Clinical trial NCT04406103: Protocol - Your Answers When Needing Sleep in New Brunswick
Official title: Your Answers When Needing Sleep in New Brunswick (YAWNS NB): A Randomized Controlled Trial Comparing Sleepwell, EMPOWER, and Treatment as Usual for Benzodiazepine Receptor Agonist Discontinuation in Older Adults (Protocol)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Keywords: insomnia
benzodiazepines
deprescribing
cognitive-behavioural therapy for insomnia (CBTi)
Lead sponsor: Dalhousie University
Sponsor class: OTHER
Collaborators: name: University of New Brunswick
name: Dalhousie University
First posted: 2020-05-28
Enrollment: 594
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian average of 10%. The rate of use is higher in women and increases with age, as do risks for serious harms.

Sleeping pills risks are substantial and costly, especially to seniors. Research does not support their long-term use. Risk for falls causing injuries, including hip fractures, is a leading concern. They impair mental and physical functioning resulting in a loss of independence and cause impaired driving and a higher rate of serious crashes. The rate of near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise. Stopping treatment can be difficult due to physical dependence and withdrawal symptoms.

Cognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these recommendations are not reflected in primary care practice.

Internationally, many educational interventions targeting prescribers have been tried, yet have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly to seniors in a clinical trial was associated with a large reduction in sleeping pill use. Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by providing specific information and recommendations regarding CBTi in addition to guidance on how to stop sleeping pills.

This study will evaluate the effectiveness of direct-to-patient interventions on long-term sleeping pill use.

Detailed description: The investigators are proposing to investigate direct-to-patient health promotion interventions that promote sleeping pill dose reduction and treatment discontinuation by enhancing self-efficacy through various behaviour change techniques embedded in printed information provided to patients. Seniors will be invited to participate via direct telephone contact, information sharing through seniors' organizations, education sessions for seniors, and public notices. Prospective participants will be given the option of which way they would like to participate in the research:

Option 1: full participation including baseline interview, 6-month interview, and access to specific data from the participant's personal health record); Option 2: limited participation to baseline and 6-month interviews only; and Option 3: limited participation to baseline interview and access to specific data from the participant's personal health record.

This will form two sets of participants; those who do and those who do not permit access to outcomes from their personal health record. Participants that select Options 1 or 3 will consent to their medication and health resources use being assessed objectively over a six month period. Participants that choose Options 1 or 2 will directly provide baseline information about their health, medication use, and use of health resources via communications with researchers. Similar information will be collected directly from participants in this group after six months.

Random group allocation:

Options 1 and 2: i) Sleepwell package; ii) Empower package; iii) No package Option 3: i) Sleepwell package; ii) No package

The investigators will compare the rates of reducing and stopping sleeping pill use among the different groups over 6 months. Safety outcomes including falls and hospital visits will be measured. The investigators will also track participant access to online CBTi resources using Google Analytics.

Encouraging results from this study of direct-to-patient health promotion regarding insomnia management and sleeping pill use can be utilized repeatedly over time to reach all individuals who could benefit from the intervention, leading a transformational change in insomnia management.

Eligibility criteria: Inclusion Criteria:

* residents of New Brunswick, Canada
* age 65 or older
* English speaking
* community dwelling with no anticipated change of address for the next 6 months
* current user of BZRAs (3 or more bedtime doses in previous 7 days)
* long-term user of BZRA: use 3 months or longer
* BZRA indication: insomnia.

Exclusion Criteria:

* using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin, diphenhydramine, dimenhyrdinate)
* use of alcohol or cannabis 3 or more nights a week for sleep problems
* diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs syndrome, narcolepsy, sleepwalking
* severe anxiety disorder
* obsessive compulsive disorder
* severe cognitive impairment
* dementia
* seizure disorder
* spinal injury
* chronic psychotic disorder (e.g., schizophrenia)
* bipolar disorder
* cancer
* receiving palliative care
* living in a Long Term Care facility

Primary outcomes:
measure: Number of participants discontinuing BZRA treatment within 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants discontinuing BZRA treatment within 3 months
timeFrame: 3 months
measure: Number of participants with BZRA dose change of 25% or more within 6 months
timeFrame: 6 months
measure: Number of participants starting a new non-BZRA sedative-hypnotic
timeFrame: 6 months
Other outcomes:
measure: Score on the Beliefs about Medicines Questionnaire (BMQ)
timeFrame: baseline, 6 months
measure: Number of visits to mysleepwell.ca website
timeFrame: 6 months
measure: Time to fall asleep (minutes)
timeFrame: baseline, 6 mo.
measure: Time spent asleep (minutes)
timeFrame: baseline, 6 months
measure: Sleep efficiency (%)
timeFrame: baseline, 6 months
measure: Score on the Epworth Sleepiness Scale
timeFrame: baseline, 6 months
measure: Score on the Insomnia Severity Index
timeFrame: baseline, 6 months
measure: Score on the Generalized anxiety disorder - 7
timeFrame: baseline, 6 months
measure: Vulnerable elderly survey, 13-item version
timeFrame: baseline, 6 months
measure: Score on the Quality of life SF-12v2
timeFrame: baseline, 6 mo.
measure: Number of participants reporting having a fall (subjective)
timeFrame: baseline, 6 months
measure: Number of participants reporting having a fall-related health visit
timeFrame: baseline, 6 months
measure: Responses to the prescriber acceptability survey
timeFrame: 6 months
Locations:
city: Fredericton
country: Canada
facility: University of New Brunswick
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: David M Gardner, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murphy AL, Turner JP, Rajda M, Magalhaes S, Allen KG, Gardner DM. A protocol for a randomized controlled trial comparing Sleepwell, EMPOWER, and treatment-as-usual for benzodiazepine receptor agonist discontinuation in older adults: the your answers when needing sleep in New Brunswick (YAWNS NB) study. Explor Res Clin Soc Pharm. 2022 Aug 3;7:100164. doi: 10.1016/j.rcsop.2022.100164. eCollection 2022 Sep.