AgingNCT03902743
Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
A study testing Anticipatory Care Plan group in people with Aging, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The purpose of this study is to explore the feasibility of delivering anticipatory care planning provided by nurses through a series of home visits. Many people with long-term health conditions can benefit from an anticipatory care plan as it helps them feel more in control of their life and allows them to manage… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Anticipatory Care Plan group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Mar 2019to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged ≥70 years
- In receipt of a valid general medical services (GMS) card in the Republic of Ireland, or for Northern Ireland registered for NHS primary care services
- ability to complete a postal questionnaire
Who cannot join
- receiving specialist palliative care
- record of assessed cognitive impairment at the level that would impact their ability to complete screening postal questionnaire, outcome measures and participate in a patient care conference(s) (defined as Mini Mental State Examination (MMSE) ≤20)
- experiencing a psychotic episode at the time of recruitment
- hospitalised long-term, in a nursing home, homeless or in sheltered accommodation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queens University Belfast
Belfast, BT9 7BL
Kevin Brazil, PhD, (0)28 9097 ext. 5782, k.brazil@qub.ac.uk
About this study
The purpose of this study is to explore the feasibility of delivering anticipatory care planning provided by nurses through a series of home visits. Many people with long-term health conditions can benefit from an anticipatory care plan as it helps them feel more in control of their life and allows them to manage changes in their health and well-being. The purpose of this study is to find out if effect of home visits by specially trained nurses for people aged 70 years and over who have been identified as being 'at risk' of developing frailty would be beneficial. Half of the patients in this study will receive home visits from trained nurses in addition to their usual care. Nurses will work with their GP, other healthcare providers and possibly family caregivers to plan and arrange any additional services that the participants require. The other half of patients in the study will receive usual care.
Read the detailed description
Aim: to determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
Design and sample:
We will perform a feasibility cluster randomised controlled trial where 8 primary care practises will be randomly assigned (4 facilities per arm) to the intervention group versus usual care alone. Randomisation will be stratified according to location (Northern Ireland /Republic of Ireland - Louth, Monaghan). Primary care practices will be randomly allocated to the intervention or usual care arm before patient screening for risk of functional decline. A total of 64 patients (32 per study arm, 8 patients, randomly selected, per primary care practise) will be enrolled into the study. A sample of 32 patients per study arm is considered adequate to allow the size of any definitive trial to be determined more accurately and therefore minimise the number of patients required overall.
Setting:
Practices located in Northern Ireland will be recruited via the Northern Ireland Clinical Research Network (Primary Care). In the Republic of Ireland the HRB Primary Care Trials Network will recruit primary care practises located in the border counties of Louth and Monaghan. Practises will be drawn from both urban and rural settings that serve a socioeconomically deprived population.
Patient enrolment:
Individuals who screen as at risk of functional decline will be sent a letter from their GP inviting them to participate in the study. A project research assistant will recruit consenting patients by telephone. Allocation to the intervention vs. usual care will be communicated to the study participant by a member of the research team after the research assistant has obtained consent and conducted the baseline-standardised interview. In the case of two or more eligible participants in any one household, all will be eligible for enrolment into the study. In the intervention arm the study nurse employed by the project will then commence arrangements to visit the appropriate patients.
Intervention:
The nurse led ACP intervention will be integrated into regular care where the study nurse will involve the patients' GP in care planning and is informed about patients' goals and plans. As a first step in the intervention, the study nurse will contact the patient by telephone to schedule an initial home visit. This will typically be conducted within 4 weeks of the return of the participant's PRISMA 7 postal questionnaire. At the initial home visit the study nurse will, with the aid of a medical summary including current repeat prescription provided by the GP practise, will employ a structured protocol conduct a brief Comprehensive Geriatric Assessment (CGA) that will also encourage discussion about present and future care and patient goals.
