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End-of-life needs can be only partly met by formalized health and palliative care resources. This creates the opportunity for the social support network of family and community to play a crucial role in this stage of life. Compassionate communities can be the missing piece to a complete care model at the end of life.
The main objective of this study is to evaluate the REDCUIDA (
The study is a 2-year nonrandomized controlled trial using 2 parallel groups. For the intervention group, we will combine palliative care treatment with a community promoter intervention, compared with a control group without intervention. Participants will be patients under a community palliative care team’s supervision with and without intervention. The community promotor will deliver the intervention in 7 sessions at 2 levels: the patient and family level will identify unmet needs, and the community level will activate resources to develop social networks to satisfy patient and family needs. A sample size of 320 patients per group per 100,000 inhabitants will offer adequate information and will give the study 80% power to detect a 20% increase in unmet needs, decrease families’ burden, improve families’ satisfaction, and decrease the use of health system resources, the primary end point. Results will be based on patients’ baseline and final analysis (after 7 weeks of the intervention). We will carry out descriptive analyses of variables related to patients’ needs and of people involved in the social network. We will analyze pre- and postintervention data for each group, including measures of central tendency, confidence intervals for the 95% average, contingency tables, and a linear regression. For continuous variables, we will use Student
Ethical approval for this study was given by the Clinical Research Committee of Andalusian Health Service, Spain (CI 1020-N-17), in June 2018. The community promoter has been identified, received an expert community-based palliative care course, and will start making contacts in the community and the palliative care teams involved in the research project.
The results of this study will provide evidence of the benefit of the REDCUIDA protocol on the development and assessment of networks of compassionate communities at the end of life. It will provide information about clinical and emotional improvements, satisfaction, proxy burden, and health care resource consumption regarding patients in palliative care.
RR1-10.2196/10515
Palliative care provides professional, scientific, and human responses to the needs of those living with advanced disease or facing the end of life, while also supporting their families [
The main family caregiver is recognized as the person most involved in the patient’s care. This person, in Latin countries, usually is the contact with health and social care professionals and has to cope with the patient’s daily physical, social, and emotional needs [
Kellehear’s theoretical framework of a compassionate community is gathering momentum internationally [
Health care organizations and policy makers are increasingly involved in the design, development, and evaluation of compassionate community models. It is recognized that they offer an opportunity to support the reconfiguration of health and social services, reduce costs, and facilitate models of integrated care [
One of the largest and most successful models of compassionate communities in the world began in Seville, Spain. All with You [
To our knowledge, no protocol or tool is available to assess systematically these types of intervention, so it remains difficult to compare them and to assess their real effect.
As a part of the All with You program, the REDCUIDA (short for
The primary objective of this study is to evaluate the REDCUIDA intervention protocol for the creation and management of networks of care that cover the unmet needs of a person with advanced diseases or at the end of life.
The secondary objectives are to (1) identify the precise nature of a patient’s unmet needs by palliative care teams that can be addressed through mobilization of the community, (2) detect members of the support networks that can meet the patient’s identified needs and describe their fundamental characteristics (caregiver profiles), (3) analyze the influence of a community promoter’s interventions on the emergence and growth of support networks as the disease progresses, (4) assess whether the REDCUIDA intervention improves the patient’s quality of life and decreases the main caregiver’s burden, (5) establish whether this intervention reduces professionals’ workload and health and social resource consumption during end-of-life care, and (6) analyze the influence of the REDCUIDA intervention on the preference of the place of care and death.
We hypothesize that the use of the REDCUIDA protocol in a community intervention program allows for the expansion of care networks that can meet the needs and improve the quality of life of patients, increase family satisfaction, reduce the burden on main caregivers, improve the possibilities of care and death in the preferred place, and reduce the consumption of health care and social care resources during the end of life.
The study is a 2-year nonrandomized controlled trial using a 2-arm parallel group design conducted in the community. For the intervention group, we will combine the standard palliative care treatment with a community promoter’s intervention; the control group will benefit from standard palliative care.
Intervention and control group participants will be patients under the community palliative care team’s supervision living in 2 areas with and without community promoter intervention.
