Abstract
Keywords
High rates of nonadherence appear endemic among those suffering chronic illness, with more than 50% of patients across illness categories failing to take their medication as prescribed [1], [2]. As a chronic health problem, mental illness has also been beset with problems of adherence, with between 42% [3] and 80% [4] of patients not correctly following directions on how to use their antipsychotic medication. Given that antipsychotic medication is the primary intervention in the management of illnesses such as schizophrenia [5] and that these medications significantly reduce relapse [6–8], medication nonadherence in this population has attracted considerable attention.
While the reasons for nonadherence are multifaceted and complex [9–11], Sawyer and Aroni [2] observe that the responsibility for improving adherence lies predominantly with the health professional, not the patient. Such views underlie contemporary ‘cognitive-behavioural’ adherence interventions such as ‘compliance therapy’ [12], [13] and Gray's ‘medication management’ model [14].
In the development of ‘compliance therapy’, Kemp et al. [12] adapted motivational interviewing techniques [15] for use with psychotic patients by taking a more active therapeutic stance, using guided problem solving and increasing the educational component. Cognitive approaches to psychotic symptoms were also included. Research has demonstrated that, compared to a control group, patients receiving ‘compliance therapy’ show significantly greater improvements in their attitudes to treatment, insight into illness and clinician-rated compliance with treatment. These differences were maintained across an 18 month follow-up period [13].
While ‘compliance therapy’ has become the benchmark for the management of nonadherence with antipsychotic medications [16], there are some fundamental problems to be overcome prior to its widespread implementation. Key among these problems is the issue of therapist skills. In Kemp's work, ‘compliance therapy’ was delivered by highly trained and experienced clinicians (psychiatrist and psychologist). However, both in the UK [14] and in Australia [17], the delivery of the bulk of mental health services is provided by nurses and other allied health professionals. For ‘compliance therapy’ techniques to be effectively utilized, it would need to be demonstrated that front-line clinicians can be effectively trained in their delivery. Skills gaps in areas such as psychosocial interventions for severe mental illness have been identified as a ‘critical challenge’ in the UK [18]. This includes medication adherence where research has identified that a majority of nurses in the UK have poor skills and knowledge [19].
Recently, Gray et al. in the UK [14] reported a 10 day ‘medication management’ training program delivered across 10 weeks and aimed at enhancing medication adherence skills of mental health nurses. The program involved training in assessment of medication adherence issues (such as patient attitudes to treatment, insight into illness and medication side effects), cognitive and compliance therapy skills, psychopharmacology and ongoing (weekly) clinical supervision of the trainees’ implementation of ‘medication management’ [14].
Sixty community mental health nurses were recruited into the ‘medication management’ study, with complete data sets obtained for 43 participants. The effect of training on skills was assessed through a 10 minute standardized role-play task which was blind-rated by a trained cognitive behaviour therapist using the Cognitive Therapy Scale (CTS) [20], [21]. Gray et al. [14] reported significant improvements across all 10 subscales of the CTS, as well as significant improvements in knowledge. They concluded that improvements in both skills and knowledge increased the potential for the participants in their study to effectively deliver ‘compliance therapy’ techniques.
Coombs et al. [17] found that Australian mental health workers (in particular, nurses), also need training in strategies to manage medication adherence issues. In their study, 84% of their sample reported receiving no prior training in medication adherence even though they indicated that facilitating medication adherence was one of their primary roles. Coombs et al. also reported that 40% of respondents either ‘always’ or ‘often’ had difficulties discussing adherence issues with patients.
Clearly there is a need for medication adherence training in Australia. Given the results reported by Gray et al. [14], can Australian training needs be met through the importation of ‘medication management’? While the results obtained by Gray and colleagues are encouraging, the study had several limitations. In their work, Gray et al. did not measure staff attitudinal variables. Given suggestions that staff attitudes toward medication use may have an influence on the way they facilitate medication adherence [17], this constitutes a significant omission. Within the domain of clinician attitudes, optimism is of particular importance. It has been suggested that clinicians ‘transmit’ their treatment expectations to patients and that the expectations of the clinician may have a greater impact upon the outcome of treatment than the expectations of the patients themselves [22]. In addition, while they emphasized the development of clinician skills as indicative of program efficacy, the Gray et al. study was limited by the lack of interrater reliability data with respect to participant skill acquisition ratings.
