Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05958108 |
| Other study ID # |
G57326324 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
September 2023 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Fundació d'investigació Sanitària de les Illes Balears |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aims: To evaluate the effectiveness of SinergiAPS (a patient-centered audit and feedback
intervention) in reducing avoidable hospital admission, and; to explore the factors that may
affect its implementation.
Design: 24-month, parallel, open-label, multicentre, pragmatic, hybrid type 1 randomized
clinical trial.
Setting, sample, and randomization: 118 primary healthcare centers from multiple regions in
Spain will be randomly assigned (ratio 1:1) to two groups (control and intervention). The
intervention group will receive two audits (baseline and intermediate at 12 months). The
audits will consist of the administration of the PREOS-PC questionnaire (a measure of
patient-reported patient safety) to a sample of around 100 patients per center. The
intervention group will receive reports on the results of both audits, along with resources
aimed at facilitating the design and implementation of safety improvement plans. The
intervention will be deployed through the SinergiAPS web tool, developed and validated in
previous projects. The control group will have access to the intervention after the end of
the clinical trial (waitlist).
Outcomes: Primary outcome: rate of avoidable hospitalizations (electronic health records).
Secondary outcomes: patient-reported patient safety (PREOS-PC questionnaire); patient safety
culture perceived by professionals (MOSPC questionnaire); adverse events experienced by
healthcare professionals (ad hoc questionnaire); the number of safety improvement actions (ad
hoc questionnaire). Outcome data will be collected at baseline and at 24 months follow-up.
Implementation evaluation: Drawing on the CFIR model, we will collect and analyze qualitative
(30 individual interviews, implementation logbooks) and quantitative (questionnaires for
professionals from intervention centers, level of use of the SinergiAPS web tool) data to
examine the implementation of the intervention in the Spanish primary healthcare centers.
Description:
GENERAL OBJECTIVE To evaluate the effectiveness and implementation of SinergiAPS, an
intervention based on patient perceptions and experiences, aimed at improving patient safety
in primary healthcare centers.
SPECIFIC OBJECTIVES
- To evaluate, through a hybrid type I randomized clinical trial with a 24-month
follow-up, the effectiveness of the SinergiAPS intervention in improving patient safety
in primary healthcare centers by reducing avoidable hospitalizations (primary outcome
variable), as well as increasing the safety culture, increasing the number of patient
safety improvement actions in the centers, and increasing patient-perceived safety
(secondary outcome variables).
- To study the degree of usage of the SinergiAPS intervention in the primary healthcare
centers allocated to the intervention group; as well as the contextual factors
associated with its successful implementation.
METHODS Study design: Hybrid type 1 clinical trial, pragmatic, multicenter, open-label, with
a 24-month follow-up. The primary healthcare centers will be randomly assigned to the
intervention group (which will receive the SinergiAPS intervention - described below) and the
control group (waitlist design: usual clinical practice during the 24-month follow-up, after
which they will have access to the SinergiAPS intervention).
Description of SinergiAPS
SinergiAPS is an assessment and monitoring tool designed to support primary healthcare
centers to identify potential problems and areas for improvement related to patient safety
based on information provided by their own patients. This intervention consists of three main
elements:
1. Patient safety audit of healthcare centers: Patient safety is evaluated from the
perspective of patients using the validated Patient Reported Experiences and Outcomes of
Safety in Primary Care (PREOS-PC) questionnaire. A baseline audit will be conducted at
the beginning of the intervention, followed by an intermediate audit at 12 months.
2. Feedback of results to healthcare centers: Once the questionnaires are completed,
SinergiAPS automatically generates a report with the audit results. This report is
specific to each healthcare center and includes a comparison with other participating
centers to facilitate benchmarking. Healthcare centers are encouraged to form a working
group, consisting of approximately 3-6 professionals with a designated leader. This team
is granted access to the result reports and other functionalities of the SinergiAPS web
tool.
3. Design of action plans: The working group of each center meets to design patient safety
improvement plans based on the problems identified in their center's result report. For
this purpose, the SinergiAPS web tool provides resources, training materials, and
recommendations on how to improve patient safety in primary healthcare. It also offers a
tracking template to collect and evaluate the measures proposed by the centers to
address the identified safety issues.
