Clinical trial NCT03786315: Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention
Official title: Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decision Making
Aged
Multimorbidity
General Practice
Keywords: Primary care
Elderly
Older age
Multimorbidity
Shared decision-making
Patient involvement
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: University of Leeds
First posted: 2018-12-26
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients (aged 65 and above) and the GPs that they consult with

Brief summary: Trial Design

A mixed-methods sequential explanatory approach in general practices, using quantitative questionnaire data followed by qualitative interviews.

Trial Participants

Patients aged 65 years and above with more than one long-term health problem (multimorbidity); and the GPs that these patients consult with.

Planned Sample Size

5 GP practices; 15 GPs; 150 patients

Planned study period:

01/01/21 - 30/12/21; 1 year

Objectives

Primary

To establish the determinants of adoption, implementation and maintenance of the critical, core components of the VOLITION intervention, designed to be embedded within GP consultations, and to determine those components of VOLITION that can be tailored to ensure that the intervention is modifiable in context.

Secondary

To describe the current context of GP consultations for older patients with multimorbidity in England, including current innovations, in light of recent organisational changes as a result of the COVID-19 pandemic.

To describe the effect of recent changes to the context of GP consultations (towards remote consulting) on patients' and GPs' perceptions of shared decision-making To investigate factors which could potentially influence the successful implementation of interventions such as VOLITION in the context of remote vs. face-to-face consultations.

The Intervention 'VOLITION':

* half-day training workshop for GPs in shared decision-making
* written involvement-facilitating tool for patients (delivered by post and available in the waiting room).

Detailed description: 1 BACKGROUND

The VOLITION intervention was developed to facilitate the involvement of older people with multimorbidity in clinical decision-making during general practice consultations.The overarching project follows the Intervention Mapping framework as a means of systematically applying existing literature and relevant theory to each step of intervention development and evaluation.

There are two core intervention components:

* A patient tool, in the form of a leaflet, to facilitate patients to convey their preferences for involvement to the GP
* A workshop for GPs, to train them in shared decision-making orientated communication skills, delivered in the context of the challenges facing GPs when consulting with this patient group

To enable transparency and sustainability in complex intervention development it is important to theorise the context in which intervention mechanisms will work. Further research is required to determine the factors affecting the incorporation of patients' priorities and preferences during clinical decision-making in the context of remote GP consultations for older people with multimorbidity. This study will inform the final iteration of 'VOLITION' ahead of testing the intervention in a randomised controlled pilot study.

3 OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS

The aim of this study is:

To establish the determinants for future adoption, implementation and maintenance of the VOLITION intervention, and to determine those components of VOLITION that can be tailored to ensure that the intervention is modifiable in context.

To describe the current modalities of GP consultations for older patients with multimorbidity in England, including any existing innovations to improve quality and access to GP consultations for this patient group, in light of recent organisational changes as a result of the COVID-19 pandemic.

To describe the effect of recent changes to the modality of GP consultations (towards remote consulting) on patients' and GPs' perceptions of shared decision-making.

To investigate factors which could potentially influence the future implementation and evaluation of VOLITION in the context of remote vs. face-to-face consultations.

4 STUDY DESIGN

A mixed methods sequential explanatory study undertaken in UK general practices. Quantitative questionnaire data will be collected first. Qualitative interview data will then be used to explain, build, and elaborate on the quantitative findings by exploring participants' views in more depth. Questionnaire data will inform the purposive selection of patient participants. The quantitative and qualitative phases are therefore connected in the intermediate stage of the study, prior to the interpretation of the combined findings.

5 STUDY SETTING

Five GP practices will be recruited from Devon, UK. Recruitment of local practices will be prioritised in order to reduce travel expenses for the research team and with the aim of shortening the recruitment period. However, to obtain sociodemographic diversity in the participant sample, practices will be recruited from both rural and urban areas.

A minimum practice size of 3,000 patients will ensure sufficient numbers of eligible participants. (It is anticipated that there will be approximately 800 older patients with multimorbidity in an average 8,000 patient practice.

7 STUDY PROCEDURES

7.1 Sampling

An average of three (total = 15 GPs), and at least 2, GPs per practice will be recruited. Patients aged 65 and above with known multimorbidity, defined as the presence of two or more long-term conditions, will be approached.

Patient participants will be identified using an automated practice database search strategy designed by the research team. Recruited GPs will use this 'flag' to identify ten consecutive potential participants from their working schedule. Random sampling of patients is not required as the clinical presentations, and therefore the nature of the decision-making between consecutive consultations, is expected to be random. A total of 150 (minimum 100) potential patients will be identified across five practices, with the aim of obtaining data from at least half of these patients.

The sample size is sufficient to allow for the estimation of standard deviations for the clinical outcome measures being tested and to tentatively report between-group differences in outcomes by mode of consultation (e.g. face-to-face vs. remote). It is also sufficient to obtain a purposively selected sub-sample of participants for qualitative interviews.

7.2 Recruitment

Drop-out and loss to follow-up will be taken into account at patient, GP or practice level by over-recruiting. Practices will receive an email followed by telephone correspondence inviting their participation. Practice recruitment will be dependent on an expression of interest from at least two of their GPs. Practices will be incentivised through payment for local coordination, set-up, and for GPs' time and workload. Payments were determined by advisors from the South West Clinical Research Network.

