Impacts on practice
-
Pharmacist-led consultations to discuss patients’ medication adherence and barriers to adhere to medication seem feasible.
-
The challenge remains to identify a patient group that is eligible for adherence enhancing interventions.
-
Extensive communication skills training, easy-to-use and system integrated intervention materials and sufficient time seem necessary to implement adherence enhancing interventions in daily practice.
Introduction
Aim of the study
Ethics approval
Method
Study design
Conceptual framework for implementation fidelity
Key intervention components | Research questions | Data source | Outcomes | Rating |
---|---|---|---|---|
Coverage
| ||||
In general | What proportion of selected patients were invited to participate? | I | In order to include enough patients and to reach the pre-calculated sample size, seven additional pharmacies were recruited, resulting in a total of 20 pharmacies. In total, 1338 patients from 20 pharmacies were selected with the SFK database search and invited to participate. The intended amount of 75 patients to select per pharmacy was achieved in 13 pharmacies. In other pharmacies the amount ranged from 26 to 74 patients, mainly depending on the size of the pharmacy | Moderate |
How was the selection of patients perceived by pharmacists? | IV | A considerable number of pharmacists indicated that for a few participants, the refill non-adherence was explained by missing pharmacy dispensing data. Pharmacists also indicated that the degree of participants’ intake non-adherence assessed by a self-report questionnaire was limited | Moderate | |
Was the selection procedure performed according to the study protocol? | I | The method to select patients according to the pharmacy dispensing data was adequately performed. When the information on switching drugs and hospital stays was available to the researcher could easily verify gaps in the dispensing records. The self-reported questionnaire on medication adherence was administered adequately to the patients | High | |
How was the eligibility of participants perceived by pharmacists? | IV | Some pharmacists were not sure whether certain participants were eligible for the intervention, since they did not experience substantial difficulty with their medicine intake or only used one or a few medicines. Moreover, pharmacists perceived that the degree of adherence was already quite high among selected some participants | Moderate | |
What proportion of invited patients did not respond, was not eligible or declined participation? And why? | I | Of the 1338 patients that were invited, 852 (63.7%) did not respond, 108 (8.1%) did not meet the inclusion criteria and 208 (15.5%) declined to participate. Reasons to decline participation were no interest, no time, or not considered useful | Moderate | |
What proportion of invited patients participated? And why? How was drop-out? | I, V | 170 patients (12.7%) were eligible and willing to participate, and 85 patients were randomised to the intervention group. For 53 out of 69 complete cases (76.8%), the reason to participate was finding it important to contribute to scientific research. During follow-up, 29 participants (17.1%) withdrew and five participants (2.9%) were lost to follow-up | Moderate | |
Content
| ||||
A. First consultation—barrier identification B. First consultation—information & advice C. First consultation—written summary D. Follow-up consultation | To what extent were the different components of the first consultation delivered as planned? | III, IV | For 62 out of the 75 participants (82.7%) who attended the first consultation, at least one barrier was identified by means of the QBS. For 55 out of the 62 participants (88.7%) with an identified barrier, the correct corresponding IM (including tailored information and recommendations) was selected. For most incorrect selections, the pharmacist identified a barrier with the QBS, but they did not perceive it as a specific reason for medication non-adherence and therefore decided to only provide information and no specific recommendations. For 47 out of the 75 participants (62.7%), a written summary was made at the end of the first consultation including the discussed information and advice. The content of the summaries varied; however, the content was rated as clear and extensive by the researchers for the majority of written summaries | High |
To what extent was the follow-up consultation delivered as planned? | II, IV | For the 66 participants that attended the follow-up consultation, their experiences with and implementation of information and advice in the prior period were discussed. However, objective data concerning the implementation of intervention recommendations by participants have not fully been reported. Nevertheless, it can be concluded that for at least 35 of the 66 participants (53.0%), there was an improvement or change in adherence-related beliefs or behaviour. For instance, multiple participants reported becoming more aware of the necessity of antihypertensive medication and reported less forgetting due to the use of pill boxes, reminder systems and making changes to daily habits. In addition, participants seemed more actively involved with their medicines, and in a few cases, healthy lifestyle changes were made with regard to smoking, eating and exercise behaviour | Moderate | |
Frequency and duration
| ||||
A. First consultation—barrier identification B. First consultation—information & advice C. First consultation—written summary D. Follow-up consultation | How many first and follow-up consultations were performed? | I | The first consultation was completed by 75 out of 85 intervention participants (88.2%). Ten consultations were not performed due to withdrawal of participants (n = 3) or logistic and time management problems of pharmacists (n = 7). There were 66 follow-up consultations. If a participant did not attend the first consultation, a follow-up consultation was not applicable. The number of first consultations per pharmacy varied between two and six, with an average of four first consultations per pharmacy | High |