Eligibility criteria for healthcare centers: We will include public primary healthcare
centers from any autonomous community in Spain that willingly agree to participate through
informed consent. Centers that exclusively provide specific services (such as pediatrics or
women's health centers), and centers that have been established for less than 12 months at
the time of recruitment will be excluded.
Recruiting healthcare centers: We will recruit primary healthcare centers from various
regions in Spain. Each participating node will recruit centers from their own community and,
if possible, from neighboring regions. Researchers from eight autonomous communities
(Balearic Islands, Catalonia, Andalusia, Madrid, Castilla y León, Aragon, Galicia, and the
Canary Islands) are involved in this multicenter study. In autonomous communities where we do
not have a node or researcher, we will utilize our network of key informants, including
researchers from the Patient Safety group of semFYC, the research boards of semFYC, and the
national network of the European General Practice Research Network. This network will
facilitate the recruitment of healthcare centers for this study. The study will be presented
to the relevant territorial management authorities and healthcare centers. A healthcare
center will be considered recruited once informed consent is obtained from the center
coordinator.
Sampling of healthcare centers: For each region, an intentional sample of healthcare centers
will be selected, aiming for heterogeneity in terms of size, rurality, and inclusion of both
teaching and non-teaching centers.
Collection of healthcare center characteristics: We will collect the following information:
the number of visits to the center in the last 12 months, the number of registered patients
at the center, the number of patients per physician, the percentage of patients over 65 years
old, the percentage of female patients, whether the center is a teaching center or not, the
rurality index, and the adjusted morbidity group (GMAs - percentage of patients in each of
the five complexity groups). This data will be obtained from territorial management
authorities or our information systems platforms.
Randomization of healthcare centers: After recruiting the centers and collecting baseline
data, the centres will be randomly assigned in a 1:1 ratio to either the control group or the
intervention group. This randomization process will be conducted using specialized software
to generate a list of random numbers. Stratification for randomization will be based on the
autonomous community (CCAA) and whether the center is a teaching center or not.
Selection of primary healthcare professionals: All professionals, including healthcare and
non-healthcare professionals, who have been working at the center for at least 3 months will
be invited to participate in the study. Invitations and questionnaire links (detailed in the
"outcome variables") will be sent to professionals via email. The questionnaires will be
self-administered electronically.
Selection of patients: Using our information systems, we will randomly select adult patients
(18 years or older) who are registered at each participating healthcare center and have had
at least one recent consultation (either in-person or remote) for a health-related issue
within the last three months. These patients will be invited to self-complete the validated
PREOS-PC Compact questionnaire over the phone or via email. In addition, patients may also be
invited to complete the questionnaire face to face in the centre waiting room - in which case
they will be consecutively approached by a research assistant and invited to self-complete
the questionnaire using tablet computers. To collect post-intervention data, we will follow
the same procedure to obtain another separate sample of patients. The following patient
characteristics will be also collected: age, gender, educational level, nationality,
employment status, number of visits to the healthcare center in the last 12 months, duration
of registration at the healthcare center, self-perceived health status, number of
medications, and presence of chronic diseases.
Primary outcome variable: The rate of avoidable hospitalizations will be assessed based on
the definition provided by the Agency for Health Research and Quality. Data for this
assessment will be extracted from the Minimum Basic Data Set (CMBD) using predefined CIE-9
codes. The rate of avoidable hospitalizations will be calculated specifically for conditions
such as asthma, chronic obstructive pulmonary disease, congestive heart failure, angina, and
chronic kidney disease. For each participating healthcare center, we will obtain the total
number of registered patients and the total number of avoidable hospitalizations recorded
during the previous twelve months.
Secondary outcome measures:
1. Perceptions and experiences of patients (scores from the scales of the PREOS-PC Compact
questionnaire): This questionnaire will be administered to a sample of around 100
patients per healthcare center. This sample size is estimated to achieve a reliability
of at least 0.7 in the mean scores of the healthcare centers for the questionnaire's
scales. The following scales will be utilized
- "Activation of healthcare centers": 4 items (Cronbach's α = 0.70) that measure the
proactivity of healthcare centers towards patient safety.
- "Experiences of safety incidents (errors)": 12 items (Cronbach's α = 0.67) that
capture whether patients have experienced specific safety problems such as
diagnostic errors, medication issues, etc.
- "Experience of harm (severity)": 3 items (Cronbach's α = 0.85) that assess the
level of harm suffered by patients as a result of the healthcare they received.
