Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial

Groenen, Carola J.M.; Faber, Marjan J.; Kremer, J.A.M.; Vandenbussche, Frank P.H.A.; Duijnhoven, Noortje T.L. van

doi:10.1186/s13063-016-1326-0

Cited by 9 publications

(5 citation statements)

References 16 publications

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“…Whilst there are many examples of national epidemiological research and audit conducted using EPR data over the past 20 years [ 2 ], clinical trials using data collected from EPR have only become more prevalent in the last 5 years. Examples in maternal and perinatal medicine come from Canada [ 3 ], Sweden [ 4 ], the Netherlands [ 5 ], Scotland [ 6 , 7 ], Wales [ 8 ] and England [ 9 , 10 ].…”

Section: Introductionmentioning

confidence: 99%

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

Relph

Elstad

Coker

et al. 2021

Trials

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Background The use of electronic patient records for assessing outcomes in clinical trials is a methodological strategy intended to drive faster and more cost-efficient acquisition of results. The aim of this manuscript was to outline the data collection and management considerations of a maternity and perinatal clinical trial using data from electronic patient records, exemplifying the DESiGN Trial as a case study. Methods The DESiGN Trial is a cluster randomised control trial assessing the effect of a complex intervention versus standard care for identifying small for gestational age foetuses. Data on maternal/perinatal characteristics and outcomes including infants admitted to neonatal care, parameters from foetal ultrasound and details of hospital activity for health-economic evaluation were collected at two time points from four types of electronic patient records held in 22 different electronic record systems at the 13 research clusters. Data were pseudonymised on site using a bespoke Microsoft Excel macro and securely transferred to the central data store. Data quality checks were undertaken. Rules for data harmonisation of the raw data were developed and a data dictionary produced, along with rules and assumptions for data linkage of the datasets. The dictionary included descriptions of the rationale and assumptions for data harmonisation and quality checks. Results Data were collected on 182,052 babies from 178,350 pregnancies in 165,397 unique women. Data availability and completeness varied across research sites; each of eight variables which were key to calculation of the primary outcome were completely missing in median 3 (range 1–4) clusters at the time of the first data download. This improved by the second data download following clarification of instructions to the research sites (each of the eight key variables were completely missing in median 1 (range 0–1) cluster at the second time point). Common data management challenges were harmonising a single variable from multiple sources and categorising free-text data, solutions were developed for this trial. Conclusions Conduct of clinical trials which use electronic patient records for the assessment of outcomes can be time and cost-effective but still requires appropriate time and resources to maximise data quality. A difficulty for pregnancy and perinatal research in the UK is the wide variety of different systems used to collect patient data across maternity units. In this manuscript, we describe how we managed this and provide a detailed data dictionary covering the harmonisation of variable names and values that will be helpful for other researchers working with these data. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered on 02/11/16.

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Section: Introductionmentioning

confidence: 99%

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

Relph

Elstad

Coker

et al. 2021

Trials

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“…The current process evaluation was carried out alongside the stepped-wedge cluster randomised controlled trial studying the effectiveness of introducing a PHR in maternity care. Details on the study design have been described in the study protocol [18].…”

Section: Methodsmentioning

confidence: 99%

Personal Health Records in Maternity care “a process evaluation”

Groenen¹

2017

JCSAIT

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Background: Personal Health Records [PHR, a private, secure, online environment for patients] have been reported to empower patients, to achieve better collaboration between health care professionals and to improve outcome. This process evaluation study explores the feasibility of the introduction of PHR in Dutch maternity care and possibilities for sustainable implementation. Methods: A process evaluation study was carried out alongside the entire period of the effect study. Quantitative and qualitative methods were used and described reach, dose delivered en dose received of the intervention. Results: 88% of the target population was reached, while 4% started a PHR [dose delivered] and 83% [out of 4%] used the PHR as intended [dose received]. It took more time for the professionals to integrate this new intervention into their care process than expected before. Pregnant women did not start a PHR when they favoured an alternative way to communicate with the health care professional or when they felt the PHR lacked additional value. Active involvement of the professional in the patients PHR is explicitly mentioned as desirable by pregnant women. Conclusions: The introduction of a PHR in maternity care is feasible, requiring the following steps: a dialogue between patients and professionals about expectations and wishes, sufficient time for the implementation, using early adopters as part of the implementation and integration of the PHR in standard care.

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“…This study demonstrated an adoption rate of 4%, which was explained by the low perceived usefulness of the PHR by healthy women with uncomplicated pregnancies. The authors suggested that the PHR might be more useful if it would be embedded in standard care [ 20 , 21 ]. Searching for new ways to facilitate patient involvement and foster patient-centered care, MijnZorgnet has recently been made interoperable with the infrastructure of the Dutch National Connection Point, which is used for the exchange of summary records between GPs and out-of-hour GP services and of medication lists between GPs and pharmacies.…”

Section: Introductionmentioning

confidence: 99%

Use and Effects of Patient Access to Medical Records in General Practice Through a Personal Health Record in the Netherlands: Protocol for a Mixed-Methods Study

Vreugdenhil¹,

Kool²,

Boven³

et al. 2018

JMIR Res Protoc

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BackgroundIn the Dutch health care system, general practitioners hold a central position. They store information from all health care providers who are involved with their patients in their electronic health records. Web-based access to the summary record in general practice through a personal health record (PHR) may increase patients’ insight into their medical conditions and help them to be involved in their care.ObjectiveWe describe the protocol that we will use to investigate the utilization of patients’ digital access to the summary of their medical records in general practice through a PHR and its effects on the involvement of patients in their care.MethodsWe will conduct a multilevel mixed-methods study in which the PHR and Web-based access to the summary record will be offered for 6 months to a random sample of 500 polypharmacy patients, 500 parents of children aged <4 years, and 500 adults who do not belong to the former two groups. At the patient level, a controlled before-after study will be conducted using surveys, and concurrently, qualitative data will be collected from focus group discussions, think-aloud observations, and semistructured interviews. At the general practice staff (GP staff) level, focus group discussions will be conducted at baseline and Q-methodology inquiries at the end of the study period. The primary outcomes at the patient level are barriers and facilitators for using the PHR and summary records and changes in taking an active role in decision making and care management and medication adherence. Outcomes at the GP staff level are attitudes before and opinions after the implementation of the intervention. Patient characteristics and changes in outcomes related to patient involvement during the study period will be compared between the users and nonusers of the intervention using chi-square tests and t tests. A thematic content analysis of the qualitative data will be performed, and the results will be used to interpret quantitative findings.ResultsEnrollment was completed in May 2017 and the possibility to view GP records through the PHR was implemented in December 2017. Data analysis is currently underway and the first results are expected to be submitted for publication in autumn 2019.ConclusionsWe expect that the findings of this study will be useful to health care providers and health care organizations that consider introducing the use of PHR and Web-based access to records and to those who have recently started using these.Trial RegistrationNetherlands Trial Registry NTR6395; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6395 (Archived by WebCite at http://www.webcitation.org/71nc8jzwM)Registered Report IdentifierRR1-10.2196/10193

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Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial

Cited by 9 publications

References 16 publications

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

Personal Health Records in Maternity care “a process evaluation”

Use and Effects of Patient Access to Medical Records in General Practice Through a Personal Health Record in the Netherlands: Protocol for a Mixed-Methods Study

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