How many times were the different components of the first consultation performed? | III, IV | On average, two barriers were identified per participant. The most often identified barriers were related to forgetfulness, side effects and perceived necessity of medication use. For 13 participants (17.3%), no clear barrier was identified with the QBS. The most frequently discussed recommendations were related to supportive medication-intake tools. For 47 out of 75 participants (62.7%), a written summary was made. Pharmacists’ most frequently mentioned reason for not making a summary was not seeing the need for it, because the amount of information was limited and the provided recommendations were simple to remember | High | |
What was the average consultation time of the first and follow-up consultation? | II | The average time of the first consultation was 36 min (range: 15 to 85 min). The average time of the follow-up consultation was 20 min (range: 5 to 45 min) | Moderate | |
How many days were there between both consultations? | I | On average, there were 94 days (range: 20 to 158 days) between the first and follow-up consultation | High |
Key intervention components | Research questions | Data source | Outcomesa,b |
---|---|---|---|
Intervention complexity
| |||
A. First consultation—barrier identification B. First consultation—information & advice C. First consultation—written summary | How detailed was the protocol description of the first consultation? | IV | The majority of pharmacists evaluated the protocol description as clear and informative. A few pharmacists indicated that the protocol description was too detailed, extensive and time-consuming to fully read in advance of the study |
How complex were the different components of the first consultation? | IV | Most pharmacists positively evaluated the intervention materials, especially the use of the flow chart. Herewith, pharmacists were able to identify barriers and were easily guided to the corresponding intervention module. A few pharmacists found it difficult to switch between asking the standardized questions of the QBS and having a normal conversation. For participants were no clear barrier could have been identified or for which the degree of non-adherence was quite limited, pharmacists indicated that it was difficult to properly use the intervention materials, since for these participants providing information and advice seemed not necessary | |
D. Follow-up consultation | How detailed was the protocol description of the follow-up consultation? | I | During the study, a few pharmacists indicated that the protocol description for the follow-up consultation was unclear. Therefore, pharmacists received additional protocol instructions prior to the execution of the follow-up consultation, including which questions to ask and what information to document |
How complex was the follow-up consultation? | IV | The pharmacists that made a written summary indicated that it was an easy way to start the follow-up consultation. Almost all pharmacists indicated that a follow-up is necessary for these kind of interventions, since it is important to monitor patients over time | |
Facilitation strategies
| |||
A. First consultation—barrier identification B. First consultation—information & advice C. First consultation—written summary D. Follow-up consultation | What were strategies to support the implementation of the first and follow-up consultation? | I | One-day training session: The majority of pharmacists (65%) followed the training session prior to the study, including an introduction in medication adherence, instructions on the study protocol and intervention materials and they practiced with patient-pharmacist role-playing. Structured protocol: at the start of the study, pharmacists received a detailed manual with information on study procedures and intervention materials. Intermediate instructions: pharmacists also received intermediate written instructions. Intensive monitoring: the researcher had extensive contact with pharmacists in order to monitor progress and meeting deadlines and to provide feedback if necessary. Incentives: pharmacists received financial compensation for every intervention participant that attended the consultations. Participants did not receive incentives |
How were these strategies perceived by the pharmacists? | I, IV | All pharmacists rated the one-day training session as useful and sufficient in terms of content and practical applicability. Only three pharmacists indicated that they wanted to practice their communication skills even more extensively. Based upon the pre-post knowledge and competences test developed by the researchers, eight of the 13 pharmacists who attended the training session (61.5%) improved their knowledge, and three pharmacists (23.1%) remained the same. Almost all pharmacists (90%) reported that their competences related to communicating with patients about medication adherence were enhanced. The majority of pharmacists evaluated the detailed protocol as informative and useful and indicated that it was helpful that there were multiple contact moments with the researcher to monitor the progress. Pharmacists appreciated the relatively small financial compensation as an incentive for the execution of the intervention | |
Quality of delivery
| |||
A. First consultation—barrier identification B. First consultation—information & advice C. First consultation—written summary D. Follow-up consultation | How was the quality of the different components of the first consultation evaluated by pharmacists? | IV | Almost all pharmacists rated the intervention materials as of good quality. They indicated that by using the QBS, they were able to identify barriers in most cases and that by means of the flow chart, the corresponding IM and recommendations were easy to select. Some pharmacists did not see the need for making a written summary at the end of the first consultation |
How was the quality of the first consultation evaluated by participants? | V | Almost all participants (59 out of 63 complete cases) agreed that the consultations were pleasant. For 39 out of 66 complete cases (59.1%) of the participants, the information and advice were helpful, and even 13 out of 66 complete cases (19.7%) of the participants indicated it was very helpful. Participants rated the first and follow-up consultation with eight points on average on a satisfaction scale from 0 to 10. Certain participants appreciated that pharmacists took enough time to discuss their medication and were convinced that the patient-provider relationship can improve by means of these consultations | |
