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Testing 'VOLITION' (VOLITION)

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ClinicalTrials.gov Identifier: NCT03786315
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
University of Leeds
Information provided by (Responsible Party):
University of Exeter

Brief Summary:

Trial Design

A cluster randomised controlled feasibility trial with parallel qualitative interviews; to test a new intervention to be delivered in UK general practice.

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

6 GP practices; 18 GPs; 180 patients

Treatment duration

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

Objectives

Primary

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.

Secondary

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
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: Single (Participant)
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

Arm Intervention/treatment
Experimental: Intervention
VOLITION: Two intervention components; one targeted at patients and one at GPs.
Other: VOLITION

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. Rates of referral and investigation following the index consultation [ Time Frame: 12 weeks after index consultation. ]
    Case note review carried out by a researcher



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786315


Contacts
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Contact: Jo Butterworth, MRCGP 01392 726362 ext 6362 j.e.butterworth@exeter.ac.uk
Contact: John Campbell, FRCGP 01392 722740 ext 2740 john.campbell@exeter.ac.uk

Locations
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United Kingdom
University of Exeter Medical School
Exeter, Devon, United Kingdom, EX1 2LU
Sponsors and Collaborators
University of Exeter
National Institute for Health Research, United Kingdom
University of Leeds
Investigators
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Principal Investigator: Jo Butterworth, MRCGP University of Exeter Medical School

Publications:
Abraham, C. (2012) Designing and evaluating interventions to change health-related behaviour patterns. In I. Boultron and P.M.D. Ravaud (Eds.), Randomized Clinical Trials of Nonpharmacological Treatments. (pp. 357-368). London: Chapman and Hall.
Bartholomew, L.K., Parcel, G.S., Kok, G., Gottlieb, N.H., Fernandez, M.E. (2011) Planning health promotion programs: an intervention mapping approach. London: Willey Press.
Croker J.E. and Campbell J.L. (2009) 'Satisfaction with access to healthcare: qualitative study of rural patients and practitioners' Primary Healthcare Research & Development, vol. 10, pp. 309-319.
Department of Health (2013) Liberating the NHS: No decision about me, without me, [Online], Available: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216980/Liberating-the-NHS-No-decision-about-me-without-me-Government-response.pdf [02 Nov 2015].
Department of Health (2012) Long Term Conditions Compendium of Information: Third Edition, [Online], Available: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216528/dh_134486.pdf [02Nov 2015].
Department of Health (2011) Atlas of variation, [Online], Available: https://www.rightcare.nhs.uk/index.php/atlas/atlas-of-variation-2011 [02 Nov 2015].
Department of Health (2001) National Service Framework for Older People, [Online], Available: https://www.gov.uk/government/publications/quality-standards-for-care-services-for-older-people [02 Nov 2015].
Eldridge, S. and Kerry, S. (2012) A Practical Guide to Cluster Randomised Trials in Health Services Research, 1st Edition, New Jersey USA: Wiley.
Glaser, B.G. and Strauss, A.L. (1967) The discovery of grounded theory, Chicago, IL: Aldine.
Green, J. and Thorogood, N. (2009) Qualitative methods for health research, 2nd Edition, California USA: Sage.
Johnson, B.T., Scott-Sheldon, L.A., Carey, M.P. (2010) 'Meta-synthesis of health behaviour change meta-analyses', American Journal of Public Health [electronic], vol 100, no 11, Available: doi.org/10.2105/AJPH.2008.155200 [21 Nov 2015].
McCabe, R., et al. (2015). Shared Decision Making in Dementia: The ShareD Project, [online], Available: http://medicine.exeter.ac.uk/research/healthserv/shared/ [14 Nov 2015].
Melzer D., Tavakoly, B., Winder, R.E., Masoli, J.A.H., Henley, W.E., Ble, A., Richards, S.H. (2014) 'More medicine for the oldest old: Observational study in general practice records 2003 to 2011', Age & Ageing, [electronic] Available: doi: 10.1093/ageing/afu113 [02 Dec 2015].
Michie, S., Johnston, M., Francis, J., Hardeman, W., Eccles, M. (2008) 'From theory to intervention: mapping theoretically derived behavioural determinants to behaviour change techniques', Applied Psychology, vol. 57, no. 4, Oct, pp. 660-680.
NHS Information Centre. (2009) Trends in consultation rates in general practice 1995 to 2008: analysis of the Q Research® database [online], Available: https://catalogue.ic.nhs.uk/publications/primary-care/general-practice/tren-cons-rate-gene- prac-95-09/tren-cons-rate-gene-prac-95-09-95-08-rep.pdf [03 Nov 2015].
Pawson, R. and Tilley, M. (1997) Realistic Evaluation, London: Sage.
Richards, D.A. and Hallberg, I.R. (2015) Complex Interventions in Health. An overview of research methods. 1st edition, Abingdon UK: Routledge.
Royal College of General Practitioners (2013). The 2022 GP Compendium of Evidence, [online], Available: http://www.rcgp.org.uk/~/media/Files/Policy/A-Z-policy/The-2022-GP-Compendium-of-Evidence.ashx [20 Oct 2015].
The Cochrane Collaboration. (2011) Cochrane Handbook of Systematic Reviews, [online], Available: http://handbook.cochrane.org/ [03 Nov 2015].
The Equator Network (2015). Enhancing the QUAlity and Transparency Of health Research, [online], Available: http://www.equator-network.org/ [27-10-2015].
Wong, G., Westhorp, R., Pawson, R., Greenhalgh, T. (2013) Realist synthesis RAMESES training materials, [online], Available: http://www.ramesesproject.org/media/Realist_reviews_training_materials.pdf [24 Oct 2015].
World Health Organization (2016). Definition of an older or elderly person, [online}, Available: http://www.who.int/healthinfo/survey/ageingdefnolder/en/ [13/10/2016]
World Health Organization (1994). A declaration on the promotion of patients' rights in Europe, [online], Available: http://www.who.int/genomics/public/eu_declaration1994.pdf [03 Nov 2015].

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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03786315     History of Changes
Other Study ID Numbers: 1819/06
253014 ( Other Identifier: IRAS )
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Exeter:
Primary care
Elderly
Older age
Multimorbidity
Shared decision-making
Patient involvement