Pregnancy complications Pregnancy and Childbirth
Conditions
Interventions
Current intervention as of 17/10/2022:
This research project, which will run for 23 months, consists of three Work Packages:
1. Work Package 1: Evaluation of healthcare professionals' and providers'
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 17/10/2022: Work Package 1: Healthcare professionals/providers providing and/or managing maternity care in participating Trusts Work Package 2: Women booking for maternity care at participating Trusts who have: 1. Registered for the Tommy's Clinical Decision Tool 2. Given permission for researchers to contact them 3. Consented to participate in this study. Work Package 3: Aggregate data from women booking for maternity care at participating Trusts who have registered for the Clinical Decision Tool _____ Previous inclusion criteria: Work Package 1: Healthcare professionals/providers providing and/or managing maternity care in participating Trusts Work Package 2: Women booking for maternity care at participating Trusts who have: 1. Registered for the Clinical Decision Tool 2. Given permission for researchers to contact them following the birth of their baby Work Package 3: Aggregate data from women booking for maternity care at participating Trusts who have registered for the Clinical Decision Tool
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 17/10/2022: Work Package 1: unwilling to participate in the study Work Package 2: 1. Women who have not registered to use the tool during this pregnancy 2. Those unwilling to give permission for researchers to contact them. Work Package 3: women who have indicated their NHS data should not be used for research purposes _____ Previous exclusion criteria: Work Package 1: unwilling to participate in the study Work Package 2: unwilling to participate in the study Work Package 3: women who have indicated their NHS data should not be used for research purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 17/10/2022: Acceptability and useability measured using: 1. Qualitative data from focus groups and interviews with women (two focus groups per site; 10 interviews per site) and healthcare professionals/providers (two focus groups per site; five interviews per site) 2. Tommy’s App Healthcare professional, Antenatal and Postnatal Questionnaires, study-specific online questionnaires that includes the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps . Timepoints: HCP focus groups: 3 and 6 months post-Tommy’s App launch HCP questionnaires; from 3 months post-Tommy's App launch HCP interviews: 3-6 months post-Tommy’s App launch Antenatal questionnaire: from 20 weeks of pregnancy Postnatal questionnaire: 3-6 weeks post-birth Women’s interviews: from 20 weeks of pregnancy to 6 weeks post-birth Women's focus groups: from 20 weeks of pregnancy to 6 weeks post-birth _____ Previous primary outcome measures: Acceptability and useability measured using: 1. Qualitative data from focus groups and interviews with women (two focus groups per site; 10 interviews per site) and healthcare professionals/providers (two focus groups per site; five interviews per site) 2. Tommy’s App Postnatal Questionnaire, a study-specific postnatal online questionnaire that includes the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients Timepoints: Focus groups: 3 and 6 months post-Tommy’s App launch HCP interviews: 3-6 months post-Tommy’s App launch Postnatal questionnaire: 3-6 weeks post-birth Women’s interviews: 6-12 weeks post-birth | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/10/2022: 1. Barriers and facilitators measured using: qualitative data from focus groups, interviews and postnatal questionnaires 2. Reach (whether the Tool is used by, and for risk assessment of, a representative sample of the population of maternity service users) measured using: qualitative data from focus groups and interviews; postnatal questionnaires; exploration of demographic characteristics, risk status, interventions and outcomes, and comparison of aggregate data collected through the Tool with Trust maternity data 3. Fidelity (whether implementation proceeds as expected) measured using: qualitative data from focus groups and interviews; postnatal questionnaires; exploration of demographic characteristics, risk status, interventions and outcomes, and comparison of aggregate data collected through the Tool with Trust maternity data 4. Unexpected consequences measured using: qualitative data from focus groups and interviews; questionnaires, as well as data collected through the App and Trust-wide maternity statistics Timepoints: HCP focus groups: 3 and 6 months post-Tommy’s App launch HCP questionnaires; from 3 months post-Tommy's App launch HCP interviews: 3-6 months post-Tommy’s App launch Antenatal questionnaire: from 20 weeks of pregnancy Postnatal questionnaire: 3-6 weeks post-birth Women’s interviews: from 20 weeks of pregnancy to 6 weeks post-birth Women's focus groups: from 20 weeks of pregnancy to 6 weeks post-birth Women's focus groups: from 20 weeks of pregnancy to 6 weeks post-birth _____ Previous secondary outcome measures: 1. Barriers and facilitators measured using: qualitative data from focus groups and interviews; postnatal questionnaires 2. Reach (whether the Tool is used by, and for risk assessment of, a representative sample of the population of maternity service users) measured using: qualitative data from focus groups and interviews; postnatal questionnaires; exploration of demographic ch | — |
Countries
England, United Kingdom
Outcome results
None listed