Expert Think tank overview Introduction to MORECare Capacity and - - PowerPoint PPT Presentation

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MORECare Capacity - Mental capacity

and processes of consent for research on end-

• f-life care

Expert Think-Tank

Dr Catherine Evans NIHR Clinical Lecturer Palliative Care Clinical Nurse Specialist Sussex Community NHS Trust On behalf of MORECare Capacity

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• Introduction to MORECare Capacity and

MORECare

• Debate three areas to provide solutions and

guidance on best research practice

• Format of brief presentation (whole group),

structured group work (two groups) and feedback (whole group)

Expert Think–tank overview

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www.csi.kcl.ac.uk

MORECare Capacity

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• MORECare Capacity came to life as the

daughter of MORECare –Methods of research and evaluating end of life care (funder: MRC/NIHR)

• MORECare provided much needed

guidance on developing and evaluating services and treatments in palliative and end

• f life care (Higginson et al 2013 BMC Medicine)
• MORECare Capacity intended to provide

more detailed examination on capacity and consent

MORECare

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• A major barrier to improving the evidence

base on EoLC is how to include people near to death and their families in research studies that aim to innovate and test better treatments and models of care.

• It is essential to include those at the end of

life if we are to understand how to provide the best care and treatment

Why is this important?

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Why is research on end-of-life care important?

Science is not for the sake of piling up miscellaneous information or curious facts, but for the sake of saving life and increasing health and comfort (Florence Nightingale)

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Expert ‘think tank’ workshop to debate areas of contention or uncertainty identified in the preliminary synthesis and critically discuss proposed solutions Preliminary synthesis of the research findings compiled as the 1st draft of the methods guidance on processes of consent for adults lacking capacity Final synthesis of the research findings published as methods guidance on processes of consent for adults lacking capacity. Guidance publication and disseminated Systematic literature appraisal asking ‘What solutions to processes of consent have research studies incorporated to enable the inclusion of individuals with declining mental capacity?’ Consensus exercise: a face-to-face consultation with stakeholders (e.g. research ethics committee members) on needs and views to involving ALC in research using Nominal Group to generate recommendations, then an online consensus survey to ascertain level of agreement and identify areas of contention/uncertainty. Electronic survey to national and international leading academics on best practice to involve adults lacking capacity (ALC) in research, particularly participants towards the end of life

MORECare Capacity:research methods

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MORECare Capacity is funded by Marie Curie Cancer Care. PI: Catherine Evans and Joint PI Irene J

• Higginson. Co-investigators – Matthew

Hotopf, Jonathan Koffman, Penney Lewis, Bee Wee, William Bernal; Project Advisory Group – Deb Tanner, Claire Henry, Gunn Grande, Steve Dewar, Gareth Owen, Rachel Burman, Dimitrios Adamis, Michael Dunn, Scott Kim, Simon Woods. Researchers – Katie Stone and Rowena Vohora

MORECare Capacity Team

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• 1. To present and debate the contentious

issues from the consensus exercise and systematic literature appraisal on how best to include individuals near to death in research on end-of-life care

• 2. To help understand the narrative and

debates underpinning the main areas of contention or uncertainty

Think-Tank aims….

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• 1. The involvement of consultees in the

consent process

• 2. Training and education on consent and

ethical considerations; the challenges and solutions

• 3. Legislative frameworks; incorporation into

practice and limitations

Three main areas of contention

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• Generated 29 recommendations, online scoring on

level of agreement (1-9, low to high)

• Contention/Uncertainty indicated by:
• 1. Average score (median) between:

– 4-6 recommendation equivocal – 1-3 recommendation not indicated – 7-9 recommendation indicated

• 2. Score spread (inter-quartile range IQR)

– IQR in any three-point range broad agreement – IQR in one region strict agreement for recommendation

(Jones and Hunter 1999)

Contention/uncertainty

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The involvement of consultees in the consent process

Area 1

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Adults lacking capacity

• A person is unable to make a decision for himself if

he has impairment of, or disturbance to, the mind or the brain (long-term condition e.g. Dementia or temporary loss e.g. Emergency medicine).

