How effective is a professionally led, group based intervention in improving medication adherence in individuals with a chronic (long term) condition? Author: Alex Johnston Date: January 2013 Introduction Non adherence to prescription medication has received increased attention particularly in the setting of chronic medical conditions. The incidence of reported medication non adherence varies greatly however, most reviews agree that between one third and a half of medicines prescribed for long-term medical conditions are not taken as directed (World Health Organisation, 2003). In chronic, asymptomatic diseases such as glaucoma and hypertension non adherence has significant effects on treatment outcomes often leading to increased resource utilisation, more frequent hospital appointments and diagnostic tests, increases in doses or changes in medications and risk to the patients if subsequent surgical intervention is required (Gray et al, 2010). Barriers to treatment adherence include situational and environmental factors (major life events, travel, competing activities); medication regimen factors (refill, complexity, adverse events, cost); patient related factors (age, knowledge, memory, motivation, comorbidity, health beliefs) and provider related factors (satisfaction with and communication by clinicians) (Taylor et al, 2002; Noecker, 2009) Recent reviews of studies in patients with many different chronic conditions reveal familiar themes in strategies to address non adherence: social support (DiMatteo, 2004); simplification of treatment regimes (Tsai, 2009; Gupta et al, 2009); multidisciplinary efforts at patient support and education and structural support such as patient reminders, more frequent clinic visits or telephone phone calls from staff (Handley et al 2006). However, few significantly affected long term clinical outcomes (Kripalani et al 2007; McDonald et al, 2002) Therefore the aim of this rapid review is to better understand the strengths and limitations of a professionally led, group based intervention in improving medication adherence in individuals with a chronic (long term) condition. Please note, given the lack of empirical studies on professionally led, group based interventions to improve medication adherence in patients with glaucoma this review has expanded its search strategy to include a range of chronic diseases. 1 Search Strategy A thorough search of the literature was performed in order to identify available literature relating to the effect of a professionally led, group based intervention to improve medication adherence in individuals with a chronic (long term) condition. Inclusion Criteria Study type Randomised Controlled Trials (RCT) Non-experimental design Pilot Phenomenological Exclusion Criteria Studies that do not focus on professionally led, group based interventions to improve medication adherence in individuals with a chronic condition. Studies which focused on mental health conditions. Non English studies Participants Adults Outcomes The primary outcome measure was improved adherence, however all studies with various primary and secondary outcome measures were included. Language of population English Language - 1990 to 2012 Search terms A thorough search of electronic databases and journals was implored using the keywords: Condition Glaucoma 2 Chronic open-angle glaucoma (GOAG) Chronic disease Long term condition Intervention Group based intervention professionally led Health education Outcomes Improved adherence Improved compliance Improved concordance Improved clinical outcomes 3 Databases/Resources Searched A literature search of studies published between 1990 and 2012 was performed. Databases and search engines used included: OVID, MEDLINE, AMED, Cochrane Library, Web of Knowledge and Google Scholar. Due to time restraints only electronic journals were appraised. Ancestral searching of reference lists to identify all relevant empirical studies also took place. All the included studies were published in English. Critical Appraisal Nine studies were identified for appraisal: Zwikker et al 2012, Nielsen et al 2010, Chen et al 2009, Lacey et al 2009, Okeke et al 2009, Blondeau et al 2007, Jiang et al 1999, Windsor et al 1990, Dunn et al 1990 (Appendix 1). Study purpose These studies all shared a common purpose to examine if a professionally led, education intervention improved medication adherence in individuals with a chronic (long term) condition. However, the studies were delivered in different settings and used multifaceted interventions. Zwikker (2012) described the systematic development and content of a short intervention to improve medication adherence to diseasemodifying anti-rheumatic drugs in non-adherent patients with rheumatoid arthritis (RA). Nielsen (2010) evaluated a group based educational programme to increase patients’ knowledge of osteoporosis and level of adherence with medical treatment. Chen (2009) compared patients understanding of glaucoma Lacey (2009) obtained narratives from participants who described satisfying and dissatisfying therapy experiences. Okeke (2009) investigated the impact of an intervention programme to improve adherence with topical therapy for glaucoma. Blondeau (2007) investigated if a two hour information session improved glaucoma patients’ understanding and compliance. Jiang (2008) evaluated the impact of diabetic education programmes on diabetic control. 4 Windsor (1990) evaluated the efficacy and cost effectiveness of health education methods to increase medication adherence among adults with asthma. Dunn (1990) examined the impact of a formal diabetes education programme on diabetes specific knowledge and attitude and the relationship between these characteristics and metabolic control of the disease. 