How was the quality of the follow-up consultation evaluated by pharmacists? | IV | Most pharmacists indicated that the follow-up consultations were necessary to follow-up on participants’ implementation of the provided recommendations and also to monitor the intake behaviour in the prior period. When no clear barriers were identified during the first consultation, they indicated that a follow-up consultation was not needed and difficult to execute. Pharmacists indicated improvements of participants’ engagement to and appreciation of the pharmacy due to the personal consultations | |
How was the quality of the follow-up consultation evaluated by participants? | V | For 31 out of 63 complete cases (49.2%) of the participants, the follow-up consultation was of added value, and the majority of participants (61 out of 69 complete cases) indicated they would recommend the consultations to others. Most participants (52 out of 69 complete cases) would again ask for help from a pharmacist in case of medication-related problems in the future, whereas 14 participants would rather ask the general practitioner | |
Participant responsiveness
| |||
In general | To what extent were participants in need for help at the start of the study? | V | Only a small number of participants (20 out of 69 complete cases) indicated that they were in considerable need for help, and only a few participants (5 out of 69 complete cases) indicated that difficulties with medicine use had a substantial negative influence on their daily life |
How engaged and satisfied were participants with the intervention? | I, IV, V | The attendance rate of the first and follow-up consultation was 88.2% and 78.8%, respectively. Most missed consultations were because of time management problems of pharmacists, rather than due to lack of participant interest. According to pharmacists, the willingness of participants to engage varied. Some participants were receptive for advice and willing to seriously address the problem, while others were willing to listen but did not want to make any effort to change, did not find it necessary or useful or did not find the time to make changes. For a few participants, it became clear that they only participated to contribute to scientific research or for doing the pharmacist a favour. Most participants (52 out of 66 complete cases) reported that the consultations helped them to better cope with difficulties. In addition, the majority of the participants (48 out of 68 complete cases) rated the provided information and advice by the pharmacist as useful. About one-third of participants indicated that their knowledge was increased (28 out of 69 complete cases) and their medicine intake was improved (26 out of 69 complete cases) due to both consultations | |
How engaged and satisfied were pharmacists with the intervention? | I, IV | The majority of pharmacists were well engaged with the intervention; however, for a few pharmacists, implementation of the intervention was difficult, and frequent monitoring was needed. In one pharmacy, the pharmacist devoted the execution of the intervention to a pharmacy technician. The missed consultations were mainly because of logistic and time management problems of pharmacists. The majority of pharmacists indicated that the intervention was useful for supporting patients with adherence problems. Moreover, most pharmacists would like to perform these kind of consultations with their patients in the future. Some pharmacists indicated that it was difficult to deliver the intervention in a proper manner to participants that seemed not eligible for the intervention |
Data collection
Data from researcher
Data from pharmacists
Data from participants
Data analyses
Results
Adherence
Coverage
Content
Frequency and duration
Quick Barrier Scan | N (%)a | Corresponding IM |
---|---|---|
Do you believe you have insufficient knowledge about your disease or medicines? | 22 (35.5) | IM1 |
Do you forget to take your medicines on regular days? | 29 (46.8) | IM2 |
Do you forget to take your medicines on irregular days? | 20 (32.3) | IM2 |
Do you experience side effects of your medicines? | 23 (37.1) | IM3 |
Do you experience anxiety about developing side effects? | 4 (6.5) | IM3 |
Do you have difficulties with medicine intake due to a complex intake schedule? | 8 (12.9) | IM4 |
Do you have difficulties with opening packages or swallowing pills? | 6 (9.7) | IM4 |
Do you experience negative beliefs about medicines in general? | 11 (17.7) | IM5 |
Do you believe that the use of your prescribed medicines is not necessary? | 20 (32.3) | IM5 |
Do you believe that your prescribed medicines are not effective or that the disadvantages of your medicines outweigh the advantages? | 9 (14.5) | IM5 |
Do you not quite so much still enjoy the things you used to enjoy? | 6 (9.7) | IM5 |
Intervention module | Recommendations for participants to overcome barriers | Na,b |
---|---|---|
IM1 | Visit preselected informative websites on hypertension or adequate medicine intake | 8 |
IM1 | Read provided information leaflets on hypertension or adequate medicine intake | 13 |
IM1 | Get additional information or support from other health care providers | 6 |
IM2 | Try to connect medicine intake to daily habits, e.g. brushing teeth, coffee break | 25 |
IM2 | Ask for support with medicine intake from friends or family | 6 |
IM2 | Try out the adjusted schedule of medicine intake | 4 |
IM2 | Purchase a pill box to organise and store multiple medicines | 12 |
IM2 | Use a reminder system to prevent forgetting | 11 |
IM2 | Download a smartphone application as a reminder or supportive tool | 15 |
IM2 | Register for the pharmacy dispensing service: pill packaging | 4 |
IM2 | Register for the pharmacy dispensing service: repeat dispensing | 21 |
IM2 | Permit the pharmacist to contact GP for medication review if desired | 3 |
IM3 | Try to weigh out disadvantages of side effects with advantages as discussed with pharmacist | 17 |
IM3 | Permit the pharmacist to contact GP for medication review if desired | 8 |
IM4 | Try out the adjusted schedule of medicine intake | 3 |
IM4 | Try out the instructions on how to open packages or how to press through pills | 1 |
IM5 | Try to weigh out disadvantages of medicines in general with advantages as discussed with pharmacist | 2 |
IM5 | Try to weigh out disadvantages of prescribed medicines with advantages as discussed with pharmacist | 3 |
IM5 | Permit the pharmacist to contact GP to discuss potential depressive symptoms | 1 |