Testing 'VOLITION' (VOLITION)
|ClinicalTrials.gov Identifier: NCT03786315|
Recruitment Status : Suspended (Recruitment and site set-up on hold due to Covid-19)
First Posted : December 26, 2018
Last Update Posted : March 27, 2020
A cluster randomised controlled feasibility trial with parallel qualitative interviews; to test a new intervention to be delivered in UK general practice.
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
6 GP practices; 18 GPs; 180 patients
2 weeks (delivery of patient and GP components of intervention)
Follow up duration
12 weeks (from index consultation and initial data collection to final case note review and completion of data collection)
Planned Trial Period 01/06/20 - 30/06/21; 1 year 30 days
To feasibility test a new intervention 'VOLITION', with a view to informing the design of a fully-powered clinical trial to assess its effectiveness in routine clinical care.
The development of a new intervention 'VOLITION': To facilitate the involvement of older patients with more than one long-term health problem, in joint decision-making about their healthcare, during GP 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).
|Condition or disease||Intervention/treatment||Phase|
|Decision Making Aged Multimorbidity General Practice||Other: VOLITION||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Clusters will be defined at practice level with randomisation to usual care or to the intervention, carried out after practice recruitment. Although statistically more powerful, randomising by patient would be impractical and vulnerable to contamination. We will cluster randomise using block randomisation. Block randomisation will be stratified by site; two practices in inner city Plymouth, two practices from Exeter and two from rural Devon.
In order to reduce bias, practice randomisation on a 1:1 allocation (90 patients per arm) will be conducted using computer allocation software by an independent statistician. We will report comparisons in pre- and post-intervention data between the control and intervention groups when analysing results. The sample size if sufficient to compare standard deviations in our primary outcome between the intervention and control group.
|Masking Description:||Blinding of the research team will not be possible for the purposes of this feasibility study due to resource availability. Participants will be informed via participant information sheets that their practice will either be assigned to intervention or to control. Participants will not be informed which arm of the study their practice has been randomised to, however participants in the intervention arm are likely to be aware that they are receiving more than the standard 'usual care'.|
|Primary Purpose:||Supportive Care|
|Official Title:||Testing 'VOLITION' - a Randomised Feasibility Trial of a New Intervention: To Facilitate the inVolvement of OLder Patients With multimorbidITy in decisION-making About Their Healthcare During General Practice Consultations|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||July 2021|
VOLITION: Two intervention components; one targeted at patients and one at GPs.
The intervention will incorporate a training workshop for GPs in the use of shared decision-making surrounding an index consultation, and a written involvement-facilitating tool for patients attending an index consultation with these GPs. Evaluation will focus around the index consultation between participating patients and GPs. The intervention outcomes will be compared with 'usual care' in the control group.
A written decision-support tool may include simple bullet points prompting the patient to ask to be involved in decision-making when visiting a GP, with examples of the phrases to use. The tool will be mailed to the 'flagged' potential patient participants along with their patient information pack, ahead of the index consultation, and it will also be available in the waiting room.
No Intervention: Usual care
Usual care: GP consults with patient as per usual care.
- Observer rating of shared decision-making [ Time Frame: At two to four weeks post-index consultation. ]Two observers rate video-recorded consultations using the OPTION5 scale (Elwyn 2017), a measure of shared decision-making. Five elements of GP-patient communication are rated, the scores are summed, and converted to a percentage to provide an overall score (0-100) for each GP consultation. Higher scores indicate greater patient involvement in decision-making about their healthcare.
- Patient and GP ratings of shared decision-making [ Time Frame: Up to one week; for completion immediately after index consultation. ]Assessment of shared decision-making from both GP and patient perspectives. Questionnaires completed on the day of index consultation, immediately following the consultation. One questionnaire per patient participant, taking approximately 10 minutes to complete. Participants are asked to rate their perceptions of shared decision-making on a 5-point likert scale with higher scores indicating greater perceived involvement.
- Patient re-attendance within 28 days of the index consultation [ Time Frame: Notes reviewed at 12 weeks after index consultation (the 12 weeks allows for data entry into notes to 'settle' in order to retrieve accurate data regarding both outcomes 3 and 5) ]Case note review carried out by a researcher
- Patient enablement instrument following the index consultation [ Time Frame: Up to one week; for completion immediately after index consultation. ]Measure of patient enablement embedded in post-consultation patient questionnaire. Ratings completed following index consultations (10 minute consultation per patient participant). Questionnaires completed on the day of index consultation, immediately following the consultation. One questionnaire per patient participant, taking approximately 10 minutes to complete. Elements of patient enablement are rated on a three point likert scale with greater enablement receiving a higher score. Maximum score of 12, minimum score of 0, per consultation.
- Rates of referral and investigation following the index consultation [ Time Frame: 12 weeks after index consultation. ]Case note review carried out by a researcher
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786315
|University of Exeter Medical School|
|Exeter, Devon, United Kingdom, EX1 2LU|
|Principal Investigator:||Jo Butterworth, MRCGP||University of Exeter Medical School|