Following the initial home visit the study nurse will draft a structured summary report of the home visit that will include patient goals, preferences for care, identified problems and action list. The study nurse will forward to a pharmacist, who will be an adjunct to the study, the summary report generated from the brief CGA highlighting the patient medication list and the identification of potentially inappropriate prescribing (PIP). The pharmacist will cross check and verify the presence of PIPs. A record will be maintained by the pharmacist on the accuracy of the study nurse identifying PIPs during the trial. The results of this audit will contribute to the finalisation of the intervention. Subsequent to PIP feedback from the pharmacist the study nurse will finalize the summary report and will meet with the GP who will be informed through a structured format patients goals and wishes, results of the patient assessment, problem list and recommended actions. The GP with appropriate participation of other members of the health care team, will review, provide feedback and confirm agreement with the plan of care.
In the second home visit the study nurse will meet with the patient and family carer to discuss identified problems, review proposed options for support, document the agreed support plan and consider options for follow up and set a date for review. The study nurse may conduct, depending on clinical need, the second visit in the patients' home or the GP practise so the GP can be present. The finalised care plan will be left with the patient and a copy will be placed in the patient's chart in the GP practise.
All outcome measures will be assessed at baseline, six weeks and six months.
- Conditions
- Aging
- Being tested
- Anticipatory Care Plan group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticipatory Care Plan groupOther
The Anticipatory Care Plan will be delivered by a trained nurse. At the initial visit, the nurse will conduct a hollistic assessment using the EasyCare Assessment Tool. Following this visit, the nurse will draft a strucutred summary report of the home visit to include patient goals, preferences for care, identified problems and action list. The nurse will then consult with a pharmacist to identify any potential inappropriate prescribing. The nurse will then meet with the participants GP and review and provide feedback. The nurse will then re visit participants and discuss the report and agree a support plan and actions for follow up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive an Anticipatory Care Plan Receives: Other: Anticipatory Care Plan group |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
EQ-5D-5L
Is a widely used self-reported generic measure of health reported quality of life that has been validated in different patient populations. The five-level version contains the same dimensions as the earlier three-level version but has been designed to provide greater reliability and sensitivity.
Measured: 10 minutes
Center for Epidemiological Studies Depression Scale (CES-D)
This 20- item scale has been used extensively with older adults. Respondents use a four choice scale to rate how they have felt in the past week expressing depressed mood.
Measured: 10 minutes
Secondary outcomes (2)
Patient Assessment of Chronic Illness Care (PACIC) Scale
This 20 item scale was designed to assess from the patient perspective the receipt of patient-centered care and self-management behaviors.
Measured: 15 minutes
Health Economic Evaluation
The health economic analysis will consist of trial-based economic evaluation and will incorporate both cost effectiveness analysis and cost utility analysis to compare the alternative treatment strategies: (1) the Anticipatory Care Planning (ACP) Intervention; and (2) usual care in general practice.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start12 Mar 2019
- Primary completionFeb 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland, National University of Ireland, Galway, Ireland
- Responsible party
- Principal investigator, Kevin Brazil, Queen's University, Belfast
- Investigators
- Kevin Brazil, PhD, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902743
- Sponsor's protocol ID
- B18/46
- Status last verified
- Nov 2019
- First submitted
- 2 Apr 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan in preparation
Publications
Brazil K, Cardwell C, Carter G, Clarke M, Corry DAS, Fahey T, Gillespie P, Hobbins A, McGlade K, O'Halloran P, O'Neill N, Wallace E, Doyle F. Anticipatory care planning for community-dwelling older adults at risk of functional decline: a feasibility cluster randomized controlled trial. BMC Geriatr. 2022 May 25;22(1):452. doi: 10.1186/s12877-022-03128-x.
PubMed 35610581Corry DAS, Carter G, Doyle F, Fahey T, Gillespie P, McGlade K, O'Halloran P, O'Neill N, Wallace E, Brazil K. Successful implementation of a trans-jurisdictional, primary care, anticipatory care planning intervention for older adults at risk of functional decline: interviews with key health professionals. BMC Health Serv Res. 2021 Aug 25;21(1):871. doi: 10.1186/s12913-021-06896-1.