• Assessment of capacity: decision-specific AND time

specific

 Understand the information related to the decision  Retain the information (even if for a short time)  Use or weigh the information  Communicate decision (by any means)

• Preparations for losing capacity e.g. Lasting Power
• f Attorney

Mental Capacity Act 2005

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Adults lacking capacity- Online toolkit https://connect.le.ac.uk/alctoolkit

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The findings from our research highlighted the involvement of consultees as an area of contention leaving the research team with a central question: How can we enable consultees’ involvement as surrogate decision makers for adults lacking capacity in research on end-of-life care in ways that minimise the burden of participation?

Involvement of consultees; an area of greatest contention/uncertainty

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Rec ecomm mmend endatio ation n 27: Estab abli lishmen hment t of a nationally tionally recognised gnised body dy that at prov

• vides

ides support pport and d informa

• rmati

tion

• n to family

mily members bers and d carers rers acti ting g as consult ltee ees and/ d/or

• r proxi

xies es Median dian 5, I IQR 3-6 6 Comments ments hi highl hlig ighted ted a general eral disagree sagreeme ment nt wi with th th this recom ecomme mendat dation

• n (n

n = 13) as the role e could ld be taken ken on by exist istin ing g chari arita table ble groups. ups. Rec ecomm mmend endatio ation n 17: Health alth and d social al care re pra racti ctitioners tioners to act as advo voca cate tes for both h par arti tici cipa pants, nts, their ir consu sult ltee e and/or d/or pro roxi xies es to su suppor port t decision ision makin ing g on taking ng par art t in a resear earch ch study. Media dian n 5, IQR 4-6 Comments ments highligh ighted ted unea ease se with the recommen commendati dation n with par arti ticip cipan ants ts citin ing g a conflict flict of i interest erest as the main n issue ue of conten tenti tion n (n = 5) and d how clinicia icians ns could uld acc ccomm mmoda

• date

te (n n = 5).

Area 1: Involvement of consultees

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Rec ecomm mmend endatio ation n 15: Carers rers or pro rofess fessional ional consult ltee ees are e encour urag aged ed to indic icate ate to rese searc archers hers their ir availab ailabilit ility y to act as s a consu sult ltee ee on behal half f of an indiv ividua idual.

• l. Med

edian ian 5, I IQR R 4-6 Parti ticipa ipant nts divid vided ed betw twee een n the recommen commendati dation n rein info forcin rcing the importanc

• rtance of involving

ving the consul sultee tee ear arly ly in the rese searc arch process

• cess (n = 4)

and nd str tron

• ng

g disagree sagreeme ment nt from oth thers ers th that t coerc ercive ive and nd impr pract actical ical (n n = 3). Rec ecomm mmend endatio ation n 6: Researc archers hers to make e availa ailable ble to pati atients ents and/o d/or r carers rers a pati tient ent advo voca cate te or publi blic c repr presenta sentative tive to su support port them m to decide ide if they wish to par articip ticipate ate in a research arch study dy and d in the consent nt proce

• cess
• ss. Median

dian 5, IQR 3-6.2 6.25 Parti ticipa ipant nts s ambiguous biguous with a researc search link seen een as helpf pful ul, but not frame amed d in n te term rms s of an n advocate vocate (n n = 6), oth thers ers disagre sagreed ed as paterna aternalist istic ic (n = n = 3).

Area 1: Involvement of consultees

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Consultees; literature findings

• 17 studies on involving personal consultees in

the decision-making process

• Disparity between participants’ responses to

hypothetical scenarios on acting as a consultee and engagement of consultees in research.

• Hypothetically most agree to participate, but in

research studies engagement ranged from 3.6% to 51% (unable to identify or engage, functionally unable, or refused)

• High number of eligible participants excluded
• Use nominated (‘professional’) consultee

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Limitations of the research

• Only 3 papers involved those

adults nearing the end-of-life and were situated in care home

• The majority of papers

concerned Alzheimer’s patients in early to late stages

• The sample sizes in the vast

majority of studies was small and population specific meaning the data could not be generalised

• There was often recruitment

bias through those willing to engage in discussions with researchers

1) Time given to identify in advance a consultee for research purposes 2) Support given to staff to help identify appropriate consultees and minimise the burden of the research process 3) Researcher flexibility to arrange and accommodate interviews with consultees at a time and place most convenient to them 4) The use of a professional consultee (a nominated consultee) when a personal consultee cannot be contacted to give an opinion on participation Evidence based solutions to involving consultees

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How can we enable consultees’ involvement as surrogate decision makers for adults lacking capacity in research on end-of-life care in ways that minimise the burden of participation?

