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Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902743
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborators:
Royal College of Surgeons, Ireland
National University of Ireland, Galway, Ireland
Information provided by (Responsible Party):
Kevin Brazil, Queen's University, Belfast

Brief 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 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.

Condition or disease Intervention/treatment Phase
Aging Other: Anticipatory Care Plan group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Anticipatory Care Planning Intervention for Older Adults at Risk of Functional Decline: A Primary Care Feasibility Study
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Intervention group
Participants will receive an Anticipatory Care Plan
Other: Anticipatory Care Plan group
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.

No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Patient Assessment of Chronic Illness Care (PACIC) Scale [ Time Frame: 15 minutes ]
    This 20 item scale was designed to assess from the patient perspective the receipt of patient-centered care and self-management behaviors.

  2. Health Economic Evaluation [ Time Frame: 15 minutes ]
    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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03902743


Contacts
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Contact: Kevin Brazil, PhD (0)28 9097 ext 5782 k.brazil@qub.ac.uk
Contact: David Scott, PhD (0)28 9097 ext 5759 david.scott@qub.ac.uk

Locations
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United Kingdom
Queens University Belfast Recruiting
Belfast, United Kingdom, BT9 7BL
Contact: Kevin Brazil, PhD    (0)28 9097 ext 5782    k.brazil@qub.ac.uk   
Sponsors and Collaborators
Queen's University, Belfast
Royal College of Surgeons, Ireland
National University of Ireland, Galway, Ireland
Investigators
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Principal Investigator: Kevin Brazil, PhD Queens University Belfast
  Study Documents (Full-Text)

Documents provided by Kevin Brazil, Queen's University, Belfast:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kevin Brazil, Professor Kevin Brazil, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03902743    
Other Study ID Numbers: B18/46
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan in preparation
Supporting Materials: Study Protocol
Time Frame: August 2021
Access Criteria: Those requesting access will be required to submit a letter of intent to the study PI after which the research team will review their request

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