For each recruited GP, ten potential patient participants with consecutive GP contacts, for any mode of consultation (telephone, video, eConsult or face-to-face), will be screened by GPs using pre-specified eligibility criteria (see eligibility form) at the time of consultation. Eligibility data will be collected anonymously. If eligible, GPs will label patient packs to be sent by post following the consultation. Eligible patients will receive a cover letter, participant information sheet\* and a post-consultation questionnaire with a pre-paid envelope for return to the research team. Using the questionnaire, patients will indicate their consent to be contacted for a subsequent telephone interview with the researcher and they will be asked to provide their contact information. Patients who do not wish to participate will not be expected to return their questionnaire. All recruited GPs will also be asked to complete a post-consultation questionnaire and to participate in a telephone interview.

7.3 Consent

Written consent from GPs will be obtained at the time of practice recruitment. Consent to identify and approach potential patient participants will be obtained from the practice manager. Consent from patients, to use their questionnaire data, will be confirmed by return of questionnaires and patients will be advised of this using the Participant Information Sheet. Written consent will be obtained prior to telephone interviews, informed by an interim telephone call to clarify procedures and to answer participant's questions, by return of consent forms in pre-paid envelopes. Verbal consent will also be confirmed before commencing interviews. If stated, reasons for declining to participate in interviews will be recorded anonymously. Identifiable data will not be accessed without prior patient consent.

7.4 Baseline data

Practice level data (list size, location and deprivation, practice size, staffing, rural/urban) and GP participant data (age, gender, ethnicity and time since qualification) will be collected at the time of recruitment. Information will be requested from practices regarding whether, and how, they have identified, or addressed, the potential for inequality in experience of remote consultations for the patient group of interest.

Data will be obtained at practice level regarding the mode (phone, video, eConsult or face-to-face) and relative frequency of consultations with older patients with multimorbidity. A template will be provided to GP surgeries in order to collect and compare data regarding each practice's interpretation and delivery of remote vs. face-to-face consulting and how GPs' workload is being managed in respect of these. Data will be obtained from GPs, at the time of recruitment, regarding their preferences for the different consultation modalities when consulting with older patients with multimorbidity.

Patient demographics (age, gender and ethnicity) and health status data will be collected via self-report using post-consultation questionnaires. An electronic frailty index score, for each patient where applicable, will be obtained from GPs on post-consultation questionnaires.

7.5 Study assessments

Quantitative outcome measure data

The General Practice Patient Survey (GPPS) uses five-point Likert scales. A subset of these are appropriate for evaluation of Patient Reported Outcome Measures (PROMs) on the post-consultation patient questionnaires. PROMs will be used to collect data on patients' preferences for involvement in decision-making, the extent to which patients felt engaged in decision-making, the patient's preferred mode of consultation and whether they obtained this, their satisfaction with the care received, whether they felt they were given enough time, and a measure of patient enablement.

A post-consultation questionnaire for GPs will collect data regarding the mode and approximate duration (using a scale) of consultation and GPs' ratings of the extent to which they felt they involved the patient in decision-making.

Qualitative interview data

Following receipt and initial analysis of post-consultation participant questionnaires, twenty patients will be sampled and twice this number will be approached. Patients will be selected purposively and iteratively, using questionnaire data to ensure heterogeneity by age, sociodemographic characteristics and health status, and also by mode of consultation received, preferences for and experiences of shared decision-making. Patients will be contacted by telephone to arrange an interview. All participating GPs (n = 10-15) will be invited by email. The sample size will be reviewed when assessing thematic saturation.

Semi-structured telephone interviews will be aided by a topic guide and will be digitally audio recorded, transcribed and supported by field notes. Following initial open discussion, the topic guide will encourage participants to discuss the reasoning behind their questionnaire responses. For example, participants may be prompted to discuss their ratings of shared decision-making, or their preferences for a particular consultation modality, in greater depth. The intervention will be described to participants (see topic guide in Appendix) at a suitable mid-point during telephone interviews, in order to stimulate discussion regarding factors that could potentially affect the implementation of VOLITION. Participants will be prompted to discuss these factors in the context of different consultation modalities and in light of ongoing social distancing measures in the UK. Intervention materials will not be posted to patients in advance of interviews so as to avoid the influence of materials on the earlier interview dialogue. Participants will be encouraged to discuss their own ideas in order to collect fresh data without the influence of the researcher. Audio recordings of participant interviews will be coded using Nvivo computer software.

Mixed methods

Data analysis will take a sequential-explanatory approach .The quantitative questionnaire data and subsequent analysis (see details below) will provide a general understanding of participants' perspectives on the research problem. The qualitative data and their analysis will refine and explain the statistical results by exploring purposively selected participants' views in more depth. Interpretation of interviews will combine both deductive and inductive methods to investigate whether the theory developed earlier in the project holds, but also being open to new data and emerging themes. The concept of thematic saturation will be applied and negative cases will be actively sought. The consistency with which the coding is applied will be assessed on a fifth of the data.

Eligibility criteria: Inclusion criteria:

* GP practice located in Devon, UK
* GP participants must be permanent practice employees
* Patient participants must be aged 65 and above with multimorbidity

Exclusion criteria:

* Previous participation in the focus group study to refine the intervention
* Locum GPs
* Trainee GPs and junior doctors working in general practice
* Temporarily registered patients
* Vulnerable patients (as screened by usual GP)

Primary outcomes:
measure: Factors potentially influencing the future successful implementation and evaluation of VOLITION
timeFrame: 2 months
Secondary outcomes:
measure: The current context of GP consultations for older patients with multimorbidity
timeFrame: 2 months
measure: The effect of recent changes to the context of GP consultations on perceptions of shared decision-making
timeFrame: 2 months
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter Medical School
state: Devon
Study officials:
affiliation: University of Exeter Medical School
name: Jo Butterworth, MRCGP
role: PRINCIPAL_INVESTIGATOR
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