HOPE-AO overprescribing in older adults with chronic pain: a protocol for qualitative interviews with patients and healthcare professionals

Background

Epidemiological studies demonstrate that chronic pain is experienced by over 40% of UK community dwelling older adults,and is often poorly managed.¹ Ageing impacts upon the pain experience in ways that are not yet fully understood, with suggested mechanistic changes including, decrease in a-delta nerve activity, loss of proprioception, alteration in peripheral nerve activity, lower pain thresholds and hyperalgesia.² There is evidence of several painful conditions being more prevalent in older adults, including osteoarthritis, which results in joint pain.³ Vertebral compression fractures are also very common.⁴

About 95 million people across Europe are estimated to have chronic pain,^5–8 compounded by inequalities in access to treatment. A large-scale survey across 15 European countries⁵ showed high levels of pain medicine prescribing: NSAIDs (44%); weak opioids (23%); paracetamol (18%); and strong opioids (5%). Also, 40% of people experiencing pain have inadequate pain management. Whilst this survey focussed across all age groups, a recent overview by the International Association for the Study of Pain highlights disparities in effective pain management by age, along with sex/gender, ethnicity and socioeconomic status.⁹ Our study aims to address these sociodemographic and cultural disparities, through a focus on older adults in two contrasting diverse areas (inland and coastal).

Overprescribing of pain medication is a substantial concern, and a key DHSC report¹⁰ has highlighted the problem of overprescribing of dependence forming pain medications, including opioids and gabapentinoids. Overprescribing of opioids is particularly prevalent in older adults.^11,12 Tertiary amine tricyclic anti-depressants are also often used for management of neuropathic pain, but are not advisable for older adults, because of side effects.¹³ Management of pain in older adults presents many challenges, including a reduction in the effectiveness of medication in the long term and increased tolerance (which can make pain worse – e.g. opioid-induced hyperalgesia), along with multimorbidity and polypharmacy (prescribing of multiple drugs).^14,15 The recent report by England’s Chief Medical Officer¹² suggests that overprescribing in older adults needs to be reduced, to enable improved quality of life, noting that this is the fastest growing population in society, with much to contribute within their families and communities. We therefore have a social responsibility to ensure older adults can contribute effectively as opposed to becoming increasingly frail, and losing dignity and independence. Myths and misconceptions surrounding pain and ageing are prevalent such as, “you get used to the pain”, “I expect pain at my age” and “older adults do not feel as much pain as their younger counterparts”.¹⁶

In addition to overprescribing, analgesic medication it is often co-prescribed with other medications, such as psychotropic drugs used to treat psychological distress. Older adults are prescribed a median of seven different medications.¹⁷ Polypharmacy (use of multiple medications) is particularly common amongst older adults and is strongly associated with increased mortality and morbidity.¹⁷ Excessive polypharmacy (>10 medications) is associated with inappropriate medication use.¹⁷ Notably, several medications are prescribed for both pain and distress (e.g. tricyclic antidepressants and gabapentinoids), and pain and distress syndromes (such as fibromyalgia and depression) together represent a range of related disturbances of brain-body functioning¹⁸ that share underlying social causes including trauma and adversity.¹⁹ Such medications share distinct but related mechanisms of tolerance and withdrawal.²⁰ A related issue is the link between chronic pain, poor sleep and low mood, with prescribing of multiple medications to manage this complex interaction of pain and distress. The European Pain Federation has issued a position paper on the use of these drugs in the general population, but no such paper has been produced for older adults.¹² There is therefore a strong rationale to consider wider co-prescribed psychotropic medication, when investigating issues around prescribing for chronic pain in older adults.

A review by Williams et al.²¹ suggested that rational deprescribing of prescription drugs would reduce the risk of adverse reactions and hospitalisations. Other studies have reported positive benefits to older adults from deprescribing, including a 24% decline in mortality, a significant reduction in referrals to acute care, and reduced healthcare costs.²² There have been some steps towards deprescribing and better prescribing of pain medication, and several tools have been developed, including FORTA, BEERS, and the STOPP/START criteria.²³ Another review²⁴ identified interventions including decision support tools, educational programmes, and medication reviews by pharmacists and/or healthcare providers. The authors concluded that deprescribing interventions using the STOPP criteria seem effective in reducing pain overprescribing and polypharmacy in older adults, by providing a physiological systems-based tool that defines clinically important issues relating inappropriate medications. However, further research is needed on the effectiveness of these approaches on clinical outcomes, and how to implement them most effectively. Furthermore, these frameworks fail to address patients’ preferences, which are key to cooperation and adherence, nor do they identify patients’ individual needs and plan care delivery accordingly. This is a major limitation that this study aims to address by using a person-centred approach, where patients are at the heart of planning and development.