Question Area 1

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Training and education on consent and ethical considerations; the challenges and solutions

Area 2

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Our research findings showed limitations in

researchers and clinicians knowledge of consent for adults lacking capacity and the potential impact of training on the process of research What are the best ways to provide education and support for researchers and clinicians on approaching patients at the end-of-life and their families on participating in research, assessing capacity and seeking consent from a patient with impaired capacity or surrogate decision-maker for patients lacking capacity?

Education and training; area of uncertainty in implementation

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Rec ecommendatio mmendation n 16: Research rchers ers to atte tend nd adva dvanc nced ed commun unica icati tion n traini ining ng to increa rease e their r sensitiv ivit ity y and nd confiden fidence ce when seeking g to consent nt a patien tients ts to parti rticip ipate te in a research ch study

• dy. Media

ian n 7, IQR 5-8 8 Some e (n = = 6) quer eried ied who would approve

• ve and provid

vide the e trainin ning, g, other ers s (n = 5) disa sagre greed as all researche searchers s should ld be equipped uipped with comm mmun unicatio ication n skill lls, s, and some e (n = = 4) consid sidered red th this s is essent sential. ial.

Area 2: Education and training

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Reco ecomm mmen endatio ation 19: Rese sear archers chers to have e timely ly access cess to experienced perienced member bers of the researc earch h team m to provi vide e supervi ervision

• n on the consent

nt process cess, particularly when an individual’s level of capacity is uncertain or fluctuating. Median dian 8, IQR 7-9 Participants’ indicated consistent concern about the feasibility of ensuring researchers’ availability to an experienced team member. Rec ecomm mmend endatio ation n 3: Increa reased ed support port and d trainin aining g for clinici ician ans is requir uired ed to improve prove their ir skills in discu cussing ing research earch with pati tients nts duri ring ng routine tine clini nical cal contact.

• tact. Media

dian n 7.5, IQR 6.75-9 Ma Many y agree reed d (n = n = 4) but ut quer ueried ied wh who provide vided d th the tr traini aining g and nd clinicians icians availa ailabilit lity. y.

Area 2: Training and education

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• Seven studies on clinicians’ and/or researchers’

knowledge of the ethics of consent for adults lacking capacity and legislative frameworks, and the impact

• f training on the research process.
• Two papers found that clinicians’ and researchers’

had poor knowledge of the legislation governing the process of assent for adults lacking capacity. The authors of both advocated greater efforts to be made to educate researchers and clinicians on the ethical issues involved in assent.

Education and training; literature findings

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Limitations of the research

• Only 2 papers involved adults

nearing the end-of-life

• Surveys detailing hypothetical

scenarios may not be representative of researcher/physician behaviour in real world scenarios

• The sample sizes in the vast

majority of studies was small and population specific meaning the data could not be generalised

• Inability to determine whether

respondents differ in any significant way from non- respondents

1) Education sessions for palliative health clinicians’ enabling an increase in clinicians’ engagement and interest in a study 2) Researchers liaising closely with clinical staff 3) Researchers and research nurses undertaking a two training session on informed consent and assent 4) Training on interviewer techniques to improve recruitment and retention

Studies reported methods of improvement in researchers and clinicians knowledge through training

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Question Area 2

What are the best ways to provide education and support for researchers and clinicians on approaching patients at the end-of-life and their families on participating in research, assessing capacity and seeking consent from a patient with impaired capacity or surrogate decision-makers for patients lacking capacity?

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Legislative frameworks; implementation into research practice and limitations

Area 3

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The findings from our research and the MORECare work examined the implementation and limitations of the Mental capacity Act 2005 (MCA). A key question raised from the synthesis of both the MORECare Capacity and MORECare work is: What are the strengths and limitations of legislative frameworks, notably the Mental Capacity Act 2005, to enable the inclusion of adults lacking capacity in research on end-of-life care?

