Dataset Information

Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial.

ABSTRACT:

Background

Close to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote patient autonomy; create a better foundation for important decisions in the case of medical emergencies and at the end of life; and gain experiences in order to find out what characterizes good ACP and good implementation strategies.

Methods/design

This study was a mixed method study including a cluster-randomized clinical trial. Eight nursing home wards or "clusters" were pair-matched, and one ward from each pair was randomly selected for a 12-month intervention. The intervention consisted of implementing an ACP-guideline. Implementation strategies were training and supervision of project teams and staff in using the guideline, written information to patients and next of kin, and information meetings with nursing home staff. The project was evaluated using both quantitative and qualitative data, and both outcome and process evaluation. Quantitative data included patient chart reviews of ACP, diagnoses, patient preferences for decision-making and treatment, values and wishes that are more general, documented life-prolonging treatment and hospitalizations, and concordance between patient wishes and treatment. The primary outcome was documented ACP. Qualitative data included observations of conversations, interviews with patients, next of kin and health care personnel, logs from project coordinators and conversations, and transcripts from meetings with project teams in the intervention group.

Discussion

This project attempted to increase the quality and use of ACP in Norwegian nursing homes (NH). A mixed methods approach, inclusion of patients with dementia, attempts to involve, as many patients as possible, and a sustainable implementation plan adapted to real life in nursing homes were strengths of the project.

SUBMITTER: Sævareid TJL

PROVIDER: S-EPMC6090595 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial.

Sævareid Trygve Johannes Lereim TJL Lillemoen Lillian L Thoresen Lisbeth L Førde Reidun R Gjerberg Elisabeth E Pedersen Reidar R

BMC geriatrics 20180813 1

<h4>Background</h4>Close to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote ...[more]

PMID: 30103692

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Project description:BACKGROUND:Research has highlighted the need for improving the implementation of advance care planning (ACP) in nursing homes. We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care. We describe here the protocol of a cluster randomised controlled trial (RCT) that aims to evaluate the effects of ACP+ on nursing home staff and volunteer level outcomes and its underlying processes of change. METHODS:We will conduct a cluster RCT in Flanders, Belgium. Fourteen eligible nursing homes will be pair-matched and one from each pair will be randomised to either continue care and education as usual or to receive the ACP+ programme (a multicomponent programme which is delivered stepwise over an eight-month period with the help of an external trainer). Primary outcomes are: nursing home care staff's knowledge of, and self-efficacy regarding ACP. Secondary outcomes are: 1) nursing home care staff's attitudes towards ACP and ACP practices; 2) support staff's and volunteer's ACP practices and 3) support staff's and volunteers' self-efficacy. Measurements will be performed at baseline and eight months post-measurement, using structured self-reported questionnaires. A process evaluation will accompany the outcome evaluation in the intervention group, with measurements throughout and post-intervention to assess implementation, mechanisms of impact and context and will be carried out using a mixed-methods design. DISCUSSION:There is little high-quality evidence regarding the effectiveness and underlying processes of change of ACP in nursing homes. This combined outcome and process evaluation of the ACP+ programme aims to contribute to building the necessary evidence to improve ACP and its uptake for nursing home residents and their family. TRIAL REGISTRATION:The study is registered at ClinicalTrials.gov (no. NCT03521206). Registration date: May 10, 2018. Inclusion of nursing homes started March, 2018. Hence, the trial was retrospectively registered but before end of data collection and analyses.