- "Burden of harm": 3 items (Cronbach's α = 0.73) that evaluate the impact and
consequences of the harm experienced by patients.
- "Overall assessment of the center's safety level" (1 item). Visual analog scale.
2. Patient safety culture of healthcare professionals: We will calculate the average
center-level score of the Patient Safety Culture Composite Score (ranging from 1-5
points), based on the responses of professionals to the Spanish version of the MOSPC
questionnaire.
3. Adverse events experienced by healthcare professionals in the last 12 months: An ad hoc
questionnaire will be adapted from a previous study to assess the adverse events
experienced by professionals.
4. Number of actions aimed at improving patient safety in the center in the last 12 months:
An ad hoc questionnaire will be administered to the safety representative of each
center, including both intervention and control centers, to determine the number of
actions taken to enhance patient safety.
Sample size calculation: The sample size calculation was performed based on the primary
outcome variable of this trial, the rate of avoidable hospitalizations. Assuming an alpha
risk of 0.05 and a beta risk of 0.2 in a one-sided test, a total of 118 healthcare centers
(59 in the intervention group and 59 in the control group) are required to detect a
difference equal to or greater than 1.5 units in the rate of avoidable hospitalizations per
1000 patients. This corresponds to a 15% reduction in the rate of avoidable hospitalizations
(Cohen's d = 0.49). Based on the results of our previous study, we assume a mean rate of 11.2
and a standard deviation of 3.3. A follow-up loss rate of 0.5% has been estimated.
Statistical analysis First, we will conduct descriptive statistical analysis to characterize
the participating healthcare centers. For each of the two groups (control and intervention),
we will calculate frequencies (percentages) for binary or categorical variables, and medians
(along with interquartile range) or mean (standard deviation) for continuous variables. The
effectiveness of the intervention will be analyzed by comparing the mean score of the primary
outcome variable (rate of avoidable hospitalizations) between the control and intervention
groups after 24 months of follow-up. A linear regression model will be used, including the
baseline rate as an adjusting variable. Stratified effectiveness analyses will be performed
based on baseline audit scores (which will allow us to measure the independent effect of the
intervention in centers with different levels of potential improvement according to the audit
results). All analyses will be conducted on an intention-to-treat basis. An equivalent
methodology will be applied for the secondary outcome variables. All outcome variables
(including scores from patient and healthcare professional questionnaires) will be analyzed
at the level of healthcare centers (mean score per center).
Study of the implementation of SinergiAPS The second objective of this project is to assess
the degree of success in the implementation of the SinergiAPS intervention and identify
contextual factors associated with greater implementation success. This will provide the
necessary evidence to design a future large-scale implementation strategy for this
intervention. To achieve this, we will evaluate each of the five constructs of the
Consolidated Framework For Implementation Research (CFIR) model: the intervention itself, the
inner setting, the outer setting, the individuals involved, and the processes by which the
intervention implementation is achieved.
The data collection will be carried out through:
- In-depth qualitative interviews with professionals from the intervention group
(approximately 30 qualitative interviews, until reaching saturation of discourse). These
interviews aim to: examine the overall assessment of the SinergiAPS intervention,
identify aspects for improvement, and gather suggestions to facilitate the large-scale
implementation of the intervention. Sampling will be intentional, including informants
of both genders, different age groups, professional categories, and territorial areas.
- Quantitative interviews: Through an online questionnaire administered quarterly to the
project referent in each center, we will measure the usability of the intervention, as
well as the degree of use, acceptability, and perceived usefulness.
- Analysis of the degree of usage of the web tool: We will examine the degree of usage of
the tool by monitoring the number of accesses to it by healthcare centers. We will
determine whether the healthcare centers have accessed the feedback report or not. We
will also determine the number of accesses and usage time of the module of the tool that
contains the training and support materials for the design and implementation of action
plans.
- Each of the three main modules of the web tool (results report, training materials, and
action plan record) will include a space (free-text box) for healthcare centers to
provide their comments and suggestions for improvement.
- Analysis of the action plans proposed by the healthcare centers: The web tool includes a
module aimed at systematically recording the action plans that healthcare centers decide
to carry out. This information remains registered in the tool and provides valuable
insights for examining the implementation of the intervention.
- Implementation diary: In each node, the researchers will maintain an active record of
the barriers encountered during the implementation process of the intervention in the
healthcare centers.