The study will be developed in the community, in 2 different geographic areas in Seville, Spain. The main difference between them will be the presence of a community promoter as a part of a new city program called All with You [
Inclusion criteria are patients living in Seville, with any advanced or terminal illness and receiving palliative care supervision, and having any of the following conditions: (1) total or serious dependence for basic and instrumental daily activities (Barthel Activities of Daily Living Index score <40; Lawton and Brody Instrumental Activities of Daily Living Scale score <3), (2) more than 40% of their needs not covered by the community, (3) a high score in loneliness on the Scale of Social Loneliness (ESTE) II (score >20 points), (4) having a person (family member, friend, neighbor, social worker, or other person) who acts as a communicator and principal person for support and is prepared and able to participate in the development of the network of care and share information with the community promoter, (5) having a main caregiver with an intense physical or emotional burden (scoring >56 on the Zarit Scale), and (6) accepting of the support and guidance by the community promoter with informed consent.
Exclusion criteria are patients who are in a very advanced terminal stage with life expectancy less than 1 week; those who do not have a high level of dependency and have their needs met by their family and other members of the community; and those who do not wish to participate.
Potential participants will receive information from palliative care team members. Reasons for declining to participate will be recorded as not interested, too busy, don’t believe in it, and other.
Palliative care teams will arrange an appointment with the patient for the baseline assessment. This first appointment will take place in the patient’s home. At this appointment, written informed consent for participation in the study will be obtained from participants.
Patients assigned to the intervention group will be those living in the San Pablo-Santa Justa area, Seville (60,000 inhabitants), who accepted the community promoter intervention. Patients assigned to the control group will be those living in an area with no community promoter available.
We will deliver the REDCUIDA intervention over the course of 7 weeks (
We will conduct an initial (V0) assessment of the sociodemographic data of the beneficiary and his or her needs. This first step aims to detect the degree of care and support networks that could be mobilized during the progression of the disease. At this point, the community promoter will complete the beneficiary’s referral sheet (
Following V0, we will determine the needs of care networks and interventions. Then, we will arrange a meeting among the beneficiary and his or her family, health care professionals, and the community promoter to inform all of them about creating and managing a specific caring network within their community (V1). This first visit will be used to understand the starting point as a baseline analysis for the activities ahead.
During the subsequent interventions, we will conduct several assessments (
Action procedures for the REDCUIDA protocol.
REDCUIDA protocol for applying assessments to the beneficiary and the networks of care.
Assessment | Evaluation step | |||||||
V0 | V1 | V2 | V3 | V4 | V5 | V6 | V7 | |
Inclusion and referral sheet | Yes | — | — | — | — | — | — | — |
Networks of care | Yes | Yes | Yes | Yes | Yes | Yes | Yes | — |
Barthel Index | Yes | Yes | Yes | Yes | Yes | Yes | Yes | — |
Lawton and Brody scale | Yes | Yes | Yes | Yes | Yes | Yes | Yes | — |
Loneliness scale | Yes | — | — | — | — | — | Yes | — |
Zarit Scale | Yes | — | — | — | — | — | Yes | — |
EQ-5D-3La | — | — | — | — | — | — | Yes | — |
Family and network of care satisfaction | — | — | — | — | — | — | — | Yes |
aEQ-5D-3L: 3-level EuroQol 5 dimensions questionnaire.
We have adapted Abel and colleagues’ circles of care (
During the intervention processes and the creation of networks of care, the community promoter will follow a series of activities based on Horsfall and colleagues’ method for the creation of ecosystems of care around people at the end of life [
At the end of the interventions, a final evaluation (V7) will be conducted to reevaluate the needs coverage by the network and to evaluate family and caregivers’ satisfaction. This phone questionnaire will be administered by an independent professional to avoid information bias.
The variables we will use for the descriptive study on the REDCUIDA protocol are the following: for patients’ clinical and sociodemographic data: age, sex, and diagnosis; for families’ sociodemographic data: age, sex, and relationship to the patient; for network of care profiles: relationship to the patient, age, and sex; number of needs according to Barthel Index and the Lawton and Brody scale; number of members of the care network; number of needs covered by the network; quality of life according to the quality of life scale EQ-5D-3L; degree of loneliness according to ESTE II Scale; burden of the principal caregiver according to the Zarit Scale; satisfaction regarding the care network according to the Satisfaction Scale; and place of death.
