An RCT of a Patient-initiated Treatment Service for BEB and HFS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-02-28

Brief Summary

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Blepharospasm and hemifacial spasm are debilitating conditions which significantly impact on patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary relief but the duration of treatment efficacy is variable. The standard model of patient care defines routine fixed- time based scheduled treatment cycles which may lead to unnecessarily frequent treatment for some patients and experience of distressing symptoms in others if symptoms return before the scheduled follow up period. The present study aims to compare a patient-initiated model of care, where patients determine treatment timing, with the standard model of care by using a two-arm randomised controlled trial design. It is expected that patients able to initiate their own treatment will experience less variation in disease severity and disability over a treatment cycle as they will be empowered to take the initiative when they feel they need to have treatment. A range of other outcomes will be assessed including: confidence and satisfaction in the service, depression, anxiety, quality of life and, illness and treatment beliefs. If the patient-led care model is shown to be effective in preventing distress and reducing disability in these populations; and is found to be acceptable to service users, this will have significant implications for service organisation across the NHS.

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Detailed Description

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Blepharospasm is a dystonia described by sustained, forced, involuntary closure of both eyelids, caused by muscle contraction. Hemifacial spasm occurs on one side of the face and can result in complete closure of one eye, and spasms across the cheek, face and neck. Hemifacial spasm, as its name implies, is unilateral, whereas blepharospasm always affects both eyes. Blepharospasm and hemifacial spasm are debilitating conditions, which carry the risk of functional blindness and can lead to appearance concerns, social embarrassment and isolation, depression and poor quality of life.\[1-3\]

Botulinum toxin is the treatment used in standard care to stop spasms, but results in a fluctuating pattern of relief and aggravation\[4\] and hence patients return for repeated injections. A recent systematic review indicated that the patient reported benefits of botulinum toxin in blepharospasm ranged from no improvement to 96% of patients reporting a significant relief in symptoms.\[5\] Evidence for the duration of benefit provided by repeated treatment is was also markedly inconsistant.\[5\] Although the definition of benefit did differ between studies in this review, research cannot explain such inconsistencies. Despite this a standardised treatment regimen, of injections on average 3 times a year, is currently used across all patients at Moorfields Eye Hospital and is typical throughout the UK. This may mean that some people are left experiencing debilitating symptoms until their next scheduled appointment and some are being seen too often, hence alternative models of care need to be considered.

Patient-centred care is at the forefront of the NHS,\[6;7\] reflecting the shift away from the paternalistic model of healthcare. Patients are now encouraged to take a more active role in knowing and managing their health, and this is especially important in conditions such as dystonia where the reality of living with the condition is demanding. As a result patient-led healthcare services are becoming increasingly more common and have the potential to address the inconsistencies found in the current botulinum toxin treatment regimen.

Research studies trialling patient-initiated services, where the patient rather than healthcare professional initiates treatment and care, have shown promise. These services provide patients with information on when and how to access services, rather than having regular scheduled appointments. A systematic review conducted by Whear et al\[8\] synthesised the evidence for this model of care across three conditions: irritable bowel disease, breast cancer and rheumatoid arthritis. Overall, there were few differences in psychological or health-related quality of life between those initiating their own outpatient follow-up appointments compared to standard care, despite in many cases patients having less contact with healthcare professionals. Patient and clinician satisfaction were also significantly greater in the patient-initiated services compared to regular appointment scheduling. Since this systematic review members of the research team have led on the development and evaluation of a patient-initiated follow-up service for patients with arthritis. Using a mixed methods study design the service was found to reduce healthcare utilisation in a RCT, without compromising clinical or psychosocial well-being, and was found to be acceptable to patients in the embedded qualitative study.\[9\]

Adopting a patient-led model of care could reduce discomfort and disability in patients with a short-term response to botulinum toxin and reduce unnecessary hospital visits and treatment for patients with a longer-term response. There is currently one patient-initiated, nurse-led botulinum toxin clinic running in the UK for patients with blepharospasm or hemifacial spasm,\[10\] but is yet to be evaluated in comparison to usual care. Due to the variable nature of treatment response blepharospasm and hemifacial spasm are appropriate conditions in which to evaluate a service of this nature. This study therefore, provides a unique opportunity to empower patients with dystonia to take control of their treatment and optimise the effects of botulinum toxin, by allowing them to seek treatment when they feel it is necessary rather than it being dictated by the clinical team, within the context of a methodologically robust evaluative.

Conditions

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Blepharospasm Hemi Facial Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Participants randomized to the intervention group (patient-initiated treatment) will be asked to initiate their own treatment during the nine months they are taking part in the trial. Intervention group participants will receive information about when and how to initiate an appointment. Contact details for the service will be provided along with information on how quickly an appointment will be made, with whom and the procedure in the case of an emergency. All patients requesting an appointment will be booked in to the next available slot within the twice weekly ring-fenced nurse-led clinics. Any subsequent scheduled appointments will be cancelled and all future treatment will be initiated by the patient.

Group Type EXPERIMENTAL

Patient-initiated treatment

Intervention Type OTHER

Please see Intervention Arm

Control

Participants in the control group will receive treatment as usual. This consists of scheduled appointments in the hospital-based nurse-led botulinum toxin clinic. The frequency with which these appointments takes place are based on clinical judgement, but tend to range between every 6 weeks to every 4 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Patient-initiated treatment

Please see Intervention Arm

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of hemifacial spasm or blepharospasm
* Attending a hospital-based botulinum toxin clinic at Moorfields Eye Hospital NHS Foundation Trust.
* Patients stable on botulinum toxin treatment, defined as receiving toxin treatment at stable doses over two previous cycles and free from and side effects.
* Aged 18 years old and over.
* Capacity to give informed consent to participate in the study, judged by the Research Nurse.

Exclusion Criteria

* Participants with significant co-morbidities (i.e. their predominant treatment is for another illness).
* Inability to communicate fluently in written and/or spoken English, to complete study measures.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No