit. This presentation covered pessary self-management, each aspect of the intervention, why it was necessary and the information to be included. A training manual to refer back to if necessary was also provided. During the site visit, the TOPSY team ensured that the intervention was compatible with how pessary self-management was currently taught and could be feasibly delivered. By ensuring additional training was not onerous and did not conflict with established working, this ensured cognitive participation and collective action amongst clinicians and key stakeholders in intervention delivery [23]. Following the site visit, healthcare professionals who accepted delegated responsibility for intervention delivery were asked to sign a record confirming they had received training and felt confident to deliver self-management support as part of the trial.
A case report form was designed to record the delivery of each aspect of the intervention. This ensured standardised delivery of the intervention but also enabled reflexive monitoring [23]. Analysis of the case report form facilitated the identification of any recurring aspects of the intervention which clinicians did not deliver and the reasons for this. There were also free text boxes for clinicians to record whether they omitted or added any content to the intervention session. This enables analysis of how clinicians feel about the delivery of the intervention and for adaptions and improvements to be made if advocated. In addition to the analysis of the intervention delivery case report form, a sample of pessary using women and health care professionals were interviewed and a number of self-management support sessions and follow-up calls audio recorded as part of the process evaluation [6].