5 Literature Review All nine studies provided detailed discussions on the background to each study/paper, succeeded in aggregating relevant information (previous research etc.) and commented on the clinical importance of the subject. Design Using a phenomenology approach Lacey (2009) sought to capture patients’ subjective experiences with glaucoma therapy. Three of the studies adopted randomized designs (Nielsen 2010, Okeke 2009, Windsor 1990). Chen 2009, Jiang 1999 and Dunn 1990 chose non experimental designs. Blondeau (2007) presented findings from an information session which aimed to improve patients understanding and compliance on glaucoma. Whilst Zwikker (2012) described the development of a short intervention to improve medication adherence in patients with RA, the intervention was then piloted twice. Chronic conditions The nine included studies recruited participants with a wide range of conditions including: glaucoma, osteoporosis, asthma, RA and diabetes. Settings Studies were conducted in the UK (Lacey 2009), Taiwan (Jiang 1999), Australia (Dunn 1990), Netherlands (Zwikker 2012), Denmark (Nielsen, 2010), China (Chen 2009) and three studies took place in North America (Windsor 1990, Blondeau, 2007, Okeke 2009). Sample sizes A total of 1803 participants were recruited across all the studies, with individual studies having between 24 and 309 participants. Participants were recruited from either primary or secondary care settings. According to Aveyard (2007) researchers should demonstrate how they determined the sample size, also known as power calculation and should be clearly documented in the paper only Nielsen (2010), and Okeke (2009) did so, (not applicable to Zwikker 2012 or Lacey 2009). Zwikker (2012) Chen (2009) and Dunn (1990) did not provide inclusion and exclusion criteria. All studies referenced previously published study methodology. 6 Okeke (2009) and Jiang (1999) incorporated the use of multi site trials increasing sample size and improving external validity of the study. According to Aveyard (2007) qualitative samples are often small and this was recognised by Lacey (2009) who recruited twenty four participants. Ethical Approval The following authors, provided details on obtaining ethical approval from committees and informed consent from participants, thus reassuring the reader that research was conducted in accordance with accepted community principles (Nielsen 2010, Lacey 2009, Okeke 2009, Windsor 1990). Follow-up Six studies reported information on follow-up rates. 3, 12 and 24 month Nielsen (2010) 12 month Windsor (1990) 1, 4 and 10 month Blondeau (2007) 3 and 6 month Okeke (2009) 4 month Jiang (1999) 3 month Dunn (1990) Brief summary of the interventions Zwikker (2012) evaluated a short intervention programme consisting of two motivational interviewing guided group sessions led by a pharmacist. Nielsen (2010) assessed a multi disciplinary team led group based programme (four classes over four weeks) to improve patient knowledge and adherence on osteoporosis. Okeke (2009) assessed a multifaceted intervention administered by study staff, involving, a ten minute education video stressing the importance of regular drop taking, structured discussion with the study coordinator, use of a diary, reminder telephone calls and administration of a questionnaire about drop taking behaviour. Lacey (2009) used information gathered from focus groups to inform ten, one-to-one, home based, semi-structured in depth interviews. Chen (2009) used group based interventions to compare compliance, life style, habits and knowledge of glaucoma with an intervention and control group. Blondeau (2007) assessed a nurse led, two hour group education session to improve patient understanding and compliance. 7 Based on recommendations from the American Diabetes Association Jiang (1999) evaluated a diabetes education programme provided by a team of diabetes physicians, dieticians and nurse educators. Windsor (1990) offered a 30 minute one to one session with instructions on the use if a peak flow meter, a 60 minute asthma support group session and two brief telephone reinforcement calls within one month of group session. Dunn (1990) assessed a two day diabetic education programme in which 6 to 8 patients some accompanied by a relative or friend attended a two day programme. Below is a table consisting of two columns and 10 rows, including a header row. Study Zwikker (2012) Nielsen (2010) Okeke (2009) Lacey (2009) Chen (2009) Blondeau (2007) Jiang (1999) Windsor (1990) Dunn (1990) Outcome measures Improved medication adherence. Improved medication adherence and increased knowledge. Improved adherence with topical once daily therapy for glaucoma. A better understanding of the obstacles to and motivations for adherence with glaucoma medication. Improved medication adherence and increased knowledge. Improved medication adherence and increased knowledge. Improved diabetes self care techniques and metabolic outcome. Increased medication adherence Improved metabolic improvement in diabetes control. 