Project description:Introduction: The majority of nursing home (NH) patients suffer from complex diseases, including dementia. This makes advance care planning (ACP) particularly important. Objectives: The aim was to investigate the effect of an ACP intervention on communication among NH staff, patient, and family. We further investigated whether the intervention affected nursing staff distress. Methods: The ACP intervention was a part of the 4-month cluster randomized controlled COSMOS trial with a 9-month follow-up. Norwegian NH units (n = 72), with 765 patients were invited, and eligible units were cluster randomized to usual care or the intervention group. The ACP intervention consisted of an education program targeting all NH staff (nurses and physicians) and managers. Implementation was supported by a train-the-trainer approach, with regular phone calls from the researchers. The effect of the intervention was assessed by a data collection form and questionnaires. Nursing staff distress was assessed by the Neuropsychiatric Inventory -Nursing Home version. Results: Five hundred and forty five patients from 67 NH units were included and randomized to the intervention (N = 297; 36 units) and control group (N = 248; 31 units). Organized meetings between the family, patient, and nurses were conducted more frequently in the intervention compared to the control group at month 4 (OR = 3.9, 95% CI = 1.6 to 9.4, p = 0.002). Monthly contact between family and nurses was also more frequent in the intervention group (OR = 6.5, 95% CI = 1.6 to 3.5, p = 0.010). Nurses and families were more satisfied with their communication in the intervention compared to the control group. Staff distress was reduced in the intervention group at month 4 (B = -1.8, 95% CI = -3.1 to -0.4, p = 0.012). The intervention effect at month 4 did not persist during follow-up at month 9. Conclusion: Compared to control, the ACP intervention improved the communication, and family and staff satisfaction as well as reduced staff distress. However, during the follow-up period these positive effects were not persistent. Indicating the necessity for ongoing staff support regarding ACP. Trial Registration: www.ClinicalTrials.gov (NCT02238652).

Project description:ImportanceStandardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking.ObjectiveTo test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness.Design, setting, and participantsThe Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle.InterventionsFive 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices.Main outcomes and measuresTwelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video.ResultsThe study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]).Conclusions and relevanceThis study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes.Trial registrationClinicalTrials.gov Identifier: NCT02612688.

Project description:BACKGROUND:Due to the gradual loss of function, it is crucial for persons with dementia to discuss advance care planning in due course. However, nursing home staff, residents and their families feel uncomfortable to start this type of conversation, resulting in unknown (care) preferences. 'We DECide optimized' will provide tools to nursing home staff for discussing advance care planning. The primary objective is to enhance the level of shared decision-making in advance care planning conversations. We hypothesize that the training will enhance the perception of the importance, competence and frequency in which participants engage in advance care planning conversations. The secondary objective is to assess barriers and facilitators in the implementation of advance care planning policies at the ward level. METHODS:'We DECide optimized' will consist of two four-hour workshops and a homework assignment between sessions. Training components will include information on advance care planning and shared decision-making, role-play exercises and group discussions on implementation barriers at the ward level. Participating wards will receive supporting materials to stimulate residents and their families to initiate conversations. The study uses a cluster randomized controlled design, with 65 Flemish nursing home wards taking part (311 staff members). Data will be collected through a pretest-posttest model, with measurements up to 9?months after training. The RE-AIM framework will be used to evaluate the effectiveness of the implementation. Quantitative and qualitative data at the clinical, organizational and resident level will be collected. DISCUSSION:This study describes a hands-on, in-depth and multi-level training approach to improve shared decision-making in advance care planning conversations. By providing tools to ward staff, engaging the management and informing residents and their families, 'We DECide optimized' aims to decrease evidence-based barriers and to provide all stakeholders with incentives to engage in conversations about (care) preferences in an informative and participatory manner.