Another factor that influences pain prescribing and reporting is the “7- minute consultation”.²⁵ Tai-Seale et al demonstrated that the time allowed for a GP consultation prohibits a thorough pain related discussion. Consequently, prescriptions are often quickly initiated and repeated. Developing a joint framework between healthcare professionals and patients would enable optimum use of the 7-minute consultation to ensure medication management meets the STOP/START criteria.²⁶ Additionally, the potential for simple changes to deliver impacts has been demonstrated on a small scale. For example, an approach in Somerset²⁷ has used a simple opening question (“show me your meds please”) during routine care visits to identify unnecessary and unneeded medicines, helping to reduce wastage and save resources – while also leading to more optimised prescribing for some patients. There has been very little research into older adults’ perceptions of taking medication, in addition to uncertainty about who to target – which this study will address. A survey¹⁷ of 100 adults aged 65+ years regarding their medication intake revealed that 81% percent believe they take a large number of medications. Whilst 79% believed these are necessary, 85% would be willing to stop if recommended by their GP, 62% would be willing to take fewer medications, and 41% would want follow-up by a specialist polypharmacy clinic. This small study suggests that there is an appetite amongst older adults to reduce their medication intake, but more research is needed. Such decisions are complex and to some extent, both patients and professionals need to accept uncertainty in this process (e.g. SHERPA: a new model for clinical decision making in patients with multimorbidity.²⁸

A scoping review²⁹ highlighted how both patients and healthcare professionals were anxious about stopping medications, even though patients felt overwhelmed by the amount they were being prescribed. Using JBI methodology³⁰ the review identified 20 papers highlighting that deprescribing can be safe and acceptable to clinicians, but specific effects were very varied and patient views were often not reported (to be addressed in our study). The PPIE partners in this review highlighted that medicines represented more to the patient than just tablets, suggesting the need for person-centred prescribing. Such findings highlight the lack of theory underpinning deprescribing.

In summary, overprescribing of chronic pain medication is a pressing problem in older adults. There is limited research and limited understanding of person-centred approaches to pain management within this population, as well as a lack of understanding about the population itself. Such issues are compounded by poor medication monitoring and infrequent reviews. A combined caregiver–patient-centred approach should encourage collaboration between prescribers and pharmacists to reduce overprescribing in older adults. Reducing and stopping medicines encompasses many factors including: life expectancy; reduced survival prognosis; excluding medication with questionable evidence of effectiveness; and promoting medication prescriptions with favourable risk-benefit ratios. There is evidence that withdrawal of unnecessary medication has positive impact upon the quality of life in older adults, along with potential health economic benefits from reducing waste. However, the most appropriate framework for person-centred medication deprescribing, optimisation and pain management in older adults is yet to be established. To establish the focus of such a programme, we need to know more about the population and their varied concerns.

We therefore propose a study that explores the prescribing of drugs (including opioids, non-steroidal pain medication, low dose tricyclics, paracetamol and gabapentinoids) for chronic pain management in older adults (65+), along with experiences of pain symptoms, the wider healthcare system, and people’s priorities and preferences around pain management. We will adopt a person-centred approach for engaging with older adults, empowering them to be heard, whilst helping to develop potential solutions for better pain management. We will incorporate both quantitative and qualitative work packages (WPs), to better understand the older adult population who are taking medication for chronic pain, along with their experiences of prescribing and pain management – and the views of family carers and healthcare professionals. Interpretation of the results with our lived experience partners will allow us to determine the focus of future programme grant funding to work with older adults in co-designing a patient-centred prescribing and pain management framework, encompassing the attitudes and beliefs of patients and healthcare professionals.

Aims and objectives

The aim of the study is to explore chronic pain prescribing in older adults, both in terms of the population itself, and in terms of their experiences and overall needs. This includes 1) developing a good understanding of analgesic prescribing patterns in the context of various clinical, therapeutic and sociodemographic factors, which will help identify which patients are most likely to benefit from targeted interventions as well as shaping potential intervention strategies, while 2) also learning about the perspectives of people prescribed these drugs, along with perspectives from carers and multidisciplinary team members, which will further help inform intervention design. This work will provide the foundation for co-designing a pilot intervention/framework within a future research Programme (see Future Work Plans) and identifying participants who will work with us as experts by experience. As outlined in the background and rationale, some of the key knowledge essential for this future programme is lacking. Our development project aims will provide this core knowledge. Several key objectives (Obs) will allow us to achieve these aims:

Ob1: Understand which sociodemographic (e.g. age [above 65+], gender, deprivation, rurality, ethnicity) and clinical (e.g. mental health, multimorbidity, co-prescribing) factors are associated with prescribing of key analgesic drug classes (i.e. weak opioids, strong opioids, NSAIDs, paracetamol, gabapentinoids, low-dose tricyclics), combinations of these drug classes, and changes over time. (WP1).

Ob2: Investigate the association between the aforementioned analgesic drug classes (including clusters of drug classes and temporal changes), and important clinical and health service outcomes (particularly adverse outcomes). (WP1).

Ob3: Identify alternative treatment solutions to reduce the use of unnecessary analgesic pain medicines through exploring older adults and their caregiver’s: acceptability of currently used analgesic pain medicines (and other pharmacological agents for mood or sleep aspects of chronic pain); their current use; their trust of different prescribing professionals; and their willingness to try and accept other pain management modalities (e.g, self-management, non-pharmacological, safer pharmacological options) (WP2).

