SHARECONTRACEPT, a shared decision-making tool for hormonal contraception
| ISRCTN | ISRCTN58279944 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58279944 |
| Secondary identifying numbers | PI18/00915 |
- Submission date
- 07/03/2019
- Registration date
- 15/04/2019
- Last edited
- 09/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Decision-making tools represent a paradigm shift in the relationship between the clinician and the user/patient. They offer the advantage of compromising the patient, especially in those decisions that are sensitive to their preferences and values when there is more than one reasonable health option, they reduce the stressful burden that uncertainty can cause due to lack of information, and increase the proportion of people active in the management and management of their health. Allowing the user to freely access them from any digital device, not necessarily located in a clinic, at any time, facilitates personal reflection in making the decision that best suits their preferences, needs and state of health. However, there is a lack of research studies that demonstrate that online digital decision making tools in contraception provide advantages in relation to pre-technological care/attention. The aim of this study is to assess the effectiveness of a decision-making tool in contraception (SHARECONTRACEPT: http://decisionscompartides.gencat.cat/ca/decidir-sobre/anticoncepcio_hormonal/).
Who can participate?
Women aged 16 (updated 06/06/2019, previously: 18) to 49 who attend consultations at the clinical contraceptive counseling units participating in the study
What does the study involve?
The health professionals participating in each unit are randomly allocated to one of two groups. Clinicians allocated to the experimental group perform contraceptive counseling assisted by SHARECONTRACEPT, and those of the control group follow the usual procedure of their clinical unit. The selected users are followed up for one year. Data is collected through questionnaires, a logbook of incidents and validated instruments for measuring decisional conflict and adherence to treatment.
What are the possible benefits and risks of participating?
The results obtained from this study will help us to establish a Decision Support Tool in hormonal contraception, if it is shown that it has clear benefits, in giving better care to women who come for contraception counseling. Participation in this study does not pose any risk, but there may not be any health benefits from participating in this study.
Where is the study run from?
Clinical contraceptive counseling units of six autonomous regions in Spain
When is the study starting and how long is it expected to run for?
January 2019 to June 2023
Who is funding the study?
Instituto de Salud Carlos III (Ministry of Science, Innovation and Universities co-funded by the European Fund for International Development of the European Union)
Who is the main contact?
Dr Maria Inmaculada de Molina Fernandez
inmaculada.demolina@urv.cat
Contact information
Principal Investigator
Avenida Catalunya No. 35
Nursing Department
Tarragona
43002
Spain
 ORCID ID |
0000-0002-1429-4455 |
|---|---|
| Phone | +34 (0)625454741 |
| inmaculada.demolina@urv.cat |
Scientific
Institut Català de la Salut.
Gran Via de les Corts Catalanes, 587, 589
Barcelona
08004
Spain
| Phone | (+34) 627480724 |
|---|---|
| dcreus.lleida.ics@gencat.cat |
Scientific
Hospital Universitari de Tarragona Joan XXIII
Tarragona
43005
Spain
| ORCID ID |
0000-0002-6232-7266 |
|---|---|
| Phone | (+34) 977295800 |
| mdelaflor.hj23.ics@gencat.cat |
Scientific
Catalan Health Service
Government of Catalonia
Faculty of Health Sciences Blanquerna-URLL
Barcelona
-
Spain
| ORCID ID |
0000-0002-7277-3331 |
|---|---|
| Phone | (+34) 933156966 |
| rescuriet@gencat.cat |
Scientific
Universitat Rovira i Virgili
Tarragona
-
Spain
| Phone | (+34) 977299414 |
|---|---|
| isabel.font@urv.cat |
Scientific
Institut Català de la Salut.
Gran Via de les Corts Catalanes, 587, 589
Barcelona
08004
Spain
| Phone | (+34) 977920400 |
|---|---|
| gmarch.tgn.ics@gencat.cat |
Scientific
Institut Català de la Salut
Barcelona
-
Spain
| ORCID ID |
0000-0001-5437-812X |
|---|---|
| Phone | (+34) 934824391 |
| cmartinezbu@gencat.cat |
Scientific
Dirección general de asistencia sanitaria del SERGAS
Santiago de Compostela
-
Spain
| ORCID ID |
0000-0003-2797-4166 |
|---|---|
| Phone | (+34) 881548640 |
| maria.dolores.martinez.romero@sergas.es |
Scientific
Midwifery training unit
Madrid
-
Spain
| Phone | (+34) 917277470 |
|---|---|
| luciamartinezvillarejo@gmail.com |
Scientific
Agència de Qualitat i Avaluació Sanitaries
Generalitat de Catalunya
Barcelona
08005
Spain
| Phone | (+34) 935513905 |
|---|---|
| mmoharra@gencat.cat |
Scientific
Hospital Universitario de Basurto
Bilbao
-
Spain
| Phone | (+34) 944006000 |
|---|---|
| josecruz.quilezconde@osakidetza.eus |
Scientific
Universitat Rovira i Virgili
Tarragona
-
Spain
| Phone | (+34) 977299416 |
|---|---|
| lourdes.rubio@urv.cat |
Scientific
Institut Català de la Salut
Barcelona
-
Spain
| Phone | (+34) 675782222 |
|---|---|
| dpatricio.tgn.ics@gencat.cat |
Scientific
Universitat Rovira i Virgili
Tarragona
-
Spain
| Phone | (+34) 977558350 |
|---|---|
| francesc.valls@urv.cat |
Scientific
Centro de Salud Sexual y Reproductiva
Departamento de Alcoi. Conselleria de Sanitat.
