Study design
We will use qualitative inquiry (36) and adopt a pragmatic approach in separate work packages using diverse methodological approaches to achieve our objectives (see Figure 1). Work package 1 will include interviews with residents and their family members/friends about their experiences, focus groups with staff and healthcare professionals about their experiences, and observations at care homes to identify the key barriers, facilitators and contextual factors from various stakeholders and different care homes (Objective 1). Work package 2 includes cognitive interviews with care home staff and healthcare professionals about current deprescribing approaches to evaluate the perceived acceptability, feasibility, and suitability of these approaches (Objective 2). Explicit feedback and rich data on existing deprescribing interventions will be gathered. Work package 3 will synthesise the findings of Work packages 1 and 2 to produce an early version of a deprescribing approach which is suitable for care homes (Objective 3).
Study setting and context
Data collection will be conducted at six care home sites of two different care home providers. These providers were approached to partner for this research as they represent contrasting models of care home provision. That is, one provider is a smaller independently-owned organisation consisting of two residential care home sites and a large organisation with 27 care homes in several locations in the South of England. Care home sites included in this study were chosen in partnership between the research team and senior care home staff and selected as they mainly provided residential care (i.e., personal care without nursing) for older adults (over 65 years old).
Participants
In this project, we will work with four groups of participants: care home residents, residents’ family and friends, and care home staff and healthcare professionals (e.g., general practitioners, nurses, and pharmacists). Purposive sampling will be used to select and recruit a wide range of experiences from the participants. Initially, the eligibility criteria will be applied to recruit participants for the different participant groups. We will then iteratively recruit participants to capture meaningful experiences within the sample.
The eligibility criteria for care home residents taking part in the research are:
- being a resident of the participating care home; age 65 and over;
- take multiple medications or experience of polypharmacy;
- ability to converse in English without an interpreter or professional assistance;
- absence of serious cognitive impairment, as identified by the care home staff or healthcare profession;
- and have capacity to consent to participation.
Residents with severe cognitive impairment which inhibits consent will be excluded from being interviewed, but their family members and carers will be included, as this group are particularly at risk of overall drug burden and often benefit from deprescribing interventions.
The eligibility criteria for care home residents’ family member or friend taking part in the study are being a family member or friend of a resident taking multiple medications at the care home participating in the study and ability to converse in English without an interpreter or professional assistance.
The eligibility criteria for care home staff and healthcare professionals participating in the focus groups and cognitive interviews will be the same. They must be currently working directly with older adults with polypharmacy and/or in the care home setting and ability to converse in English without an interpreter or professional assistance.
Ethical considerations
Ethical approval to conduct the study was given by the Social Care Research Ethics Committee (19/IEC08/0058). Participants will be informed both verbally and in writing about the aims, methods, procedures and measures performed during the study. They will be also informed about ethical issues such as confidentiality, their right to ask any questions during the study, and their right to withdraw at any time without penalty. To ensure that all participants have received proper information about the study and have agreed to participate, participants will be asked to sign a written consent form.
For the care home observations, some residents without capacity may be observed. For these residents, consent of behalf of these residents will be obtained from a designated Personal Consultee (a family member or friend) who will be identified by the senior care home staff. Personal Consultees will receive the same written information as would have been provided to their resident. If the resident does not have a family member or close friend who is able or willing to act as a Personal Consultee then a Nominated Consultee will be appointed.
We will not encourage any participants to stop or reduce their medicines or change their medicine-taking behaviour. If they wish to change their medications as a result of the discussion with the researcher, we will let the care home staff know so that the resident and the care home team can discuss this with their general practitioner and any other relevant healthcare professionals and advise them not to change anything until they have consulted a healthcare professional.
If it is observed that a resident participating in the research is getting upset or tired from taking part, we will stop the observations or interview. The researcher will inform the care home staff what happened so appropriate steps can be taken.
Patient and public involvement and partnership approach
A patient and healthcare professional partnership underpins this project. We have worked with care home residents and carers to developing the research, design this protocol, and prepare study materials. A patient/carer representative and a patient involvement facilitator are on the research team and will work together ensure full integration of patient involvement through the study. A group of care home residents will contribute to the interpretation of the study findings and development of dissemination materials and activities.
Data collection
Data collection will continue until data saturation occurs, meaning that no new ideas are being generated. The sample size was determined using previous literature on qualitative methods and purposeful sampling to select and recruit a wide range of experiences (37).
Work package 1
To identify the barriers, facilitators and contextual factors to deprescribing in care homes (Objective 1), we will conduct individual interviews, focus groups and observations in this work package.
We will conduct semi-structured individual interviews with care home residents and family members from 6 different care home sites to elicit their perceptions, problems, and experiences regarding multiple medicines and deprescribing (i.e., reducing or stopping medicines). Resident and family member interviews will be conducted separately so that participants can speak openly about their views. We will meet in a private room within the care home to accommodate functional impairments, mobility issues and frailty and for resident safety. Based on literature (22, 28, 30, 32) and CFIR, topics of discussion will include practices of medicine management in care homes; the lived experience of taking multiple medicines; attitudes and beliefs towards deprescribing. However, we will allow for flexibility in topics to pursue issues in more depth as they emerged from the interviews. We expect the interviews will last approximately an hour. Interviews will be audio-recorded and then they will be transcribed verbatim for analysis. Reflective notes will be taken after the interview.
