Background
Methods
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Stage 1: selecting delivery mechanisms. We aimed to create an adaptable implementation package based upon resources typically available within primary care. Commonly used delivery mechanisms known to be effective [1] were selected by the intervention development team: audit and feedback [8], educational outreach [11] and computerised prompts and reminders [10]. We aimed to embed evidence-based features known to increase their impact, e.g. repeated feedback of audit data, the requirement for users to select a reason for over-riding a computerised prompt [8, 10].
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Stage 2: identifying candidate BCTs. We aimed to enhance selected delivery mechanism effects by embedding BCTs (e.g. ‘feedback on behaviour’ or ‘action planning’ [23]). Team members with experience of applying behavioural theories to implementation strategies (LG, RL, RM and RF) independently mapped the 12 determinants from the TDF [34] to one or more of the 16 broad BCT categories and then to individual BCTs using an electronic spreadsheet. Results were collated and any BCT category nominated by three or more researchers was considered eligible. The team discussed discrepancies until consensus was agreed. We aimed to generate an inclusive list of ‘candidate’ change techniques. A matrix was produced to indicate BCTs with the potential to target one or more theoretical determinants.
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Stage 3: identifying and prioritising relevant theoretical determinants of behaviour. We have earlier described the methods and findings of interviews with primary care clinicians and managers to explore determinants of adherence [35]. Given the timeframe required to analyse and compare four substantial sets of interview data, emerging interview findings (themes and illustrative quotes) based on interviewer field notes and exploration of frequency data were compiled for each indicator. We convened a series of multi-disciplinary stakeholder panel meetings, one for each quality indicator. The intervention development team used their previous knowledge to identify stakeholders involved in achieving each quality indicator. We invited five to ten stakeholders representing clinicians (general practitioners, practice nurses, pharmacists), practice managers, quality improvement specialists and service commissioners. All invited stakeholders were willing to participate in the consensus process. We presented them with emerging interview analyses [35] (frequency data and illustrative quotes for each determinant of achievement). After reviewing the range of determinants, stakeholders were asked to suggest additional professional or organisational determinants and contextualise our findings. Candidate BCTs (identified during the mapping exercise in stage 2) and messages which could be framed were reviewed for potential fit within the organisational context of primary care and feasibility of operationalisation within the different delivery mechanisms. Evidence-based intervention features were discussed to explore their acceptability prior to implementation. Field notes were used to record discussion points. We simultaneously convened a parallel group of nine patient and public representatives and followed similar methods. The research team communicated key messages from one panel to another. Suggestions from both groups were reviewed by the intervention development team, including social scientists and clinicians, to maximise acceptability and feasibility.
Title and abstract | ||
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S1 | Title | Indicate qualitative approach ‘A prospective directed content analysis’ p1. |
S2 | Abstract | Abstract includes background, purpose, methods, results and conclusions p2/3. |
Introduction | ||
S3 | Problem formulation | Significance of the problem studied p3, relevant theory p4, and empirical work p3/4. |
S4 | Purpose or research question | Specific research objectives and research questions p4/5. |
Methods | ||
S5 | Qualitative approach and research paradigm | Multi-method qualitative approach (individual semi-structured interviews, observation, consensus panel work and a directed content analysis) informed by psychological theory p5, adopting an interpretivist stance p5. |
S6 | Researcher characteristics and reflexivity | Researcher personal attributes, qualifications/experience p5& 7, and relationship with participants’ p7. |
S7 | Context | Setting and salient contextual features p5. |
S8 | Sampling strategy | How and why research participants’ p7 and p8 selected and rationale for no further sampling p8. |
S9 | Ethical issues pertaining to human subjects | Review p7, consent p7 and data security issues N/A. |
S10 | Data collection methods | Types of data collected p7/8, data collection procedures (start/stop dates, analysis plan and any modifications p7/8). |
S11 | Data collection instruments and technologies | Instruments (guides/questionnaires N/A opportunistic conversations) and devices (audio recorders N/A field notes taken). |