Generalitat Valenciana
Valencia
-
Spain
| Phone | (+34) 966527766 |
|---|---|
| villagrasa_fed@gva.es |
Study information
| Study design | Longitudinal and prospective community clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | SHARECONTRACEPT, a digital decision-making-tool. Does it improve adherence to the chosen contraceptive method? |
| Study acronym | SHARECONTRACEPT |
| Study hypothesis | This study will find out the effectiveness of a shared decision-making tool in contraception in health settings in Spain. The study aims are to evaluate the effectiveness of shared decision-making tool on hormonal contraception (SHARECONTRACEPT) measured by: 1. The improvement of counseling on hormonal contraception at the clinic consultation 2. The increase of clinical healthcare professionals knowledge on contraception 3. The improvement of adherence to contraception treatment selected 4. The decreasing unwanted pregnancies and voluntary interruption of pregnancy |
| Ethics approval(s) | Ethics Committees of Clinical Research: 1. Comité Ético de investigación del Instituto Pere Virgili, Institut d’Investigació Danitària Pere Virgili (IISPV), Centre d'R+D+I en Nutrició i Salut, Avda. de la Universitat, 1 - 2a planta, 43204 Reus (Tarragona), Spain, Tel: +34 (0)977 75 93 94, ref: 186/2018 2. Comité Ético Investigación Clínica del IDIAP Jordi Gol, Fundació Institut Universitari per a la recerca d’Atenció Primària de Salut Jordi Gol i Guirina (IDAPJGol), Gran Via Corts Catalanes, 587, 08007 (Barcelona), Spain, Tel: +34 (0)93 482 41 24, Email: idap@idiapjgol.org, 28/11/2018, ref: PI18/208 |
| Condition | Contraception |
| Intervention | This study will include an intervention group and a control group and data will be collected during a year in 6 autonomous regions in Spain. The health professionals participating in each unit will be randomly assigned by simple randomization to one of two groups. Clinicians assigned to the experimental group will perform contraceptive counseling assisted by SHARECONTRACEPT, and those of the control group will follow the usual protocol of their clinical unit. It is planned to study 1,708 health users, recruited from women who attend the consultations of the units participating in the study. The selected users will be followed for one year. The data will be collected through ad-hoc questionnaires and validated instruments for measuring decisional conflict and adherence to treatment. A set of bivariate and multivariable descriptive analyses, besides a regression study analysis, will be carried out. |
| Intervention type | Other |
| Primary outcome measure | Adherence to treatment: compliance with dosage and method of administration and persistence in the duration of prescribed treatment, evaluated through a structured interview ad-hoc including questions about a) the compliance with the contraceptive method chosen in the clinical consultation, b) information about the usage of this method and c) unwanted pregnancy incidences. Assessed by a phone call at 1 month, 6 months and 1 year. |
| Secondary outcome measures | 1. Sociodemographic characteristics of the patient: age, educational level, occupation, marital status/couple, assessed at a structured interview ad-hoc at the first contact in the clinical consultation 2. Medical history: smoking habits, HBP, uterine malformations, diabetes, assessed at a structured interview ad-hoc at the first contact in the clinical consultation 3. Obstetric and gynecological antecedents: menstrual formula, menarche, term or premature pregnancies, ectopic pregnancies, spontaneous abortions, IVE, gynecological reviews according to the guidelines of each community, active sexually transmitted diseases, living children, desire to have children, assessed at a structured interview ad-hoc at the first contact in the clinical consultation 4. Contraceptive method: contraceptive method contemplated by the patient before counseling, prejudices against other contraceptives, experiences with other methods, possible beneficial non-contraceptive effects, importance of the cost in her choice, women's behavior with respect to compliance (Morisky-Green's adherence to treatment), finally chosen contraceptive, incidents with the chosen method, management of the incidences, decisional conflict of the woman before the choice of the contraceptive method (O'Connor Scale), assessed at a structured interview ad-hoc at the first contact in the clinical consultation 5. Professional: satisfaction of the advisor or clinician with the use of the Digital HATD (Likert scale), acquired knowledge (ad-hoc knowledge test) assessed after the first year recruiting women for the study |
| Overall study start date | 01/01/2019 |