Project description:Importance:Better advance care planning (ACP) can help promote goal-directed care in patients with advanced dementia. Objectives:To test whether an ACP video (vs usual care) has an effect on documented advance directives, level of care preferences, goals-of-care discussions, and burdensome treatments among nursing home residents with advanced dementia. Design, Setting, and Participants:The Educational Video to Improve Nursing home Care in End-stage dementia (EVINCE) trial was a cluster randomized clinical trial conducted between February 2013 and July 2017, at 64 Boston-area nursing homes (32 facilities per arm). A total of 402 residents with advanced dementia and their proxies (intervention arm, n?=?212; control arm, n?=?190) were assessed quarterly for 12 months. Interventions:A 12-minute ACP video for proxies with written communication of their preferred level of care (comfort, basic, or intensive) to the primary care team. Main Outcomes and Measures:The primary outcome was the proportion of residents with do-not-hospitalize (DNH) directives by 6 months. Secondary outcomes included preference for comfort care, documented directives to withhold tube-feeding and intravenous hydration, documented goals-of-care discussions, and burdensome treatments (hospital transfers, tube-feeding, or parenteral therapy) per 1000 resident-days. Exploratory analyses examined associations between trial arm and documented advance directives when comfort care was preferred. Results:The mean age of the 402 study residents was 86.7 years [range, 67-102 years]; 350 were white (87.1%) and 323 were female (80.3%), with DNH directives that by 6 months did not differ between arms (63% in both arms; adjusted odds ratio [AOR], 1.08; 95% CI, 0.69-1.69). Preferences for comfort care, directives to withhold intravenous hydration, and burdensome treatments did not differ between arms. Residents in intervention vs control facilities were more likely to have directives for no tube-feeding at 6 months (70.10% vs 61.90%; AOR, 1.79; 95% CI, 1.13-2.82) and all other time periods, and documented goals-of-care discussions at 3 months (16.10% vs 7.90%; AOR, 2.58; 95% CI, 1.20-5.54). When comfort care was preferred, residents in the intervention arm were more likely to have both DNH and no tube-feeding directives (72.20% vs 52.80%; AOR, 2.68; 95% CI, 2.68-5.85). Conclusions and Relevance:An ACP video did not have an effect on preferences, DNH status, or burdensome treatments among residents with advanced dementia, but did increase directives to withhold tube-feeding. When proxies preferred comfort care, advance directives of residents in the intervention arm were more likely to align with that preference. Trial Registration:clinicaltrials.gov Identifier: NCT01774799.

Project description:BACKGROUND:The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families. METHODS:In semi-structured telephone interviews at 4 and 15?months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities (N =?119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research's domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P). RESULTS:Implementation facilitators identified by Champions included: the intervention's adaptable mode of presentation and minimal time burden (IC) as well as the program's customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI). CONCLUSIONS:Despite the promise of PROVEN's intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN's implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02612688. Registered 19 November 2015.

Project description:Advance Care Planning (ACP) is the repeated communication and decision-making process between the patient, family, and healthcare professionals. This study describes an ACP intervention in nursing homes and evaluates the outcomes of the implementation process.The ACP intervention was part of a 4-month complex, cluster randomized controlled trial (COSMOS). 37 Norwegian nursing homes with 72 units (1 cluster?=?1 unit) and 765 patients were invited to participate and eligible units were randomised to the intervention group or control. Nursing home staff in the intervention group was offered a standardized education programme to learn early and repeated communication with patients and families and to implement ACP in their units. We used a train-the-trainer approach to educate staff in the units, supported by regular telephone calls and a midway seminar after two months. Individual patient logs consisting of different communication deliverables were used to evaluate the implementation process. Supported by Qualitative Content Analyses, we identified facilitators and barriers of the ACP implementation based on feedback during midway seminars and individual patient logs.The ACP intervention was conducted in 36 NH units (n?=?297); 105 healthcare providers participated at the education seminar prior to the study, and 3-4 employees from each unit participated in the midway seminar. NH staff reported the educational material relevant for the implementation strategy. The patient logs showed that ACP was successfully implemented in 62% (n?=?183) of the patients using our predefined implementation criteria. The staff emphasized the clear communication of the relevance of ACP addressed to leaders and staff as important facilitators, along with the clearly defined routines, roles and responsibilities. Identified barriers included lack of competence, perceived lack of time, and conflicting culture and staff opinions.Monthly communication with the family was the most frequently conducted communication, and the predefined criteria of successfully implemented ACP were largely achieved. Nursing home routines and engagement of leaders and staff were crucial facilitators, whereas lack of time and competence reduced the implementation success.The COSMOS-trial was registered in the ClinicalTrials.gov ( NCT02238652 ) July 7th, 2014.