Two focus groups will be conducted separately with both care home staff and healthcare professionals (38). Focus groups are used to analyse the specific nature of the problem, determine who is involved or affected by the problem, and how the problem is perceived from different perspectives (39). Each focus group will be attended by two members of the research team (one to facilitate discussion and one to take notes of the discussion). Before the start of the focus group, the facilitator will explain their role and the ground rules for the discussion. It will be stressed that the discussion is confidential and every opinion will be respected to encourage open discussion and the group members feel comfortable. Topics will be oriented to deprescribing in practice, and the topic guide will be informed by CFIR and previous literature (23-26, 29, 40, 41). Discussions will focus on their views and experiences with deprescribing, structures and relationships between general practitioners, other healthcare professionals, staff and residents, and the deprescribing practices already in place. This data will provide the perspectives of clinicians and other health providers on their priorities for the implementation (or non-implementation) of deprescribing It will also identify the perceived barriers, facilitators and contextual factors that they perceive as relevant. Responses will help ensure that findings are translated into meaningful recommendations for changes in approaches to deprescribing in care homes. Conflicting views and interactions between stakeholders and sites will be documented. We expect the discussion will last approximately an hour.
Observations will be conducted at each of the 6 different care home sites (2 from the smaller provider and 4 from the larger provider). To start, detailed accounts of the existing procedures and policies regarding medicines management and monitoring for each site will be collected. Care home staff will be asked to demonstrate and tell the researcher about medicines routines and administration. The researcher will ask staff to talk them through medicine-taking practices and identify what informs them. Then, informed by the practices at each site, observations of the different practices and procedures will be conducted (e.g., medication reviews, medicine administration or relevant training). Over 2-3 weeks, approximately 10 observations (lasting approximately 30 minutes to one hour) will be conducted at varying times at each care home site to capture a range of behaviours and practices. Observations will be conducted in communal areas of the care homes and only in private areas (e.g., resident’s bedroom) if the researcher is invited by the resident. Observations will be recorded using anonymised fieldnotes and a reflective diary. This method allows the opportunity to see the daily routines and experiences in context−not retrospectively−which may provide differing findings.
Work package 2
In Work package 2, explicit views about existing deprescribing approaches will be investigated, building on a better understanding of contextual factors influencing deprescribing gained from the previous work package. Cognitive interviewing is a widely used method for developing and evaluating questionnaires; it identifies thought processes behind decisions (42). It has not been used in the evaluation of deprescribing approaches and may generate fresh insight. Cognitive interviewing uses two techniques: the ‘think aloud interview’ where participant thought processes are described and ‘verbal probing’ where the investigator asks the participant direct questions, followed by questions to explore participant motivations and understanding. Probes and questions will be informed by CFIR. The method will allow for feedback and criticisms of five existing deprescribing approaches (e.g. Screening Tool of Older Person's Prescriptions or STOPP (43)), recommended by clinical and pharmaceutical colleagues and NICE guidelines. Responses will help determine whether the existing approaches are suitable in care homes and identify key components that may be missing, inappropriate or crucial for care homes. Findings will specify explicit limitations, facilitators and possible modifications for existing deprescribing approaches. We expect the interview will last approximately an hour. Responses will be audio-recorded and transcribed verbatim.
Data analysis
For Work package 1, the Framework approach (44) will be employed for thematic analysis of the interview and focus group responses as well as the observation notes. In this approach, data is sifted, charted and organised using a coding framework. This will be informed by both CFIR and unexpected themes, allowing for comparing across stakeholder groups and care homes. Any disagreements among the research team in the analysis process will be discussed and resolved. Preliminary findings will be discussed with PPI and project advisory groups to ensure that our interpretations are clinically relevant and fit for purpose. Lay summaries of the preliminary findings will be developed and sent to participants for comment.
For Work package 2, the analysis will begin with interview transcripts being subject to the first cycle of evaluative coding, assigning a judgement about the merit or significance of the approach (45). We will note the presence or absence of an attribute (e.g. shared decision-making) and how positively or negatively it was evaluated. Second cycle coding will extend the mapping of variance across the dataset, enabled by within-case and cross-case analysis (45). Findings from this analysis will determine the limitations and suitability of specific deprescribing approaches for different types of care homes. Any discrepancies among the research team will be discussed and resolved. The findings will then be mapped onto CFIR and compared with its constructs and themes. Summaries of the findings will be developed and sent to participants for comment.
The final work package will combine Work packages 1 and 2 data. Using a narrative synthesis approach (46), we will synthesise the overarching findings and identified themes and interpret them, with the aid of CFIR and PPI group input, to create detailed guidance for a deprescribing approach (Objective 3). This synthesis will identify what barriers, facilitators and contextual factors need to be addressed in the development of a deprescribing approach for care homes. We will compare findings from the individual interview and focus groups with cognitive interviews, ascertain any discrepancies between different stakeholders and types of care homes. We will determine the areas for improvement of the implementation of existing deprescribing approaches.
First, the data will be aggregated for similar themes, then it will be configured for thematically diverse findings. Facilitators and barriers to deprescribing will be listed, using established techniques (e.g. tabulation and vote counting) (46). We will consider how and why barriers, enablers and contextual factors operate from emerging relationships via conceptual mapping and triangulation. This theoretical understanding will inform guidance for further intervention development.
All data will be managed with NVivo 12 software which can manage the diverse types data collected (i.e., fieldnotes, focus group and interview transcripts) (47), and NVivo's framework matrix provides a way to summarize source materials by case (e.g. for each care home) and theme (e.g. CFIR construct).