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Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial.

ABSTRACT: BACKGROUND:The use of patient-reported outcome (PRO) could potentially contribute to the reorganization of the health care system. AmbuFlex is a PRO system used in remote patient monitoring, in which questionnaires are sent to patients at fixed intervals. The PRO data are used by clinicians to decide whether patients need clinical attention. Better self-management and cost-saving follow-up activities may be achieved by letting patients initiate need of contact. We evaluated the effects of patient-initiated PRO-based outpatient follow-up on health care resource utilization, quality of care, and the patient perspective. METHODS:We conducted a parallel two-arm pragmatic randomized controlled trial at the Department of Neurology, Aarhus University Hospital, Denmark. Outpatients with epilepsy (? 15?years old), attending fixed-interval PRO-based follow-up with web-based questionnaires, were randomly assigned in a ratio of 0.55:0.45 to either 1) patient-initiated PRO-based follow-up (open access telePRO) or 2) fixed-interval PRO-based follow-up (standard telePRO). The primary outcome was the number of outpatient hospital contacts related to epilepsy retrieved from a regional registry. Hospitals admissions and emergency room visits were also assessed. Secondary self-reported outcomes including general health, well-being, health literacy, self-efficacy, number of seizures, side effects, confidence, safety, and satisfaction were retrieved from questionnaires. Data were analyzed by the intention-to-treat and per-protocol approaches. RESULTS:Between January 2016 and July 2016, 593 patients were randomized to either open access telePRO (n?=?346) or standard telePRO (n?=?247). At 18?months, no statistically significant differences were found between the arms regarding number of telephone consultations or outpatient visits. Patients in the open access arm had a slightly lower, statistically significant number of emergency room visits than patients in the standard arm. Self-reported mental well-being in the open access arm was slightly, statistically significantly lower than in the standard arm. Other secondary outcomes did not differ statistically significantly between arms. CONCLUSION:This study did not find, as hypothesized, less use of health care resources or improved patient self-management or satisfaction in the patient-initiated PRO-based initiative compared to fixed-interval PRO-based follow-up. Patient-initiated PRO-based follow-up may be used as an alternative to fixed-interval PRO-based follow-up in patients who prefer this approach, but there is insufficient evidence for recommending a system-wide shift to patient-initiated PRO-based follow-up. TRIAL REGISTRATION:Registered 4 February 2016 with ClinicalTrials.gov: NCT02673580 .

SUBMITTER: Schougaard LMV

PROVIDER: S-EPMC6744536 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial.

Schougaard Liv Marit Valen LMV Mejdahl Caroline Trillingsgaard CT Christensen Jakob J Lomborg Kirsten K Maindal Helle Terkildsen HT de Thurah Annette A Hjollund Niels Henrik NH

Journal of patient-reported outcomes 20190913 1

<h4>Background</h4>The use of patient-reported outcome (PRO) could potentially contribute to the reorganization of the health care system. AmbuFlex is a PRO system used in remote patient monitoring, in which questionnaires are sent to patients at fixed intervals. The PRO data are used by clinicians to decide whether patients need clinical attention. Better self-management and cost-saving follow-up activities may be achieved by letting patients initiate need of contact. We evaluated the effects o ...[more]

PMID: 31520247

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Project description:BackgroundThe traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective.MethodsThe study is a pragmatic, randomised, controlled trial in outpatients with epilepsy. Participants are randomly assigned to one of two follow-up activities: a) standard telePRO or b) open access telePRO. Inclusion criteria are age ≥ 15 years and previous referral to standard telePRO follow-up at Aarhus University Hospital, Denmark. Furthermore, patients must have answered the last questionnaire via the Internet. The number of contacts will be used as the primary outcome measure. Secondary outcome measures include well-being (WHO-5 Well-Being Index), general health, number of seizures, treatment side effects, mortality, health literacy (Health Literacy Questionnaire), self-efficacy (General Self-Efficacy scale), patient activation, confidence, safety, and satisfaction. In addition, the patient perspective will be explored by qualitative methods. Data will be collected at baseline and 18 month after randomisation. Inclusion of patients in the study started in January 2016. Statistical analysis will be performed on an intention-to-treat and per-protocol basis. For qualitative data, the interpretive description strategy will be used.DiscussionThe benefits and possible drawbacks of the PRO-based open access approach will be evaluated. The present study will provide important knowledge to guide future telePRO interventions in relation to effect on resource utilisation, quality of care, and the patient perspective.Trial registrationClinicalTrials.gov: NCT02673580 (Registration date January 28, 2016).

Project description:ObjectivesTo determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist.DesignTwo year randomised controlled trial extended to six years.SettingRheumatology outpatient department in teaching hospital.Participants209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04).Main outcome measuresClinical outcomepain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis.ResultsParticipants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001).ConclusionsOver six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.

