Exploring 'VOLITION' in Context - a Study to Inform the Implementation of a New Intervention

NCT03786315 | Completed

• 2 other identifiers: 1819/06253014
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Decision Making; Aged; Multimorbidity; General Practice

Keywords

Primary care; Elderly; Older age; Multimorbidity; Shared decision-making; Patient involvement

Outcome Measures

Primary Outcomes (1)

• Factors potentially influencing the future successful implementation and evaluation of VOLITION

  Questionnaire \& interviews with data integration Qualitative data Common themes from the analysis of interview data regarding the perceived impact of the changes towards remote consulting, on patients and on GPs, will be reported. Significant divergent themes will be actively sought. Data integration Interview findings will be presented in line with the purposive sampling (informed by participant questionnaire data). Findings may therefore be interpreted in the context of participant characteristics, or by consultation modality, for example. Where interview themes provide greater depth regarding findings from questionnaire items, the interpretation of these findings will be discussed in the context of existing literature and previously developed theory. Reporting will be designed with a view to informing future policy and interventions to support older people with multimorbidity during remote consultations.

  2 months

Secondary Outcomes (2)

• The current context of GP consultations for older patients with multimorbidity

  2 months

• The effect of recent changes to the context of GP consultations on perceptions of shared decision-making

  2 months

Study Arms (1)

Usual care

Older patients with multimorbidity and the GPs with whom they consult, from across five GP practices in Devon

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older patients (aged 65 and above) and the GPs that they consult with

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Exeter: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Leeds: collaborator

Study Sites (1)

University of Exeter Medical School

Exeter, Devon, EX1 2LU, United Kingdom

Location

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MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jo Butterworth, MRCGP

  University of Exeter Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: December 26, 2018
• Study Start: January 4, 2021
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)