Advanced Care Planning for the Severely Ill Home-dwelling Elderly

Официальное название

Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial

Обзор

This study will develop and evaluate a complex intervention to implement advance care planning for severely ill home-dwelling elderly acutely admitted to hospital, by using a cluster randomized design. Twelve Norwegian acute geriatric hospital units will participate in the main study, each as one cluster. Of the twelve clusters, half will receive implementation support and training immediately, and the other half will receive similar support after the intervention period. The study includes 1) assessment of implementation outcomes (fidelity) in the participating units,2) health service and clinical outcomes including a) questionnaires to all staff in the units before and after the implementation period, questionnaires to attending clinicians and qualitative interviews with health personnel and local unit leaders b) questionnaires to patients and their relatives, patients records and data from central health registers and qualitative interviews with patients and relatives. Furthermore we will assess barriers and facilitators for advance care planning in 1) a wider health service context, and 2) at the national, regional and municipal level, and do economic analyses.

Подробное описание

Background:

Severely ill elderly patients and their relatives are often poorly involved in treatment and care decisions. Advance care planning is a well-documented tool to comply with the ethical and legal imperative to involve both the patient and their next of kin in the planning of current and future treatment and care. The overall aim of this project is to improve health services, user involvement and quality of life for severely ill elderly people living at home, and their relatives, in an efficient, sustainable and coordinated way, through better implementation of Advance care planning (ACP).

Setting: Twelve hospital wards providing care to acutely admitted elderly home-dwelling patients, either pure geriatric units or mixed units with specialists in geriatric medicine.

Research questions:

1. What is the current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in the participating clinical units? 2. What are the most important facilitators and barriers among all relevant stakeholders - to implementing ACP at the a) clinical, b) health care service- and c) national, regional and municipal level? 3. What are the most important moral dilemmas and conflicting interests related to ACP, and how can these be resolved? 4. What are the benefits and disadvantages with the implementation support and ACP experienced by the patients, among next of kin, health personnel and implementation teams? 5. Does the implementation support program - compared to no such support - improve a) the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians? 6. Is the implementation support program associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives? 7. Is higher level of implementation (fidelity) of ACP associated with improved outcomes for patients, relatives, the staff and the services? 8. Is the implementation support program for ACP a cost-effective intervention?

Hypotheses:

1. The current level of implementation of ACP for home-dwelling elderly patients with severe somatic disease in participating clinical units is low. 2. There are important facilitators for and barriers to implementing ACP among all stakeholders at the a) clinical, b) health care service- and c) national and other higher levels. 3. There are important moral dilemmas and conflicting interests related to ACP, and they can be dealt with through systematic approaches and ethics reflection. 4. Patients, among next of kin, health personnel and implementation teams experience both benefits and disadvantages with the implementation support and ACP. 5. The implementation support program - compared to no such support - will improve a) improve the implementation of ACP (fidelity), b) quality of communication and decision-making for patients and relatives when approaching the end of life, and c) congruence between the patient's preferences for information and involvement and the attending clinician's perceptions of the same, and other relevant outcomes for patients, relatives, and the attending clinicians. 6. The implementation support program is associated with changes in health personnel's perceptions, attitudes, self-efficacy, confidence in, and experiences in relation to information giving and involvement of patients and relatives 7. Higher level of implementation (fidelity) of ACP is associated with improved outcomes for patients, relatives, the staff and the services 8. Outcomes for patients, relatives and the public health- and welfare services justify the costs of the implementation support program and of ACP in routine care.

Вмешательства

• Другое Implementation support program
  The intervention consists of: I Implementation strategies: 1.1 Ensuring leadership commitment 1.2 Responsive evaluation 1.3 Whole ward approach 1.4 Train the trainer model 1.5 Sustainability after the study II Implementation interventions 2.1 Implementation team 2.2 ACP coordinator 2.3 Training and supervision: Kick-off, training of resource persons and health care personnel including practical exercises, network conferences 2.4 Toolkit and shared resources: ACP guideline, teaching material,

Первичные конечные точки

• Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning [Срок оценки: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.]
• Clinical effectiveness study 1: Patient-reported outcome [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 2: Relative-reported outcome [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 3: Clinician outcome [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]

Вторичные конечные точки (12)

• Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 1 [Срок оценки: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.]
• Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 2 [Срок оценки: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.]
• Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 3 [Срок оценки: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.]
• Clinical effectiveness study 1: Patient-reported seondary outcome 1 [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 1: Patient-reported seondary outcome 2 [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 1: Patient-reported seondary outcome 3 [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 1: Patient-reported seondary outcome 4 [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 1: Patient-reported seondary outcome 5 [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 1: Patient-reported seondary outcome 6 [Срок оценки: During the intervention period (10-18 months after the start of the implementation support)]
• Clinical effectiveness study 1: Patient registry data 1 - Number of hospital admissions [Срок оценки: From 18 months before to 18 months after inclusion (or until death)]
• Clinical effectiveness study 1: Patient registry data 2 - Other use of health care services and use of medication [Срок оценки: From 18 months before to 18 months after inclusion (or until death)]
• Clinical effectiveness study 1: Patient registry data 3 - Time before death (for patients dying before 18 months after inclusion) [Срок оценки: From inclusion to 18 months after inclusion]