S12 | Units of study | Number and relevant characteristics of participants p7/8, documents N/A or events N/A. |
S13 | Data processing | Methods prior to and during analysis (transcription N/A, data entry N/A, data management (see methods for different stages). |
S14 | Data analysis | Process inferences, themes identified and developed (reported in separate paper), who involved p7/8. |
S15 | Techniques to enhance trustworthiness | Rationale for member checking (not done), audit trail p7/8, triangulation N/A. |
Results/Findings | ||
S16 | Synthesis and interpretation | Main findings and integration with prior research or theory p10-end. |
S17 | Links to empirical data | |
Discussion | ||
S18 | Integration with prior work, implications, transferability and contribution(s) to the field | Main findings p8, how they challenge, support or elaborate on earlier scholarship p10-end. Scope of application/generalizability p10. Identification of unique contribution to scholarship p10-end. |
S19 | Limitations | Trustworthiness and limitations p11 of findings. |
Other | ||
S20 | Conflicts of interest | Perceived influences and how managed p16. |
S21 | Funding | Source of funding and role of funders in data collection, interpretation and reporting p16. |
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Stage 4: designing intervention content. We created a prototype outline for each delivery mechanism (feedback report, educational outreach session and computerised prompts and reminders) including features known to enhance effectiveness [10, 16] and findings from stages 1 to 3. Computerised prompts were not developed for diabetes or blood pressure control because they were already widely used. Stakeholders also suggested patient-directed checklists to guide discussions around diabetes and blood pressure control respectively. We then embedded candidate BCTs (stage 2) that could target modifiable determinants of adherence (stage 3). Using contextual data from interviews, the prototype was adapted and tailored for each quality indicator. We used the vocabulary and experiences expressed in interviews with health care professionals and stakeholder panellists to tailor BCT content within delivery mechanisms. A graphic designer enhanced the final intervention template. All prototypes were reviewed by the intervention development group for feasibility and acceptability prior to piloting.
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Stage 5: piloting intervention content and refinement. We piloted each delivery mechanism for all quality indicators with five consenting general practices involved in our earlier interview study [35]. Brief opportunistic semi-structured interviews were conducted by EI a social scientist researcher, previously unknown to the practice. She directly observed the delivery of each educational outreach session. Feedback reports, patient-directed checklists and protocols for computerised prompts were presented as written documents. She conducted brief, opportunistic semi-structured interviews with relevant practice staff (six GPs, two practice managers and three practice nurses). Participants commented on the acceptability and feasibility of prototype delivery mechanisms. Field notes were taken and reviewed by the intervention development team, leading to refinements of the first feedback report template. Participants were not asked to comment on the presence or absence of BCTs. The impact of BCTs on hypothesised determinants was not explored when piloting interventions.
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Stage 6: verification of BCTs included within implementation packages. Three trained coders (LG, RL and KG-B) applied the BCT Taxonomy version 1 in two stages to identify intended and verified BCTs [23]. First, two members of the intervention development team (LG and RL) assessed which BCTs were included in a sample of delivery mechanisms (feedback reports, educational outreach visit plan for one quality indicator) to identify intended content. A directed content analysis exploring the consistency of identification was completed by a researcher external to the intervention development team (KG-B) [37]. All implementation package delivery mechanisms were coded to one or more BCTs independently by LG and KG-B. Discrepancies were noted and decisions made about sufficient evidence to verify inclusion. We then examined the extent to which BCT content was shared across (or unique to) the adapted implementation package and different delivery mechanisms.
Ethics
Results
Layered identification of theoretical determinants | Capability | Opportunity | Motivation | Other | |||||||
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Physical | Psychological | Social | Physical | Reflective | Automatic | ||||||
Skills | Knowledge | Memory | Behavioural regulation | Social influences | Environmental context | Beliefs about capabilities | Beliefs about consequences | Social professional role | Emotion | Patient factors | |
1. Interviewer consensus | AF | All | BP RP DC | DC | AF BP DC | BP RP DC | BP RP | All | AF RP DC | All | |
2. Emerging interview finding (most frequently cited determinant) | BP | All | AF RP DC | All | AF BP DO | DC | All | All | All | ||