8 Results Medication adherence The following authors demonstrated improved adherence to glaucoma therapies: Okeke (2009) (p = <0.001) effect was sustained during the follow up observation period and Blondeau (2007) (following session 19% of respondents reported improved adherence at 1 and 4 months but increased to 37% after 10 months). Chen (2009) demonstrated a positive trend. Whilst Lacey (2009) identified multiple obstacles to adherence and suggested emphasis should be placed on identification of the stage(s) where adherence is breaking down. Zwikker (2012) demonstrated that adherent patients had higher ‘necessity’ belief scores about medications than non adherent patients (p = 0.02), patients with recent onset RA were more adherent than patients with a longer RA duration (p = 0.05) and adherent patients reported fewer adverse medication effects than non adherent patients. Nielsen (2010) reported that self reported adherence to medication for osteoporosis was significantly higher in the intervention group (p = 0.001). Likewise, Windsor (1990) found that the experimental group exhibited a significantly higher level of improvement in adherence among adults with asthma (44% compared to 2% in control group). There were contrasting results in the two studies investigating diabetic metabolic outcomes. Jiang (1999) concluded that an intensive diabetes educational programme provides an effective method for improving both self care techniques and metabolic outcomes (p < 0.001) whilst Dunn (1990) reported that diabetes knowledge did not predict improvement in the control of diabetes. Cost effectiveness The actual or estimated cost of delivering the programme per participant were reported in two studies: Blondeau (2007) Can$16-18 per patient and Windsor (1990) $32.03 per patient. Harms None of the studies reported that they had received any complaints. No adverse outcomes were reported in any of the included studies. 9 Discussion In this rapid review of studies designed to improve medication adherence in chronic medical conditions, eight of the nine studies (Dunn, 1990 was the exception) reported significant improvement in adherence. However, the paucity of studies which examined outcomes beyond twelve months, (Nielsen, 2010 and Windsor 1990 were the exceptions) make it difficult to speculate whether benefits would be maintained long term, or indeed if there are benefits which only become apparent over time. Through the use of a questionnaire Chen (2009) illustrated that the Glaucoma Club (educational lectures using a holistic approach) is an effective platform to improve patient’s knowledge and self management of glaucoma. A contributing factor to study scores was patient educational attainment; more patients from the Glaucoma club had attended university. To ensure effective therapeutic outcomes, the study emphasises an ‘open and honest’ approach to communication techniques. It is worth noting that although the subjective measure of self report is the most utilised method for assessing adherence (Chang, 1991, Nelson 2006) it is said to be unreliable as patients tend to over-estimate their adherence level. This was indeed acknowledged by Nielsen (2010) and Windsor (1990) however, Windsor’s reported use of psychometric analysis increases the studies internal validity. In Okeke’s (2009) multifaceted intervention, the monitoring device used could only provide data on one type of medication (travoprost) therefore, self report results were also used as a measure of adherence. The use of IOP as a clinical outcome identified that improvement in adherence was not matched by lower IOP levels. In addition, data showed that poorly adherent patients increase drop taking two weeks prior to their appointment suggesting that IOP measurements are not an accurate measure of adherence. Small sample size and a low baseline adherence rate may have also influenced results. As in other studies, (Domino, 2005, Hoeveaars, 2008, Budenz, 2009), Jiang (1999), reported that when used alone, patient education has been found to be ineffective in improving adherence. Again the use of self reporting as a measure of adherence may affect study outcomes. The use of questionnaires (non-standardised) was used by Blondeau (2007) and Nielsen (2010) both of whom assessed participants’ knowledge and level of adherence. Only Dunn (1990) discussed the use of a previously validated adherence tool, a five point Likert scale. 10 An attitudinal change specifically ‘necessity’ beliefs and how they may be predictive of subsequent improvements in adherence were discussed by Dunn (1990) and Zwikker (2012). Motivational interviewing (MI) delivered by a multidisciplinary team and targeting only non adherent patients was investigated by Zwikker (2012). He acknowledges that the group format might compromise MI effectiveness as it could prevent individual needs from being met. This was also identified by Windsor (1990) who complemented group sessions with one to one sessions; Zwikker (2012) addresses individual patient needs through the discussion of individual beliefs and barriers. Whilst Nielsen (2010), who reported significant improvement in adherence, concludes, that group based patient educational programmes can not be a substitute for individual face to face discussion with clinical staff. Lacey (2009) reported that age related issues identified by younger participants only emerged during one to one interviews and not in the focus groups. She suggests that as a taboo subject, age may not have been discussed in the focus groups to avoid offence. The introduction of an education assistant is recommended and results suggest that intervention should be focused at diagnosis and be tailored to the individual. Member checking, a strategy to ensure the trustworthiness of research was used with all participants to clarify and elaborate further on their earlier responses. This shows a degree of collaboration between the researchers and the participants and contributes to the trustworthiness of the study (Curtin and Fossey, 2007). 11 Conclusion It is not possible to draw definitive conclusions about which features of the included interventions are most beneficial. However, educating patients about their condition in a group setting, complemented with one to one sessions and multifaceted interventions have all contributed to positive findings for improving adherence levels. It is important to recognise that there is a large amount of research on interventions for improving adherence to glaucoma therapy. 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