Критерии участия

Inclusion and exclusion criteria for patients and relatives the quantitative and triadic sub-study:

Inclusion criteria for patients:

• Home-dwelling
• 70 years or older
• Acutely admitted to the participating unit
• Sufficient language proficiency in Norwegian to answer the questionnaire
• Clinical frailty score of 4 or more
• The physician responsible for the patient's medical care answers "no" to "Surprise question" from Gold Standards Framework proactive identification guidance
• Both patient and a close relative (preferably the closest relative) would participate in ACP together if offered
• Both patient and the close relative consent to participate in the research project

Exclusion criteria for patients:

• The patient is not competent to consent to research participation
• The patient is expected to die within 24 hours
• The patient has participated in ACP prior to the current hospital admission
• In the intervention arm

• ACP is not conducted with patient, next of kin and physician before hospital discharge
• The clinician that participated in the ACP conversation has not consented to research participation
• In the control arm

• The patient would not have been able to participate in ACP during hospitalization
• An attending clinician has not consented to research participation

Inclusion criteria for relatives:

• A close relative of a patient who fulfill all inclusion criteria and no exclusion criteria; and who would be willing to participate in ACP together with the patient if offered
• 18 years or older
• Sufficient language proficiency in Norwegian to answer the questionnaire
• Both patient and the close relative consent to participate in the research project

Exclusion criteria for relatives:

• The relative is not competent to consent to research participation
• In the intervention arm

• ACP is not carried out with the patient, next of kin and attending clinician before hospital discharge
• In the control arm

• The relative would not have been able to participate in ACP during hospitalization

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Норвегия · 12 центров

• Vestre Viken Hospital Trust, Bærum — Oslo
• Hospital of Southern Norway, Arendal — Arendal
• Vestre Viken Hospital Trust, Drammen — Drammen
• Innlandet Hospital Trust, Elverum — Elverum
• Innlandet Hospital Trust, Gjøvik — Gjøvik
• Vestre Viken Hospital Trust, Kongsberg — Kongsberg
• Hospital of Southern Norway, Kristiansand — Kristiansand
• Akershus University Hospital — Lørenskog
• … и ещё 4 центра

Публикации

• Detering KM, Hancock AD, Reade MC, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010 Mar 23;340:c1345. doi: 10.1136/bmj.c1345. PMID 20332506
• Molloy DW, Guyatt GH, Russo R, Goeree R, O'Brien BJ, Bedard M, Willan A, Watson J, Patterson C, Harrison C, Standish T, Strang D, Darzins PJ, Smith S, Dubois S. Systematic implementation of an advance directive program in nursing homes: a randomized controlled trial. JAMA. 2000 Mar 15;283(11):1437-44. doi: 10.1001/jama.283.11.1437. PMID 10732933
• Lund S, Richardson A, May C. Barriers to advance care planning at the end of life: an explanatory systematic review of implementation studies. PLoS One. 2015 Feb 13;10(2):e0116629. doi: 10.1371/journal.pone.0116629. eCollection 2015. PMID 25679395
• Rietjens JAC, Sudore RL, Connolly M, van Delden JJ, Drickamer MA, Droger M, van der Heide A, Heyland DK, Houttekier D, Janssen DJA, Orsi L, Payne S, Seymour J, Jox RJ, Korfage IJ; European Association for Palliative Care. Definition and recommendations for advance care planning: an international consensus supported by the European Association for Palliative Care. Lancet Oncol. 2017 Sep;18(9):e543- PMID 28884703
• Weathers E, O'Caoimh R, Cornally N, Fitzgerald C, Kearns T, Coffey A, Daly E, O'Sullivan R, McGlade C, Molloy DW. Advance care planning: A systematic review of randomised controlled trials conducted with older adults. Maturitas. 2016 Sep;91:101-9. doi: 10.1016/j.maturitas.2016.06.016. Epub 2016 Jun 23. PMID 27451328
• Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014 Sep;28(8):1000-25. doi: 10.1177/0269216314526272. Epub 2014 Mar 20. PMID 24651708
• Bernacki RE, Block SD; American College of Physicians High Value Care Task Force. Communication about serious illness care goals: a review and synthesis of best practices. JAMA Intern Med. 2014 Dec;174(12):1994-2003. doi: 10.1001/jamainternmed.2014.5271. PMID 25330167
• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426

Идентификаторы

NCT: NCT05681585 · NSD 805491

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