Perhaps most problematic from an Australian perspective is the expense and logistic difficulties in disseminating a 10 day training program across geographically dispersed services. Preliminary consultations by the authors with mental health services in Australia quickly revealed that release of staff and back-filling positions for a 10 day program would not be workable.
Kemp demonstrated that ‘compliance therapy’ techniques enhanced medication adherence and Gray showed that these techniques could be delivered by front-line mental health staff. The development of Medication Alliance [23] was an attempt to adapt the best features of these programs for transfer to the Australian context.
Medication Alliance
Medication Alliance is a multidisciplinary training program (Table 1) developed after an extensive review of the literature and in consultation with patients, carers, clinicians and other researchers in the field. The therapy skills included in Medication Alliance are broadly modelled on ‘compliance therapy’ and can be matched to the range of identified reasons for nonadherence. For example, problem-solving can be used to assist patients who have cognitive deficits or who lack resources or support to maintain medication-taking behaviour [24], while motivational interviewing can facilitate the development of life goals that include medication use [11], [25]. Similarly, cognitive therapy techniques can be usefully employed to overcome delusional beliefs regarding medication [26] and assist in the development of insight into illness [27].
Outline of the Medication Alliance training program
Newell et al. [28] and Haynes et al. [29] argue that in seeking to facilitate adherence, multiple-strategy interventions are consistently more effective than singlestrategy interventions. However, rather than adopting a ‘shotgun’ or ‘cookbook’ approach, with the concomitant danger of the intervention appearing irrelevant to the patient, Medication Alliance emphasizes the need to carefully evaluate the specific causal variables surrounding medication-taking behaviour and to use that information to derive a clinical formulation of nonadherence [30]. Thus, assessment of medication-taking behaviour draws heavily from functional analysis [10], [31], [32]. This approach then influences the choice of ‘compliance therapy’ technique for each unique patient nonadherence context.
The aim of the present study was to evaluate the immediate clinician training outcomes of the Medication Alliance program. It was hypothesized that there would be pre-post training improvements in knowledge, attitudes toward working with individuals with medication adherence problems, therapeutic optimism, and medication alliance therapy skills.
Method
Participants
A total of 23 mental health workers from Tasmania, participated in the training program. Sixty-four percent were women and most trainee participants were community mental health nurses (n = 18), with two psychologists and two social workers (missing data for one participant). Thirteen trainees reported that their current position was as a member of a community mental health team, three were involved in assertive community treatment teams, two were in administrative roles, and the remaining four were in a range of other specialist mental health services. The trainees had worked in mental health services for an average of 14.8 years (SD = 7.50). Trainees were asked about medication-related difficulties for patients on their caseloads. The average caseload at the time of training was 31 patients (SD = 22). Most patients (mean = 70%, SD = 22%) on their caseloads had a diagnosis of schizophrenia, bipolar or major depressive disorder. An average of 65% of their patients were taking antipsychotic medications (SD = 27%). Nineteen percent (SD = 15%) of their patients were variable in their use of medication and on average they described 16% (SD = 13%) of patients as ‘very unreliable’ in their use of medication. In total, 35% of the caseloads of participating mental health workers were thought to have significant adherence problems.
Procedure
The Medication Alliance training program was developed by the authors in consultation with clinicians, patients and academics. This included specific consultation with two of the authors of the Gray et al. [14] study (Gray and Gournay). Consistent with the Gray et al. [14] design, this study had a ‘within subjects repeated measures’ design. Training was provided over 3 days to two separate groups (n = 13 and n = 10). In addition to the three training days, participants were involved in approximately 1 day of data collection. After a brief introduction, pretest measures were administered in booklet form on the first morning of training. All data and forms were coded and de-identified. The extent that trainees had acquired Medication Alliance therapy skills was assessed by rating a 15 minute pre-training and a 15 minute posttraining video of the trainee providing a brief therapeutic intervention to a ‘patient’ role-played by two of the researchers (FD and GL). Each trainee was provided with a written case vignette describing, relevant background information, the change in the patient's use of antipsychotic medication and the key tasks to be completed in the 15 minute contact (such as collaboration, agenda setting, problem analysis, problem solving and the setting of homework). Trainees were allowed 5 minutes to consider the information and make notes before conducting the role-play interview. After 15 minutes, or when they determined that they had finished (whichever came first), the interview was terminated and they returned to the large training room to complete pencil and paper assessments.