PubMed 34433441Brazil K, Scott D, Wallace E, Clarke M, Fahey T, Gillespie P, O'Halloran P, Cardwell C, Carter G, McGlade K, Doyle F. Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial. Trials. 2020 Feb 11;21(1):168. doi: 10.1186/s13063-020-4100-2.
PubMed 32046767
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
- ClinicalTrials.gov ID
- NCT03902743
- Acronym / sponsor ID
- B18/46
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland, National University of Ireland, Galway, Ireland
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the feasibility of delivering anticipatory care planning provided by nurses through a series of home visits. Many people with long-term health conditions can benefit from an anticipatory care plan as it helps them feel more in control of their life and allows them to manage changes in their health and well-being. The purpose of this study is to find out if effect of home visits by specially trained nurses for people aged 70 years and over who have been identified as being 'at risk' of developing frailty would be beneficial. Half of the patients in this study will receive home visits from trained nurses in addition to their usual care. Nurses will work with their GP, other healthcare providers and possibly family caregivers to plan and arrange any additional services that the participants require. The other half of patients in the study will receive usual care.
Detailed description
Aim: to determine the feasibility of a cluster randomised trial to evaluate the implementation and outcomes of Anticipatory Care Planning (ACP) in primary care to assist older adults identified as at risk for functional decline by developing a personalised support plan.
Design and sample:
We will perform a feasibility cluster randomised controlled trial where 8 primary care practises will be randomly assigned (4 facilities per arm) to the intervention group versus usual care alone. Randomisation will be stratified according to location (Northern Ireland /Republic of Ireland - Louth, Monaghan). Primary care practices will be randomly allocated to the intervention or usual care arm before patient screening for risk of functional decline. A total of 64 patients (32 per study arm, 8 patients, randomly selected, per primary care practise) will be enrolled into the study. A sample of 32 patients per study arm is considered adequate to allow the size of any definitive trial to be determined more accurately and therefore minimise the number of patients required overall.
Setting:
Practices located in Northern Ireland will be recruited via the Northern Ireland Clinical Research Network (Primary Care). In the Republic of Ireland the HRB Primary Care Trials Network will recruit primary care practises located in the border counties of Louth and Monaghan. Practises will be drawn from both urban and rural settings that serve a socioeconomically deprived population.
Patient enrolment:
Individuals who screen as at risk of functional decline will be sent a letter from their GP inviting them to participate in the study. A project research assistant will recruit consenting patients by telephone. Allocation to the intervention vs. usual care will be communicated to the study participant by a member of the research team after the research assistant has obtained consent and conducted the baseline-standardised interview. In the case of two or more eligible participants in any one household, all will be eligible for enrolment into the study. In the intervention arm the study nurse employed by the project will then commence arrangements to visit the appropriate patients.
Intervention:
The nurse led ACP intervention will be integrated into regular care where the study nurse will involve the patients' GP in care planning and is informed about patients' goals and plans. As a first step in the intervention, the study nurse will contact the patient by telephone to schedule an initial home visit. This will typically be conducted within 4 weeks of the return of the participant's PRISMA 7 postal questionnaire. At the initial home visit the study nurse will, with the aid of a medical summary including current repeat prescription provided by the GP practise, will employ a structured protocol conduct a brief Comprehensive Geriatric Assessment (CGA) that will also encourage discussion about present and future care and patient goals.
Following the initial home visit the study nurse will draft a structured summary report of the home visit that will include patient goals, preferences for care, identified problems and action list. The study nurse will forward to a pharmacist, who will be an adjunct to the study, the summary report generated from the brief CGA highlighting the patient medication list and the identification of potentially inappropriate prescribing (PIP). The pharmacist will cross check and verify the presence of PIPs. A record will be maintained by the pharmacist on the accuracy of the study nurse identifying PIPs during the trial. The results of this audit will contribute to the finalisation of the intervention. Subsequent to PIP feedback from the pharmacist the study nurse will finalize the summary report and will meet with the GP who will be informed through a structured format patients goals and wishes, results of the patient assessment, problem list and recommended actions. The GP with appropriate participation of other members of the health care team, will review, provide feedback and confirm agreement with the plan of care.