| Overall study end date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 1708 |
| Total final enrolment | 895 |
| Participant inclusion criteria | Current participant inclusion criteria as of 28/05/2019: 1. Women aged 16 or older 2. Women aged 49 years or younger 3. Have primary studies and are proficient in Spanish and/or Catalan 4. Have access to the internet 5. Agree to voluntarily participate in the study Previous participant inclusion criteria: 1. Women aged 18 or older 2. Women aged 49 years or younger 3. Have primary studies and are proficient in Spanish and/or Catalan 4. Have access to the internet 5. Agree to voluntarily participate in the study |
| Participant exclusion criteria | 1. Women aged 17 years or younger 2. Women aged 50 or older 3. Women who wish to have children before one year from the date of the consultation 4. Don't have access to internet 5. Don't understand Catalan and/or Spanish |
| Recruitment start date | 01/07/2019 |
| Recruitment end date | 30/06/2020 |
Locations
Countries of recruitment
- Spain
Study participating centres
50009
Spain
Spain
50740
Spain
50015
Spain
50007
Spain
50003
Spain
50610
Spain
50800
Spain
08015
Spain
08015
Spain
08013
Spain
08037
Spain
08027
Spain
08033
Spain
08033
Spain
08016
Spain
08042
Spain
08042
Spain
08032
Spain
08204
Spain
08280
Spain
08201
Spain
08192
Spain
08207
Spain
08211
Spain
08302
Spain
08291
Spain
08922
Spain
08206
Spain
25230
Spain
25100
Spain
25126
Spain
25001
Spain
25300
Spain
25180
Spain
25001
Spain
25006
Spain
25005
Spain
25310
Spain
25730
Spain
25740
Spain
25110
Spain
25123
Spain
25003
Spain
25200
Spain
25005
Spain
25400
Spain
25005
Spain
43005
Spain
43007
Spain
43006
Spain
43100
Spain
43840
Spain
43202
Spain
43005
Spain
43800
Spain
203801
Spain
15701
Spain
15970
Spain
15821
Spain
15680
Spain
15800
Spain
15174
Spain
15570
Spain
15510
Spain
27002
Spain
32400
Spain
32003
Spain
36162
Spain
36860
Spain
28045
Spain
28047
Spain
28044
Spain
28012
Spain
28901
Spain
26004
Spain
20014
Spain
20500
Spain
20850
Spain
48008
Spain
48006
Spain
48013
Spain
01006
Spain
48903
Spain
48903
Spain
48903
Spain
Sponsor information
University/education
Department and Faculty of Nursing
Av/Catalunya, 35
Tarragona
43002
Spain
| Phone | +34 (0)977299402 - 625454741 |
|---|---|
| inmaculada.demolina@urv.cat | |
| Website | http://www.fi.urv.cat |
"ROR" |
https://ror.org/00g5sqv46 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- SaludISCIII, InstitutodeSaludCarlosIII, Instituto de Salud Carlos III | Madrid, Spain, Carlos III Institute of Health, Institute of Health Carlos III, Carlos III Health Institute, ISCIII
- Location
- Spain
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository, Available on request |
| Publication and dissemination plan | 1. A general report of all results will be made (end of 2021) 2. Congress contributions (poster and communications) 3. At least one or two paper will be submitted to an international journal during 2021 (preferably Q1 Journal) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Maria Inmaculada de Molina (inmaculada.demolina@urv.cat). Data will be available at the end of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 27/11/2021 | 11/01/2022 | Yes | No | |
| Protocol article | 04/09/2019 | 11/01/2022 | Yes | No |
Editorial Notes
09/06/2023: The participant level data sharing summary was updated.
06/12/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2022 to 30/06/2023.
2. The intention to publish date was changed from 31/12/2021 to 30/06/2023.
3. The plain English summary was updated to reflect these changes.
06/07/2022: A study contact has been updated and the plain English summary has been updated accordingly.
11/01/2022: The following changes were made to the trial record:
1. The total final enrolment was added.
2. The overall trial end date was changed from 31/12/2021 to 31/12/2022.
3. Publication references added.
4. Contact details updated.
20/06/2019: The scientific contact Dr Sira Repolles-Lasheras was removed.
19/06/2019: The address of the scientific contact Dr Cristina Martinez-Bueno was corrected and ORCID ID was added.
12/06/2019: The ORCID ID was added for the scientific contact Maria-Dolores Martínez Romero
11/06/2019: The ORCID ID was added for the scientific contact Dr José Ramón Escuriet-Peiro.
06/06/2019: The following changes were made to the trial record:
1. The plain English summary was up[dated to reflect the change in the inclusion criteria made on 28/05/2019.
2. 16 scientific contacts were added.
28/05/2019: The inclusion criteria have been changed.
12/03/2019: Trial's existence confirmed by the Ministerio de Ciencia, Innovación y Universidades - Institute of Health Carlos III.