Legislative frameworks; contention on limitations and implementation

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Rec ecomm mmend endatio ation n 25: The Menta tal Capaci pacity ty Act 2005 05 to be amend nded ed allowin wing g paid id profess

• fessional

ional carers rers to act as a consult ltee ee for indiv ividua iduals who lack ck capaci pacity ty to give e advi vice ce on whether her the indiv ividua idual would d have e wante nted d to par arti tici cipa pate te in the resear earch ch study dy had ad they y had d capa pacit city y to indicate icate this Median dian 5, I IQR 3-6 6 Comments ments highligh ighted ted the ambi bigu guit ity y of the recommen commendati dation n due e to conflicts flicts

• f inter

erest, st, time e limitations, tations, and the issue ue of a formal mal car arer er not knowing ng the individ ividual ual when n they y had d cap apacit acity. y. MOREC ECare are Rec ecomm mmend endatio ation n 14: Seek to chan ange ge the law, so that t advance vance consent nt is legal ally ly effec ecti tive ve for r all research arch and d not limite ted d to Clinica ical Trials als of Investi tigat gational

• nal Medici

icina nal l Products

• ducts (CTIMPs

MPs). Media dian n 7, I IQR 5–8.2 8.25

Area 3: Legislative frameworks

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Recomm mmend endation ation 26: The Mental tal Capac pacit ity y Act 2005 05 to be amended nded to simplify plify the prov

• visi

isions

• ns on Lasting

sting Powers ers of Attorney.

• rney. Median

dian 7, IQR 5-8 Parti ticipa ipant nts s (n = 3) quer eried ied who would d dra raft ft the new versi rsion

• n of the law and

d how would it be implemented to meet everyone’s needs MOREC ECare are rec ecomm mmendation ndation 15; When obtaining aining consent nt from

• m a compete

petent nt par arti ticip ipan ant t for a non-CT CTIMP IMP study, y, anticip ticipate ate the poten tenti tial loss of capacity pacity and d fulfil fil the requireme quirements nts of the Mental tal Capac pacit ity y Act 2005 05 by obtain taining ing assent nt from m a carer rer and d meetin ing g the risk/b /benefi enefit t crite teria ria for r non-thera therapeuti utic c proj

• jects.

cts. Median dian 7, I IQR 5-8.25 .25

Area 3: Legislative frameworks

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Findings from the systematic literature appraisal

• Six studies examined implementation of the Mental

Capacity Act 2005 in research, and its limitations. All the studies were undertaken in the UK after the implementation of the MCA 2005.

• Five studies discussed the implementation of the

MCA 2005 to guide the inclusion of adults lacking capacity and the limitations of the legislation. The findings indicate further requirement to enable participation for adults lacking capacity and complex consent procedures to ensure adherence to the MCA 2005

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• Higher research costs to ensure researcher time for

preparatory work to access adults lacking capacity and identification and engagement of consultees

• Lack of research resource and preparation may

compromise recruitment of adults lacking capacity and accrue only a small increase in trial recruitment

• Continuing ongoing consent for adults with impaired

capacity and assent for adults lacking capacity

• Advanced consent for adults with anticipated

declining capacity with identification of consultee at initial consent stage

• Use of a nominated or professional consultee in the

absence of a personal of consultee

Limitations of the research

• Studies concerned end-of-life

care, but not care in the last days and hours of life

• Although there are a variety of

tools to assess capacity there is little consensus on the best ways in which to assess a patients capacity

• Selection bias is often present in

these studies

• Procedures used may only be

suitable for the particular population under study

Requirements to enable participation for adults lacking capacity in accordance to the MCA 2005

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What are the strengths and limitations of legislative frameworks, notably the Mental Capacity Act 2005, to enable the inclusion of adults lacking capacity in research on end-of-life care?

Question Area 3

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Acknowledgements

MORECare Capacity is funded by Marie Curie CRUK (no. C38812/A12533) The members of MORECare Capacity are- Principle investigators - Catherine Evans and Irene J Higginson. Co-investigators - Bee Wee, Penney Lewis, Jonathan Koffman, William Bernal, Matthew Hotopf; Project advisory group – Deborah Tanner, Claire Henry, Gunn Grande, Steve Dewar, Gareth Owen, Rachel Burman, Dimitrios Adamis, Michael Dunn, Scott Kim, Simon Woods; and Researchers – Katie Stone and Rowena Vohora.