Clinical trial NCT05681585: Advanced Care Planning for the Severely Ill Home-dwelling Elderly
Official title: Implementing Advanced Care Planning in the Routine Care for Acutely Admitted Patients in Geriatric Units: a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Advance Care Planning
Keywords: Implementation science
Decision-making processes
Hospital
Geriatric
Next of kin
Clinical ethics
Qualitative methods
Cluster randomized clinical trial
Complex intervention
Health services for the aged
End of life
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo Metropolitan University
name: Norwegian University of Science and Technology
name: The Research Council of Norway
name: Helse Sor-Ost
name: Sykehuset Innlandet HF
name: Vestre Viken Hospital Trust
name: Ostfold Hospital Trust
name: The Hospital of Vestfold
name: Hospital of Southern Norway Trust
name: University Hospital, Akershus
name: Oslo University Hospital
name: Diakonhjemmet Hospital
First posted: 2023-01-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a cluster RCT, with a complex intervention containing implementation interventions and strategies, and a clinical intervention (ACP). Twelve clusters were recruited and stratified into two strata according to number of beds and randomized to intervention or control arms (allocation ratio of 1:1). The six hospital units in the intervention arm will receive a comprehensive implementation support program, whereas the control units receive no support in the intervention period.

A similar number of patients, relatives and attending clinician will be recruited from both arms in triads for the quantitative sub-study. Data for each patient will be supplemented by health record and register data. Patients, relatives, staff and implementation teams will be recruited from the intervention units to qualitative interviews. All health personnel in the participating units will be recruited to answer a questionnaire twice. We will also interview key stakeholders in a wider context.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning
timeFrame: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Clinical effectiveness study 1: Patient-reported outcome
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported outcome
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 3: Clinician outcome
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
Secondary outcomes:
measure: Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 1
timeFrame: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 2
timeFrame: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Implementation outcome study: Fidelity to the intervention model - Advanced Care Planning 3
timeFrame: Baseline, 9 and 18 months in the intervention arm. Baseline and 18 months in the control arm.
measure: Clinical effectiveness study 1: Patient-reported seondary outcome 1
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 1: Patient-reported seondary outcome 2
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 1: Patient-reported seondary outcome 3
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 1: Patient-reported seondary outcome 4
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 1: Patient-reported seondary outcome 5
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 1: Patient-reported seondary outcome 6
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 1: Patient registry data 1 - Number of hospital admissions
timeFrame: From 18 months before to 18 months after inclusion (or until death)
measure: Clinical effectiveness study 1: Patient registry data 2 - Other use of health care services and use of medication
timeFrame: From 18 months before to 18 months after inclusion (or until death)
measure: Clinical effectiveness study 1: Patient registry data 3 - Time before death (for patients dying before 18 months after inclusion)
timeFrame: From inclusion to 18 months after inclusion
measure: Clinical effectiveness study 1: Patient health records data
timeFrame: From 18 months before to 18 months after inclusion (or until death)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 1
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 2
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 3
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 4
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 5
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 6
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 2: Relative-reported seondary outcome 7
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 3: Clinician secondary outcome 1
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 3: Clinician secondary outcome 2
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
measure: Clinical effectiveness study 4: All staff - 1
timeFrame: Baseline and 18 months in both intervention and control arm
measure: Clinical effectiveness study 4: All staff - 2
timeFrame: Baseline and 18 months in both intervention and control arm
measure: Clinical effectiveness study 4: All staff - 3
timeFrame: Baseline and 18 months in both intervention and control arm
measure: Clinical effectiveness study 4: All staff - 4
timeFrame: Baseline and 18 months in both intervention and control arm
measure: Clinical effectiveness study 4: All staff - 5
timeFrame: Baseline and 18 months in both intervention and control arm.
measure: Economic sub-study: Increased costs related to implementing and practicing ACP
timeFrame: Measured before baseline and then throughout the implementation period (0-18 months).
Other outcomes:
measure: Clinical effectiveness study 1: Clinical data about the patient from participating/attending clinician
timeFrame: During the intervention period (10-18 months after the start of the implementation support)
Locations:
city: Oslo
country: Norway
facility: Vestre Viken Hospital Trust, Bærum
state: Bærum kommune
city: Arendal
country: Norway
facility: Hospital of Southern Norway, Arendal
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust, Drammen
city: Elverum
country: Norway
facility: Innlandet Hospital Trust, Elverum
city: Gjøvik
country: Norway
facility: Innlandet Hospital Trust, Gjøvik
city: Kongsberg
country: Norway
facility: Vestre Viken Hospital Trust, Kongsberg
city: Kristiansand
country: Norway
facility: Hospital of Southern Norway, Kristiansand
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
affiliation: Professor, Centre for medical ethics, University of Oslo
name: Reidar Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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-e551. doi: 10.1016/S1470-2045(17)30582-X.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.