After the completion of pre-test measures, the Medication Alliance training commenced. Post-test information was collected at the conclusion of the training program. The post-test procedure replicated the pre-test procedure, including the order of presentation of assessments. The only pre-test/post-test variation was that the trainees were directed to undertake their second role-play with the alternate trainer who played the role of patient. At post-test the trainees were advised to start their interview with the patient from the beginning and not to assume any carry-over from the previous role-play. These strategies were used to minimize experimenter variance in pre-post role-play conditions.
Measures
Medication Alliance and Cognitive Therapy Scale for Psychosis (skills assessment)
The present study used the Medication Alliance and Cognitive Therapy Scale for Psychosis (MACTS–Psy) in order to assess videotaped skills demonstrations specific to medication adherence (the scale is available from the first author). The MACTS-Psy has five skill domains reflecting core areas of Medication Alliance: agenda setting; problem assessment; Medication Alliance intervention skills (derived from demonstration of motivational interviewing, problem solving and CBT for medication beliefs); homework; and quality of the intervention. The MACTS–Psy was based on the Cognitive Therapy Scale for Psychosis (CTS-Psy) [33], which was adapted from Young and Beck's [20] Cognitive Therapy Scale. With specific anchor points for therapy evaluation, the MACTS-Psy requires the rating of each skill on a 7-point scale, ranging from 0 to 6, such that the higher the score, the greater the assumed competency. Ratings for individual items within a skill category are coded as 1 if the item was appropriately included, 0 if the item was inappropriately omitted and 9 if the item was appropriately omitted or not applicable. The rater assigns 1 point for both the 1 rating and the 9 rating. Total score ranged from 0 to 30.
Videotapes of the trainees’ therapy sessions were blind-rated by two clinical psychologists with knowledge of cognitive, behavioural and motivational intervention strategies. Before commencing ratings of video segments, each rater was provided with a training session on the use of the MACTS-Psy. Both pre- and post-training videos of trainee skills were randomly assigned to raters and they were unaware of whether role-plays were pre- or post-training versions. Approximately 45% of the assigned segments for each rater were also assigned to the alternate rater for the purposes of evaluating interrater reliability.
Functional analytic case formulation
This comprised a case vignette in which there were a number of potential factors influencing the patient's medication use. The task was to identify all potential factors, especially those which had a temporal relationship (a key component of a functional relationship) with the patient's medication-taking behaviour. Two scores were provided: total number of variables identified and total number of temporal (functionally related) variables identified. The temporal variables were a subset of the total variables and reflected greater specificity and therefore skills. The potential range of scores was 0–9 while the temporal component could range was 0–5.
Medication Alliance clinician knowledge questionnaire
A 15-item multiple-choice questionnaire was used to assess pre- and post-training knowledge of areas related to the application of Medication Alliance. Domains included motivational interviewing, problem analysis, therapeutic alliance and cognitive therapy. Items were developed specifically for the Medication Alliance program.
Medication Alliance beliefs questionnaire
The Medication Alliance Beliefs Questionnaire (MABQ) is a 22 item questionnaire that uses a 5-point Likert scale to measure clinician beliefs and attitudes as they relate to working with persons who have medication adherence issues. It was modified from a measure reported by McLeod et al. [26] who used a similar scale to assess the outcomes of a training program in the use of CBT for delusions and hallucinations. The MABQ selected only items that McLeod et al. drew from the alcohol and alcohol problems perception questionnaire (AAPPQ) [34], [35]. The AAPPQ has been used in the development of other questionnaires [36] and provides the five subscales relevant to the present study:
Adequacy – the way that trainees felt about the adequacy of their knowledge in working with people who have medication nonadherence issues;
Legitimacy – the degree to which trainees felt that they had a right to work with people who have medication nonadherence issues;
Motivation – the trainees motivation or willingness to work with people who have medication nonadherence issues;
Work satisfaction – the extent to which trainees expect to derive work satisfaction from engaging with people who have medication nonadherence issues;
Self-esteem – the trainees’ self-esteem in relation to working with people who have medication nonadherence issues.