3. Consensus panel of clinical and patient stakeholders | DC | DC | |||||||||
4. Extended qualitative analysis of interview data | AF RP DO | AF RP | AF | BP DC | All | All | All | All | |||
Combined analysis | AF BP DC | All | AF RP DC | All | All | All | BP RP DC | All | All | AF RP DC | All |
Potential behaviour change technique (BCT) categories [23] ordered by likelihood of targeting core, prominent and less-evident determinants | Importance of determinant | ||||||||||
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Core to all indicators | Prominent across indicators | Less evident | Not identified | ||||||||
Environmental context | Social professional role | Knowledge | Memory | Social influences | Beliefs about consequences | Skills | Beliefs about capabilities | Motivation and goals | Emotion | Behavioural regulation | |
Social support | ● | ● | ● | ● | ● | ||||||
Antecedents | ● | ● | ● | ||||||||
Comparison of behaviour | ● | ● | ● | ● | ● | ● | ● | ||||
Feedback and monitoring | ● | ● | ● | ● | ● | ● | |||||
Identity | ● | ● | |||||||||
Covert learning | ● | ● | |||||||||
Comparison of outcomes | ● | ● | ● | ● | |||||||
Natural consequences | ● | ● | ● | ● | |||||||
Shaping knowledge | ● | ● | |||||||||
Goals and planning | ● | ● | ● | ● | |||||||
Repetition and substitution | ● | ● | ● | ● | |||||||
Associations | ● | ● | ● | ● | |||||||
Regulation | ● | ● | ● | ||||||||
Reward and threat | ● | ● | |||||||||
Self-belief | ● | ||||||||||
Scheduled consequences | ● | ● | |||||||||
Number of potentially relevant BCT categories | 2 | 5 | 4 | 6 | 4 | 3 | 3 | 6 | 8 | 7 | 7 |
Audit and feedback | Educational outreach (supplemented by audit and feedback) | Computerised prompts and paper-based reminders | |
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Rationale | We aimed to develop an adaptable implementation package which can be implemented within existing primary care systems and resources and adapted to specifically target barriers to change for four quality indicators. | ||
Control interventions | Both control and intervention practices will be exposed to standard practice quality improvement initiatives e.g. national guidelines and financial incentives. | ||
Materials and training |
Practice-specific quarterly audit reports
Each report contained a comparison of the practices’ behaviour or outcomes in relation to the other participating practices within their locality (i.e. their Clinical Commissioning Group responsible for commissioning services) and all participating practices across West Yorkshire to reflect on progress and to prompt the need for change. Information on clinical recommendations and potential change strategies were provided. Consequences of inaction were described. Practices were encouraged to set goals based on graded tasks (based on the number of clinical recommendations and number of patients to be targeted within each recommendation) and use an action planning template to detail who would do what; in what circumstances; and how and when the achievement would be reviewed. Subsequent reports included potential actions identified during outreach sessions.
Computerised searches
Searches could be included in the practice’s Clinical Information System (CIS) to systematically identify all patients whose care should be reviewed and facilitate repeat searching.
Short and longer significant event audit (SEA) templates
Short and longer forms were developed for risky prescribing and anticoagulation for AF indicators to facilitate root cause analyses and action planning from harmful events or near misses. | We commissioned for and recruited experienced Pharmacist facilitators who received 2 days training aimed to increase motivation, prompt individual and group reflection, increase confidence and intention to act. For each outreach visit, a practice-specific outreach pack was developed containing: the most recent (and all previous) audit report(s); a session outline; an action plan template that included space for noting current performance, setting a target, identifying who will do what and review date; and templates for assessing costs and benefits. We did not articulate the discrepancy or specifically request that the team did so and although it is possible that the team might do this, they might also explain the lack of achievement away in other ways and not those related to behaviours. As we can only infer that this technique was deployed we did not code for it. Training in BCT coding requires that inferences are not made. | For risky prescribing nine computerised prompts were developed to be triggered within the consultation and during repeat prescribing on the basis of a clinical code algorithm for age/diagnosis/drug and duration. When triggered a brief message notified that the patient was at risk and presented one sentence of evidence-based risk (e.g. ‘This patient has CKD. NSAID use accounts for an estimated 15% of all cases of acute renal failure and 36% of drug-induced cases’). A one-click justification was required (e.g. continue with risk, add medication, or stop medication). Two prompts were developed for anticoagulation for AF but could not be made available within the study timelines.