For community promoter activity data, we will determine the number of interventions performed at home and number of interventions carried out in the community (eg, district, neighborhood, city, community of neighbors).
To assess health care system resources, we will determine the number of hospital admissions in the last month; days of hospital stays in the last month; number of emergency visits in the last month; number of visits of the palliative care team to the home; number of visits of the palliative care team to a hospital; and number of telephone calls made by the palliative care team.
We have calculated a sample size of 320 patients per group for a population of 100,000 inhabitants based on the number of people dying of cancer each year (7000 people per million inhabitants) and the number of people in the final stage of nononcologic illnesses (approximately 4500 cases per million inhabitant). In a population of about 700 people, per year, 65% will require specialized palliative care (455 patients eligible for the study [
We have considered that 30% of patients will not sign the informed consent forms or will not meet all the inclusion and exclusion criteria.
We will collect data from the patient’s own medical history and the information from the REDCUIDA protocol.
Data regarding variables not included in the protocol, such as the use of the health care system, will be collected through a direct interview with the patient or caregiver and the principal health care professionals regarding visits in the last month (
The community promoter and health care professionals will have access to the beneficiary’s clinical information once enrolled in a palliative care program. The permission of the beneficiary and their main caregiver or closest connection shall be required in writing and verbally in order to be able to access the data and use the corresponding data of the interventions for analytical purposes. To ensure confidentiality, the beneficiary’s identification data will be coded so that they can’t be identified by their clinical information.
The deidentified data will be returned to the community promoter and the New Health Foundation for data processing and analysis. The questionnaires will be coded with an alphanumeric identifier in a separate database independent of that containing the participant’s identification data.
We will carry out an initial descriptive analysis of variables related to patients’ needs and the profiles of people involved in the social network by degree of kinship.
We will analyze pre- and postintervention data for each group. These will include measures of central tendency (mean), confidence intervals for the 95% average, contingency tables (frequencies), and a linear regression.
To compare the groups, we will compare means. For continuous variables, we will use Student
Ethical approval for this study was given by the Clinical Research Committee of Andalusian Health Service, Spain (CI 1020-N-17), in June 2018. The study uses informed consent sheets approved by the Clinical Research Committee of Andalusian Health Service, Spain. The right to guarantee data protection will be fulfilled.
This is a 2-year nonrandomized trial. The protocol has been approved by the Clinical Research Committee of Andalusian Health Service. The community promoter has been identified and has received an expert community-based palliative care course (550 hours). The community promoter will start making contacts in the community and the palliative care teams involved in the research project.
Results from this study would be applicable among a vast population, including palliative care patients in developing countries. It is known that 7000 people per million population globally die each year, 2500 per million die of cancer, and approximately 4500 per million die in the final stage of any nononcologic illnesses [
If our results confirm that community social networks improve patients’ and families’ satisfaction at the end of life and correlates with the best use of health system resources, new palliative care systems may be developed.
As it is not a randomized clinical trial, some selection bias could be considered. If the protocol offers positive results, further randomized investigations will be warranted.
It could be difficult to achieve a clear conclusion if the intervention and control group results are very different, although our results from the descriptive analysis of the intervention group will provide relevant information.
We acknowledge that other clinical or psychosocial variables not included in this protocol can influence patients’ needs and satisfaction. We have chosen basic variables that are recorded in the patient’s medical history and are part of the palliative care approach. Depending on the results, we will consider modifying them for future studies in this line of research.
This is, to our knowledge, one of the first trials to measure the effectiveness of a nonprofessional network intervention on patient and family satisfaction, family burden, and use of heath resources.
The results of this study may provide some directions for future palliative care interventions at the community level with frail populations. These interventions may also provide a basis for training health professionals and social resources to improve patient–professional communication about end-of-life care for patients at home and stimulate the development of systematic palliative care community networks for this population.
REDCUIDA protocol: inclusion and referral of the beneficiary.
REDCUIDA protocol: beneficiary's scale of needs (adapted from Mahoney and Barthel [
Circle of the community network.
ESTE II Loneliness Scale.
EQ-5D-3L quality-of-life scale.
Zarit Scale for caregiver burden.
Family and social support network scale of satisfaction.
Questionnaire on use of the health care system.
3-level EuroQol 5 dimensions questionnaire
Scale of Social Loneliness II
None declared.