Project description:BackgroundThe traditional cancer follow-up (FU) model for cancer survivors is by scheduled clinic appointments; however, this is not tailored to patient needs and is becoming unsustainable. Patient-initiated follow-up (PIFU) may be a more effective and flexible alternative. This systematic review aims to analyse all existing evidence from randomised controlled trials (RCTs) on the effectiveness of PIFU compared with other FU models that include routinely scheduled appointments in adults who have been treated with curative intent for any type of cancer.MethodsStandard systematic review methodology aimed at limiting bias was used for study identification, selection and data extraction. MEDLINE, Embase, CINAHL, the Cochrane Database of Systematic Reviews and Epistemonikos were searched for systematic reviews to March 2022, and Cochrane CENTRAL was searched for RCTs from 2018 (April 2023). Ongoing trial registers were searched (WHO ICTRP, ClinicalTrials.gov, April 2023). Eligible studies were randomised controlled trials comparing PIFU with an alternative FU model in adult cancer survivors. Risk of bias assessment was via the Cochrane risk of bias tool-2. Meta-analysis was precluded by clinical heterogeneity and results were reported narratively.ResultsTen RCTs were included (six breast, two colorectal, one endometrial cancer and one melanoma, total n = 1754); all studies had risk of bias concerns, particularly relating to how missing data were handled, and populations were unlikely to be representative. Limited findings in breast cancer suggested that type of FU does not affect recurrence detection or patient-related outcomes, while PIFU may reduce the number of clinic visits. Adding patient-led surveillance to routine FU may increase melanoma detection. Evidence for other types of cancer is too limited to draw firm conclusions.ConclusionsPIFU may be a viable FU model in breast cancer, but further research is needed for other types of cancer and on long-term outcomes. A protocol was registered with PROSPERO (CRD42020181424).

Project description:BackgroundInflammatory Arthritis is characterized by lifelong medical treatment and an unpredictable trajectory because of the fluctuating nature of the diseases. Proactive disease management is recommended, which includes close monitoring of disease activity that traditionally has been ensured by outpatient visits to rheumatologists at various fixed intervals. Internationally, there is a growing interest in how healthcare systems can be more flexible, individual-oriented and increasingly involve patients with lifelong diseases in their own treatment and care. We aimed to explore how patients with Inflammatory Arthritis with low disease activity or remission (DAS-CRP < 2.9) experience patient involvement in a reorganized follow-up care based on flexibility and patient-initiated contact.MethodsWe conducted a qualitative study based on four mixed group discussions focused on patients with inflammatory arthritis (rheumatoid arthritis [n = 21], axial spondyloarthritis [n = 3] and psoriatic arthritis [n = 1]) participating in a reorganized follow-up care. Changes in follow-up included access to a nurse and patient-initiated follow-up (PIFU). The analysis was based on content analysis. The reporting adheres to the Consolidated Criteria for Reporting Qualitative Research (COREQ).ResultsIn total, 25 patients (20 females (80%), mean age 61.8 [range 28-79]) participated. We identified three categories. 1) Patient-Initiated Follow-Up do not affect patients' perceived support in disease control; this refers to patients' experience of more time available through better resource utilization, as well as trust that access to professional support would be available whenever needed. The category 2) Information is valued by patients to delineate responsibilities in a new patient role reflects patients' uncertainty in the transition to PIFU, combined with confusion about the distribution of responsibilities. 3) Patients need both extended perspectives of their arthritis and focused dialogue is about expanding patients' understanding of their arthritis by interaction over time with both a rheumatologist and a rheumatology nurse in a focused dialogue to involve the patient.ConclusionsPatients participating in PIFU welcome the flexibility and involvement. However, patients need relevant information to act adequately within a new patient role. Interaction with both rheumatologists and nurses, combined with sufficient time for dialogue, broaden patients' perspective, make opportunities for action visible, and contribute to patients' ability to participate in follow-up care.

Project description:BackgroundOutpatient care is steadily changing from hospital consultations to other platforms, such as phone consultation and online virtual clinics. It is prudent to maintain quality of care with such initiatives. Currently, patients with chronic kidney disease (CKD) have frequent scheduled visits, but it may be possible to optimise the frequency of hospital consultations using information from patient-reported outcome (PRO) questionnaires filled in at home (PRO-based follow-up). This approach may provide a more individually tailored follow-up based on actual needs for clinical attention. We aimed to evaluate the effectiveness of the quality of care, use of resources and patient outcomes associated with PRO-based follow-up in patients with CKD.MethodsThis study is a pragmatic, non-inferiority, randomised controlled trial in outpatients with CKD (Grove BE et al., Qual Life Res 27: S143, 2018). Newly referred patients with an estimated glomerular filtration rate (eGFR) of ≤40 ml/min 1.73m2 will be randomised to either: 1. PRO-based remote follow-up 2. PRO-based telephone consultation 3. Usual outpatient follow-up (control group) In the two intervention groups, a diagnosis-specific PRO questionnaire completed by the patient at home will substitute for usual outpatient follow-up visits. The PRO questionnaire will in part be used as a screening tool to identify patients in need of outpatient contact and to identify focus areas. Responses from the questionnaire will be processed according to a disease-specific algorithm and assigned green, yellow or red status according to patients' needs. The primary outcome will be loss of renal function evaluated by eGFR. Secondary outcomes are 1. Clinical outcomes, including initiation of acute dialyses, hospitalisation and mortality, 2. Utilisation of healthcare resources and 3. PRO measures, primarily quality of life (Euroqol EQ-5D) and illness perception (Brief Illness Perception Questionnaire (BIPQ).DiscussionBenefits and possible drawbacks of the PRO-based follow-up will be evaluated. If PRO-based follow-up proves non-inferior to usual outpatient follow-up, a reorganisation of routine clinical practice in nephrology outpatient clinics may occur. Further, results may impact other patient groups with chronic conditions attending regular follow-up.Trial registrationClinicalTrials.gov identifier NCT03847766 (Retrospectively registered on January 23, 2019).

Dataset Information

Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial.

Publications

Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial.

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