Patient-directed checklists
Checklists were developed to facilitate shared decision making for managing blood pressure and diabetes outcomes but could not be made available within the study timelines so were not included in the directed content analysis. Paper-based reminders in the form of laminated information sheets were created to convey key clinical information (blood pressure, risky prescribing and anticoagulation for AF). Pens and post-it notes were sent to all practices with a topic specific reminder to prompt behaviour. |
Supportive activities | None. | Pharmacist training included a one-day face-to-face meeting with intervention developers focussing on goal setting, action planning, clinical barriers, and persuasive communication. This was followed by a half day of independent study using a folder of supporting documentation relevant to each clinical priority. The first outreach meeting of each facilitator was observed by an experienced facilitator and feedback was given. | None. |
Intervention provider | Reports, searches and templates were created by the research team. | Professional outreach education company. | Reminders were created. |
Mode of delivery | Reports were sent by post and e-mail. Practices were sent invitations to use computerised searches from a task from within their clinical information system. An email was sent from the ASPIRE team to the practice manager and colleagues introducing SEA templates. | Face-to-face sessions were offered to practices. | Practices were sent invitations to use computerised prompts from a task within their clinical information system. An email was also sent from the ASPIRE team to the practice manager and colleagues alerting them to option to accept the prompts into their CIS. |
Schedule and intensity | Quarterly feedback reports. Practices were offered access to searches and SEA templates at the beginning of the study and reminded of their availability via quarterly feedback reports. | Practices were offered an initial 30-min session. All practice staff involved in identifying/reviewing appropriate patients were invited to attend. A key clinical contact was identified to support practice engagement. Initial visits focussed on practice achievement data (from audit reports), identifying models of good practice, addressing barriers to change and creating an action plan to facilitate and review the change. Two days of pharmacist provision was offered to support patient identification and review. An additional follow-up visit was offered to review action plan progress and supportthe practice to create more challenging or attainable plans. | Practices were offered access to prompts at the beginning of the study and reminded of their availability via quarterly feedback reports. Practices were offered access to checklists at the beginning of the study and reminded of their availability via quarterly feedback reports. Post-it notes and pens were sent to all practices. |
Tailoring | Searches could be tailored by practices, allowing them to identify patients relevant to all or individual recommendations, or adjust target values to select specific groups of patients. | Session content could be modified to practice requirements. | Prompts could be copied and modified to practice requirements. |
Modifications | None. | ||
Fidelity of delivery, receipt and enactment | Will be assessed in the subsequent process evaluation. |
Behaviour change techniques (BCTs) for changing determinants of behaviour [35] | BCTs excluded because of delivery mechanism or contextual constraints (BCT taxonomy code reference [23]) | BCTs intended but not subsequently identified by independent coder | |
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Relevant determinants | |||
Core determinants ‘environmental context’ and ‘social and professional role’. | Social support | Social support emotional (3.3) | |
Antecedents | Avoidance/reducing exposure to cues for the behaviour (12.3) Distraction (12.4) Body changes (12.6) | ||
Comparison of behaviour | Demonstration of the behaviour (6.1) | ||
Feedback and monitoring | Monitoring of behaviour by others without feedback (2.1) Monitoring of outcomes of behaviour without feedback (2.5) Biofeedback (2.6) | ||
Identity | Incompatible beliefs (13.3) Valued self-identity (13.4) Identity associated with changed behaviour (13.5) | Identification of self as role model (13.1) | |
Covert learning | Imaginary punishment (16.1) Imaginary reward (16.2) | ||
Prominent determinants ‘knowledge’, ‘memory’, ‘social influences’ and ‘beliefs about consequences’. | Comparison of outcomes | Comparative imagining of future outcomes (9.3) | |
Natural consequences | Monitoring of emotional consequences (5.4) Information about emotional consequences (5.6) | Anticipated regret (5.5) | |
Shaping knowledge | Behavioural experiments (4.4) | ||
Goals and planning | Discrepancy between current behaviour and goal (1.6) | ||
Repetition and substitution | Behavioural practice/rehearsal (8.1) Behaviour substitution (8.2) Habit reversal (8.4) Overcorrection (8.5) Generalisation of target behaviour (8.6) | ||
Associations | Cue signalling reward (7.2) Reduce prompts/cues (7.3) Remove access to the reward (7.4) Remove aversive stimulus (7.5) Satiation (7.6) Exposure(7.7) Associative learning (7.8) | ||
Regulation | Pharmacological support (11.1) Reduce negative emotions (11.2) Paradoxical instructions (11.4) | ||
Reward and threat | Material incentive (behaviour) (10.1) Material reward (behaviour) (10.2) Non-specific reward (10.3) Social incentive (10.5) Non-specific incentive (10.6) Self-incentive (10.7) Incentive (outcome) (10.8) Self-reward (10.9) Reward (outcome) (10.10) Future punishment (10.11) | ||
Less-evident determinants ‘self-belief’ and ‘scheduled consequences’ | Self-belief | Mental rehearsal of successful performance (15.2) Self-talk (15.4) | Verbal persuasion about capability (15.1) |
Scheduled consequences | Behavioural cost (14.1) Punishment (14.2) Remove reward (14.3) Reward approximation (14.4) Rewarding completion (14.5) Situation-specific reward (14.6) Reward incompatible behaviour (14.7) Reward alternative behaviour (14.8) Reduce reward frequency (14.9) Remove punishment (14.10) |