The main modification of the McLeod items (drawn from the AAPPQ) was the replacement of references to ‘people who have delusions or hallucinations’ with ‘people who have medication nonadherence issues’. We included a twenty-third item, a modified version of the single question, adapted by McLeod et al. [26] from Wilson et al. [37], that assessed the extent of perceived difficulty in working with people who have medication nonadherence issues. This was rated from 1 (extremely difficult) to 10 (very easy).
Elsom Therapeutic Optimism Scale
The Elsom Therapeutic Optimism Scale (ETOS) [38] is a 10 item scale that measures the extent to which the clinician believes that positive outcomes are possible or likely for the patients with whom they work (e.g. ‘Even the most challenging clients can benefit from my intervention’). Each item is rated on a 7-point Likert scale from 1 (Strongly disagree) to 7 (Strongly agree).
Results
Data were analysed using SPSS for windows, version 11.0. To identify pre-post training change, a series of paired t-tests were performed. In order to control for Type-1 error for the multiple planned comparisons, Bonferroni correction was used for each block of analyses.
Knowledge measures
Table 2 details the results obtained for measures of participant knowledge. Pre-test/post-test comparison of participant knowledge indicated that there was a significant improvement in factual knowledge about medication adherence and Medication Alliance strategies to redress these issues. While enhanced factual knowledge arising from training is important, training in the use of that knowledge, enabling accurate identification of the reasons for consumer nonadherence, was a key strategic target in the Medication Alliance program. The Functional Analytic Case Formulation exercise demonstrated both a general enhancement in the participant's ability to identify possible reasons for nonadherence, as well as improvements in their identification of specific reasons for nonadherence.
Pre-post training means and standard deviations on knowledge variables
Attitudinal measures
Measures of attitudinal change are detailed in Table 3. The MABQ provided a comprehensive measure of participant attitudes to working with people who have adherence problems. There was an overall improvement in the full scale of the MABQ after training, (t[20] = 6.86, p < 0.001 [mpre = 78.61, SD = 6.35; mpost = 88.57, SD = 8.16]), indicating more positive attitudes toward working with nonadherence issues in general. Subscale analysis indicated that participants felt their knowledge was more adequate for working with nonadherence (adequacy) and that they expected to derive greater work satisfaction when working with nonadherence (work satisfaction). Another item assessed within the MABQ was the single question: ‘How difficult do you think it is to work with people who have nonadherence issues?’ There was a significant reduction in perceived difficulty of working with nonadherence (t[20] = 3.70, p < 0.001 [mpre = 3.95, SD = 1.36; mpost = 5.48, SD = 1.99]). The second attitude measure of clinician optimism showed a significant increase in scores (Table 3) from pre- to post-test.
Pre-post training means and standard deviations on attitude variables
Skills measure
Table 4 outlines the results obtained on the skills measure. Significant improvements were obtained on four of the five skills. Interrater reliability was adequate for the four skill domains that showed significant improvements. Importantly, both the ‘quality of intervention’ and ‘Medication Alliance intervention skills’ demonstrated improvement.
Pre-post training means and standard deviations on skill variables
Discussion
Medication Alliance seeks to effect changes in three domains: clinician knowledge; clinician attitudes; and clinician skills. From the results it can be seen that changes occurred across these three domains. While there were improvements in factual knowledge of medication adherence issues, one of the key concepts underlying Medication Alliance is that treatment should be individualized. This is in keeping with Fenton et al. [10] who state:
Because non-compliance as a clinical problem is multidetermined, an individualized approach to assessment and treatment, which is often best developed in the context of an ongoing physician-patient relationship, is optimal. The differential diagnosis of non-compliance should lead to interventions that target specific causal factors thought to be operative in the individual patient. (p. 637)
Medication Alliance aims to improve participants’ knowledge of individualized assessment techniques and their ability to apply that knowledge to specific case material. This was measured through the ‘functional analytic case formulation’ exercise where participants showed significant improvement in their ability to discern potential and temporally related causal variables.
