Assessing the impact of a digital job aid on clients' experience of family planning counselling and choice of long acting contraception methods

• Register: ISRCTN
• Last refreshed on: 27 August 2018
• Main ID: ISRCTN11040557
• Date of registration: 02/03/2017
• Prospective Registration: No
• Primary sponsor: Marie Stopes UK
• Public title: Assessing the impact of a digital job aid on clients' experience of family planning counselling and choice of long acting contraception methods
• Scientific title: Evaluating the impact of Marie Stopes International's digital family planning counselling application (DCA) on the uptake of long-acting methods in Vietnam and Ethiopia: a multi-country randomised control trial
• Date of first enrolment: 01/06/2016
• Target sample size: 2475
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11040557
• Study type: Interventional
• Study design: Parallel-group two-arm cluster randomised controlled trial (Other)

Countries of recruitment

Ethiopia, Viet Nam

Contacts

• Name: Emily Robinson

• Name: Laura Bates

Key inclusion & exclusion criteria

Inclusion criteria: Recruiting clients:
1. All female clients recruited must be between 18 and 49, and have received FP counselling
2. They must be adopting an FP method, or switching from one FP method to another
3. In the intervention arm, they must have received counselling using the app
4. Clients who consented to participate in the research

Recruiting providers:
1. Providers who work in clinics assigned to the intervention
Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Long-acting and permanent contraceptive method (LAPM) uptake, and client experience of counselling amongst family planning switchers and adopters
Pregnancy and Childbirth

Intervention(s)

The intervention being tested is the Digital Counselling Application (DCA). It is a job aid for use by the provider during client FP counselling. It is designed as an application on a tablet, to assist providers during counselling sessions to guide their clients through the process of making a decision about which contraceptive method best fits their lifestyle and needs.

Country clinics in Ethiopia (24) and then Vietnam (11) were listed alphabetically and numbered 1-35. Using Excel, a simple numeric randomisation was used to allocate the first 18 clusters (clinics) into the intervention arm (13 Ethiopia and 5 Vietnam). The remaining 17 were allocated to the control arm (11 Ethiopia and 6 Vietnam). The allocations within each country were visually checked that roughly half of clinics were in each arm.

Group 1 (Intervention): All providers within the intervention clinics will be recruited to receive refresher training on client-centred FP counselling approaches and on the use of the Digital Counselling App. It is anticipated that 13 and 5 clinics in Ethiopia and Vietnam will be recruited respectively.
Group 2 (Control): In all control arm clinics providers will receive no intervention, namely no additional refresher training on client-centred FP counselling unless they have received no training within the last 18 months, and no DCA training, and will continue to offer clients their usual family planning counselling; termed here as ‘usual care’.

Clients are followed up at 4 months.

Primary Outcome(s)

1. Uptake of LAPM of contraception, measured via telephone questionnaire with client within 1 day of counselling
2. Client satisfaction (scaled), measured via telephone questionnaire with client within 1 day of counselling

Secondary Outcome(s)

1. Length of and quality of consultation using the DCA based on pre-defined quality checklist, measured via 14 structured observations of provider client counselling with 1 provider over three days, for each of the 8 intervention clinics in Ethiopia and 6 intervention clinics in Vietnam)
2. Association between provider cadre and experience on adherence to DCA, measured via 14 structured observations of provider client counselling for each of the 8 intervention clinics in Ethiopia and 6 intervention clinics in Vietnam
3. Themed responses from the providers on their experience of using the DCA, measured via in-depth interviews with providers in Vietnam and Ethiopia who are observed using the DCA during the 3 days of structured observation
4. Themed responses from clients on their experience of the FP counselling and its influence on method choice and continuation, measured via in-depth interviews with clients who receive DCA counselling, and are observed by a researcher, within 3 days receiving counselling
5. Continuation rates of methods chosen by clients, measured via telephone interviews with clients who received telephone questionnaires and subsequently agreed to a follow up phone questionnaire 4 months after their FP counselling
6. Clients’ post counselling response to their chosen FP method, measured via telephone interviews with clients who received telephone questionnaires and subsequently agreed to a follow up phone questionnaire 4 months after their FP counselling

Secondary ID(s)

MSIApp_V_E_Trial

Source(s) of Monetary Support

Marie Stopes International

Ethics review

Status:
Approval date:
Contact:

1. Marie Stopes International Ethics Review Board, 20/09/2016, ref: 007_16_May 2. Regional Health Bureaus of Ethiopia, 24/10/2016, ref: 30-214/22768; 18/11/2016, ref: 564/1418/8; and 26/12/2016, ref: 1097/227 3. Ministry of Health Hanoi School of Public Health in Vietnam, 26/04/2016, ref: 226/2016/YTCC-HD3

Results

• Results available: Yes
• Date Completed: 31/12/2017