In the second home visit the study nurse will meet with the patient and family carer to discuss identified problems, review proposed options for support, document the agreed support plan and consider options for follow up and set a date for review. The study nurse may conduct, depending on clinical need, the second visit in the patients' home or the GP practise so the GP can be present. The finalised care plan will be left with the patient and a copy will be placed in the patient's chart in the GP practise.
All outcome measures will be assessed at baseline, six weeks and six months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Anticipatory Care Plan groupParticipants will receive an Anticipatory Care Plan |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged ≥70 years
- In receipt of a valid general medical services (GMS) card in the Republic of Ireland, or for Northern Ireland registered for NHS primary care services
- ability to complete a postal questionnaire
Key exclusion criteria (4 listed)
- receiving specialist palliative care
- record of assessed cognitive impairment at the level that would impact their ability to complete screening postal questionnaire, outcome measures and participate in a patient care conference(s) (defined as Mini Mental State Examination (MMSE) ≤20)
- experiencing a psychotic episode at the time of recruitment
- hospitalised long-term, in a nursing home, homeless or in sheltered accommodation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticipatory Care Plan groupThe Anticipatory Care Plan will be delivered by a trained nurse. At the initial visit, the nurse will conduct a hollistic assessment using the EasyCare Assessment Tool. Following this visit, the nurse will draft a strucutred summary report of the home visit to include patient goals, preferences for care, identified problems and action list. The nurse will then consult with a pharmacist to identify any potential inappropriate prescribing. The nurse will then meet with the participants GP and review and provide feedback. The nurse will then re visit participants and discuss the report and agree a support plan and actions for follow up. | Other | Intervention group |
Primary outcome
EQ-5D-5L
Time frame: 10 minutes
Is a widely used self-reported generic measure of health reported quality of life that has been validated in different patient populations. The five-level version contains the same dimensions as the earlier three-level version but has been designed to provide greater reliability and sensitivity.
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: 10 minutes
This 20- item scale has been used extensively with older adults. Respondents use a four choice scale to rate how they have felt in the past week expressing depressed mood.
2 secondary outcomes
Patient Assessment of Chronic Illness Care (PACIC) Scale
Time frame: 15 minutes
Health Economic Evaluation
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Derived from this study: PubMed 35610581Brazil K, Cardwell C, Carter G, Clarke M, Corry DAS, Fahey T, Gillespie P, Hobbins A, McGlade K, O'Halloran P, O'Neill N, Wallace E, Doyle F. Anticipatory care planning for community-dwelling older adults at risk of functional decline: a feasibility cluster randomized controlled trial. BMC Geriatr. 2022 May 25;22(1):452. doi: 10.1186/s12877-022-03128-x.
- Derived from this study: PubMed 34433441Corry DAS, Carter G, Doyle F, Fahey T, Gillespie P, McGlade K, O'Halloran P, O'Neill N, Wallace E, Brazil K. Successful implementation of a trans-jurisdictional, primary care, anticipatory care planning intervention for older adults at risk of functional decline: interviews with key health professionals. BMC Health Serv Res. 2021 Aug 25;21(1):871. doi: 10.1186/s12913-021-06896-1.
- Derived from this study: PubMed 32046767Brazil K, Scott D, Wallace E, Clarke M, Fahey T, Gillespie P, O'Halloran P, Cardwell C, Carter G, McGlade K, Doyle F. Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial. Trials. 2020 Feb 11;21(1):168. doi: 10.1186/s13063-020-4100-2.
- Individual participant dataSharing planned: Yes. Plan in preparation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Brazil, PhD principal investigator
Queens University Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticipatory Care Plan group in people with Aging, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Brazil, PhD ((0)28 9097 ext. 5782, k.brazil@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ-5D-5L (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902743, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.