Ob4: Identify the current barriers and facilitators for optimising, deprescribing, and preventing unnecessary prescribing of analgesic pain medicines for older adults through exploring the experiences of health professional prescribers managing medicines for older adults living with chronic pain in the primary care setting. (WP2).

Ob5: Identify potential engagement strategies, prior to support, which can aid the optimisation and deprescription of unnecessary prescribing of analgesic pain medicines through exploring older adults, their caregivers and health professional prescribers (primary care) understanding of analgesic pain medicine risks and their willingness to engage in the optimisation and deprescription of unnecessary analgesic pain medicines. (WP2).

Ob6: Develop a prioritised list of acceptable engagement strategies and alternative treatment solutions to reduce use of analgesics and increase use of self-management, non-pharmacological or safer pharmacological options to manage chronic pain which can be tested in a future intervention, using the accounts of key stakeholders (older people, their caregivers and health professional prescribers). (WP2).

Methods

The NIHR PPIE statement emphasizes the importance of Patient and Public Involvement and Engagement (PPIE) in research. We have included PPIE throughout the development, design and delivery of the study as active advisors in their role as experts by experience.

This 18-month study will use separate, parallel quantitative and qualitative work packages (WPs), integrating the findings at the end to inform the design of a future programme grant. The first quantitative WP will use an analysis of the CPRD database, so that we can get a clearer understanding of patterns and relationships of chronic pain prescribing within older 65+ adults in England. The second qualitative WP will use interviews to explore the perceptions and experiences of older adults, along with informal carers, and healthcare professionals, including prescribers. The findings of these two work packages will stand alone as important contributions to the literature, but in the final months of the project, we will also integrate the findings of both into a plan for a future programme of research, to codevelop a framework for optimal prescribing and pain management.

Work package 1 (0–15 months).

The full technical protocol for this WP is being written up for separate publication. A summary is provided here. The aim of this WP will be to explore the patterns of prescribing of analgesics and related medicines amongst older adults (65+ years). This will produce invaluable insights into the extent of prescribing for pain, how this changes over time, factors associated with prescribing, and potential consequences of analgesic use. This will provide us with a better understanding of which patients are most likely to benefit from targeted interventions, as well as informing what potential future interventions might look like and which aspects of care they might address. Our PPIE panel will be consulted before, during, and after the WP1 analyses, to inform both our approach and our interpretation of findings.

Dataset: This aspect of the project will use data from the Clinical Practice Research Datalink (CPRD). The CPRD collects representative, real-world data on 18 million active patients from GP practices across the UK, including sociodemographic data and key coded information on diagnoses, administrative activity and prescribing. It is linked to a range of other healthcare data, providing a powerful longitudinal dataset, and is widely used for pharmacoepidemiology and health services research, evident in over 3000 peer reviewed publications. For this study we will access the data through Exeter University, overseen by Professor Rupert Payne who has extensive experience using the CPRD (including as a member of CPRD’s data quality advisory group). Access to the CPRD data has been made through the CPRD electronic Research Application portal (eRAP) and is covered by approved protocol #24 004610 which is summarised below.

Study design: An exploratory retrospective cohort study will be conducted, including the following analyses:

Associations will be modelled using multivariable regression (logistic, Poisson, etc. as appropriate) with random effects to account for practice-level clustering.

Study population: Older adults aged 65+ on the study index date, registered with at least 12 months of prior data, and who have received at least one prescription for analgesia in the previous 12 months.

Analgesia prescribing: The following analgesic drug classes will be considered by the analysis: high strength opioids (eg Morphine); low strength opioids (eg Codeine); non-steroidal pain medication; paracetamol; low dose tricyclics; and gabapentinoids.

Exposures and covariates: Sociodemographic factors will include age category (5-year groups), sex/gender, Index of Multiple Deprivation, ethnicity, and rurality (including coastal status if possible). Clinical factors will include Cambridge Multimorbidity Score, relevant mental health (e.g. anxiety/depression, severe mental illness, substance misuse, LD), pain conditions (e.g. osteoarthritis, endometriosis), functional disorders (e.g. irritable bowel syndrome, fibromyalgia), and other risk factors (e.g. previous falls, respiratory disorders, CKD, exploration of past trauma (if adequately coded)). Other prescribing factors to be considered will include polypharmacy (drug count) and relevant specific co-prescribing (e.g. antidepressants, benzodiazepines, z-drugs). Established codesets from our existing resources, HDRUK or similar, will be used to minimise data preparation time.

Clinical and service outcomes: Service use will be assessed using GP consultation rates, hospital admission rates (HES) and referrals to key services (e.g. physiotherapy, pain clinics). Linked HES data for unplanned hospital admissions will be used to identify important, relevant adverse clinical outcomes (e.g. AKI, bleeding, delirium, falls). Adverse drug reactions will also be captured through relevant codes within both primary care and HES data.

Methods