Along with improvements in knowledge, there were also changes in participant attitudes. Coombs et al. [17] observed that staff attitudes toward medication use might have an influence on the way they facilitate medication adherence. Negative attitudes and beliefs toward working with people who have persistent mental illness have been associated with a lack of work satisfaction [39] and motivation [40] among mental health professionals. Medication Alliance specifically focused on the development of attitudes and beliefs that support the clinician's engagement in assisting people to adhere to their medication. The MABQ indicated that participants felt their knowledge was more adequate (‘adequacy’ subscale) for working with people who do not adhere to treatment, and that they expected to derive more work satisfaction from engaging with people who have medication nonadherence issues (‘work satisfaction’ subscale). Improvements in self-esteem related to working with medication nonadherence approached significance.
The ‘attitude domain’ also included a measure of clinician optimism (ETOS). It has been observed that a lack of optimism about treatment outcomes can negatively impact upon the relationship between the patient and the clinician [41], [42]. In this study we found that clinician optimism about treatment outcomes for their patients was significantly enhanced after training.
The final, and perhaps most important changes, related to clinician skills. Participants improved in four of the five skill domains, including the key therapy skill, Medication Alliance intervention skills. The low interrater reliability coefficient for problem assessment seriously reduces the confidence in changes obtained in this domain.
While there were significant improvements in all target variables, this study had several limitations. It is unclear to what extent the participants are able to sustain improvements in knowledge, attitudes and skills over time in clinical practice. For example, the analogue Functional Analytic Case Formulation provided all the key information to participants, whereas in clinical practice, clinicians would be required not only to interpret the information, but also actively gather it in the first place.
The changes reported in participant skills while promising, warrant caution. Participants only had the opportunity to demonstrate skills in a role-play, rather than in actual clinical practice. Added to this, participants were required to demonstrate Medication Alliance skills within a 15 minute timeframe, which necessarily focused their activity on Medication Alliance therapy. Finally, the interrater reliabilities, while adequate from a research perspective, were modest, suggesting the need for caution with regard to reliability. Interrater reliability could be improved by more comprehensive preparation of raters. In the present study raters received only 45 minutes of training, although they were provided with written descriptors of the skills categories.
Notwithstanding these limitations, the results obtained in this study are highly encouraging in relation to other studies. The work of Gray et al. [14] was invaluable for demonstrating that everyday clinicians can acquire adherence therapy skills such as those developed by Kemp [12]. However, Gray et al. did not evaluate interrater reliability, and while they also used role-play assessment, the participants in their study received 10 days training and ten weekly supervision sessions in which to practise the skills taught. In a 3 day program that did not have extended supervision and skills rehearsal, the results of the present study compare favourably to those of Gray et al. Furthermore, while some medication adherence training programs have included assessment of attitudinal change in clinicians [16], most do not and we could locate no studies that assessed both attitudes and skill acquisition, as was the case in the present study.
This preliminary study found that Medication Alliance obtained comparable outcomes to those of other clinician training studies. Medication Alliance also presents a significant improvement to previous training programs given the reduced training and cost demands, increasing the potential for dissemination across a wide range of mental health services. However, prior to this dissemination there is a need for second-phase research aimed at assessing both the transfer of clinician skills to clinical practice and the extent to which this leads to improvements in patient outcomes. This ‘second phase’ research is currently underway and given that therapeutic alliance is considered an essential component of Medication Alliance, a key component in the research will involve assessing the role of therapeutic alliance [43] in improving patient medication adherence.
Footnotes
Acknowledgements
We acknowledge the support and advice provided by Richard Gray and Kevin Gournay of the Institute of Psychiatry at the Maudsley (London) in the development of the Medication Alliance training program.