Project description:BACKGROUND:While various initiatives have been taken to improve advance care planning in nursing homes, it is difficult to find enough details about interventions to allow comparison, replication and translation into practice. OBJECTIVES:We report on the development and description of the ACP+ program, a multi-component theory-based program that aims to implement advance care planning into routine nursing home care. We aimed to 1) specify how intervention components can be delivered; 2) evaluate the feasibility and acceptability of the program; 3) describe the final program in a standardized manner. DESIGN:To develop and model the intervention, we applied multiple study methods including a literature review, expert discussions and individual and group interviews with nursing home staff and management. We recruited participants through convenience sampling. SETTING AND PARTICIPANTS:Management and staff (n = 17) from five nursing homes in Flanders (Belgium), a multidisciplinary expert group and a palliative care nurse-trainer. METHODS:The work was carried out by means of 1) operationalization of key intervention components-identified as part of a previously developed theory on how advance care planning is expected to lead to its desired outcomes in nursing homes-into specific activities and materials, through expert discussions and review of existing advance care planning programs; 2) evaluation of feasibility and acceptability of the program through interviews with nursing home management and staff and expert revisions; and 3) standardized description of the final program according to the TIDieR checklist. During step 2, we used thematic analysis. RESULTS:The original program with nine key components was expanded to include ten intervention components, 22 activities and 17 materials to support delivery into routine nursing home care. The final ACP+ program includes ongoing training and coaching, management engagement, different roles and responsibilities in organizing advance care planning, conversations, documentation and information transfer, integration of advance care planning into multidisciplinary meetings, auditing, and tailoring to the specific setting. These components are to be implemented stepwise throughout an intervention period. The program involves the entire nursing home workforce. The support of an external trainer decreases as nursing home staff become more autonomous in organizing advance care planning. CONCLUSIONS:The multicomponent ACP+ program involves residents, family, and the different groups of people working in the nursing home. It is deemed feasible and acceptable by nursing home staff and management. The findings presented in this paper, alongside results of the subsequent randomized controlled cluster trial, can facilitate comparison, replicability and translation of the intervention into practice.

Project description:BackgroundResidents living in nursing homes usually have complex healthcare needs and require a comprehensive care approach to identifying and meeting their care needs. Suboptimal quality of care is reported in nursing homes and is associated with the poor health and well-being of the residents, the burden on acute care hospitals and the high costs of healthcare for the government. The aim of this study is to test the hypothesis that an Aged Care Clinical Mentoring Model will create and sustain evidence-based quality improvement in priority areas and will be cost-effective in nursing homes in Hunan Province, China.MethodsA cluster randomized controlled trial will be applied to the study. Fourteen nursing homes will be randomly allocated to either the intervention group (n?=?7) or the control group (n?=?7). Forty staff will be recruited from each nursing home and the estimated sample size will be 280 staff in each group. The intervention includes a structured, evidence-based quality improvement education program for staff to facilitate knowledge translation in evidence-based quality improvement targeting urinary incontinence, pressure injury and falls prevention. The primary outcomes are nursing homes' capacity to create and sustain quality improvement, staff perceptions of person-centered care, self-reported quality of care by residents and selected quality indicators at 12 months follow-up adjusted for baseline value. Secondary outcomes are residents' quality of life, residents' unplanned admissions to acute care hospitals, quality of care reported by staff, staff job satisfaction and staff intention to leave adjusted for baseline value. A mixed linear regression model will be adopted to compare the significant differences between groups over a 12-month period.DiscussionAlthough the Aged Care Clinical Mentoring Model has been tested as an effective model to bring positive changes in nursing homes in a high-income country, factors affecting the adaptation of the model in nursing homes in low- and middle-income countries are unknown. The carefully planned intervention protocol enables the project team to consider enablers and barriers when adapting the Model. Therefore, strategies and resources will be in place to manage challenges while demonstrating best practice in this study.Trial registrationProspectively registered via Chinese Clinical Trial Registry (ChiCTR), ChiCTR-IOC-17013109 , Registered on 25 October 2017.

Dataset Information

Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial.

Background

Methods/design

Discussion

Publications

Implementing advance care planning in nursing homes - study protocol of a cluster-randomized clinical trial.

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