Connecting callers with minor illness to a pharmacy telephone helpline after consultation with Swedish Healthcare Direct (SHD)

ISRCTN	ISRCTN93785368
DOI	https://doi.org/10.1186/ISRCTN93785368
Secondary identifying numbers	DNR 1610-10

Submission date: 01/10/2015
Registration date: 05/10/2015
Last edited: 05/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
It has been found that around 13% of GP visits and 5% of emergency department (ED) visits are unnecessary, putting needless strain on the healthcare system. Many minor illnesses, such as coughs and colds, could actually be managed by patients themselves (self-care). In many cases, people can easily obtain medicines from pharmacies without the need for prescriptions from a doctor. The Swedish Health Care Direct organization (SHD) is staffed by registered nurses who complete patient consultations over the telephone. This system could help to reduce the amount of unnecessary GP and ED visits, as the nurse is able to advise the patient whether they could pick up what they need from the pharmacy and take care of themselves. In some cases, being given extra advice or assistance can help to make the process of self-care easier. It has been suggested that patients who are satisfied are more likely to recover and less likely to go to the doctor unnecessarily. The aim of this study is to find out whether providing self-care advice through a pharmacy telephone helpline could help patients to feel more satisfied so that they recover quickly and do not need to go to the GP or ED with minor illnesses.

Who can participate?
Adults who have called the pharmacy within opening hours for advice on a minor illness that has been judged suitable for self-treatment by a nurse.

What does the study involve?
Participants are randomly allocated into two groups. Those in the first group (intervention group) are given the option to be connected to a pharmacy telephone helpline after speaking to an SHD nurse. They are then given advice and information about over-the-counter medicines that could make them feel better. Those in the control group are not connected to the pharmacy telephone helpline after speaking with the SHD nurse. One week after the call to the SHD nurse, participants are asked to complete a questionnaire to measure their satisfaction with the service, whether or not their illness has improved and whether they needed to see a GP or go into hospital.

What are the possible benefits and risks of participating?
A possible benefit is that participants will receive improved information about medicines and how to take them. A risk is that participants may become frustrated if they have to go back and forth between the nurse who initially assessed them and the pharmacy.

Where is the study run from?
Healthcare 1177, Luleå (Sweden)

When is the study starting and how long is it expected to run for?
November 2015 to December 2015

Who is funding the study?
Luleå University of Technology (Sweden)

Who is the main contact?
Mrs Siljie Gustafsson

Contact information

Mrs Silje Gustafsson
Scientific

Odlingsvägen 1
Södra Sunderbyn
95442
Sweden

ORCID ID	0000-0001-8990-752X

Study information

Study design	Single-centre interventional randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title	In careseekers with minor illness, does being connected to a pharmacy telephone helpline after consultation with Swedish Healthcare Direct (SHD) improve patient satisfaction, symtom resolution and/or health care utilization compared to careseekers not being connected?
Study acronym	ESCAP
Study objectives	Complementary self-care advice through a pharmacy telephone helpline will improve patient satisfaction and symptom resolution and reduce health care utilization in patients with minor illness.
Ethics approval(s)	Ethical review board of Umeå University, 07/08/2010, ref: 2010-225-31
Health condition(s) or problem(s) studied	Minor illnesses, e.g. conditions that do not need medical treatment
Intervention	The SHD nurses will have a stack of envelopes on their desk containing 1/2 letters saying ”no intervention” and 1/2 letters saying ”offer intervention”. Letters will be placed in the stack in random order using a randomization list and all envelopes will look the same. 1. When a patient matches the criterias for participation in the study, the nurse takes the envelope at the top of the stack and opens it at the end of the call 2. If the letter says ”no intervention” she will end the call as usual 3. If the letter says ”offer intervention” she will give quick oral information about the study and ask the caller if she may connect him/her to the pharmacist: 3.1. If the caller accepts, the nurse will connect the call to the Pharmacy helpline 3.2. If the caller declines the intervention she will end the call as usual 3.3. The nurse will fill in the letter whether the caller accepted or declined the offer 4. Nurses write down the social security number of the caller on the letter, regardless of intervention/no intervention 5. Letters, all containing social security numbers, are to be put it in another stack and collected by researcher. The duration of the treatment/intervention (e.g. the call lengths with the pharmacy helpline) is estimated to be approximately 5 minutes. The follow up will be by questionnaire 7 days after the call to the SHD.
Intervention type	Other
Primary outcome measure	1. Patient satisfaction is measured using a patient satisfaction scale (10-point Likert scale) 7 days after the intervention 2. Symptom resolution is measured by self-reporting on a 6 step scale (from full resolution to symptoms have worsened) comparing their symptoms to how they were at the day of the call to the SHD 7 days after the intervention 3. Health care utilization will be measured through self-reporting 7 days after the intervention
Secondary outcome measures	Experiences of receiving self-care advice when triaged to self-care for minor illness is measured using a questionnaire 7 days after the intervention.
Overall study start date	02/11/2015
Completion date	01/12/2015

Eligibility

Participant type(s)	Patient
Age group	Mixed
Lower age limit	18 Years
Sex	Both
Target number of participants	1100
Key inclusion criteria	1. Called is above 18 years of age 2. Person assessed by nurse at the SHD as suitable for practicing self-care for minor illness, for him/herself or for a child (No GP referral) 3. Person calling within the opening hours of the pharmacy telephone helpline (weekdays 4pm to 8pm)
Key exclusion criteria	1. Calling for mental illness 2. Calling for suspected or confirmed miscarriage
Date of first enrolment	02/11/2015
Date of final enrolment	27/11/2015

Locations

Countries of recruitment

Sweden

Study participating centre

Healthcare (Sjukvårdsrådgivningen) 1177

Robertsviksgatan 9
Luleå
972 41
Sweden

Sponsor information

Lulea University of Technology
University/education

Universitetsalléen
Luleå
97187
Sweden

Website	www.ltu.se
"ROR"	https://ror.org/016st3p78

Funders

Funder type

Government

Luleå University of Technology
Government organisation / Local government

Alternative name(s): Luleå University of Technology, LTU
Location: Sweden

Results and Publications

Intention to publish date	30/05/2016
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Following data collection and analysis, publication of results in a peer reviewed journal, as well as presentation at national and international conferences are planned. Dissemination of results to interested UK research teams is also planned.
IPD sharing plan